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June 28, 2007
FDA is placing farm-raised catfish, a related fish called "basa", shrimp, dace, and eel from China on detention without physical examination ("DWPE", or "Import Alert" status). This means that no products of these types from China can enter the U.S. without first being shown to be safe. Wild caught seafood from China is not impacted by this import alert.
From October 2006 through May 2007 FDA's import surveillance program repeatedly found that farm-raised seafood imported from China were contaminated with unapproved animal drugs or food additives. It is FDA's policy to place firms whose products have been found to contain unapproved drugs or food additives on detention without physical examination status (DWPE). A number of Chinese firms are already on DWPE status for unapproved aquaculture drugs or food additives. When it appears that the problem is not isolated to a select number of firms, but rather is endemic through a country, FDA may place the entire country on DWPE status for that product.
Malachite green, fluoroquinolones, nitofurans, and gentian violet have all been detected. These drugs are used as to inhibit the growth of bacteria and fungus on seafood or to prevent parasite infestation. However, they are not approved for use in farm-raised seafood in the United States.
The levels of the contaminants that have been found are very low, most often at or near the minimum level of detection. As a result, the health risk posed by the detected drugs is primarily from long-term exposure. Nitrofurans, malachite green, and gentian violet have been shown to be carcinogenic in study animals, while the use of fluoroquinolones in food animals may increase antibiotic resistance in human pathogens. Based on the sum of all current information, FDA believes that risk to U.S. consumers due to these drugs in seafood products from China is minimal, and do not represent an immediate risk to public health. FDA's action is precautionary.
The provisions of the import alert require importers to provide results of third-party laboratory analyses of the listed products that prove the products are free of the substances specified in the import alert. Only after FDA import authorities have received and reviewed such proof will they release individual shipments of the listed products for entry into U.S. commerce.
No. The agency does not believe it is necessary to encourage importers to recall their products absent evidence that specific products are contaminated. The agency's import alert announced today will prevent future, chronic exposure to tainted products. [See question above on risk]
Consumers can continue to consume the seafood they have already purchased.
According to statistics provided by NOAA Fisheries:
Shrimp:
90% of the total US supply of shrimp is imported
11.5% of the total US imports of shrimp is from China
9.6 % of the total US shrimp supply is imports from China
100% of imported shrimp from China is aquacultured
Catfish:
2% of the total US supply of catfish is imported
99% of the total US imports of catfish is from China
1.9 % of the total US supply of catfish is imports from China
100% of imported catfish from China is aquacultured
Basa:
100% of US supply of basa is imported
8% of the total US imports of basa is from China
8% of the total U.S. basa supply is imports from China
100% of imported basa from China is aquacultured
The Agricultural Marketing Service (AMS) of the U.S. Department of Agriculture (USDA) requires that fish be labeled regarding the products' country of origin. The USDA country of origin labeling (COOL) requirement is in addition to the generic COOL requirements for all imported products (including all food products) required and enforced by the Customs and Border Protection (CBP). Thus, consumers will be able to determine whether fish is imported from China by referring to the label or labeling of the product. FDA does not have any additional requirements for country of origin labeling for fish offered for sale to U.S. consumers. However, FDA believes that consumers need not be concerned about whether or not the seafood they purchase is from China, because the agency's import alert will prohibit the entry into the U.S. of any seafood products from China that do not meet our requirements and safety standards.
No, unapproved drugs have not been found in any domestic aquacultured products.
Other aquacultured products are imported from China (e.g., tilapia). Several exporters of these other products are subject to detention without physical examination. However, FDA has not noted a pattern of violations with these products that would warrant country-wide DWPE. Nonetheless, we will continue to monitor these products and take further action if warranted.
FDA is aware of two reports issued by the National Toxicology Program on nitrofurans. Nitrofurazone (TR-337 published in June 1988) and Nitrofurantoin (TR-341 published in Sept 1989). Both of these reports concluded that under the conditions of two year feed studies there was clear evidence of carcinogenic activity of these compounds in mice and rats.
In 1991, FDA withdrew the approvals of two nitrofuran drugs, nitrofuranzone and furazolidone. These two drugs had several approved new animal drug applications for both poultry and swine. It was determined that these this class of compounds could induce cancer in man or animals. FDA issued a Federal Register Notice in 1991 that explains the reasons for the withdrawal.
FDA is also aware of a toxicology study published in June 2004 by the National Toxicology Program on malachite green and leucomalachite green. These compounds were nominated for the study by the FDA due to the potential for consumer exposure, structural similarity to gentian violet, and lack of carcinogenicity data. The report of the 2-year feed studies concluded that there were equivocal and some evidence of carcinogenic activity for malachite green and leucomalachite green respectively, in rats
Crystal violet, sometimes referred to as the medicinal preparation gentian violet, is another dye in the triphenylmethane family that has antifungal properties similar to those of malachite green. It has been reported to be used for treatment or prevention of external fungal and parasitic infection in fish and fish eggs. Like MG, CV is readily absorbed into fish tissue from water exposure and is reduced metabolically by fish to the leuco moiety, leucocrystal violet (LCV). Several studies by the National Toxicology Program reported that the carcinogenic and mutagenic effects of crystal violet in rodents. It has also been linked to increased risk of human bladder cancer. The leuco form induces renal, hepatic and lung tumor in mice.
