FDA to Detain Certain Farm-Raised Chinese Seafood Until Proven Free of Potentially Harmful Residues

FDA states that it is taking this action as its targeting sampling from October 1, 2006 through May 31, 2007 repeatedly found that farm-raised seafood from China was contaminated with antimicrobial agents that are unapproved in the U.S. for use in farm-raised seafood.

(FDA has previously issued Import Alerts regarding aquaculture from China, but this Import Alert broadensprevious import control of subject merchandise from China. Consequently, FDA's prior Import Alert 16-130 is withdrawn and the Chinese firms producing catfish, basa, shrimp, dace, and eel currently listed on Import Alerts 16-124 and 16-129 are covered by this new alert.)

List of Products, Product Codes to be Detained Without Physical Examination

The following is a list of products and product codes that will be detained without physical examination (for the product code, the appropriate subclass and PIC (process identifier code) must still be added):

FDA Will Accept Entries of Subject Chinese Products That Demonstrate Compliance

According to the FDA, it will accept entries of these aquaculture products from Chinese firms that demonstrate compliance with U.S. requirements and safety standards.

A Chinese exporter can be exempted from FDA's detention action by providing specific information to the FDA that demonstrates that the exporter has implemented steps to ensure its products do not contain the unapproved substances and that preventative controls are in place.

Additionally, the FDA may allow the entry into the U.S. and subsequent distribution into the marketplace of individual shipments of the Chinese farm-raised seafood products if the company provides documentation to confirm the products are free of residues of antimicrobial agents.

FDA Has Found Unapproved Antimicrobial Agents in Subject Chinese Seafood

According to a FDA question and answer (Q&A) document on this Import Alert, the subject seafood from China has been found to contain the following unapproved antimicrobial agents: malachite green, fluoroquinolones, nitofurans, and gentian violet. These drugs are used to inhibit the growth of bacteria and fungus on seafood or to prevent parasite infestation.

FDA adds that nitrofuran, malachite green, and gentian violet have been shown to be carcinogenic with long-term exposure in lab animals. The use of fluoroquinolones in food animals may increase antibiotic resistance to this critically important class of antibiotics. (The use of nitrofurans and malachite green in aquaculture is also prohibited by Chinese authorities.)

No FDA Recall for Products Containing Antimicrobial Agents Already in U.S. Commerce

FDA states that the levels of the drug residues that have been found in seafood are very low, most often at or near the minimum level of detection. FDA is not seeking recall of products already in U.S. commerce and is not advising consumers to destroy or return imported farm-raised seafood they may already have in their homes. FDA is concerned about long term exposure as well as the possible development of antibiotic resistance.

¹Dace and eel may also be coded as aquaculture harvested product, not elsewhere classified (i.e., 16X[ ][ ]99).

FDA Import Alert, entitled "Detention without Physical Examination of Aquacultured Catfish, Basa (Pangasius sp), Shrimp, Dace, and Eel Products from the People's Republic of China Due to the Presence of New Animal Drugs and/or Unsafe Food Additives" (IA 16-131, dated 06/28/07) available at http://www.fda.gov/ora/fiars/ora_import_alert_text_date.html

FDA press release (dated 06/28/07) available at http://www.fda.gov/bbs/topics/NEWS/2007/NEW01660.html

FDA Q&A document on this import alert (dated 06/28/07) available at http://www.cfsan.fda.gov/frf/seadwpe.html

FDA timeline on farm-raised fish imported from China (posted 06/28/07) available at http://www.fda.gov/consumer/updates/fishtimeline062807.html