Listeria monocytogenes findings and insanitary plant conditions have led to a consent decree that prohibits a Portland, Maine, seafood processor from selling seafood until the U.S. Food and Drug Administration (FDA) has approved in writing the company's food safety plans. The FDA said the decree was signed by three executives at Portland Shellfish Co. Inc. and entered by Judge John A. Woodcock in the U.S. District Court for the District of Maine.
Part of the FDA's requirement is for Portland Shellfish to install a Listeria testing program and a sanitation program in addition to the company's Hazard Analysis and Critical Control Point (HACCP) plan. The company normally sells ready-to-eat lobster, shrimp and crab products to retailers in Massachusetts, California, Georgia, Illinois, Nevada, Washington, New Jersey and Louisiana.
FDA investigators documented significant deviations from the seafood HACCP regulation, which the FDA enforces to ensure the safety of fish and fishery products distributed to the public. Failure to comply with the seafood HACCP regulation renders food adulterated under the Act. FDA inspection during 2010 confirmed the presence of Listeria monocytogenes and the company has issued four recalls in the past two years due to Listeria contamination and potential contamination of its ready-to-eat products.
When consumed by humans, the bacteria can result in meningitis and septicemia and the disease can be fatal.
Listeriosis during pregnancy can result in miscarriage or septicemia in the newborn. An estimated 1,600
Listeriosis cases a year are reported in the U.S., which makes it a seldom form of food poisoning. But it has the highest death rate (15.9 percent) of the seven pathogens that cause 90 percent of all foodborne illlness in the country.
Despite the FDA's warnings about insanitary conditions and the company's promises to correct the violations, the most recent FDA inspection, conducted between April 2010 and June 2010, revealed that Portland Shellfish continued to violate FDA regulations and the Act, the agency said in a press release. The decree, which the FDA termed an enforcement action, also allows the FDA to order a shutdown, recall products or take other corrective action in the event of future violations. Failure to abide by the agreement also can lead to civil or criminal penalties.
