FSIS and FDA are the two primary food safety agencies. FSIS is responsible for the safety of meat, poultry, and processed egg products, and, pursuant to the Farm Bill, is given authority to inspect catfish as soon as it issues final regulations to carry out a catfish inspection program. FDA is responsible for virtually all other food, including seafood. Under the Federal Food, Drug, and Cosmetic Act, FDA is responsible for ensuring that the nation’s food supply, including seafood, is safe, wholesome, sanitary, and properly labeled. Since 1997, FDA has used the internationally recognized Hazard Analysis and Critical Control Point (HACCP) system as its main oversight tool for seafood safety. FDA requires seafood processing firms—those that, among other things, manufacture, pack, or label seafood products—to use a HACCP system. Under this system, processors are primarily responsible for the safety of the seafood they process. That is, processors are responsible for identifying where in their processing system one or more hazards are reasonably likely to occur (hazard analysis) and implementing control techniques to prevent or mitigate these hazards. Processors are to lay out their hazard analysis and control techniques in HACCP plans. FDA verifies through inspections that the techniques are adequate to control the identified significant hazards and are being effectively implemented. FDA inspects domestic and foreign seafood processors in an effort to ensure their compliance with HACCP regulations. FDA supplements its HACCP oversight activities with an import oversight program that includes examination and testing of some imported seafood at ports of entry to ensure the products meet U.S. requirements, including the absence of residues of drugs that are unapproved for use in the United States and would render the seafood adulterated under the Federal Food, Drug, and Cosmetic Act; FDA also maintains data on the shipments of seafood that it has refused to allow into the United States. The FDA Food Safety Modernization Act (FSMA), enacted in January 2011, gives FDA new authorities to improve its ability to oversee the safety of imported foods. As described in FSMA, FDA must establish a system for recognizing 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 eligible foreign entities, including seafood processors, meet applicable requirements. FDA may directly accredit third-party auditors under certain circumstances. FSMA also contains provisions on laboratory accreditation that enable FDA to leverage state, foreign government, and private laboratory resources for food testing. Furthermore, these laboratories must meet model standards developed by FDA that ensure quality and reliability of the test results used to verify the safety of any food product, including imports. In April 2011, we stated that FDA’s current program to ensure the safety of imported seafood is limited because the agency relies on document review at individual foreign processing facilities and on importers for HACCP compliance, conducts only a few inspections of foreign facilities, samples a limited number of imports at the U.S. border, and does not make effective use of laboratory resources. For example, in fiscal year 2011, FDA examined about 3.4 percent of all seafood entries and performed laboratory analysis on 0.7 percent of these entries. We recommended, in part, that FDA study the feasibility of adopting practices that the European Union employs to ensure the safety of imported seafood products, such as requiring foreign countries that want to export seafood to the United States to develop a national residues monitoring plan to control the use of drugs used in aquaculture (fish farming). Because fish grown in confined aquacultured areas can have high rates of bacterial infections, farmers may treat them with drugs, such as antibiotics and antifungal agents, to increase fish survival rates. According to a 2008 FDA report, the residues of some of these drugs can cause cancer, allergic reactions, and antibiotic resistance when consumed by humans. As imports of aquacultured seafood products increase, so do the concerns over the presence of drug residues. NMFS’s Seafood Inspection Program provides fee-for-service inspections, primarily under the authority of the Federal Agricultural Marketing Act of 1946. According to NMFS officials, NMFS’s experience with seafood controls dates to the1970s, when the agency began systematically evaluating controls as part of its inspection program. NMFS more formally adopted the systematic evaluation with the development of its Quality Management Program in 1993, which integrates quality into its HACCP-based inspection system. Currently, NMFS provides inspection services on request to the seafood industry— including domestic and foreign processors, distributors, and other firms— to certify that these seafood firms comply with HACCP requirements and other federal food safety standards, among other things. Some retailers require this certification as a condition for purchasing the seafood products. Before 2002, various fish in the order Siluriformes were commonly labeled and sold as “catfish.” However, in 2002, Congress amended the Federal Food, Drug, and Cosmetic Act to allow only fish from the family Ictaluridae (in the order Siluriformes) to use the name catfish in labeling. All other fish, such as those from the Pangasiidae family (in the order Siluriformes) that had previously been labeled as catfish, had to have other names on labels, such as basa, swai, or tra. In making catfish subject to mandatory FSIS inspection, the Farm Bill gave the Secretary of Agriculture discretion to define “catfish” for the purposes of inspection— that is, to distinguish between different types of catfish or to consider all fish in the order Siluriformes as catfish. For purposes of this report, we refer to all catfish potentially subject to regulations as catfish, including fish in the family Ictaluridae, which are primarily of domestic origin, and Pangasiidae, which come primarily from Vietnam (see fig. 1). In recent years, the volume of imported catfish of all families entering the U.S. market has continued to increase, while the volume of domestic catfish entering the market has declined. In 2002, the percentage of imported catfish in the U.S. market was estimated at 2 percent, and by 2006, imported catfish of all families accounted for an estimated 12 percent of the U.S. market. This trend has continued: by 2010, imported catfish accounted for 23 percent of the U.S. catfish market, and domestic catfish accounted for 77 percent. The most recent data show a 29- percent decline in domestic catfish production from 2010 to 2011. Figure 2 shows the trend in the volume of domestic and imported catfish from 2006 to 2010. Overall, imported Siluriformes catfish constituted a small fraction of seafood imported to the U.S. in 2010, at about 3 percent. Figure 3 shows the major countries exporting catfish to the United States. The volume of catfish subject to FSIS’s proposed catfish inspection program will depend on the definition of catfish that the Secretary of Agriculture decides to apply. In 2010, 79 percent of the catfish in the U.S. market consisted primarily of domestically processed catfish as well as some imported catfish from the family Ictaluridae, while the remaining 21 percent consisted of imported catfish from the family Pangasiidae. If the Secretary of Agriculture chose to limit the definition to catfish to the family Ictaluridae, FSIS’s inspection program would thus cover almost 80 percent of the catfish in the U.S. market in 2010. The Farm Bill requires that FSIS issue the final regulations for its new catfish inspection program before it can begin inspecting catfish. Citing requirements of the Federal Crop Insurance Reform Act of 1994, FSIS prepared a risk assessment and an impact analysis and made them available for public review. FSIS used the risk assessment to determine the primary hazard of concern associated with consuming farm-raised catfish in the United States, and it conducted an impact analysis to examine the costs and benefits of the proposed regulations. FSIS prepared these documents to evaluate the potential public health benefits of its proposed program if the primary hazard were addressed. The Federal Crop Insurance Reform and Department of Agriculture Reorganization Act of 1994 requires an analysis of the health risks and costs and benefits for major proposed regulations that regulate human health, human safety, or the environment (i.e., defined as regulations the Secretary of Agriculture estimates are likely to have an annual impact on the U.S. economy of $100 million in 1994 dollars). In addition, Executive Order 12866 established the guidance that agencies are to follow when developing regulations. Under this guidance, agencies are to identify the problem new regulations are intended to address and evaluate the significance of the problem. The executive order further directs that the agencies consider the alternative of not regulating, but it recognizes that agencies should issue regulations as required by law, as are the regulations for the catfish inspection program. The executive order directs agencies to provide a description of the need for any significant regulatory action, how that action meets the needs, and the costs and benefits of the action. A significant regulatory action includes any regulatory action that has an annual effect on the economy of $100 million or more or adversely affects, among other things, the economy or a sector of the economy. Under the executive order, the Office of Management and Budget (OMB) has a review function to, among other things; ensure that regulations are consistent with principles set forth in the executive order. In determining that Salmonella is the primary food safety hazard in catfish, FSIS officials told us that the agency focused on Salmonella at the direction of OMB, which considered Salmonella the most practical hazard to evaluate. However, we found that FSIS used outdated and limited information as its scientific basis for implementing a catfish inspection program that was required by law.