More than three weeks after removing all Korean certified shippers of molluscan fresh and frozen shellfish and shellfish products from the Interstate Certified Shellfish Shippers List, FDA today issued the following statement:

Important Information for Food Distributors, Retailers, and Food Service Operators Regarding the Sourcing of Molluscan Shellfish from Korea

May 18, 2012

Oysters, clams, mussels, and scallops from Korea should be removed from the market

On May 1, 2012, the Food and Drug Administration (FDA) removed all Korean certified shippers of molluscan shellfish (oysters, clams, mussels, and scallops) from the Interstate Certified Shellfish Shippers List (ICSSL), following a comprehensive FDA evaluation that determined that the Korean Shellfish Sanitation Program (KSSP) no longer meets the sanitation controls spelled out under the National Shellfish Sanitation Program. FDA’s evaluation of the KSSP found significant shellfish growing area deficiencies including:

a.  ineffective management of land-based pollution sources that can impact shellfish growing areas;
b.  inadequate sanitary controls to prevent the discharge of human fecal waste from fish farms and commercial fishing and aquaculture vessels operating in and adjacent to shellfish growing areas; and
c.  detection of norovirus in shellfish growing areas analyzed by FDA during the evaluation

Because of inadequate sanitation controls, the molluscan shellfish harvested from Korean waters may have been exposed to human fecal waste and have the potential to be contaminated with norovirus.

Noroviruses are a group of viruses that cause gastroenteritis. Symptoms of illness associated with norovirus include nausea, vomiting, diarrhea, and stomach cramping. Affected individuals often experience low-grade fever, chills, headache, muscle aches and a general sense of tiredness. Most people show symptoms within 48 hours of exposure to the virus. The illness typically lasts one to two days. Norovirus is usually not life-threatening and does not generally cause long-term effects.

The removal of Korean shellfish shippers from the ICSSL is intended to stop the import of molluscan shellfish harvested from polluted waters. Korean molluscan shellfish that entered the United States prior to May 1 and any product made with Korean molluscan shellfish are considered adulterated under the Federal Food, Drug, and Cosmetic Act.

FDA recommends that food distributors, retailers, and food service operators remove from sale or service, all fresh, frozen, and processed Korean molluscan shellfish and any product subsequently made with them. Korean molluscan shellfish represents only a small fraction of the oysters, clams, mussels, and scallops sold in the United States. FDA is currently working to determine the distribution of the product.

Distributors, retailers, and food service operators can continue to receive molluscan shellfish from any of the other shellfish shippers listed in the ICSSL.

Consumers who have recently bought molluscan shellfish and are concerned that it may have come from Korea, should contact the store from which it was purchased and ask where the shellfish were harvested. Product from Korea should not be consumed.

No U.S. illnesses from the consumption of Korean shellfish have been reported in 2012.

The import ban covers all fresh and frozen oysters, clams, mussels and scallops, including frozen breaded shellfish products. Canned shellfish are not affected by the ban.

The Republic of Korea was one of only five countries that had shellfish sanitation agreements with FDA, and whose raw shellfish products were accepted for the US market. The four remaining countries are Canada, Chile, Mexico and New Zealand.

While FDA has not commented on what provoked the reevaluation, it was most likely prompted by a cluster of three cases of norovirus gastroenteritis in Washington state in the autumn of 2011, and a subsequent illness reported in Pennsylvania. All of the illnesses were linked to consumption of frozen oysters imported from Korea. FDA recovered norovirus from the oysters associated both with the Washington cases and with the case in Pennsylvania.

The illnesses, combined with the confirmation of norovirus in samples of the oysters, led to a series of three recalls, on November 4th, and November 18th of last year, and on January 23, 2012.

What You Need To Know

• Norovirus infection causes nausea, vomiting, diarrhea, and some stomach cramping; most people recover within two to three days without medical treatment. People with norovirus infection should drink plenty of fluids to prevent dehydration and use good hand washing and other hygienic practices to prevent the spread of illness to others.
• FDA considers all fresh and fresh frozen molluscan shellfish and all products subsequently derived from fresh and fresh frozen molluscan shellfish from the Republic of Korea to be adulterated.
• Consumers should check the country-of-origin information typically included on the labels of fresh and fresh frozen shellfish packaging, and discard – or return to the place of purchase – any shellfish or shellfish product labeled as coming from Korea.

State governments from Arkansas to Alaska  are advising consumers that FDA has pulled the plug on the importation of fresh and frozen shellfish from the Republic of Korea.

The import ban, which went into effect on May 1, 2012, covers all fresh and frozen oysters, clams, mussels and scallops, including frozen breaded shellfish products. Canned shellfish are not affected by the ban.

According to a Press Release from the Alaska Department of Environmental Conservation, FDA’s new policy follows a comprehensive evaluation of the Korean Shellfish Sanitation Program, carried out in March of this year. The evaluation turned up “…ineffective management of land-based pollution sources that can impact shellfish growing areas, such as inadequate controls to prevent the discharge of human fecal waste from impacting fish farms and commercial fishing,” according to the Press Release. Also, FDA observed “…aquaculture vessels operating in and adjacent to shellfish growing areas and detected norovirus in shellfish growing areas.”

The Republic of Korea was one of only five countries that had shellfish sanitation agreements with FDA, and whose raw shellfish products were accepted for the US market. The four remaining countries are Canada, Chile, Mexico and New Zealand.

FDA has not released a statement on the change in status of Korean shellfish; however, the reevaluation was most likely prompted by a cluster of three cases of norovirus gastroenteritis in Washington state in the autumn of 2011, and a subsequent illness reported in Pennsylvania. All of the illnesses were linked to consumption of frozen oysters imported from Korea. FDA recovered norovirus from the oysters associated both with the Washington cases and with the case in Pennsylvania.

The illnesses, combined with the confirmation of norovirus in samples of the oysters, led to a series of three recalls, on November 4th, and November 18th of last year, and January 23, 2012.

What You Need To Know

• Norovirus infection causes nausea, vomiting, diarrhea, and some stomach cramping; most people recover within two to three days without medical treatment. People with norovirus infection should drink plenty of fluids to prevent dehydration and use good hand washing and other hygienic practices to prevent the spread of illness to others.
• FDA considers all fresh and fresh frozen molluscan shellfish and all products subsequently derived from fresh and fresh frozen molluscan shellfish from the Republic of Korea to be adulterated.
• Consumers should check the country-of-origin information typically included on the labels of fresh and fresh frozen shellfish packaging, and discard – or return to the place of purchase – any shellfish or shellfish product labeled as coming from Korea.