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GAO warns FDA, FSIS about drug residue in seafood imports

U.S. seafood imports from as many as 140 countries reached 6 billion pounds by 2015, with 50 percent coming from foreign fish farms.

“As imports of farmed seafood increase, so too do the concerns over the presence of drug residues,” says a new U.S. Government Accountability Office (GAO) report prepared for Sen. Thad Cochran, R-TN, who chairs the Senate Committee on Appropriations.

Both the U.S. Food and Drug Administration and the USDA’s Food Safety and Inspection Service (FSIS) are responsible for enforcing food safety regulations for imports. FDA handed off the inspections of foreign and domestic catfish to FSIS in 2016.

The 70-page GAO report says both FDA and FSIS could do more to combat unsafe drug residues in seafood imports. The top two federal food safety agencies, however, only partially agree with GAO’s recommendations.

“(FDA) generally depends on the actions of foreign processors and U.S. importers” to ensure the safety of imported seafood from unsafe drug residues, according to the report.

Imports account for 90 percent of seafood consumed in the U.S.  The largest players in the U.S. seafood market are China, Canada, Vietnam and Chile.

With this graph, the GAO report illustrates where the United States got its imported seafood in 2015.

Although it has jurisdiction over foreign seafood, FDA’s touch is a light one. The GAO reports only 2.2 percent of 2015’s  incoming seafood was examined by FDA, only 0.4 percent was sampled; and only 0.1 percent was sampled for drug residue.

FDA does require processors and importers to conduct Hazard Analysis and Critical Control Point (HACCP) planning to identify hazards and take corrective actions. It also does “a limited number” of inspections, according to GAO, including tests for unsafe drug residues.

In taking over catfish, which amounts to about 4 percent of all seafood imports, FSIS requires countries exporting to the U.S. to show how their catfish inspection systems are equivalent to the U.S. Under a congressional mandate, FSIS also requires foreign catfish inspections go through a so-called “secondary inspection” at U.S. ports of entry.

Under the Agricultural Act of 2014, FSIS has the power to visit catfish farms to view the conditions at those locations.

“With visiting a sample of farms whose catfish are exported to the United States, FSIS may be missing an opportunity to consider the conditions under which catfish are being raised,” according to the GAO report.

Further, the GAO says now that both FDA and FSIA share responsibilities for the safety of seafood imports, the two agencies should coordinate their drug residue testing methods.

“Without this coordination, the agencies do not have reasonable assurance that they are consistently protecting consumers from unsafe residues,” GAO adds.

The report says FDA, which historically been responsible for the safety of all seafood consumed in the U.S., has more authority now under the Food Safety Modernization Act (FSMA), including the power to suspend the registration of any food facility.

The increasing popularity of catfish farms is raising concerns about drug residues in imported products.

In the 2014 Farm Bill, Congress pointed to the rapid growth of catfish imports as a reason for FSIS to take over catfish inspections. The GAO report says catfish imports totaled 250 million pounds in 2015, up from 30 million pounds 10 years earlier in 2005.

Vietnam’s share reached 95 percent in 2015, up from 79 percent in 2005.

The GAO’s team also looked at the European Union to see how it keeps drug residues in imported seafood at bay. They found the EU conducts on-site audits of its trading partners’ food safety systems. It also requires countries that export food to the EU to implement national residue monitoring plans. Those plans must include sampling and testing of food products for specific drugs “of concern to the EU.”

The GAO recommendations

  • FDA should pursue formal agreements with countries exporting seafood to the United States that commit these countries to test for drugs of concern to the FDA for maximum residual levels (MRLs).
  • FDA should coordinate and communicate with FSIS in developing drug testing methods and MRLs that may also apply to imported catfish.
  • FSIS should visit catfish farms when doing on-site audits in other countries for equivalence determinations.
  • FSIS should include residue monitoring plans for drugs and their MRLs in doing equivalence determinations.
  • FSIS should coordinate and communicate with FDA in development testing methods and MRLs.

Agency responses

FDA: On pursuing formal agreements, FDA “partially concurs,” but say it has not received any requests for “this type of arrangement.” It says “factors outside the agency’s control that could limit robust implementation of this recommendation including the country’s ability and readiness to comply with the requirements necessary to have a successful arrangement.”

In the meantime, FDA says it will use its existing tools to “ensure the safety of seafood imported into the United States.” On coordinating with FSIS, it says the agencies have a process in place for the issue.

FSIS: On the recommendation for visiting different catfish farms in exporting countries, FSIS said such visits are not always necessary. On making drug residue plans part of the equivalence determinations, FSIS gives a long explanation, saying its current policy covers the recommendation. It also partially concurs with the recommendation for working with FDA on drug residue testing issues.

The GAO conducted the performance audit in the field from January 2016 to September 2017. The National Fisheries Institute, representing 200 seafood processors, importers, and exporters, and the Consumer Federation of America, with 300 non-profit consumer organizations, provided input. The audit team was led by Steve D. Morris, director of Natural Resources and Environment for GAO.

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