On May 1, 2012, the U.S. 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.
May 30, 2012
On May 1, 2012, the U.S. 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:
- ineffective management of land-based pollution sources that can impact shellfish growing areas;
- 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
- 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.
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.
Press release