The U.S. food safety system is characterized by inconsistent oversight, ineffective coordination, and inefficient use of resources; these characteristics have placed the system on GAOÂ’s high-risk list. Assigning responsibility for examining and inspecting domestic and imported catfish to the Food Safety and Inspection Service (FSIS) adds to the potential for the ineffective coordination and inefficient use of resources in food safety. Specifically, giving the U.S. Department of Agriculture (USDA) such authority would introduce duplication into the already fragmented U.S. food safety system. Historically, FSIS has been responsible for meat, poultry, and processed egg products, and the Department of Health and Human ServiceÂ’s Food and Drug Administration (FDA) is responsible for all other food, including seafood. Moreover, the National Oceanic and Atmospheric AdministrationÂ’s National Marine Fisheries Service, through its fee-for-service inspection program, assesses seafood processorsÂ’ compliance with federal food safety regulations.
The Food, Conservation, and Energy Act of 2008 (the 2008 Farm Bill) assigned regulatory responsibility for catfish inspection to USDA once the agency issues final regulations for the catfish inspection program. As GAO reported in May 2012, should USDA begin the catfish inspection program as mandated in the 2008 Farm Bill, the program would duplicate work already being conducted by FDA, and by the National Marine Fisheries Service, which provides fee-for-service inspections of seafood for industry.
Under FSISÂ’s proposed program, processers would implement written sanitation and hazard control plans; FSIS would conduct continuous inspections of domestic catfish processing; and for imported catfishÂ—which equal about 3 percent of all seafood importsÂ—foreign countries would need to demonstrate equivalence to U.S. standards. According to FSISÂ’s estimate, the annual cost to the federal government to implement this program would be about $14 million dollars. We did not independently audit FSISÂ’s estimate, but we observed some limitations with FSISÂ’s cost data and assumptions that would affect the final accuracy of the agencyÂ’s estimate.
If FSISÂ’s proposed program were implemented, GAO expects it would cause duplication and inefficient use of resources in several key areas. First, the program would require implementation of hazard analysis plans that are essentially the same as FDAÂ’s hazard analysis requirements. For example, both agenciesÂ’ programs would require industry participants to identify hazards that are reasonably likely to occur; identify a point, step, or procedure in the production process where controls can be applied to deal with the hazard; establish corrective action plans; and establish record-keeping and documentation procedures, among other things. Second, if the program is implemented, as many as three agenciesÂ—FDA, FSIS, and the National Marine Fisheries ServiceÂ—could inspect facilities that process both catfish and other types of seafood. Both FDA and National Marine Fisheries Service officials stated that continuous inspection will not improve catfish safety and, according to FDA officials, is counter to the use of FDAÂ’s hazard analysis requirements, in which systems are most efficiently monitored periodically rather than daily. Third, the FDA Food Safety Modernization Act, enacted in January 2011, gives FDA authority to establish a system to recognize accreditation bodies to accredit third-party auditors, including foreign governments, to conduct food safety audits to determine compliance with the Federal Food, Drug, and Cosmetic Act, and to certify that foreign seafood processors and imported seafood meet FDA regulatory requirements. FDA officials stated that this new authority complements FDAÂ’s existing authority to obtain assurances about the safety of seafood exports from countries with food safety systems FDA determined are comparable to those of the United States. With its new authority under the FDA Food Safety Modernization Act, FDA has an opportunity to enhance the safety of all imported seafoodÂ—including catfishÂ—and to avoid the duplication of effort and cost that would result from FSISÂ’s implementation of its proposed program.
With FDAA’s new authority under the FDA Food Safety Modernization Act, the federal government has an opportunity to enhance the effectiveness of the food safety system of all imported seafood, including catfish, and avoid the duplication of effort and costs that would result from FSISÂ’s implementation of its proposed catfish inspection program. GAO recommended in May 2012 that Congress may wish to consider the following action:
Doing so could save U.S. taxpayers about $14 million dollars annually, according to FSIS estimates of the programÂ’s cost.
The information contained in this analysis is based on findings from the product listed in the related GAO product section. To conduct this work, GAO reviewed FSISÂ’s proposed catfish inspection program and related documents, including the risk assessment and impact analysis. In addition, GAO reviewed written public comments on the proposed regulations provided by industry and consumer groups. GAO interviewed officials from FSIS involved in the development of the proposed regulations and officials from FDA, the National Marine Fisheries Service, and other federal agencies, as well as representatives from industry and consumer advocacy groups. We reviewed the FDA Food Safety Modernization Act to identify the additional authorities to enhance the oversight of imported seafood this legislation granted FDA. We interviewed officials from FSIS, FDA, and the National Marine Fisheries Service to better understand FSISÂ’s proposed program, its costs and benefits, and the similarities and differences between it and FDA and the National Marine Fisheries Service inspection programs. Table 1 in appendix IV lists the programs GAO identified that might have similar or overlapping objectives, provide similar services, or be fragmented across government missions. Overlap and fragmentation might not necessarily lead to actual duplication, and some degree of overlap and duplication may be justified.
In commenting on the May 2012 report on which this analysis is based, USDA stated that it appreciated our work in planning, conducting, and issuing the report and added that it was committed to completing the rulemaking process on catfish inspection in a manner that was consistent with the 2008 Farm Bill provisions.
GAO provided a draft of this report section to the Departments of Agriculture, Commerce, and Health and Human Services for review and comment. The Departments did not have any comments on this report section and the Department of Agriculture reiterated its commitment to completing the rulemaking process on catfish inspection.
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In determining that Salmonella is the primary food safety hazard in catfish, the U.S. Department of Agricultures Food Safety and Inspection Service (FSIS) officials stated that the agency focused on Salmonella at the direction of the Office of Management and Budget (OMB), which considered Salmonella the most practical hazard to evaluate. However, GAO found that FSIS used outdated and limited...
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