GAO Issues Critical Seafood Safety Report (and Domestic Catfish Farmers Rejoice)

May 19, 2011

By Ricardo Carvajal

In a report titled “Seafood Safety: FDA Needs to Improve Oversight of Imported Seafood and Better Leverage Limited Resources,” GAO found fault with many aspects of FDA’s imported seafood safety program.  GAO set the stage for its review by noting that more than 80% of seafood consumed in the U.S. is imported, and half of that is the product of aquaculture.  GAO than turned its attention to the use of antibiotics and antifungal agents in aquaculture, and the potential presence of residues in imported fish. 

GAO found FDA’s efforts wanting in comparison with the efforts made by regulatory authorities in other jurisdictions, such as the EU.  In part, GAO found that FDA’s foreign inspections are generally limited to a review of HACCP records, whereas those of the EU include visits to farms and testing laboratories; the EU requires foreign countries to demonstrate the equivalence of their seafood safety system or meet requirements established by agreement, whereas FDA does not;  FDA tests for residues of 16 unapproved drugs, whereas some EU countries test for residues of as many as 50 drugs; and FDA collects a small number of samples for testing (0.1% of imports) in comparison with the number collected by some other EU countries (as much as 4%).  GAO also found that FDA and the National Oceanic and Atmospheric Administration’s National Marine Fisheries Service (NMFS) “have made limited progress in implementing” an MOU executed by the two agencies in 2009, pursuant to which FDA is expected to increase its use NMFS’ inspection resources.

In its comments on the report, FDA (through DHHS) countered that “reading the GAO report may not result  in a full understanding of FDA’s multifaceted and risk-informed seafood safety program.”  Among other things, FDA noted that its testing is considerably more rigorous than that used in other jurisdictions, which in some instances has been shown to yield results of questionable validity.  FDA also noted that it plans to deploy new authorities under the Food Safety Modernization Act to help ensure the safety of imported seafood.  Notably, neither FDA nor GAO address what appears to be a key issue, namely why FDA has approved 5 drugs for use in aquaculture as compared to more than 15 in Japan and more than 30 in the EU.

The GAO report is doubtless welcome news for domestic catfish farmers, who succeeded in their bid to grant jurisdiction over catfish to the USDA via the 2008 Farm Bill, in part due to the purported inadequacies of FDA’s oversight.  The issuance of GAO’s report was touted in a press release by Sen. Thad Cochran (sponsor of the 2008 Farm Bill measure), who took the opportunity to encourage USDA to move forward with its implementing regulation.  Public meetings on that rulemaking are scheduled for May 24 and 26.

Those who prefer a more integrated approach to government regulation of food safety might recall that GAO recently issued a hefty report identifying “opportunities to reduce potential duplication in government programs, save tax dollars, and enhance revenue.”  GAO pointed to the nation’s fragmented food safety system as one such opportunity, and observed the following: 

Although reducing fragmentation in federal food safety oversight is not expected to result in significant cost savings, new costs may be avoided by preventing further fragmentation, as illustrated by the approximately $30 million for fiscal years 2011 and 2012 that USDA officials had said they would have to spend developing and implementing the agency’s new congressionally mandated catfish inspection program.