Deputy Assistant Attorney General Arun G. Rao Delivers Remarks at the Jefferson Literary and Debating Society’s Distinguished Speaker Series
The Department of Justice has filed a lawsuit and sought a preliminary injunction against N.Y. Fish Inc.; New York City Fish Inc.; Maxim Kutsyk, Pavel Roytkov, Leonid Staroseletesky, and Steven Koyfman under the federal Food, Drug, and Cosmetic Act (FDCA). New York City Fish manufactures and distributes ready-to-eat fishery products, including smoked salmon and mackerel, and operates out of a food processing facility located at 738 Chester Street in Brooklyn. N.Y. Fish previously operated a similar fish processing business out of the same location, employing virtually all of the same employees. Although N.Y. Fish has ceased manufacturing, FDA believes that N.Y. Fish products continue to be distributed and sold. The complaint alleges that all defendants have a history of processing fishery products under insanitary conditions, with inadequate safety procedures.
“Consumers depend on food producers to follow the right procedures to make sure our food is safe to eat,” said Acting Assistant Attorney General for the Civil Division Stuart F. Delery. “As this case demonstrates, the Department of Justice is committed to taking action against those who produce or process food under insanitary conditions or with inadequate safety procedures.”
“Inspectors who visited the defendants’ facility found more than Nemo; they found life-threatening bacteria. Despite repeated warnings and direction to sanitize the facility, the defendants have failed to do so. They cannot be allowed to continue to distribute potentially unsafe food to our families. Those who store, package and sell the food that we eat must maintain basic standards of cleanliness in their facilities. We are committed to protecting the public from health risks by ensuring that food manufacturers comply with federal laws prohibiting them from preparing, packing and holding food products under insanitary conditions,” stated Loretta E. Lynch, the United States Attorney for the Eastern District of New York.
According to the complaint, FDA conducted seven inspections of the Chester Street facility between 2006 and 2013. The inspections showed a repeated failure to minimize the risk of contamination by two dangerous types of bacteria: Listeria monocytogenes and Clostridium botulinum. People who eat food contaminated with Listeria monocytogenes can contract the disease listeriosis, which can be serious,even fatal,for vulnerable groups such as newborns and those with impaired immune systems. Complications from the disease can also lead to miscarriage. Clostridium botulinum spores can produce the toxin that causes botulism. Eating food tainted with this toxin can lead to paralysis and potentially death.
FDA’s most recent inspection occurred in February 2013, when New York City Fish was operating the Chester Street facility. According to court filings, the company missed critical processing steps that are essential to prevent the growth and toxin production of Clostridium botulinum and to eliminate any Listeria monocytogenes contamination, including heating fish for a dangerously short time and using insufficiently salty brining solution.
FDA previously investigated the facility in August 2012, when it was operated by N.Y. Fish. FDA inspectors discovered widespread sanitation problems and a similar failure to meet critical steps necessary to prevent contamination. They also found salmon products and production equipment contaminated with Listeria monocytogenes, even after the company attempted to clean and sanitize the facility.
Further testing by the FDA revealed that certain strains of Listeria monocytogenes it found likely had persisted in the Chester Street facility for years. FDA contends that the facility is so infiltrated with Listeria monocytogenes that New York City Fish must institute heightened monitoring and strict sanitation procedures to have any hope of eradicating this life-threatening organism, but that it has failed to do so.
The lawsuit is being brought by Assistant U.S. Attorney Elliot M. Schachner of the Eastern District of New York, and Trial Attorney Adrienne Fowler of the Civil Division’s Consumer Protection Branch, with the assistance of Associate Chief Counsel for Enforcement Julie Dohm of the FDA.