Congress passed comprehensive food safety legislation in December 2010 (FDA Food Safety Modernization Act, or FSMA, P.L. 111-353 ), representing the largest expansion and overhaul of U.S. food safety authorities since the 1930s. FSMA greatly expanded food safety oversight authority at the Food and Drug Administration (FDA), within the U.S. Department of Health and Human Services (HHS), but did not alter oversight authorities within other federal agencies responsible for food safety, such as the U.S. Department of Agriculture (USDA). In the wake of these reforms, Congress continues to actively address concerns of the U.S. food safety system given challenges facing FDA in implementing this law and also continued food safety incidents. Congress will likely continue to monitor FDA's implementation of the law but might also continue to consider additional changes to other food safety laws and policies that have been actively debated in Congress. Ongoing budgetary constraints—both at the federal and at the state and local levels—raise questions for Congress about how to fully fund and implement policies that will protect public health and ensure the safety of domestic and imported foods. The combined efforts of the food industry and government regulatory agencies often are credited with making the U.S. food supply among the safest in the world. However, critics view this system as lacking the organization, regulatory tools, and resources to adequately combat foodborne illness. The Centers for Disease Control and Prevention (CDC) reports that each year about one in six Americans—a total of 48 million people—become sick from contaminated food. Of these, an estimated 128,000 cases require hospitalization and 3,000 cases result in death. Estimates of the economic costs associated with foodborne illness vary. Researchers at FDA report that health costs associated with foodborne illness in the United States caused by known viruses, bacteria, parasites, allergens, and marine biotoxins, as well as unspecified agents total an estimated $36 billion annually. Researchers at USDA report individual cost estimates for 15 pathogens that account for most (95%) of the illnesses and deaths from foodborne illnesses in the United States for which a specific pathogen cause can be identified, which when combined total more than $15 billion annually. Most of these costs are attributable to estimated losses from five pathogens: nontyphoidal Salmonella enterica ($3.7 billion), Toxoplasma gondii ($3.3 billion), Listeria monocytogenes ($2.8 billion), Campylobacter spp. ($1.9 billion), and norovirus ($2.3 billion). The USDA estimates update previous studies that reported that foodborne illness from 14 pathogens caused an estimated $14.0 billion in cost of illness. Another study looking at the 31 pathogens for which CDC can identify a specific pathogen cause as well as unspecified agents estimates that together they cause a total economic burden of $77.7 billion from foodborne illness in the United States each year. Differences between the studies may be explained by the number of identified pathogens included; whether or not unidentified agents causing foodborne illness are included; and differences in analytical methods. Major food safety-related incidents have heightened public and media scrutiny of the U.S. food safety system and magnified congressional interest in the issue. Since 2007, the Government Accountability Office (GAO) has placed food safety on its biennially published list of high-risk areas, among other areas needing the concerted attention of Congress and the Administration. Both the Obama and Bush Administrations addressed food safety concerns. In 2007, then President Bush released the Food Protection Plan of 2007 and Action Plan for Import Safety to address changes in food sources, production, and consumption. In 2009, President Obama established a Food Safety Working Group (FSWG) of Cabinet Secretaries and senior officials to provide advice on how to upgrade U.S. food safety laws, foster coordination throughout government, and ensure that food safety laws are effective and enforced. In 2010, as part of the FSWG's annual progress report, the Administration announced that it had taken steps to reduce the prevalence of certain food risks and implemented new food safety standards, among other actions. The HHS released a draft of its plans regarding specific food safety goals, setting percentage reduction goals for major food contaminants as well as targeted reductions in the number of cases each year by 2020. Following Congress's passage of FSMA in December 2010, FDA has been actively engaged in developing new regulations to implement the law. Under FSMA, FDA is responsible for more than 50 regulations, guidelines, and studies; however, some major provisions under FSMA have been substantially delayed, and it is uncertain whether full implementation of some provisions in the law will meet their expected deadlines. Implementation of the law will depend on the availability of discretionary appropriations, and some have questioned whether additional funding should be made available in the current budgetary climate. Each year, state health officials report data to CDC on hundreds of foodborne outbreaks. CDC reports that more than 1,000 foodborne outbreaks are investigated by local and state health departments each year. Overall, from available outbreak data, CDC reports that roughly one-half of all outbreaks involved meat, dairy, fish/seafood, and egg products, while another roughly one-third involved leafy greens, vine vegetables, and fruits and nuts ( Figure 1 ). In general, foods often associated with foodborne illnesses include raw foods of animal origin—meat, poultry, eggs, and seafood, and also unpasteurized (raw) milk—that can cause infections if undercooked, or through cross-contamination. Other foods associated with foodborne illness include shellfish eaten raw and also fresh produce, including unpasteurized juices. Some foodborne outbreaks affect multiple states, depending on how widely the food associated with the outbreak is distributed. CDC reports that 103 multi-state foodborne outbreaks occurred during the five-year period from 2008 to 2012, an increase from previous years ( Figure 2 ), thus continuing to raise questions about the adequacy of the U.S. food system's safeguards for ensuring the safety of both domestically produced foods and imported foods. Examples of foodborne outbreaks involving FDA-regulated foods include multi-state outbreaks in 2012 of Salmonella infections, involving peanut butter and cantaloupe, and E. coli infections linked to raw clover sprouts; multi-state outbreaks in 2011 of listeriosis linked to cantaloupe; the 2010-2011 multi-state recall of Salmonella -contaminated sprouts; and a 2010 nationwide recall of more than 500 million eggs associated with increased cases of Salmonella infection, among other outbreaks. A multi-state outbreak of Salmonella infections that occurred in 2008-2009 was linked to an institutional brand of peanut butter and other peanut-based ingredients from a single company, resulting in a series of expanded recalls in 2009 involving thousands of peanut-containing products from more than 200 food companies. Other widespread illness outbreaks have been linked to the consumption of bagged fresh spinach grown in California contaminated with E. coli and to Mexican produce contaminated with Salmonella . There also have been large recalls of FSIS-regulated meat and poultry products due to findings of E. coli , Listeria , and other problems. CDC regularly tracks national foodborne outbreak data from local and state public health departments and makes these data publically available online. CDC's Foodborne Outbreak Online Database (FOOD) provides access to limited descriptive summaries of national and state-level outbreak data by location of consumption and etiology (or cause of disease) in a web-based platform for searching the agency's Foodborne Disease Outbreak Surveillance System database. CDC estimates that nearly 48 million people become sick from contaminated food each year. These estimates are for two major groups of foodborne illnesses: known foodborne pathogens (31 pathogens, many of them tracked by public health systems that track diseases and outbreaks); and "unspecified agents," where insufficient data do not allow for the estimation of agent-specific burden. Foodborne illnesses from known pathogens account for about one-fifth of CDC's estimate of the total number of foodborne illnesses per year and about 40% of the estimated number of illnesses resulting in either hospitalizations or death ( Table 1 ). The remaining number of illnesses, hospitalizations, and deaths are attributable to foodborne illness from "unspecified agents." The top five pathogens contributing to foodborne illnesses annually are norovirus (58% of illnesses), Salmonella , nontyphoidal (11%), Clostridium perfringens (10%), Campylobacter spp. (9%), and Staphylococcus aureus (3%). The top five pathogens contributing to annual foodborne illnesses resulting in hospitalization are Salmonella , nontyphoidal (35% of illnesses), norovirus (26%), Campylobacter spp. (15%), Toxoplasma gondii (8%), and E. coli (STEC) O157 (4%). The top five pathogens contributing to annual foodborne illnesses resulting in death are Salmonella , nontyphoidal (28% of deaths), Toxoplasma gondii (24%), Listeria monocytogenes (19%), norovirus (11%), and Campylobacter spp. (6%). Other CDC reports indicate that there were 831 foodborne disease outbreaks in 2012. These outbreaks resulted in 14,972 illnesses, 794 hospitalizations, and 23 deaths. Norovirus was the most common disease, accounting for 41% of outbreaks and 45% of illnesses. Salmonella was the second-most common, accounting for 25% of outbreaks and 33% of illnesses. Beef, poultry, and finfish were the commodities associated with the largest number of foodborne outbreaks. Fish, vegetable row crops, and dairy were the most commonly implicated single food categories in outbreaks in which a single food category could be implicated. Trends in some foodborne illnesses show improvement for some pathogens, while infections caused by some pathogens have not declined or, in some cases, have increased (see Figure 3 ).