FDA Seeks Recall of Korean Shellfish Due to Norovirus Threat

The U.S. Food & Drug Administration (FDA) is seeking a recall of Korean shellfish over a norovirus threat, it said.

The agency is urging food distributors, retailers, and food service operators to remove from sale or service the following: All fresh, frozen, canned, and processed oysters, clams, mussels, and whole and roe-on scallops (molluscan shellfish) from Korea that have entered the United States. This also includes molluscan shellfish from Korea that entered the U.S. prior to May 1, 2012, which is when the FDA removed these products from the Interstate Certified Shellfish Shippers List (ICSSL), but which may have inadvertently entered the country after that date.

These products and any products made with them may have been exposed to human fecal waste and are potentially contaminated with norovirus.

Molluscan shellfish contaminated with fecal waste and/or norovirus are considered adulterated under the Federal Food, Drug, and Cosmetic Act. Following preliminary notifications in May, some food companies began removing these products from their distribution chain. Many others have yet to take action.

A comprehensive FDA evaluation determined that the Korean Shellfish Sanitation Program (KSSP) no longer meets the sanitation controls specified under the United States’ National Shellfish Sanitation Program. The FDA’s evaluation found significant deficiencies with the KSSP including inadequate sanitary controls, ineffective management of land-based pollution sources, and detection of norovirus in shellfish growing areas. These deficiencies led the regulator to remove all Korean certified shippers of molluscan shellfish from the ICSSL on May 1, 2012.

Consumers who have recently bought molluscan shellfish and are concerned that it may have come from Korea, should contact the store where purchased and ask about its origin or check the label on packaged seafood to determine its origin. If the origin is unclear, consumers should contact the manufacture. The FDA also advises consumers to dispose of molluscan shellfish from Korea and any products made with molluscan shellfish from Korea.

These actions only affect molluscan shellfish harvested from Korean waters and do not affect fresh and frozen molluscan shellfish from distributors, retailers, and food service operators from any of the other shellfish shippers listed in the ICSSL at: http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/Seafood/FederalStatePrograms/InterstateShellfishShippersList/default.htm. These actions also do not affect the import of canned and other processed products made with molluscan shellfish harvested from nonKorean waters.

The FDA stated that it is in discussions with Korean authorities to resolve the issue and noted that while the heat treatment that canned products undergo should eliminate the risk of norovirus, the contents of the cans of molluscan shellfish from Korea are not considered fit for human consumption because the seafood was harvested from waters subject to human fecal contamination. Fresh or frozen products or products processed by methods other than canning should also be considered unfit for human consumption and potentially carrying a risk of norovirus. While there have been norovirus illnesses in the U.S. from the consumption of Korean oysters as recently as 2011, there have been no U.S. related illnesses reported in 2012.

Norovirus are a group of viruses that cause swelling in the linings of the stomach and intestines, according to the U.S. Centers for Disease Control and Prevention (CDC). A highly contagious, severe gastrointestinal illness commonly referred to as the so-called “stomach flu,” norovirus spreads quickly because it transmits easily through the vomit and feces of people sick with the illness. Contact with only a few particles can make a person ill. Norovirus, which can survive for weeks on surfaces at room temperature, can be difficult to eliminate. People are generally considered to be contagious from when they feel ill to about three days after their symptoms subside; however, the virus can still be active in their vomit or stool for two weeks or more.