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Current Position:Home » News » Law & Regulation » International Regulations » Topic

FDA sued for failing to impose regs about shellfish bacteria

Zoom in font  Zoom out font Published: 2016-06-06  Views: 42
Core Tip: The FDA’s failure to act to protect the public from deadly bacteria in shellfish not only means the agency is in violation of the Food Safety Modernization Act, but it means at least 15 people will likely die unnecessarily every year, according to a laws
 The FDA’s failure to act to protect the public from deadly bacteria in shellfish not only means the agency is in violation of the Food Safety Modernization Act, but it means at least 15 people will likely die unnecessarily every year, according to a lawsuit filed in federal court.
 
“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,” wrote the legal team for the Center for Science in the Public Interest (CSPI) in a lawsuit filed in late May in U.S. District Court for the District of Columbia.
 
freshoysters_406x250“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.
 
FDA policies prohibit agency staff from commenting on pending litigation. The government has until July 25 to file a response to CSPI’s complaint. The FDA updated its warning to consumers in June 2015 regarding consumption of raw oysters and other shellfish because of V. vulnificus.
 
The bacteria V. vulnificus is the leading cause of seafood-associated deaths in the United States, based on data in government records.
 
“The FDA’s failure to adopt a safety standard to control these deadly bacteria is unconscionable,” Julie Murray, the Public Citizen attorney who filed the case against FDA with the CSPI, said in a news release.
 
“The technology to eliminate or reduce V. vulnificus while preserving the texture and flavor of raw oysters is readily available. What’s missing is the FDA’s resolve to do something meaningful about this public health hazard.”
 
The federal case contends the FDA’s failure to act “constitutes agency action unlawfully withheld or unreasonably delayed, in violation of the Administrative Procedure Act.” The CSPI wants a federal court order to force the FDA to issue 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.
 
Because of the well-documented presence of V. vulnificus, especially during warm weather months when water temperatures are higher, and its high fatality rate, the non-profit watchdog groups Public Citizen and CSPI contend FDA’s inaction also puts it in violation of requirements in the Food Safety Modernization Act (FSMA).
 
“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 information … to 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.”
 
Activists say hundreds have died since FDA learned of this hazard
 
Vibrio-quote-CSPI-vs-FDAThe CSPI complaint says from 1989 to 2010, at least 300 people died from V. vulnificus-related illnesses, according to the government’s own records. More individuals have died in the years since then.
 
“The FDA has recognized since the 1980s that V. vulnificus poses a hazard to public health. But in the decades since then, it has repeatedly caved to industry pressure not to adopt a safety standard that would require companies to reduce V. vulnificus to nondetectable levels,” according to the lawsuit.
 
V. vulnificus is particularly dangerous for people with certain health conditions, including diabetes, liver disease, cancer, iron overload disease (hemochromatosis), hepatitis and HIV/AIDS. These people are at greatest risk of contracting blood poisoning from a V. vulnificus infection, which can result in painful swelling and blistering wounds on the legs.
 
“Half of all individuals who are infected with V. vulnificus-related blood poisoning die, usually within a matter of days. The fatality rate is 100 percent if individuals delay seeking medical treatment for 72 hours. Many other individuals must have their limbs amputated to survive. Even a single raw oyster may contain a sufficient amount of V. vulnificus bacteria to be lethal,” according to the CSPI complaint against the FDA.
 
 
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