On May 16, the U.S. Government Accountability Office (GAO) made public a report prepared for the United States Senate Committee on Commerce, Science, and Transportation reviewing the Food and Drug Administration’s (FDA) regulation of banned antibiotics, fungicides, and other harmful drug residues in imported seafood. The report, “Seafood Safety: FDA Needs to Improve Oversight of Imported Seafood and Better Leverage Limited Resources” (GAO-11-286),” compares the FDA’s regulatory approach to that of the European Union and other major seafood importing nations. The GAO’s comparison underscores the deficiencies in the FDA’s regulatory oversight regarding imported seafood.
The GAO reviewed internal FDA documents and records not available to the public and reported:
· The GAO Report observes that (1) “tetracycline and neomycin have been determined to be highly important antimicrobials in humans” and, according to the World Health Organization “overuse of these drugs in food animals could contribute to increasing the risk of antibiotic resistant bacterial infections in humans;” (2) China allows the use of tetracycline in aquaculture; (3) Vietnam allows the use of neomycin in aquaculture; (4) Japan has “detected excessive levels of tetracycline in the shrimp products it imported from China” and the European Union “detected excessive levels of neomycin in imported catfish from Vietnam;” and (5) the FDA does not test farmed seafood imports for either tetracycline or neomycin. Based on these observations, the Report concludes: “Because FDA does not include tetracycline and neomycin in its sampling program, it has no assurance that seafood containing these drug residues has not entered the United States.” (pp. 20-21).
· In fiscal year 2009, “the seafood samples FDA reported it collected for drug residue testing amounted to 0.1 percent of all seafood products imported into the United States.” In contrast, other major seafood importing countries test a far larger amount of seafood imports for drug residues: “Canada routinely tests at least 5 percent of all seafood imports, and Japan tested about 11 percent of seafood imports in fiscal year 2009. Select EU member countries test for as much as 4 percent of their seafood imports. In addition, the EU requires more testing for countries that produce larger quantities of seafood because of the increased risk of more adulterated products.” (pp. 21, 23).
· The limited sampling that the FDA does conduct for testing drug residues shows significant contamination of banned antibiotics in shrimp imports: “Although FDA collected a total of 349 shrimp samples, it tested only 34 for residues of nitrofurans, and 6 (18 percent) of these samples were found to contain nitrofurans.” The GAO Report concludes: “Because of FDA’s limited sampling, some of the more than 2.5 million metric tons [5.5 billion pounds] of shrimp and 156,000 metric tons [344 million pounds] of catfish imports that entered the United States during fiscal years 2006 through 2009 could have contained residues of nitrofurans.” (p. 21).
· The FDA also only conducts limited inspections of foreign seafood processors. Although China “accounts for 23 percent of seafood imports into the United States,” the FDA inspected only “41 of 2,744 (or 1.5 percent)” of Chinese seafood processing facilities in the last six years. (p. 25).
· In September 2008, FDA officials went to Vietnam to obtain information regarding the Vietnamese government’s control of drug residues in farmed seafood. The information obtained by the FDA “indicated that all processing facilities’ HACCP plans stated if a drug unapproved by the EU is found in a seafood product, that product should be diverted to another market.” Appropriately, “[t]he FDA officials concluded that this HACCP plan requirement could result in such products being imported into the United States.” The FDA asked the Vietnamese government to test 100% of seafood products destined for the United States and “[t]he Vietnamese government responded that it performed 100 percent testing only for products intended for countries with which it had a bilateral agreement, of which the United States was not one.” Although Canada has such an agreement with Vietnam, “[a]ccording to FDA officials, the agency has not taken steps to develop such an agreement.” The GAO Report notes no additional steps taken by FDA to address potential diversion of contaminated seafood to the U.S. market from Vietnam. (pp. 15-16).
· The GAO Report notes that after the European Union inspected Bangladesh in November 2008, numerous problems were found with Bangladeshi control over drug residues in farmed seafood. Bangladesh voluntarily stopped the export of freshwater shrimp to Europe from May 2009 through January 2010. “The EU placed Bangladesh on special import conditions in 2008, which required 100 percent testing of all shrimp bound for the EU for chloramphenicol, tetracycline, nitrofurans, malachite green, and crystal violet in Bangladesh prior to export. In addition, 20 percent of all shrimp imports must also be tested at EU ports of entry at the importers’ expense.” The FDA inspected Bangladeshi processing facilities in February 2009 and was unaware of the European Union’s actions: “Moreover, Bangladesh did not impose a similar ban on shipments to the United States, and according to FDA officials, the agency, at the time, had no knowledge of the Bangladesh ban on shipments to the EU.” The GAO Report notes that FDA surveillance of Bangladesh imports was extremely limited, despite the strong likelihood of diversion: “In fact, from June through December 2009 – the period of the ban – FDA analyzed four shrimp samples from Bangladesh for nitrofurans.” Responding to the GAO report, the Department of Health and Human Services (HHS) criticizes the European Union’s findings regarding nitrofurans in shrimp imports from Bangladesh. But the HHS does not cite to the FDA’s own testing of shrimp imports to demonstrate that no problem existed, instead relying on a press release from the “Seafood Importers and Processors Alliance” for its account of the European Union’s actions. (pp. 18-19, 43).
· As a result of the European Union’s inspection of Indonesia in November 2009, “the EU imposed a 20 percent sampling requirement at the EU ports of entry for all farmed fish imports because it believed that there was a risk that imported farmed products from Indonesia contained residues of chloramphenicol, nitrofurans, and tetracyclines.” The GAO Report notes no additional steps taken by FDA to address potential diversion of contaminated seafood to the U.S. market from Indonesia. (p. 17).
The GAO’s summary of the Report and the full text of the Report are available at the agency’s web-site: http://gao.gov/products/GAO-11-286.