FDA Issues Warning on Korean Shellfish, says Sanitation Controls no Longer Adequate
All fresh, frozen, canned, and processed oysters, clams, mussels, and whole and roe-on scallops (molluscan shellfish) from Korea that have entered the U.S. should be removed from sale or service, said the Food and Drug Administration. This includes molluscan shellfish from Korea that entered the U.S. prior to May 1, 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, it said. According to FDA, These products and any products made with them may have been exposed to human fecal waste and are potentially contaminated with norovirus.
Sign up for a free preview to unlock the rest of this article
Timely, relevant coverage of court proceedings and agency rulings involving tariffs, classification, valuation, origin and antidumping and countervailing duties. Each day, Trade Law Daily subscribers receive a daily headline email, in-depth PDF edition and access to all relevant documents via our trade law source document library and website.
Korean Sanitation Controls Inadequate, Norovirus Detected in Growing Areas
FDA said its 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, it said.
The deficiencies in the KSSP prompted the FDA to remove all Korean certified shippers of molluscan shellfish from the ICSSL on May 1. FDA said Korean molluscan shellfish represent only a small fraction of the oysters, clams, mussels, and scallops sold in the United States.
No Effect on Shellfish from Non-Korean Waters
According to FDA, 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, FDA said, and 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, it said.
Although the heat treatment that canned products undergo should eliminate the risk of norovirus, said FDA, 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, it said.