According to a lawsuit against U.S. Food and Drugs Administration filed in U.S. District Court for the District of Columbia, the Agency has failed to protect public from deadly bacteria in shellfish and therefore, is in clear violation of the Food Safety Modernization Act. The legal team for the Center for Science in the Public Interest (CSPI) stated in the lawsuit, “The U.S. Food and Drug Administration (FDA) should stop dragging its feet and act on a four-year-old petition urging the agency to regulate deadly bacteria in shellfish harvested in Gulf Coast waters and sold for raw consumption.”“Without this safety standard, in the next year, an estimated 30 people will become seriously ill, and 15 of them will die, after consuming raw shellfish that contain the bacteria, called Vibrio vulnificus (V. vulnificus),” the complaint states, citing statistics from the FDA and Centers for Disease Control and Prevention.
As reported by government records, the bacteria V. vulnificusis known to be a principal reason behind many seafood-associated deaths in the United States. The present federal case opposes the FDA’s failure to act “constitutes agency action unlawfully withheld or unreasonably delayed, in violation of the Administrative Procedure Act.” The CSPI intends to obtain a federal court order to force the FDA into issuing a decision within 30 days on the 4-year-old petition seeking imposition of testing regulations for oysters and other shellfish sold with the intention they will be consumed raw.
“The FSMA includes a provision entitled ‘Performance standards,’ which requires FDA, ‘not less frequently than every 2 years, [to] review and evaluate relevant health data and other relevant informationto determine the most significant foodborne contaminants,” according to the complaint.
“That provision also mandates the Secretary shall issue contaminant-specific and science-based guidance documents, including guidance documents regarding action levels, or regulations.” To date, four years after CSPI’s petition and three years after the FSMA’s first deadline for the review and evaluation of significant foodborne contaminants, FDA has neither granted nor denied CSPI’s petition.