District Court Enters Permanent Injunction Against Maine-Based Seafood Company and Its Owner to Prevent Distribution of Adulterated Products

The U.S. District Court for the District of Maine entered a consent decree of permanent injunction against Hancock, Maine-based Mill Stream Corporation (doing business as Sullivan Harbor Farm) and its owner, Ira J. (Joel) Frantzman, to prevent the distribution of adulterated seafood products, the Department of Justice announced today.

The department filed a complaint in the U.S. District Court for the District of Maine at the request of the U.S. Food and Drug Administration (FDA), alleging that the defendants’ seafood products are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby the products may have become contaminated with filth or have been rendered injurious to health.

“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 FDA to prevent the distribution of adulterated food.”

The complaint alleges that the defendants prepare, process, pack, hold, and distribute refrigerated, vacuum-packed, ready-to-eat, cold and hot smoked fish or fishery products, such as smoked salmon, trout and char, for distribution to cities across the country, including Boston, Massachusetts, and Washington, D.C.  The complaint also alleges that Frantzman is Mill Stream’s owner and has the authority and responsibility to prevent and correct the violations of federal law at the company.

In conjunction with the filing of the complaint, the defendants agreed to settle the case and be bound by a consent decree of permanent injunction that requires the defendants to cease all manufacturing operations and provides that, in order for defendants to resume distributing their products, FDA first must determine that the defendants’ manufacturing practices comply with the federal Food, Drug and Cosmetic Act (FDCA). 

According to the complaint, an FDA inspection of defendants’ facility in March and April 2015 identified significant, recurring violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations and current Good Manufacturing Practices (cGMP) requirements.  As alleged in the complaint, the HACCP violations included inadequate plans to control risks of Clostridium botulinum (C. bot), which produces a potent neurotoxin that can cause botulism.  Though the incidence of botulism is rare, its effect can be severe.  Botulism can cause paralysis or death if not promptly treated. 

The complaint also alleges that FDA documented insanitary conditions at the defendants’ facility in violation of cGMP requirements.  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.

Additionally alleged in the complaint, FDA’s testing of samples collected from the defendants’ facility during a December 2011 inspection revealed Listeria monocytogenes (L. mono) in the facility’s environment and on a fish-skinning machine.  As noted in the complaint, as a result of that finding, FDA issued to defendants an Administrative Detention Order and defendants subsequently had the affected products destroyed and recalled.  L. mono is the bacterium that causes listeriosis, a disease commonly contracted by eating food contaminated with L. mono. Listeriosis can be serious, even fatal, for vulnerable groups such as newborns and those with impaired immune systems. The most serious forms of listeriosis can result in meningitis and septicemia. Pregnant women may contract flu-like symptoms from listeriosis, and complications from the disease can result in miscarriage or septicemia in the newborn.

The complaint alleges that, for more than a decade, FDA repeatedly warned the defendants about HACCP and cGMP violations at the defendants’ facility.  The complaint also alleges that FDA communicated these warnings through regulatory meetings, teleconferences, an Administrative Detention Order, Lists of Inspectional Observations and a Warning Letter.  Yet, the complaint alleges, FDA continued to observe HACCP and cGMP violations at the defendants’ facility.

The government is represented by Trial Attorney Thomas E. Ross of the Civil Division’s Consumer Protection Branch and Andrew K. Lizotte of the U.S. Attorney’s Office for the District of Maine, with the assistance of Associate Chief Counsel Yen Hoang of the Department of Health and Human Services’ Office of General Counsel – Food and Drug Division.