A seafood wholesaler on Chicago’s West Side will need to continue to work under a federal consent decree governing how it runs its business for at least the next three years, a federal judge has ruled.
Eastern Seafood Inc., which operates in the 1000 block of West Hubbard Street in the West Town neighborhood, failed in its bid to persuade a federal judge to end the arrangement ordered by the U.S. Food and Drug Administration and under which the business has operated since 2002.
However, the company’s performance in keeping its seafood free of contamination in the last 13 years was sufficient to prompt U.S. District Judge Matthew F. Kennelly to order the decree, which had been open-ended, to expire three years from now.
Kennelly’s ruling comes about six months after Eastern Seafood asked the judge to vacate the FDA consent decree.
That decree – a legally binding agreement between the company and a government agency to rectify the subject of an enforcement action without admitting liability – had been put in place in 2002 to settle a complaint the FDA had brought against Eastern Seafood over the way in which it processed and stored its fresh seafood products.
According to the 2002 complaint filed by then-U.S. Attorney Patrick Fitzgerald’s office on behalf of the federal agency, the action was initiated after regulators determined Eastern Seafood did not have a so-called Hazard Analysis and Critical Control Point (HACCP) plan in place to satisfy the legal requirements in federal law regulating the handling of “fresh scombroid-forming fishery products,” or fish products known to promote the growth of so-called scombrotoxin bacteria, which can pose health risks to humans eating fish.
The 2002 complaint indicated the lack of the plan alone led regulators to argue the fish processed by Eastern Seafood at its Hubbard Street facility could be considered “adulterated” under the meaning of the law. Regulators did not accuse the business of selling contaminated fish.
Under the consent decree, Eastern Seafood allowed the FDA to oversee the implementation of the HAACP plan and the related equipment, and then to inspect the facility without notice, whenever the FDA “deems it necessary,” and to compel the company to pay for those inspections, among other requirements.
Should the FDA determine the company had failed to abide by the decree, it could order the business closed, court documents said.
The decree did not include a “sunset” provision, or a date by which the decree would end and the company could resume normal operations.
In February, Eastern Seafood asked the judge to vacate the decree. The company noted its performance in the 13 years since the decree was put in place, noting they have been “cooperative and compliant” with the FDA and “the FDA has not found contamination in any of their products and has not cited them with any official ‘violations.’”
The company also pointed to additional upgrades it says have been made to their facility, including relocating water hoses to the ceiling to prevent contact between the hoses and fish, installing devices to prevent water backflow and bacteria growth and installing new digital temperature monitoring equipment and better coolers, among other improvements.
The FDA, however, had opposed Eastern’s request, telling the judge, while the seafood had remained contamination free, the company still had not fully abided by the decree. The FDA noted the company’s “failure to follow the procedures listed in their HAACP plans or to take the necessary steps to ensure that their HAACP plans were adequate to control food safety hazards.”
To support its assertions, the FDA pointed to the results of inspections conducted at the facility between 2009-2015, which were designated as “Official Action Indicated,” a designation given to inspected facilities in which “significant objectionable conditions or practices [are] found and regulatory action is warranted.”
The FDA also noted “personal disregard for the decree’s authority” by the owner of Eastern Seafood listed in court documents as Mario Falco.
“The government (FDA) cites, for example, to reports from FDA investigators stating that Falco told them on multiple occasions that the decree does not apply to him,” Kennelly wrote.
The judge said those FDA reports led him to deny Eastern Seafood’s request to vacate the decree.
“FDA's discovery of apparent noncompliance as recently as April 2015 makes clear that any change in factual conditions or remedy implemented has not been ‘significant’ or ‘durable’ enough to allow the Court to do away with the decree at this time,” Kennelly wrote.
However, the judge said decree cannot just continue forever.
“It bears noting that the decree has been in existence to almost 13 years,” the judge wrote. “An express sunset provision ought to be added … And none of the violations the government cites evidently was serious enough to cause the government to come back to court to seek relief under the decree.
“Given these circumstances, the court is of the view that there should be a three-year sunset period, not the five-year period the court might have set had the issue come up at the time it entered the decree.”
Eastern Seafood was represented in the action by attorney George S. Spataro, of Berwyn.