Studies and dietary recommendations have suggested that increased consumption of seafood can contribute to a more healthful diet. Nonetheless, seafood consumption is not without risk. Although hazards caused by microbes and naturally occurring toxins in seafood have been well characterized, the public health burden has been difficult to quantify or to assess over time due to data limitations. Foodborne illness data are prone to under-reporting, and in many cases the cause of the illness (called the food vehicle) may not be determined. In 2007, the U.S. Centers for Disease Control and Prevention (CDC) reported 1,097 outbreaks, which resulted in 21,244 cases of illness. Among the 235 outbreaks that could be attributed to a single commodity, seafood (finfish or shellfish) was reported as the cause for 57 outbreaks (24.2% of the total) and 318 illnesses. In comparison, red meats were reported in 54 outbreaks (23%), and poultry in about 40 outbreaks (17%). To put these data in context, annual U.S. per capita consumption of seafood was about 16 pounds in 2008, compared with 108 pounds for red meats and 73 pounds for poultry. Therefore, when compared to the consumption levels of beef and poultry, seafood is responsible for a disproportionate number of outbreaks. However, an average outbreak related to seafood consumption generally affects a smaller number of people (i.e., fewer individual cases per outbreak). Naturally occurring toxins were the cause of most seafood-associated outbreaks in 2007. Such toxins are primarily ciguatera, from certain tropical reef-dwelling finfish, and scombroid poisoning, which develops in some species after harvest due to inadequate refrigeration. Other common problems are norovirus, the bacterium Vibrio parahaemolyticus in raw shellfish, and various other pathogens, such as Clostridium botulinum, in processed seafood products. The Institute of Medicine (IOM) has cited other risks of consuming seafood: that of high levels of chemical and heavy metal pollutants from the environment such as mercury, lead, polychlorinated biphenyls (PCBs), and pesticides. Some of these problems, such as high mercury levels, are more evident in carnivorous fish at the top of the food chain, such as shark, swordfish, and bluefin tuna. But the IOM also has noted that it has been difficult to quantify the risks of some of these hazards due to incomplete data, the complexity of dietary and nondietary contaminant exposures, and the fact that certain health effects such as cancer develop over a much longer period than microbial illnesses. Recently concerns have been raised about potential contamination of seafood harvested from the Gulf of Mexico due to the Deepwater Horizon oil spill. Worldwide, nearly one-half of all seafood consumed as food comes from aquaculture. Aquacultured (farm-raised) seafood also may contain potentially harmful chemicals. This was illustrated on June 28, 2007, when the Food and Drug Administration (FDA, in the U.S. Department of Health and Human Services) issued an import alert for the "Detention Without Physical Examination" of aquacultured products of certain fish species from China. FDA said it issued the notice after targeted sampling in the prior year "repeatedly found that farm-raised seafood imported from China were contaminated with antimicrobial agents that are not approved for this use in the United States." The import alert remains in effect except for firms that have provided evidence demonstrating that their products are free of unapproved animal drugs. As of September 30, 2010, eleven Chinese firms have been exempted from the alert for "Detention Without Physical Examination." Increased imports, including from many other Asian countries in addition to China, have complicated efforts to protect consumers from unsafe fish and shellfish. In 1995, imports already constituted more than half of U.S. per-capita seafood consumption; by 2008 they reached 83%. By 2005, more than 150 countries were exporting seafood to the United States, FDA observed. FDA has primary responsibility for the safety of all domestic and imported foods, including seafood, under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended (21 U.S.C. Sec. 301 et seq . ). Excepted are most meat and poultry products, which the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) inspects under other statutory authorities. The FFDCA requires that all such foods be safe, wholesome, and accurately labeled. FDA-regulated foods may be deemed adulterated or misbranded for a variety of statutorily prescribed reasons. FDA also sets maximum safe levels of unavoidable toxic substances in foods, including fish, and requires that all domestic and foreign food manufacturing facilities adhere to Good Manufacturing Practices (GMPs; 21 C.F.R. Part 110), which address safe handling and plant sanitation. Generally exempt from GMPs are establishments such as farms, including fish farms, that merely raise and/or harvest a raw commodity. Seafood is one of the few FDA-regulated food groups further regulated under a system of risk prevention controls known as HACCP, for Hazard Analysis and Critical Control Points. Under HACCP, domestic processors are to prepare site- and product-specific plans that analyze potential safety hazards, find where they are likely to occur during processing, identify control points and how they will be monitored, and determine how hazards will be controlled. Importers of foreign seafood must take steps to verify that the products obtained from foreign processors are in compliance with the HACCP rules. As the 2001 GAO report (see footnote 5 ) noted, if a processor determines and FDA inspectors agree that a particular product is of low risk, no plan is needed; therefore not all firms necessarily will have a plan. Moreover, fishing vessels are exempt, unless they do more than minimal processing. Following publication of its HACCP rule, FDA sought to inspect all regulated seafood establishments to ensure that HACCP was being implemented, and to continue to visit each one annually. The agency recently reported that there are approximately 11,848 domestic seafood processing establishments, and that it had inspected a total of 3,415 in 2007, 3,265 in 2008, and 3,013 in 2009. The FFDCA empowers FDA to refuse entry to any food import if it "appears," based on a physical examination or otherwise, to be adulterated, misbranded, or in violation of the law. In exercising its oversight, the agency relies on a system of bonding and of prior notifications by importers and document reviews at points of entry (ports). From lists of these entries, the agency selects products for physical examination and/or testing to determine whether they contain adulterants. In FY2007, FDA processed approximately 868,000 entries of imported seafood and performed approximately 14,000 physical examinations. Foreign seafood processors are subject to the same requirements, including HACCP, as domestic firms, and the U.S. importers of their products must take "affirmative steps" to help ensure that these requirements are being met. FDA conducts inspections to check compliance of these importers and of selected foreign processors (81 processors inspected in 10 countries in 2004, 72 in 10 countries in FY2005, and 68 in 8 countries in 2006), focusing on those that are major exporters to the United States and on developing countries less likely to have sophisticated safeguards. FDA counted approximately 14,900 registered foreign exporters of seafood to the United States, but observed that "a great many more foreign firms are involved in the processing of the products that eventually are shipped to the U.S." FDA is exploring the potential use of third parties to certify foreign processors of aquacultured shrimp for compliance with FDA's seafood HACCP regulations. During Phase I of the pilot program, FDA screened requests from third-party certification bodies (private, nongovernmental, other federal government, and state government) to participate in the pilot; it announced six participants in late 2008. During Phase II, FDA is conducting onsite audits of programs by accompanying inspectors during certification inspections. FDA would use third parties to augment agency efforts, determine inspection priorities, and adjust "may proceed" rates (i.e., entry without FDA staff review) for imports of aquacultured shrimp or other food products. As of October 2010, FDA was still in the process of evaluating potential use of the pilot program. Within the Department of Commerce, the National Marine Fisheries Service (NMFS) of the National Oceanic and Atmospheric Administration (NOAA) administers the voluntary seafood inspection program under authority of the Agricultural Marketing Act of 1946 (7 U.S.C. Sec. 1621 et seq . ). The program offers additional levels and types of inspection that exceed the FDA HACCP-based requirements, which program participants also must meet. Examples include on-site NOAA inspections during production hours, certification that plants or vessels meet specified sanitation requirements, quality inspections of individual product lots, and/or laboratory testing of products, among other services. These services are provided on a fee-for-service basis and entitle participants to use various official grading and labeling marks, which are viewed as making their products more attractive to buyers. Exporters are often users of these services, in part because of foreign buyer requirements. In 2009, NOAA reported active seafood inspection contracts with 282 firms and 40 foreign participants. The number of participating firms is a small fraction of all seafood facilities, but they produce a significant portion of the total volume: In 2009, the NOAA voluntary program inspected 1.6 billion pounds or 34% of the total seafood consumed in the United States. In January 2008, the Government Accountability Office (GAO) issued a report on federal oversight of food safety.