FDA sued for deaths tied to bad oysters

Published on
May 27, 2016

A U.S. commercial shellfish group defended the industry’s increased efforts at combating foodborne illness, after a consumer group sued the Food and Drug Administration (FDA), saying the agency needs to further regulate the raw oyster industry.

The Center for Science in the Public Interest (CSPI) filed a complaint on 25 May in U.S. District Court in Washington, D.C., saying that FDA needs to act on a four-year-old petition it filed to regulate deadly bacteria in shellfish harvested in Gulf Coast waters and sold for raw consumption.

“Every year, people are getting sick and some are dying from what is a completely preventable disease,” said CSPI senior food safety attorney David Plunkett. “For too long, the FDA has observed these illnesses and deaths from its perch on the sidelines – leaving matters to state regulators and the industry. And it’s clear that that approach has been a public health failure.”

However, the industry has done everything it can to reduce V. vulnificus illnesses, Bob Rheault, executive director of the East Coast Shellfish Growers Association in Toms River, N.J., told SeafoodSource.

“It is deceptive to say that the FDA has failed to regulate for V. vulnificus. The FDA (through the Interstate Shellfish Sanitation Conference) has drastically changed the way industry handles oysters,” Rheault said. “We went from 10 hours from harvest to refrigeration, to one hour, to limit post-harvest growth of the bacteria. Every state has instituted control plans and industry has invested millions in ice machines, on-board refrigeration, refrigerated trucks and shore-side infrastructure to comply with the new regulations.”

As many as 95 cases of V. vulnificus (half of which are culture confirmed), 85 hospitalizations and 35 deaths are reported annually nationwide, according to the Centers for Disease Control and Prevention (CDC). An average of 50 culture-confirmed cases, 45 hospitalizations, and 16 deaths are reported each year from the Gulf Coast region.

Levels of V. vulnificus peak during warm weather months when water temperatures are higher. The bacteria is particularly dangerous for people with certain health conditions, including diabetes, liver disease, cancer, iron overload disease (hemochromatosis), hepatitis and HIV/AIDS.

CSPI’s petition urges FDA to set a performance standard for the shellfish industry that would reduce the threat of illness from Vibrio vulnificus (V. vulnificus) in raw oysters. FDA originally denied a similar CSPI petition in 2002, citing a voluntary plan to reduce the rate of illnesses coordinated by an ISSC.

CSPI’s 2012 petition cites “the new authority given to the agency by the FDA Food Safety Modernization Act, and the fact that the ISSC’s voluntary plan to reduce illnesses failed to achieve its goals,” CSPI said in a 2012 statement.

While CSPI wants the industry to set a regulatory limit, “Scientists cannot tell us how many cells it takes to cause an illness, so it is hard to say what that limit should be,” Rheault said. “Testing is very expensive, and few people are willing to be test subjects for a disease with a 50 percent mortality rate.”

Instead of placing additional burdensome regulations on the oyster industry, immune-compromised individuals should take precautions to avoid the disease, Rheault said.

“It would be best if everyone who was susceptible (immune-compromised individuals with liver disease or taking immune-suppressant drugs) would refrain from eating raw shellfish (and other raw and undercooked foods), but doctors are doing a poor job of informing patients about dietary restrictions and many patients continue to eat raw foods when they know they shouldn't,” he said.

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