GAO Says FDA Should Enhance Seafood Import Sampling, Look at EU

FDA Follows HACCP, but Involves Little Inspection, Foreign Assessment

GAO notes that the FDA’s program is generally limited to enforcing the Hazard Analysis and Critical Control Point (HACCP) - the internationally recognized food safety management system - by conducting inspections of foreign seafood processors and importers each year.

These inspections involve FDA inspectors reviewing records to ensure the processors and importers considered significant hazards, including those resulting from drug residues if the seafood they receive are from fish farms. The inspectors generally do not visit the farms to evaluate drug use or the capabilities, competence, and quality control of laboratories that analyze the seafood. In addition, FDA has conducted foreign country assessments in five countries to gather information about those countries’ aquaculture programs. However, these assessments have been limited by FDA’s lack of procedures, criteria, and standards.

FDA Sampling is also Limited, Ineffectively Implemented

In addition, the scope of FDA’s sampling program, which supplements its oversight program, is limited. Specifically, the sampling program does not generally test for drugs that some countries and the EU have approved for use in aquaculture. Consequently, seafood containing residues of drugs not approved for use in the U.S. may be entering U.S. commerce.

Further, FDA’s sampling program is ineffectively implemented. For example, for fiscal years 2006 through 2009, FDA missed its assignment plan goal for collecting import samples by about 30 percent. In addition, in fiscal year 2009, FDA tested about 0.1 percent of all imported seafood products for drug residues. Moreover, FDA’s reliance on 7 of its 13 laboratories to conduct all its aquaculture drug residue testing raises questions about the agency’s use of resources.

Oversight Is Limited Compared to EU Which Assesses Foreign Systems, Etc.

GAO found that the FDA’s oversight program to ensure the safety of imported seafood from residues of unapproved drugs is limited, especially as compared with the European Union (EU). For example, the EU reviews foreign government structures, food safety legislation, the foreign country’s fish farm inspection program, and visits farms to ensure that imported seafood products come from countries with seafood safety systems equivalent to that of the EU.

FDA and NMFS Have Made Limited Progress on Implementing 2009 MOU

GAO also found that FDA and NMFS have made limited progress in implementing their 2009 a memorandum of understanding (MOU) to enhance seafood oversight and leverage inspection resources. The agencies have developed procedures for certain MOU activities, but because FDA believes NMFS inspectors need training to conduct inspections according to FDA standards, it has not utilized NMFS’ inspection resources or results in a systematic manner. GAO states that better leveraging available resources is critical, especially in places like China.

Says FDA Should Consider Adopting New Practices, Enhance Import Sampling

GAO recommends that FDA study the feasibility of adopting practices used by other entities to better ensure the safety of imported seafood, enhance its import sampling program, and develop a strategic approach for enhancing collaboration with NMFS and better leveraging resources.

(Note that several in the trade have recommended that FDA’s Seafood HACCP program be used as a model for the foreign supplier verification activities that the newly enacted Food Safety Modernization Act requires food importers to implement . See ITT’s Online Archives or 03/31/11 news, 11033124, for BP summary.)