Cold Chain Compliance

The regulatory and operational requirements - primarily under FSMA - that govern how temperature-sensitive products must be handled, monitored, documented, and transported.
Glossary
Industry Specific
Cold Chain Compliance

Cold chain compliance encompasses the rules, documentation, and operational controls that ensure temperature-sensitive goods are transported safely and in accordance with food safety regulations. In the United States, the primary regulatory framework is the FDA's Food Safety Modernization Act (FSMA), specifically the Sanitary Transportation of Human and Animal Food rule, which places responsibility on shippers – not just carriers – to ensure proper temperature conditions during transit.

Compliance requires several concrete actions: defining temperature requirements for each product, verifying that carriers have adequate equipment and procedures, pre-cooling trailers before loading, maintaining temperature monitoring records throughout transit, and documenting corrective actions when excursions occur. Shippers must also keep records demonstrating that their carriers are qualified and that loads were tendered with clear temperature instructions – often specified on the bill of lading.

Failing to meet cold chain compliance requirements carries real consequences beyond regulatory penalties. Retailers and foodservice distributors increasingly mandate temperature documentation as a condition of doing business, and a pattern of compliance failures can cost a shipper shelf space or an entire customer relationship. During a food safety audit or recall event, the ability to produce complete transit temperature records for specific lot numbers becomes critical.

The shift toward digital compliance – replacing paper temperature logs with IoT-connected sensors and automated record-keeping – has made it far easier for shippers to maintain audit-ready documentation without adding manual workload to their logistics teams.

How Owlery Helps

Owlery centralizes shipment documentation and carrier performance data so cold chain shippers can maintain audit-ready records and flag compliance gaps across their carrier network without manual tracking.

Last Reviewed:
February 18, 2026

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