Importers must comply with FDA's seafood HACCP regulation (21 CFR Part 123), which requires that the foreign processor operate under a HACCP plan addressing hazards specific to the species and process. FDA may conduct prior notice review and port-of-entry examination; repeated violations can result in automatic detention of future shipments from the same facility.

CBP generally considers product 'fresh or chilled' if it has been maintained at temperatures above freezing (typically 0°C to 4°C) and has never been frozen. Product that was frozen and then thawed would typically be classified under the frozen fillet subheading. Temperature logs and supplier declarations are the primary evidence used to support the fresh/chilled classification.