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. Nonetheless, public health officials have estimated that each year in the United States, many millions of people become sick and thousands die from foodborne illnesses caused by any of a number of microbial pathogens and other contaminants. At issue is whether the current food safety system has the resources, authority, and structural organization to safeguard the health of American consumers, who spend more than $1 trillion on food each year. Also at issue is whether federal food safety laws, first enacted in the early 1900s, have kept pace with the significant changes that have occurred in the food production, processing, and marketing sectors since then. In 2007 and again in 2009, the Government Accountability Office (GAO) placed food safety on its biennially published list of high-risk areas, one of 30 needing concerted attention by Congress and the Administration. GAO has identified 15 federal agencies collectively administering at least 30 laws related to food safety. The majority of both total funding and total staffing, however, is with the Food Safety and Inspection Service (FSIS) at the U.S. Department of Agriculture (USDA), which regulates most meat and poultry, and the Food and Drug Administration (FDA) at the U.S. Department of Health and Human Services (HHS), which regulates virtually all other foods. FSIS's annual budget in FY2010 was approximately $1.1 billion in appropriated funds, plus an estimated $131 million in industry-paid user fees. FDA's annual budget in FY2010 for its human foods program was $784 million, all of it appropriated. After discussing several recent food safety incidents and the systemic food safety problems that they illustrate, this report describes the existing food safety legal and regulatory landscape and presents an overview of efforts by the 111 th Congress to revise federal food safety authorities and activities, principally at FDA. It then provides a detailed overview of the major provisions in the newly enacted law—the FDA Food Safety Modernization Act (FSMA, P.L. 111-353 ). The report is organized around a number of selected food safety issues, describing how they are addressed in previously existing law and regulations, and describing their treatment in the newly enacted law. Finally, appendixes provide a crosswalk of all provisions in FSMA, followed by a side-by-side comparison of each of these provisions with previously existing law. Food safety-related incidents frequently heighten public and media scrutiny of the U.S. food safety system. Large recalls of FSIS-regulated meat and poultry products due to findings of E. coli O157:H7, Listeria , and other problems occur each year. In addition, in recent years, several large multi-state outbreaks have been linked to FDA-regulated foods. For example, in 2006 more than 200 confirmed illnesses and three deaths were linked to bagged fresh spinach grown in California and contaminated with E. coli O157:H7. In 2008, more than 1,400 persons were infected with an unusual strain of bacteria, Salmonella Saintpaul. Officials first suspected fresh tomatoes, but later tests found the pathogen in serrano peppers and irrigation water from a farm in Mexico. These incidents raised public concerns about the safety of all fresh produce and stimulated a number of industry and government initiatives to limit future incidents. Attention focused on the safety of food imports in 2007, when pet food ingredients imported from China, contaminated with the chemical melamine, sickened or killed an unknown number of dogs and cats and contaminated some livestock feeds. In 2008, melamine contamination of infant formula in China sickened thousands of children and raised concerns about the safety of infant formula in the United States. The melamine incidents highlighted the limited reach of FDA's oversight of imports, the difficulty in tracing the many pathways taken by a common food ingredient, and the frequent confluence of human and animal food ingredients. In late 2008 and early 2009, a multi-state outbreak of Salmonella Typhimurium was linked to an institutional brand of peanut butter and other peanut-based ingredients from a single firm. The outbreak sickened more than 700 people in 46 states, and may have contributed to the deaths of nine people. A series of expanding recalls was announced by FDA in early 2009, involving thousands of peanut-containing products from more than 200 companies. Again, the incident highlighted the broad reach of a common contaminated ingredient, and the resultant challenges in rapidly tracing products and removing them from commerce. In July 2010, health officials noticed a spike in cases of infection with Salmonella Enteritidis, a strain commonly associated with shell eggs, which are regulated by FDA. In August, FDA found the same pathogen on two egg farms in Iowa, leading to the nationwide recall by the companies of more than 500 million eggs. In July 2009, FDA had published a long-awaited egg safety regulation, which became effective in July 2010 as the outbreak was well underway. Although most observers believe that the rule, if enforced, will help to prevent shell egg contamination and outbreaks in the future, many remain concerned about the apparent lack of coordination between USDA's egg quality inspection activities and FDA's food safety activities, because both agencies have regulatory responsibility for egg products. Federal responsibility for food safety rests primarily with FDA and USDA. FDA is responsible for ensuring that most domestic and imported food products—except for most meats and poultry—are safe, nutritious, wholesome, and accurately labeled. FDA also has oversight of all seafood, fish, and shellfish products. USDA's FSIS regulates most meat and poultry and some egg products. State and local food safety authorities collaborate with federal agencies for inspection and other food safety functions, and they regulate retail food establishments. The division of food safety responsibility between FDA and USDA is rooted in the early history of U.S. food regulation. Congress created separate statutory frameworks when it enacted, in 1906, both the Pure Food and Drugs Act and the Meat Inspection Act. The former addressed the widespread marketing of intentionally adulterated foods, and its implementation was assigned to USDA's Bureau of Chemistry. The latter law addressed unsafe and unsanitary conditions in meatpacking plants, and implementation was assigned to the USDA's Bureau of Animal Industry. This bifurcated system has been perpetuated and split further into additional food safety activities under additional agencies (for example, the Environmental Protection Agency, the National Marine Fisheries Service, and others) by a succession of statutes and executive directives. The separation of the two major food safety agencies was further reinforced when, in 1940, the President moved responsibilities for safe foods and drugs, other than meat and poultry, from USDA to the progenitor of HHS, the Federal Security Agency. Meat inspection remained in USDA. There has been discussion over time regarding whether this dispersal of food safety responsibilities has been problematic, or whether a reorganization would divert time and attention from other fundamental problems in the system. In the 111 th Congress, major food safety legislation—the subject of this report—was passed, focusing on changes related to FDA, not USDA. The primary law authorizing FDA activities is the Federal Food, Drug, and Cosmetic Act (FFDCA; 21 U.S.C. §§ 301 et seq.). Some key FFDCA provisions that are discussed throughout this report are presented in the text box on the next page. Two of the basic statutory components of FFDCA are "adulteration" and "misbranding." FDA-regulated foods may be deemed adulterated or misbranded for a variety of statutorily prescribed reasons. For example, food may be deemed adulterated if it contains an added poisonous or deleterious substance or an unsafe food additive or if the food was prepared, packed, or held under insanitary conditions whereby it may have become contaminated or may have been rendered injurious to health. Persons who violate FFDCA by, for example, introducing an adulterated or misbranded product into interstate commerce, commit what is referred to as a prohibited act under FFDCA § 301 (21 U.S.C. § 331). Persons who commit prohibited acts are subject to criminal and civil penalties. The George W. Bush Administration issued several reports and studies calling for major changes in the food safety system. Two Bush Administration initiatives were unveiled in November 2007 and were critiqued and debated extensively during the 110 th Congress. They were the FDA's Food Protection Plan: An Integrated Strategy for Protecting the Nation's Food Supply , and the Interagency Working Group on Import Safety's Action Plan for Import Safety: A Roadmap for Continual Improvement , part of which dealt extensively with food product imports. Both reports generally called for a more preventive risk-based approach to food safety oversight, including more attention to imported foods, among numerous other recommendations. President Barack Obama, in a March 14, 2009, weekly radio address, called the food safety system a "hazard to public health." He announced a Food Safety Working Group (FSWG) of Cabinet secretaries and senior officials "to advise me on how we can upgrade our food safety laws for the 21 st century; foster coordination throughout government; and ensure that we are not just designing laws that will keep the American people safe, but enforcing them." In July 2009, the FSWG announced a number of steps the Obama Administration was taking, under existing authorities, to improve government safeguards. The group released a one-year progress report in July 2010. Also, the Administration announced that it had "taken steps to reduce the prevalence of E. coli, implemented new standards to reduce exposure to Campylobacter, and issued a rule to control Salmonella contamination," and that "FDA has conducted a pilot study on a tracing system, and HHS, in collaboration with USDA, has rolled out an enhanced and updated www.foodsafety.gov site to provide consumers rapid access to information on food recalls."