By Madelyn Kearns, Associate Editor
Published on Wednesday, February 17, 2016
A consent decree of permanent injunction was handed down by a U.S. district judge on 12 February against a Maine-based seafood processor and its former owner at the behest of the U.S. Food and Drug Administration (FDA).
According to the FDA’s complaint, Mill Stream Corporation – which operates as Sullivan Harbor Farm – has a recurring history of health violations, with agency inspectors noting a lack of controls at its Hancock, Maine processing site, as well as improper compliance with good manufacturing practice requirements.
“When a company repeatedly violates food safety laws and procedures they are putting the public at risk,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “It is our job at the FDA to protect the food supply and we must take action to ensure that food is safe for everyone.”
A recent inspection of the business – which specializes in processing and selling vacuum packed, ready-to-eat fish products such as hot- and cold-smoked salmon, trout and char – revealed the facility’s failure to control for Clostridium botulinum (C. bot) hazards in their fish products. Investigators also discovered evidence of rodent feces and mold at the facility.
According to the Department of Justice: “FDA investigators observed, among other things, rodent excreta pellets too numerous to count in the area of the facility where smoker trays are cleaned, apparent black mold and water staining on the doorframe of the walk-in freezer where fish is stored, an open rack of salmon stored beneath a pipe with frozen condensate build-up, and water splashing from the processing floor onto a cutting board and into bins where fish is stored.”
Prior inspections uncovered the presence of Listeria monocytogenes (“L. mono”) in the plant environment and on a fish skinning machine at Sullivan Harbor Farm. L. mono, a foodborne pathogen, has been known to invoke miscarriages in pregnant women and serious illness or even death in vulnerable groups such as newborns, the elderly, pregnant women and those with impaired immune systems, said the FDA. During the time, the FDA issued an Administrative Detention Order to the firm, which led to the destruction and recall of the affected products by the company.
Sullivan Harbor Farm has been inspected by the FDA nine times since 2004, per the DOJ, and each time, the company did not meet standards. Citing public safety concerns, the U.S. Department of Justice brought the FDA’s concerns to court, where U.S. District Judge Jon D. Levy of the District of Maine eventually issued the decree.
“The failure to plan for and control the presence of bacteria and neurotoxins commonly found in seafood-processing facilities can pose a significant risk to the public health,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “The Department of Justice will continue to work aggressively with the FDA to prevent the distribution of adulterated food.”
Under the decree, Sullivan Harbor Farm and its former president and owner Ira Frantzman are required to cease processing and distributing smoked fish products until measures have been taken to achieve compliance with the Federal Food, Drug and Cosmetic Act and the seafood Hazard Analysis and Critical Control Point (HACCP) regulations. Further, the decree will prohibit a restaurant co-owned by Frantzman, the Ironbound Restaurant in Hancock, from serving Sullivan Harbor Farm fish products until the company reaches compliance.
Sullivan Harbor Farm agreed to halt production of adulterated fish on 16 February.
The company sells to wholesale customers across Maine, Massachusetts and Washington, D.C. Sullivan Harbor Farm was recently sold ahead of the 12 February injunction, however the name of the new owner has yet to be disclosed, reported Food Safety News. If the new owner wishes to re-open the shuttered facility, all employees will be required to undergo FDA-approved training.