For Immediate Release
February 16, 2016
On Friday, Feb. 12, U.S. District Judge Jon D. Levy of the District of Maine entered a consent decree of permanent injunction against Mill Stream Corporation, doing business as Sullivan Harbor Farm, and its former president and owner, Ira J. Frantzman. The decree results from a complaint filed by the U.S. Department of Justice at the request of the U.S. Food and Drug Administration.
According to the complaint, Sullivan Harbor Farm, located in Hancock, Maine, processes and sells vacuum packed, ready-to-eat fish products such as hot- and cold-smoked salmon, trout and char. The company primarily sells its smoked fish to wholesale customers in Maine, Massachusetts and Washington, D.C. Sullivan Harbor Farm products have also been served at a restaurant co-owned by Ira Frantzman, the Ironbound Restaurant in Hancock, Maine.
The complaint outlines a long history of recurring violations. During recent inspections, FDA investigators found that the company failed to control for Clostridium botulinum (C. bot) hazards in their fish products and to comply with good manufacturing practice requirements. For example, the FDA found evidence of rodent feces and mold at the facility. C. bot is a bacterium that can grow and cause botulism, which is rare but can lead to paralysis and death without prompt treatment.
“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.”
“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.”
Previous FDA testing revealed Listeria monocytogenes (“L. mono”) in the plant environment and on a fish skinning machine at Sullivan Harbor Farm. L. mono is a foodborne pathogen that can cause 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. The FDA issued an Administrative Detention Order to the firm, which led to to the distruction and recall of the affected products by the company.
The decree entered Friday requires Sullivan Harbor Farm and Ira Frantzman to stop processing and distributing smoked fish products until they have taken specific steps to achieve compliance with the Federal Food, Drug and Cosmetic Act and the seafood Hazard Analysis and Critical Control Point (HACCP) regulations. The decree also prohibits the Ironbound Restaurant from serving Sullivan Harbor Farm fish products until the company achieves compliance. Failure to obey the terms of the decree could result in civil or criminal penalties.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.