The Food and Drug Administration (FDA) announced that it is seeking a permanent injunction against Worldwide Fish & Seafood, Inc. (Worldwide Fish), Suzanne Weinstein, its president and owner, and Timothy A. Lauer, its general manager. Worldwide Fish does business as Coastal Seafood, a seafood processor located at 2330 Minnehaha Avenue, in Minneapolis, Minnesota. The firm distributes seafood products to restaurants in Wisconsin, Minnesota, Iowa, and North and South Dakota.
The government’s complaint, filed today by the United States Department of Justice in the U.S. District Court for the District of Minnesota after settlement talks failed, charges the defendants with violating the Federal Food, Drug, and Cosmetic Act by processing seafood products under conditions that may cause the food to become injurious to health.
According to the government’s complaint, seven FDA inspections over the past six years, including an inspection conducted on November 1-3, and November 6, revealed that the defendants had failed to establish and implement adequate Hazard Analysis Critical Control Point (HACCP) plans to prevent and control food safety hazards associated with each type of potentially hazardous seafood product that they process, as required by FDA regulations. The seafood HACCP regulations require that all seafood processors develop and implement adequate HACCP plans that (1) include all food safety hazards that are likely to occur for each kind of seafood product, and (2) contain preventative measures that the food processor can implement to control those hazards.
FDA inspections also showed that the defendants did not ensure that their equipment was actually recording refrigerator temperatures and that the defendants did not monitor their temperature recording devices. Despite repeated warnings from FDA, including a Warning Letter following one of the inspections, Worldwide Fish has consistently failed to have and implement adequate seafood HACCP plans for each of its potentially hazardous products.
The defendants’ lack of appropriate seafood HACCP plans poses a public health risk, because some of the seafood products handled by Worldwide Fish, e.g., clams, oysters, and smoked salmon can be sources of pathogenic bacteria, including Escherichia coli (“E. coli”), Staphylococcus aureus, Listeria monocytogenes, and Clostridium botulinum. In addition, Worldwide Fish handles fish species such as tuna, mahi-mahi, and mackerel that when handled inappropriately are known to develop histamine, which can cause adverse reactions, such as severe rash, nausea, vomiting and diarrhea of varying degrees of severity. The fish and fishery products handled by Worldwide Fish are susceptible to pathogen growth and histamine formation when exposed to abusive conditions. HACCP programs rely on strict temperature control to prevent the growth of harmful bacteria and to prevent excessive histamine accumulation.
The FDA has initiated this action to promote and protect the public health by enforcing federal food and drug laws. FDA’s mission includes ensuring the safety or safety and effectiveness of food, human and animal drugs, vaccines, blood products, medical devices, electronic products that emit radiation, and cosmetics.