FDA Sued For Its Failure To Regulate Shellfish Bacteria

BacteriaThe US Food and Drug Administration (FDA) is bracing for a legal battle after public attorney Julie Murray filed the complaint at the Center for Science in the Public Interest (CSPI). The case was filed late May at the U.S. District Court for the District of Columbia. The agency’s failure to regulate the vibrio vulnificus bacteria found in shellfish, a violation of the Food Safety Modernization Act.

The FDA’s failure to regulate the deadly bacteria can result to the death of approximately 30 people who can suffer serious illness and eventually die. The figures were cited from the FDA itself and the Centers for Disease Control and Prevention. Vulnifucus is the main cause of seafood-associated deaths in the United States.

The lawsuit alleges that the FDA’s failure to implement safety standards for controlling the deadly bacteria is unacceptable. With the technology for elimination and decreasing vulnificus while maintaining the texture and flavor of raw oysters is already in place, the only thing lacking is the resolve to act upon the public health hazard.

The CSPI is pushing for a Federal court order that will force the FDA to decide within 30 days on the 4-year old petition calling for the implementation of testing regulations for oysters and other shellfish desigend for raw consumption. CSPI cited a provision in the FSMA requiring the FDA to review and evaluate relevant health data and other relevant information in order to determine the most significant contaminant.

In addition, the provision also mandates the Secretary to issue contaminant-specific and science-based guidance documents regarding action level or regulation. It has been four years since CSPI’s petition and three afters the first deadline of the FSMA but still there is no response from the FDA.

Since the FDA has become aware of the potential hazard, at least 300 people have been killed of contamination from 1989 to 2010. The number of deaths has increased since then. The lawsuit claims that since then the FDA has not implemented a safety standard requiring companies to reduce vulnificus to nondetectable levels.

People who get infected with vulnificus die from poisoning within a few days. The fatality rate is 100 percent if the patient is not treated within 72 hours. The only chance of survival is to have the limbs amputated.

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