On November 20, 2001, in U.S. v. Blue Ribbon Smoked Fish, Inc., et al., 01-CV-3887 (E.D.N.Y.), Judge Sifton granted FDA's motion for summary judgement to enjoin Blue Ribbon, a fish processor, from violating adulteration provisions of the Food, Drug and Cosmetic Act. The case involved the contamination of food with Listeria monocytogenes (L. mono), a bacterium that can cause a serious infection in humans called listeriosis, and causes an estimated 2,500 serious illnesses and 500 deaths each year. Foodborne illness caused by L. mono in pregnant women can result in miscarriage, fetal death, or severe illness in or death of a newborn infant. Others at risk for severe illness or death are the elderly and those with weakened immune systems.
The court found that Blue Ribbon and three of its officers 1) had inadequate Hazard Analysis Critical Control Point ("HACCP") plans; 2) processed its fish products under insanitary conditions; and 3) introduced fish products contaminated with Listeria Monocytogenes ("L. mono.") into interstate commerce. The court also denied the individual defendants' motion to dismiss the complaint against them, relying upon earlier decisions from the Supreme Court which placed the responsibility for protecting the public health on individuals who had the opportunity to know about poor conditions at food processing companies, not consumers.
Rejecting Blue Ribbon's defense that new management had alleviated the insanitary conditions, the court focused instead on defendants' lengthy history of violations. The court also held that defendants' HACCP plans were facially inadequate.
Blue Ribbon challenged the adulteration charge based on the presence of L. mono. in its fish products by arguing that L. mono. is not an added substance and does not ordinarily present a risk to health because it affects only some segments of the population. In the alternative, Blue Ribbon argued that if the court found L. mono. to be an added substance, the FDA's zero-tolerance policy violates provisions of the Food, Drug and Cosmetic Act. The court rejected these arguments, finding that 1) L. mono. is an added substance; 2) L. mono. is "injurious to the health of significant populations of consumers;" and 3) the FDA is not required to set a tolerance level for L. Mono. The court granted relief as requested by the government, recognizing that it was consonant with the legislative intent behind the Act: "[b]y keeping contaminated fish processed under conditions of filth off consumer's tables, this permanent injunction will serve that important purpose."
This document was issued on November 20, 2001.
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Text of Court Decision: United States of America, vs. Blue Ribbon Smoked Fish, Inc., et alia
Additional Information on Listeriosis
Hypertext updated by cjm 2001-DEC-04