United States v. Blue Ribbon Smoked Fish, Inc.

Over a seven-year period, inspectors documented continuing unsanitary conditions at Blue Ribbon Smoked Fish Inc. (codefendant). Testing revealed the presence of L. monocytogenes, the bacteria that causes listeriosis, which is found in fish processed without heat like cold-smoked salmon. In January 2000, the New York State Department of Agriculture and Markets (NYSDAM) revoked Blue Ribbon’s license, but reissued it after Blue Ribbon passed further testing. In August 2000, a U.S. Food and Drug Administration (FDA) inspection found Blue Ribbon lacked a written hazard analysis critical control point (HAACP) plan, process schedule, and monitoring records for cold-smoked salmon used to make a batch of lox and cream cheese. Blue Ribbon recalled the batch and promised to correct deficiencies, but the January 2001 inspection revealed continuing deficiencies and unsanitary conditions. Blue Ribbon undertook 30 corrective actions, and the FDA conducted five additional tests for L. monocytogenes after April 2001 without reporting contamination. But the government (plaintiff) charged Blue Ribbon and its owners (codefendants) with failing to establish and use HAACP plans to prevent food-safety problems. The government moved for summary judgment and requested a permanent injunction barring Blue Ribbon from processing and distributing food until it met six conditions: (1) sanitize the plant; (2) hire an outside listeria expert to train staff and develop and monitoring programs; (3) obtain FDA approval; (4) examine all fish on hand for bacteria; (5) conduct a hazard analysis and develop an HAACP plan for all fish products; and (6) provide notice of compliance. Once those conditions were met, Blue Ribbon could resume operations, provided it implemented a listeria-control protocol for cold-processed products and additional monitoring and testing controls. If Blue Ribbon failed inspections, it would have to shut down and recall any adulterated product at its own expense. Blue Ribbon countered that it did not cause the L. monocytogene contamination at its plant and that it occurs naturally in cold-smoked fish. In addition, Blue Ribbon argued that the injunction would shut down its business, putting employees out of work, and that it should not have to pay for an outside listeria expert or further FDA inspections to ensure compliance.