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FDA has a Memorandum of Understanding with only a few countries for the importation of raw molluscan shellfish. The MOU is a signed agreement by the participating country to control the safety of molluscan shellfish in accordance with the NSSP. Only countries that have a current Memorandum of Understanding with FDA are permitted to import their “raw” shellfish into the United States. FDA has Memorandums of Understanding for the importation of “raw” molluscan shellfish with these four countries. In MOU countries, the hazard of pathogenic microorganisms is controlled through implementation of NSSP requirements. The NSSP requires that shellfish be grown in clean waters, harvested only from clean waters, processed in a safe and sanitary manner, properly labeled, and shipped in a safe and sanitary manner. Non-MOU countries may only import “cooked” molluscan shellfish into the United States. The cooking process must be adequate to reduce microorganisms to a non-detectable level. FDA has zero tolerance for Salmonella spp. and Listeria monocytogenes in cooked ready-to-eat products. Certain species of marine plankton can produce natural toxins. These toxins, which do not harm shellfish, can be concentrated in shellfish and cause serious illness or death if the shellfish are eaten. Molluscan Shellfish Control of Natural Toxins Cooking will not eliminate or significantly reduce the level of natural toxins in shellfish meats. 第六十一页,共七十六页。 Molluscan Shellfish Control of Natural Toxins 2 methods of Control Monitoring of shellfish meats from “key” locations in the growing
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