ROCKLAND, Maine — The U.S. Food and Drug Administration found serious violations of federal seafood safety at Linda Bean’s lobster processing plant in the city’s industrial park.
The violations were found during four inspections done by the FDA in December at 17 Merrill Drive LLC, according to department documents. A warning letter was sent out in February.
The inspection report found that the lobster and crabmeat at the plant were “prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.”
The manager of the plant said Monday, however, that the violations simply involved the plant not being able to show the federal agency scientific evidence to support the company’s position that its processing method results in the food being safe.
He said the plant continues to operate and he expects to present scientific evidence to the FDA to back up the company’s position that its operations are safe. A follow-up inspection has yet to be done.
The FDA issued a report to the company following the December inspections and the company responded in a Jan. 24 letter. But Miguel Hernandez, then the acting New England FDA director, stated in a Feb. 14 warning letter to the company that the processor’s response was inadequate.
Specifically, federal inspectors found that Bean’s processing plant had not established by a scientific study that the temperature and length of time it cooked the lobsters and crabs and the temperature of its coolers were sufficient to assure the elimination or reduction of pathogenic bacteria to an acceptable level.
The coolers also were not monitored to make sure that they maintained a certain temperature, according to the FDA.
“It is our expectation that once you have validated your process and have established new critical limits, you will reassess the monitoring, recordkeeping, verification and corrective action procedures listed in your HACCP plans at the cooking and refrigerated storage critical control points,” the FDA director stated in his February letter. The acronym stands for Hazard Analysis and Critical Control Points.
The FDA inspectors also reported finding sanitation violations.
“Your firm did not monitor the condition and cleanliness of food contact surfaces, the prevention of cross-contamination from insanitary objects, and the protection of food contact surfaces from adulteration with chemical, physical and biological contamination with sufficient frequency,” the inspection report stated.
The problems included condensation from steam generated by the cooking process dripping from the ceiling in the raw area due to inadequate exhaust/ventilation; condensation was on the ceilings of the ice-making rooms directly above totes of ice; the flange area within the ceiling where ice falls through the ice chute was observed to be rusty and discolored; and cleaning hoses were observed to be in direct contact with the wet processing room floors.
The FDA said that if the violations were not corrected, the government could seize the company’s products and shut down the operation.
Plant Manager Jason Hall said Monday that no product was seized. He said the problem was that the company did not have the scientific evidence to verify that its cooking and cooling processes are safe. He said the processes are safe but that the company has contacted the University of Maine to have a food safety expert visit the plant and validate what the firm is doing.
Jason Bolton, a food safety specialist for the UMaine Cooperative Extension and the University of Maine School of Food and Agriculture, said Monday that he has not yet visited the plant but is scheduled to do so next week.
“My goal is to educate them and help them,” Bolton said.
Bolton said the FDA expects processors to have their processing systems validated to make sure that the processed food is safe to eat right out of the package even without cooking. He said many processors have that scientific validation done before they start while others do not.
Bolton said he and another food specialist with the extension service assist 400 to 500 companies a year, ranging from seafood processors to slaughterhouses and makers of jams.
FDA compliance officer Timothy Glod said Monday he could not comment on an open case. Glod said that in cases where warning letters have gone out, the FDA will return at some point and re-inspect a plant.
Linda Bean purchased the 23,000-square-foot processing plant at 17 Merrill Drive for $1 million in December 2008 from Oak Island Seafood. She said her belief was that “the added value of processing Maine products should stay in Maine.” She later purchased two other buildings in Rockland’s Industrial Park for processing and storage.
Last year, she estimated her company would buy 7 million pounds of lobsters in 2013.