CDC estimates that contaminated food causes 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths in the United States each year. On the basis of the number of confirmed outbreaks of foodborne disease in 1997, the latest year for which CDC’s data are available, seafood is one of the leading causes of foodborne illness outbreaks in the United States. For example, seafood products represented about 15 percent, or 26, of the 169 foodborne illness outbreaks with a confirmed source—a level greater than that associated with meat and poultry products, which are consumed at, respectively, 8 and 6 times the rate of seafood. However, CDC officials said that foodborne illness outbreaks are generally underreported and that it is easier to identify the source of some diagnosable illnesses, such as scombroid poisoning from seafood, than illnesses resulting from some nonspecific gastrointestinal symptoms caused by other foods. FDA also noted that some seafood-related illnesses may be caused by fish caught recreationally. The actual number of individual cases of illness resulting from traced outbreaks were higher for meat and poultry (619 and 353 cases, respectively) compared with 108 cases for seafood. Seafood outbreaks may have involved fewer individual cases of illness because seafood has much lower consumption rates than meat and poultry. Biological, chemical, and physical hazards can cause seafood-related illnesses. Biological hazards include clostridium botulinum, listeria monocytogenes, salmonella, and pathogenic staphylococcus. Chemical hazards include compounds such as methylmercury, which can cause illness from long-term exposure. Physical hazards include foreign objects in food that can cause harm when eaten, such as glass or metal fragments. According to FDA officials, two naturally occurring marine toxins with potentially serious health effects—scombrotoxin and ciguatoxin—cause most reported seafood-related illnesses, including gastrointestinal and neurological problems. These naturally occurring toxins are biological in origin but are categorized as chemical hazards, are heat resistant, and cannot be inactivated by cooking. Appendix II provides additional information on seafood-related illnesses and their symptoms. Since 1980, seafood consumption in the United States has risen about 22 percent, from 12.5 pounds per person in 1980 to 15.3 pounds per person in 1999. According to data from the National Marine Fisheries Service, the United States imported about 3.9 billion pounds of fishery products during 1999 from about 160 countries. The top five seafood-exporting countries— Canada, Thailand, China, Ecuador, and Chile—accounted for 50 percent of the volume of imported seafood. Imported products include fresh and frozen tuna and salmon as well as crustaceans, such as shrimp and lobsters. Figure 1 shows the proportion of U.S. seafood imports from five leading exporting countries. FDA is responsible for ensuring the safety of both domestic and imported seafood under the Federal Food, Drug, and Cosmetic Act (FFDCA). In 1997, following recommendations by the National Academy of Sciences and others, FDA adopted a program of preventive controls designed to identify hazards early in the seafood-production process and minimize the risk of contamination. The HACCP regulations made seafood-processing firms responsible for identifying harmful microbiological, chemical, and physical hazards that are reasonably likely to occur and for establishing critical control points to prevent or reduce contamination. The HACCP system is based on seven principles that each seafood firm must address. Conduct a hazard analysis. Identify hazards that are reasonably likely to occur. Identify the critical control points (CCPs). Identify a point, step, or procedure in the production process where controls can be applied to prevent, eliminate, or reduce a food safety hazard that is reasonably likely to occur to an acceptable level. Establish critical limits for each CCP. Set the maximum or minimum value at which a hazard must be controlled at each CCP to prevent, eliminate, or reduce the hazard to an acceptable level. Monitor each CCP. Establish monitoring activities that will ensure that the process is under control at each CCP. Establish corrective actions. Define actions to be taken when monitoring discloses a deviation from established critical limits. Establish verification procedures. Establish verification procedures to ensure that HACCP plans accomplish their intended goal—ensuring the production of safe products. Establish record-keeping and documentation procedures. Maintain documentation, including the HACCP plan, CCP monitoring, critical limits, and verification activities. Under the HACCP rule, seafood-processing firms are responsible for conducting a hazard analysis and for developing and implementing HACCP plans for hazards determined to be reasonably likely to occur: natural toxins, microbiological contamination, chemical contamination, pesticides, drug residues, decomposition in certain species, parasites, unapproved use of food or color additives, and physical hazards. For each hazard identified, the firms must establish critical control points to prevent or reduce contamination. Firms must also establish and monitor sanitation procedures to ensure, among other things, the (1) general cleanliness of food contact surfaces, including utensils, gloves, and outer garments, and (2) control of employee health conditions. To assist industry with HACCP compliance, FDA published the Fish and Fisheries Products Hazards and Controls Guide, which discusses, among other things, how to perform a hazard analysis, develop a HACCP plan, and identify critical control points. The guide provides species-specific and process-related examples of hazards reasonably likely to occur, but as its name suggests, this document is only guidance; seafood firms are not required to follow it. The guide, according to FDA, has been translated into other languages, is used by regulatory authorities in other countries, and has served as a catalyst for discussions between the seafood industry, other interested stakeholders, and FDA about the scientific merits of hazards and controls. According to the National Fisheries Institute, seafood firms generally support the HACCP system because it has, among other things, caused the industry to look at how best to manage hazards and how to look at food safety from a science-based perspective—for example, what hazards are likely to cause illness, how frequently people are becoming ill, and how serious those illnesses are. Also, according to FDA, two surveys of the industry taken by the New York Sea Grant Extension program and others report that in response to HACCP, the industry is engaging in upgrades to facilities, equipment, and daily plant operations to ensure safety. To help implement and oversee HACCP systems, for industry personnel and FDA inspectors, FDA developed a training and certification program that is intended to ensure that they have the necessary expertise to evaluate HACCP systems. The training program is offered by the National Seafood HACCP Alliance—an academic, government, and industry consortium. The Alliance’s course is the standardized curriculum by which FDA evaluates other HACCP courses; it contains the information necessary to meet the HACCP-training requirements. Course participants receive a certificate. The seafood HACCP regulations require that industry personnel responsible for developing HACCP plans, reassessing and modifying the plan, and performing record reviews successfully complete training in the application of HACCP principles for fish and fishery products at least equivalent to those received under the FDA-approved course. However, the regulations also state that job experience will qualify an individual to perform these functions if he or she has provided knowledge at least equivalent to that provided through the standardized curriculum. FDA periodically inspects seafood firms to check on their sanitary conditions and to verify compliance with the HACCP requirements. To determine whether seafood firms identify all safety hazards and whether they are consistently controlling those hazards, FDA inspectors survey the plant and then review the HACCP records. From 1998 through 1999, FDA inspected all seafood firms in its inventory at least once to verify compliance with the new HACCP-based system. In the budget for fiscal year 2000, Congress provided $267 million for FDA’s food programs—a $32 million increase over FDA’s budget for fiscal year 1999. Some of this increase was to enhance the coverage of both domestic and imported foods, including the increased inspection of high-risk food and continued implementation of the HACCP requirement for seafood. While FDA believes that additional funds are needed to ensure the safety of the food supply, it now inspects seafood firms annually. Prior to these annual inspections, FDA inspected seafood firms once every 4 years on average, according to FDA officials. Generally, FDA personnel inspect one or two seafood products at each firm inspected. The number of seafood products handled by each firm varies. According to FDA, seafood-processing firms collectively handle over 350 species of fish. For example, the seafood firms that we visited in Norfolk and Philadelphia processed a wide range of products, including fresh and frozen fish, such as salmon, tuna, bluefish, mahi-mahi, mackerel, and grouper; crustaceans, such as lobster and crabs; and shellfish, such as oysters and clams. FDA’s policy was to give priority to inspecting products considered to be high-risk, including vacuumed-packaged seafood (these products are subject to the growth of Clostridium botulinum, a toxin producing bacteria); ready-to-eat seafood, such as cooked shrimp and crabmeat and hot or cold smoked fish (these products are subject to the growth of pathogens from post-process contamination); histamine-forming species, including mahi-mahi, tuna, and bluefish (these products are subject to histamine formation—a toxic substance); and stuffed seafood products (processing and handling may allow toxins to develop in these products). FDA can take several regulatory actions when firms are cited for HACCP violations. For example, if in the agency’s judgment the violation cited is of regulatory significance, it may issue the firm a warning letter.