D is engaged in preparing, processing, holding, and distributing a variety of seafood products. All three individual Ds work at the plant, are co-owners of D and are corporate officers responsible for plant operations. P alleges that the FDA and the New York State Department of Agriculture and Markets (NYSDAM) have documented, throughout the last seven years, unsanitary conditions at the facility as well as Ds' failure to establish and implement adequate HACCP plans necessary to control food safety hazards. According to FDA regulations, a processor of fish and fishery products is required to assess biological, chemical, and physical hazards at all stages of processing, from production of the raw materials to procurement and handling, manufacturing, distribution, and consumption of the finished products. The FDA found that D failed to comply with FDA regulations regarding HACCP plans. Ds do not dispute the FDA findings that the HACCP plans were inadequate or non-existent at the time of these inspections. Inspections of the plant were conducted in 1994, 1995, 1996, 1999, 2000, and 2001. The January 2001 inspection revealed the following unsanitary conditions: old seafood product residue on food contact surfaces; mold in the cooler, freezer, and ceiling of the slicing and packing room; a plastic dividing curtain that touched the floor and came into contact with fish; liquid dripping onto seafood from other seafood stored above; and old dripping product residue on the walls and fan shrouds in the cold smoking/drying room. There was a failure to adequately sanitize and wash cutting boards, knives, and slicing machine. Employees were touching unclean surfaces and then touching ready-to-eat fish without sanitizing their gloves, wearing street clothes in the processing areas without protective coverings, eating and drinking in the processing areas, inadequate hand washing and sanitizing, and wearing unrestrained hair and beards. The plant's construction was not designed to prevent bacterial contamination and filth and that there were inadequate doors or barriers between the slicing and packing room and the garage and toilet, lack of control over foot traffic and product flow to prevent cross-contamination of the finished ready-to-eat product, and that surfaces were in disrepair making adequate cleaning impossible. The FDA also found instances of L. monocytogenes contamination in seafood products and in the plant environment. L. monocytogenes causes listeriosis, and food contaminated with this bacterium is harmful to human health. Listeriosis can be serious and even fatal Ds alleged that conditions have improved. The FDA has adopted a 'zero-tolerance' policy on L. monocytogenes and has established procedures for fish processors to follow to eliminate and control its presence in food. Ds dispute the seriousness of the risk that small amounts of L. monocytogenes. The incidence of disease associated with the bacteria as of approximately two to ten cases per million people and that epidemiological studies show a 1 in 59 million chance of infection from a 50 gram serving of fish containing 100 bacteria per gram. While L. monocytogenes is frequently found in fish, there have been few instances of listeriosis from fish products. At least one group of researchers has stated that 'listeria contaminated fish products should not represent a serious impact on human health.'