Drugs in Chinese seafood trigger FDA import ban

Jun 28, 2007 (CIDRAP News) – The US Food and Drug Administration (FDA) today banned importation of five types of farmed Chinese seafood because of contamination with outlawed antimicrobial drugs, including one that can spawn antibiotic resistance.

The FDA banned farm-raised catfish, shrimp, eel, dace (a carp-like fish), and basa (similar to catfish) from China after testing over an 8-month period revealed many cases of contamination with drug residues, according to an agency news release.

The contaminants include nitrofuran, malachite green, gentian violet, and fluoroquinolone, the agency said. The first three cause cancer in lab animals with prolonged exposure, while fluoroquinolones are a class of antibiotics whose use in food animals has been known to promote resistant bacteria. All four are banned in farmed seafood in the United States.

China outlaws the use of nitrofurans and malachite green in fish farming but allows fluoroquinolones, the FDA said. It did not say whether China allows gentian violet use.

"We've now reached a point where between October 2006 and May 2007 over 15% of samples we tested were positive," David Acheson, the FDA's assistant commissioner for food protection, said at a teleconference today. "That basically reaches a point where we need to set up controls that are broader than company by company. The best way to protect public health in America is to broaden it to country-wide."

The drug residues have been at low levels, and there is no imminent threat to public health, he said. "However, the substances could cause serious problems if consumed over a long period of time."

The FDA said it is not seeking a recall of the Chinese products already in the United States or advising consumers to return or destroy products on hand. "FDA is concerned about long term exposure as well as the possible development of antibiotic resistance," the agency said.

Imported seafood is not required to be labeled with the country of origin, though some products have such labels, FDA officials said.

Officials said individual companies will be allowed to resume exporting the affected products to the United States if they can demonstrate that they are free of the contaminants and were processed in accord with FDA and Chinese government requirements.

China accounts for 70% of the global supply of farmed fish and is the third largest exporter of farmed fish to the United States, said Acheson. However, he said he couldn't estimate the economic effects of the ban on China, commenting. "FDA does not track those sorts of economic issues."

The FDA's concern about Chinese seafood dates back several years. "We began to see these problems in farmed fish from China predating 2001," said Margaret O' K. Glavin, associate commissioner for regulatory affairs.

The agency began barring some seafood products from certain Chinese companies in 2001. Last year the FDA barred all Chinese farmed eel because of malachite green, Glavin said. She said the agency inspects about 5% of Chinese seafood, a larger share than for seafood from other countries.

Officials said the FDA has been working extensively with Chinese authorities on the problem but still finds it necessary to take action to protect US consumers.

In the past the FDA allowed the use of fluoroquinolones in poultry, but in 2000 the agency proposed to ban such use because it was linked with antibiotic-resistant Campylobacter in poultry meat. The concern was that human Campylobacter infections associated with raw or undercooked poultry would become harder to treat.

When the FDA first proposed its ban on fluoroquinolones in poultry, one of two drug companies that made such drugs for poultry voluntarily withdrew its drug from the market. But another company appealed the decision, which led to a series of hearings. The FDA finally made the ban official in 2005.

See also:

Jun 28 FDA news release
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108941.htm

July 29, 2005, CIDRAP News story "FDA to ban enrofloxacin use in poultry"
http://www.cidrap.umn.edu/cidrap/content/fs/food-disease/news/july2905baytril.html

Jul 28, 2005, FDA news release about the ban on fluoroquinolone use in poultry
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108467.htm

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