February 11, 2013 Update:
After evaluating improvements made to the Korean Shellfish Sanitation Program, FDA has reinstated Korean shellfish shippers to the Interstate Certified Shellfish Shippers List (ICSSL). The reinstatement applies to shipping fresh and frozen molluscan shellfish harvested in Korea on or after February 8, 2013. State and local retail food codes modeled after the FDA Food Code contain requirements that make it unlawful for retailers and food service operators to obtain molluscan shellfish from sources not included on the ICSSL.
December 21, 2012 Update:
After reviewing new information and data that the Ministry of Food, Agriculture, Forestry and Fisheries of the Republic of Korea provided regarding the conditions of the Korean molluscan shellfish growing areas, in addition to the results of FDA’s on-site evaluation earlier this year, the Agency maintains its view that canned molluscan shellfish harvested from growing Areas 1 or 2 during 2012 is not fit for human food and should be removed from the market. FDA may take action to restrict the import and/or distribution of canned and processed products harvested from Areas 1 or 2 during 2012.
FDA does not intend to restrict the import and/or distribution of canned molluscan shellfish harvested from Areas 1 or 2 prior to 2012 and canned product harvested from Chilcheondo or other areas during any year. Importers and distributors are responsible for ensuring that products in commerce have not originated from Areas 1 or 2 during 2012.
FDA NEWS RELEASE
For Immediate Release: June 14, 2012
Consumer Inquiries: 888-INFO-FDA
FDA urges that oysters, clams, mussels, and some scallops products from Korea should be removed from the market
The U.S. Food and Drug Administration is urging food distributors, retailers, and food service operators to remove from sale or service 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 includes molluscan shellfish from Korea that entered the United States prior to May 1, 2012, when the FDA removed such products from the Interstate Certified Shellfish Shippers List (ICSSL), and that 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 initial notifications last month, a number of food companies have begun to remove these products from their distribution chain. However, 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.
The deficiencies in the KSSP prompted the FDA to remove all Korean certified shippers of molluscan shellfish from the ICSSL on May 1, 2012. Although Korean molluscan shellfish represent only a small fraction of the oysters, clams, mussels, and scallops sold in the United States, the removal of Korean shellfish shippers from the ICSSL is an important step in stopping the importation of molluscan shellfish harvested from polluted waters.
Consumers who have recently bought molluscan shellfish and are concerned that it may have come from Korea, should contact the store where it was purchased and ask about its origin. Consumers can check the label on packaged seafood to see if it is from Korea. If it is not clear where the product is from, consumers can call the manufacturer to find out. Consumers should 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. They do not affect the receipt of fresh and frozen molluscan shellfish by distributors, retailers, and food service operators from any of the other shellfish shippers listed in the ICSSL
. Further, these actions do not affect the importation of canned and other processed product made with molluscan shellfish harvested from non-Korean waters. The FDA is in ongoing discussions with Korean authorities to resolve the issue.
Although the heat treatment that canned products undergo should eliminate the risk of norovirus, the contents of the cans of molluscan shellfish from Korea are still considered not fit for human food because the products were harvested from waters subject to human fecal contamination. For fresh, frozen, or products processed by methods other than canning, the products should also be considered food not for human consumption and may also carry a risk of norovirus.
Noroviruses 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 12 to 48 hours after exposure to the virus. The illness typically lasts one to three days. Dehydration is the most common complication, especially in young children and older adults, which may require medical care. While there have been norovirus illnesses in the United States from the consumption of Korean oysters as recently as 2011, there have been no U.S. illnesses from the consumption of Korean shellfish reported in 2012.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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