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Statement from FDA about imported seafood

Food and Drug Administration spokesman Michael L. Herndon responds to questions raised by a TODAY investigation into toxic chemicals in imported seafood.
/ Source: TODAY

On Wednesday, Nov. 17, TODAY aired a report about toxic chemicals in imported seafood. Below is a statement in response from Food and Drug Administration spokesperson Michael L. Herndon:

What kind concern is the use of banned antibiotics, fungicides, and other illegal drug compounds by oversees seafood farmers — and the presence of these illegal compounds in seafood imported into the USA?

A range of chemicals is used to control or prevent specific diseases, to control parasites, to affect reproduction and growth, to improve water quality conditions, and to manage pests  (e.g., weeds , invertebrates) or stress problems. In some cases, aquaculture producers may  rely on drugs to overcome issues associated with high density farming or poor on-farm hygiene. Since relatively few drugs have been approved for aquaculture, some farmers may use unapproved drugs. This prospect raises concerns about potential adverse human health consequences. These unapproved drugs may be toxic, allergenic, carcinogenic, and/or may contribute to the development of antibiotic resistance in pathogens that affect humans.  The administration of drugs during the various stages of aquaculture production may result in the presence of residues of these drugs or their metabolites in the edible portion of  seafood products. Though a number of antibiotics have been banned for application in aquatic food animals by many countries, there are still concerns over illegal use of these drugs. In the U.S., all drugs for use in food animals, whether they are for direct medication or for addition to feed, must be approved by FDA. Drugs not approved by FDA for aquatic species are not allowed to be used at any level and any amount detected is considered to render the product adulterated and in violation of the U.S. law. The most frequently detected unapproved animal drug residues in imported seafood products are: Chloramphenicol, Nitrofurans, Fluoroquinolones, Malachite green, Crystal (Gentian) violet, and Quinolones (Oxolinic acid and Flumequine).

Are there any estimates as to how often the FDA finds these banned compounds in imported seafood? What percentage of imported seafood tested by FDA is found to contain these banned compounds?

The FDA testing program is designed to sample and analyze selected import and domestic aquaculture seafood products to determine the presence of unapproved chemicals. The program is reviewed and reissued each year. Approximately 5 to 7 percent of all samples tested each year under the program have been found to be contaminated with unapproved drug residues. However, products from foreign manufacturers or shippers that have been found to use unapproved new animal drugs are subject to detention without physical examination (DWPE) by FDA. As a result of being placed on DWPE, all subsequent shipments from these firms are automatically stopped at the port of entry and not permitted to be sold in, or imported into, the United States. Shipments may be released by FDA if evidence can be provided by the importer demonstrating that the appearance of the violation (i.e., residues of an unapproved new animal drug) has been overcome and the product complies with applicable FDA regulations.

What kind of health risk does imported seafood containing these banned compounds pose to American consumers?

There is no acceptable level for any residue of an unapproved animal drug found in a seafood product. The current FDA methodology allows detecting drug residues in seafood at parts per billion (ppb) and parts per trillion (ppt) levels. There is no imminent health hazard to American consumers at these levels. Rather, health risk concerns are about the potential for long-term exposure to antibiotics as a result of ongoing consumption of seafood contaminated with residues and potential adverse effects that could include toxicity-related reactions, carcinogenic and mutagenic potential or increased prevalence of infectivity due to antibiotic-resistant microorganisms.

How effective is the FDA's current testing and import alert system in preventing imported seafood contaminated with these banned compounds from reaching consumers?

In the United States, any chemical that is also a new animal drug and intended for commercial distribution (as opposed to investigational study) is required to be the subject of an FDA approved new animal drug application per Section 512 of the Federal Food, Drug, and Cosmetic Act (FFDC Act). FDA approves a drug for specific species, certain disease conditions, route of administration and specific dosages. If this requirement is not met, the drug is adulterated and any food found to contain residues of the drug is also adulterated and, thus, prohibited from interstate commerce. To prevent adulterated fishery products from entering domestic commerce,  FDA has a monitoring program to test for residues of new animal drugs that are not approved for use in farmed fish in the U.S. Any use of an unapproved new animal drug which is of concern to FDA and is revealed through inspection of a foreign facility or through the testing program is communicated to a competent authority and would result in increased surveillance of the potentially adulterated products. Regulatory enforcement actions are taken against entries where positive samples are detected at or above the limit of detection of the most current analytical methodology used. FDA’s general policy is to place violators on an Import Alert which results in detention without physical examination of all subsequent shipments from these firms. In addition, evidence of unapproved  new animal  drug use has been used to place firms on import alert, even when residue levels are below FDA limits of detection. To gain entry of subsequent shipments, these firms subject to an import alert must demonstrate that the product complies with the FD&C Act and FDA regulations and is not contaminated with unapproved new animal drug residues. This provides assurance that if a problem has been detected in the source firm's affected product, and in some situations even that of an entire source country, it effectively becomes subject to 100 percent testing.