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FDA Clarifies that Packaged Frozen Food is Not Subject to STF Rule

The Global Cold Chain Alliance (GCCA) is continuing its engagement with the U.S. Food and Drug Administration (FDA) regarding implementation of the Food Safety Modernization Act (FSMA) Sanitary Transportation of Human and Animal Food Regulation (STF). As companies across the food supply chain are preparing for compliance, questions have arisen regarding the applicability of the STF rule to packaged frozen food. 

FDA has indicated in previous documents that they recognized the lower risk presented by frozen foods, and tentatively concluded that it would be rare for a frozen food to be considered a Temperature Control for Safety (TCS) food. While recognizing the lower risk, this statement left some ambiguity as to whether packaged frozen foods would be subject to the STF rule. GCCA has asked for, and received, clarification from FDA that the transportation of packaged frozen food is NOT subject to the STF rule. Frozen food that is not fully enclosed in packaging would still be subject to the regulation, but with the focus on sanitation and not on temperature control.

This is an important clarification for GCCA members who have loads that are comprised of only packaged frozen products. While these loads/products, would not be subject to the STF rule, GCCA still encourages members to follow industry best practices. Click here to access the IRTA Refrigerated Transportation Best Practices Guide and other compliance resources.

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