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TAG October 12, 2017 0 Comments

In the wake of the Inspector General report blasting FDA for its deficiencies in food facility inspections, the Government Accountability Office (GAO) is now giving FDA – and USDA this time – a dressing down, and – again – putting the deficiencies right into the title of the report: “FDA and USDA Could Strengthen Efforts to Prevent Unsafe Drug Residues.” The report, released October 2, is a review of the oversight of unsafe drug residues in imported catfish which transitioned from FDA to USDA/FSIS in April 2016. However, while FSIS now has primary regulatory oversight of catfish and catfish products, FDA has dual jurisdiction over establishments that prepare, pack, hold, or otherwise handle fish and fishery products – including catfish. I have to interject here that even as that regulation was being passed, I saw it as a waste of federal resources, a fact I also touted in the headline of a column I wrote for Forbes in June 2016, titled “Catfish Regulation: A Perfect Example Of Wasted Resources In The U.S. Government.” So I guess I’d say that I’m not overly surprised that deficiencies are being found in this area. But to get back to the report, GAO examined how each, FDA and FSIS help to ensure the safety of imported seafood from unsafe drug residues and ways each agency could strengthen its efforts, and the extent to which FDA and FSIS coordinate their oversight efforts. From that, GAO made five recommendations – two to FDA and three to FSIS: FDA should pursue formal agreements with countries exporting seafood to the U.S. to commit these countries to test for drugs of concern and their corresponding maximum residue levels (MRLs). FSIS should visit a sample of farms whose catfish are exported to the U.S. to determine the conditions under which the catfish are being raised, including the drugs being used. FSIS should require that these countries include in their residue monitoring plans the drugs of concern to FSIS and the corresponding MRLs. FDA should coordinate and communicate with FSIS in developing drug residue testing methods and corresponding MRLs for imported seafood that may also be applicable to imported catfish. FSIS should coordinate and communicate the same with FDA Providing more detail on these, the report explains that FDA currently requires processors and importers to follow HACCP, performing a limited number of inspections of processors and importers and tests of imported seafood for contaminants, including unsafe drug residues. However, GAO feels that FDA could strengthen its efforts by pursuing agreements with other countries requiring that they test seafood exported to the U.S. for unsafe drug residues. Under an agency plan, FDA is to coordinate with other countries to increase their capabilities related to the safety of food exported to the United States and better leverage their resources. FDA officials have stated that it might be worthwhile to pursue agreements with some countries, but it would have to carefully consider a number of factors in determining which countries would be appropriate. This has not yet been done. In the regulatory transition, USDA/FSIS provided an implementation transition period through September 1, 2017. At that time, countries that export catfish to the U.S. would have to request equivalence determinations by providing documentation showing that their catfish safety inspection systems are equivalent to the U.S. system. GAO feels that FSIS could strengthen its efforts by conducting visits to fulfill the requirements of the Agricultural Act of 2014 which directs FSIS, in part, to consider the conditions under which catfish are raised, domestically and abroad, but FSIS has not made farm visits a routine part of an equivalence determination. As GAO states, “It is not clear how FSIS could consider the conditions under which imported catfish are raised consistent with the act without visiting farms.” GAO notes, as well, that although FDA and FSIS took steps to accomplish the transfer of catfish oversight as called for in the 2014 memorandum of understanding (MOU) that both agencies signed, they generally have not coordinated on drug residue testing methods. Thus, in some cases, there are differences in drug residue levels used to determine if seafood is unsafe—specifically for unapproved drugs—as called for in the 1984 MOU. Without this coordination, GAO states, the agencies do not have reasonable assurance that they are consistently protecting consumers from unsafe drug residues. FDA/USDA Response FDA agreed with or partially agreed with two; FSIS partially agreed with two and stated it already addresses a third. GAO disagrees and believes the recommendations should be implemented. In its written comments, FDA agreed with the FSIS coordination/communication recommendation, stating that it has a process in place to notify FSIS of new tolerances and changes in tolerances for FSIS-regulated products; that it will extend this process to notify FSIS of concentrations of specific unapproved drugs in catfish; and that it has contacted FSIS about rejoining its quarterly meetings on aquaculture method prioritization and development. FDA partially agreed with GAO recommendation for formal agreements, while stating that it had not received any requests to establish this type of arrangement. FDA also stated that factors outside its control include a country’s ability and readiness to comply with the requirements for a successful arrangement and that applicable test methods, analytical capacity and adequate government oversight would be among essential criteria. GAO recognized that there are external factors, but stated that such factors have not hindered the EU and other countries that have successfully pursued such agreements. In its written comments, FSIS stated that the draft report contains a few misleading or inaccurate statements, such as: “FSIS has not made farm visits a routine part of initial equivalence determinations and verification on-site audits….” FSIS said it has not made any initial equivalence determinations for foreign catfish fish inspection systems so it has not yet had the opportunity to conduct such on-site verification audits. FSIS partially agreed with the recommendation that it visit at least a sample of farms. While recognizing that FSIS does not yet have the required information and documentation from foreign governments for such audits, GAO stated that it still believes it is important that FSIS visit at least a sample of catfish farms as a routine matter instead of relying on a review of documentation describing a foreign country’s fish farm oversight program – as FDA and the EU do as part of their seafood oversight efforts. FSIS also stated that its current policy addresses GAO recommendation that it require countries exporting catfish to the U.S. include in their residue monitoring plans the drugs of concern to FSIS and the corresponding MRLs. It appears that the request for this GAO report was from Senator Thad Cochran who is the current senior United States Senator from Mississippi. Mississippi is one of the four main states that produce domestic catfish, so this request from Senator Cochran is not a coincidence. As I have said many times in the past, the current “Catfish Wars” are politically driven and not public health driven. However, the GAO report has laid out some very nice examples of lack of coordination between our two regulatory agencies as well as a “duh” moment.  The “duh” moment relates to the fact that the main issue with imported seafood is drug resides, and that the drugs are used on farms – but the inspectors don’t go to the farms – duh!!!! About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance.


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