The nation’s food supply has evolved into a complex system involving more than $450 billion worth of food each year under the jurisdiction of the U.S. Food and Drug Administration (FDA), more than 156,008 FDA-regulated firms (FDA, 2010), and an additional 2,000 FDA-licensed feed mills (Behnke, 2009). Many parties are responsible for providing safe food, including suppliers, farmers, food handlers, processors, wholesalers and retailers, food service companies, consumers, third-party organizations, and government agencies in the United States and abroad. The path from production to consumption can involve only one step—from a farmer directly to a consumer at a farmer’s market—or as many as six or even more steps—for example, from a farmer, to various processers, to a warehouse, to a transporter, to a grocer, to a consumer.
Paralleling the evolution of the food system is a similarly complex history of legislative actions that form the foundation for the current governance of the safety of the food supply in the United States. Since 1906, the Federal Food, Drug, and Cosmetic Act (FDCA) and amendments thereto have charged the FDA with oversight of this governance function (with the exception of meat, poultry, and egg products). This means the FDA has regulatory authority over approximately 80 percent of the U.S. food supply, encompassing products from fresh produce, to seafood, to packaged snack foods, to cereal, to pet food, to animal feed for food-producing animals. The major FDA entities with responsibility for food safety are the Office of the Commissioner, the Office of Foods, the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM), the Office of Regulatory Affairs, and the National Center for Toxicological
Research. At the same time, the FDA is only one of many federal agencies that administer at least 30 laws related to food safety. The U.S. Department of Agriculture (USDA) is responsible for the safety of meat, poultry, and egg products, while state and local governments have jurisdiction over foods produced or sold within their borders. All of the significant agencies and departments that are responsible for various aspects of food safety are detailed in Chapter 2.
According to a recent public opinion poll, in general, confidence about the safety of the food supply appears to be lower now than it has been since 2001 (Gallup, 2010). The complexity of the system, combined with highly publicized recalls and outbreaks costing millions of dollars, the resulting impacts on the public health, and the piecemeal nature of the current system, has raised concern about the FDA’s ability to ensure the safety of the nation’s food supply. The purpose of this study is to identify gaps in the FDA’s food safety system and recommend actions that can be taken to fill those gaps.
Increasing Discussion and Controversies About the FDA’s Ability to Ensure Safe Food
Many recent changes in the nation’s food system have prompted increasing discussion of the FDA’s ability to ensure safe food. The 1998 Institute of Medicine (IOM)/National Research Council (NRC) report Ensuring Safe Food: From Production to Consumption identifies some of these changes, such as the food safety implications of emerging pathogens, the trend toward the consumption of more fresh produce, the trend toward eating more meals away from home, and changing demographics, with a greater proportion of the population being immunocompromised or otherwise at increased risk of foodborne illness.1 These developments must be understood in the context of a wide range of global and societal changes that greatly increase the complexity of the food safety system and the challenges faced by those responsible for implementing the system. These changes, detailed in Chapter 2, include changes in the food production landscape, climate change, evolving consumer perceptions and behaviors (e.g., the growing demand for fresh produce and for its availability year-round2), globalization and increased food importation, the role of labor–management
relations and workplace safety, heightened concern about bioterrorism, increased levels of pollution in the environment, and the increasing role of international trade agreements. Food production is changing as well, with the number of firms involved with food having increased by roughly 28 percent since 2001 (GAO, 2008b).3 The importation of food is also increasing; roughly $49 billion worth of food was imported to the United States in 2007 (GAO, 2008a).
A number of high-profile food-related outbreaks have occurred in recent years, including E. coli O157:H7 in spinach in 2006, melamine in pet food in 2007, Salmonella in produce and in peanut butter in 2008, and E. coli O157:H7 in cookie dough in 2009. In 1999, Mead and colleagues estimated that foodborne infections caused about 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths each year in the United States (Mead et al., 1999). It should be emphasized that these data were reported in 1999, and the morbidity, mortality, and hospitalization estimates would likely be different today; new estimates are in preparation but were not available at the time of this writing. Nonetheless, data for 2008 from the U.S. Centers for Disease Control and Prevention (CDC) suggest that there has been no significant change in the incidence of foodborne infections by the major bacterial agents transmitted through food over the last several years (in some cases, disease may be acquired through other nonfood vehicles, such as reptiles). CDC therefore concludes that problems with bacterial contamination through food are not being resolved (CDC, 2009). According to CDC, the lack of recent progress toward national health objectives for food safety and the continual occurrence of large multistate outbreaks point to gaps in the food safety system. The most recent FoodNet surveillance data (CDC, 2010) show reductions in 2009 (compared with 2006–2008) in the incidence of some infections (shiga toxin-producing E. coli O157:H7 and Shigella) but not others (Campylobacter, Listeria, Salmonella). The data also show an increase in other infections from food-associated pathogens (Listeria and Vibrio).
During the last two decades, many organizations and individuals, including the IOM, have devoted effort to identifying needed improvements in food safety. Attention has been focused in particular on the FDA’s food safety program. According to a number of reports (GAO, 2004a,b, 2005, 2008a,b; FDA Science Board, 2007), although the FDA is working to ensure safer food, problems with its capacities, functions, and processes persist. The IOM, the NRC, and other groups, including consumer organizations, have made recommendations for strengthening food protection, a few of which are listed here (see Appendix B for a detailed listing):
The 1998 IOM/NRC report Ensuring Safe Food: From Production to Consumption concludes that the U.S. food system is fragmented and is facing unprecedented challenges from a global marketplace, a greater reliance on imports, shifting demographics, and changing societal practices. The report recommends modifying the federal statutory framework for food safety to eliminate fragmentation and enable the development and enforcement of science-based standards as well as creating a single food safety agency.
The 2003 IOM/NRC report Scientific Criteria for Ensuring Safe Food (IOM/NRC, 2003) examines the scientific basis for criteria that underlie U.S. food safety regulations, presents a blueprint for how agencies responsible for regulating food safety should develop appropriate science-based criteria, and identifies the failure to adopt new technologies and enforce standards as barriers that impede regulatory action.
The 2009 IOM report HHS in the 21st Century (IOM, 2009) highlights food safety regulatory activities as an area of weakness within the U.S. Department of Health and Human Services (HHS). Specifically, the report offers recommendations for uniting the food safety responsibilities of the two salient agencies (the FDA and USDA’s Food Safety and Inspection Service) within HHS.
Both consumer groups and industry have issued reports addressing food safety: the Center for Science in the Public Interest issued a white paper, Building a Modern Food Safety System for FDA Regulated Foods (DeWaal and Plunkett, 2007), while the Grocery Manufacturers Association (GMA) issued Commitment to Consumers: The Four Pillars of Food Safety, which focuses on prevention of foodborne illness (GMA, 2007).
An important factor influencing the FDA’s ability to fulfill its mission is the resources available to the agency given that, in addition to food, it is required to regulate cosmetics, drugs, biologics, medical devices, and tobacco. Although the agency is responsible for the safety of more than 80 percent of the nation’s food supply, its budget accounts for only 24 percent of expenditures on food safety (GAO, 2008b) (see Chapter 2). Moreover, after the events of September 11, 2001, the FDA was given additional responsibilities related to bioterrorism (GAO, 2008b), stretching its funds even thinner. For example, even though the number of domestic food establishments was increasing, the numbers of inspectors and inspections (both domestic and abroad) and the amount of funding allocated to food safety both decreased during the period 2003–2006 (FDA/CFSAN, 2008; GAO, 2008b)
In the face of its decreasing resources, the FDA must continue to make decisions about both appropriate short-term responses to a food crisis and
longer-term prevention functions focused on continued improvements in the public health. While the need to respond to a crisis is clear, the agency has been criticized as responding only reactively to food problems, to the neglect of its preventive functions. In addition to the need to increase efficiency and prioritize its efforts, the FDA’s success depends greatly on maintaining strong cooperative relationships with other partners in food safety (e.g., other federal departments and agencies; local, state, and foreign governments; industry). Although the division of responsibilities for food safety with respect to research, commodities, and public health surveillance among different agencies has been long criticized, no genuine attempt has been made to consider alternatives for the governance of food safety. Technological, scientific, environmental, and societal shifts have generated discrete actions, such as reorganizations within the food program at the FDA or amendments to the law, and the result has been the current piecemeal approach to food safety. The unprecedented speed and nature of such changes in the 21st century demand a different kind of response at this time—one that is comprehensive and systematic, giving the FDA and its partners a real opportunity to realize the vision of an integrated food safety system.
There have also been significant leadership and organizational changes in the FDA’s operations and their context since this study was requested by Congress in 2008. In addition to a new administration, some of the most significant of these have been the establishment of the White House Food Safety Working Group (FSWG) to advise the administration on food safety matters; the establishment of a new Office of Foods within the FDA, with oversight and authority over CVM and CFSAN; the development of plans for a state–federal Integrated Food Safety System; and the hiring of additional high-level leaders and subject matter experts in food safety management.
The FDA’s Food Protection Plan
In 2007, the FDA issued its Food Protection Plan (FPP) (FDA, 2007) (Appendix G), setting forth a general strategy for food safety and defense and identifying three core elements—prevention, intervention, and response (Box 1-1). In each of these areas, the plan describes key actions and needed legislative authority (Box 1-2). The approaches laid out in the plan include new regulatory authority for recalls, preventive controls for high-risk foods, and a shift to a risk-based system for inspections.
PURPOSE AND SCOPE OF THIS STUDY
In response to the heightened public health concerns outlined above, the Consolidated Appropriations Act of 2008 tasked the FDA to contract
Three Core Elements of Food Safety in the U.S. Food and Drug Administration’s Food Protection Plan
with the National Academies for a comprehensive study of gaps in the public health protection offered by the food safety system in the United States.4 Box 1-3 presents the statement of task for this study.
The FPP’s overarching strategy for food protection encompasses and focuses on microbiological and chemical contaminants that can affect public health. The committee was tasked to evaluate the FDA’s plan and to identify its strengths and weaknesses, determine whether it can be implemented effectively, and identify what additional resources (e.g., finances, equipment, personnel) the agency may need for this purpose. The committee was also tasked with evaluating the various additional legislative authorities the FDA has requested and determining whether these authorities are adequate to fulfill the agency’s public health mission.
Clarification of the committee’s task came from extensive dialogue with FDA food program leadership. Accordingly, the committee addressed microbiological contaminants, chemical contaminants, and intentional food contamination, including financially motivated contamination (as in the
Additional Protections That Involve Legislative Changes to the U.S. Food and Drug Administration’s (FDA’s) Authority
Prevent foodborne contamination:
Intervene at critical points in the food supply chain:
Respond rapidly to minimize harm:
recent case of melamine in pet foods) and contamination by terrorists. The committee excluded from its deliberations management of the safety of certain products (see Table 1-1). In particular, although the FDA’s regulatory authority encompasses dietary supplements and food additives, the committee was asked to exclude them from its deliberations because their safety determination is not usually based on issues of contamination. Dietary supplements fall into a “gray area” of being a special category of food, and the determination of their safety is typically made by the industry. Manufacturers need not obtain FDA approval before producing or selling them. The
Statement of Task
An ad hoc committee of the Institute of Medicine and the National Research Council will undertake a study to examine gaps in public health protection provided by the farm-to-table food safety system under the purview of the Food and Drug Administration (FDA) and identify opportunities to fill those gaps. The study will address the recommendations of the November 2007 FDA Food Protection Plan by evaluating the plan and identifying gaps and opportunities (recommendations) to fill the gaps. The committee’s consensus report will include legislative, regulatory, and administrative recommendations and estimates of costs of such recommendations, as feasible.
Specifically, the committee will:
safety of dietary supplements is regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA). The committee excluded from the study a review of the process for notification or self-determination of generally recognized-as-safe ingredients. Food and color additives for both human food and animal feed are subject, respectively, to the 1958 Food
TABLE 1-1 Scope of This Study
Outside the Scope
Within the Scope
Additives Amendment5 and the 1960 Color Additives Amendments6 to the 1938 FDCA, and they must be preapproved for safety before being added to food or feed. In the case of such additives, the burden of proof is on the manufacturer, who must provide evidence that the additive is safe for consumption. In 1992, the FDA concluded that, with regard to genetically modified foods, “The agency is not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform way, and that, as a class, foods developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding.”7 Therefore, these foods were not considered separately in this study. Likewise, the safety of organic foods was not considered separately.
In defining the scope of the study described in its statement of task, the committee was also guided by the FDA’s jurisdiction in food safety. The FDCA, section 201, defines “food” as (1) articles used for food or drink by man or other animals, (2) chewing gum, and (3) articles used for components of any such article.8 In accordance with this definition, the FPP includes food for both humans and animals. The latter encompasses both pet food and feed for “food-producing animals,” a category that includes animals whose products will end up in the human food supply (including, for example, dairy cattle, beef cattle, swine, and chickens [FDA, 2007]). The committee consulted with the FDA on the precise scope of the study with respect to pet food and animal feed. This dialogue resulted in a decision to include in the study issues related to pet food and animal feed only as they might directly affect human health (e.g., because of drug or contaminant residues in pet food consumed or handled by humans or in human foods of
animal origin). In this report, the term “food” encompasses pet food and animal feed unless explicitly indicated otherwise.
Committee Composition and Membership
The committee was assembled to include individuals with extensive knowledge of FDA programs, policies, and operations, as well as those with expertise in health policy, food law and regulations, risk analysis and communication, economics, epidemiology, monitoring and surveillance, food microbiology, and toxicology. Representation of state officials with food safety responsibilities was crucial because of the key role of state governments in keeping food safe. In addition, perspectives of the food industry and consumer interest groups were necessary as these sectors are responsible partners in food safety and would be affected by the implementation of the recommendations in this report. Expertise in animal feed was also sought because, as noted above, the safety of these products has the potential to affect human health, and feed safety is within the purview of the FDA.
Information Gathering, Meetings, and Workshops
The committee gathered information for this study from previous NRC and IOM reports, reports from authoritative groups, plans and initiatives from industry, FDA leadership and staff, numerous public sessions at committee meetings, teleconferences and written statements in response to specific queries, expert testimony before congressional committees, and the FDA website. The committee held three workshops to hear expert perspectives and obtain answers to its questions (see Appendix A for the workshop agendas). Participants from all relevant sectors attended the workshops, and the committee found their experience and insights invaluable to this study. They spoke on such topics as the FDA’s organization and responsibilities; approaches to food safety prevention, inspection, and research; and perspectives on the FDA from industry and consumer stakeholders. Additionally, the committee held six closed meetings and numerous conference calls.
As noted above, the FPP is a road map founded in basic principles of prevention, intervention, and response. Since its publication and the congressional request for this study, leadership and organizational changes in the government have altered the U.S. food safety scene and affected
the FDA’s food programs. As discussed above, these include a change in administration, the formation of the White House FSWG, and the FDA’s establishment of the new Office of Foods.
Although the FPP is widely regarded as a positive development, it is only a first step. Since its release, questions have been raised, for example, by the Government Accountability Office (GAO), about the specifics of its implementation—including a lack of clarity on its execution, efficient targeting of resources, budgetary constraints, and the timeline for implementation—as well as about the agency’s statutory authority (GAO, 2008a,b). Without sufficient attention to these matters, there is concern that the plan cannot be appropriately implemented, and the likelihood of its success cannot be determined. Additional concern has been raised because of the failure to implement many past recommendations to the FDA.
In this new food safety environment and based on nature of the FPP, the committee concluded that to be useful, the FPP needs to evolve and be supported by more detailed strategic planning. Therefore, in its deliberations, the committee envisioned the FPP as a point of departure but focused its efforts on identifying additional tools and capacities that the FDA needs to improve food safety today and in the future.
In adhering to its statement of task, the committee reviewed the Food Protection Plan and formulated its recommendations in the context of an evaluation of the FDA’s functions and operations. Thus, elements of the Food Protection Plan are considered in all chapters of this report, and they are also discussed in the context of the committee’s recommendations. As an example, the FPP states that the FDA needs to “strengthen the establishment of a risk-based process to continuously evaluate which FDA-regulated products cause the greatest burden of foodborne disease.” The committee recommends a stepwise process for achieving that objective. A synthesis of the committee’s evaluation is presented in Chapter 4, which focuses on governing philosophy. The committee took this approach to its task to provide the FDA with a report that would be useful today and reflect all organizational and leadership changes within the agency since the FPP was written in 2007.
In identifying tools and capacities for an effective food safety system, the committee focused on investigating the FDA’s food safety programs and operations as well as its progress toward the committee’s view of such a system. The committee took great pains to provide recommendations that would maintain a balance between being too general and too prescriptive, and it formulated a number of concrete recommendations to guide the FDA in its food safety management mission, emphasizing the need for the agency to move toward a risk-based approach. Some of these concrete recommendations, for example, are aimed at overcoming current limitations in the acquisition and sharing of data (Chapters 5 and 11), in the FDA’s research
capacity and portfolio (Chapter 6), in risk communication and education (Chapter 9), and in legal authorities (Chapter 10). The committee believes that many details of the implementation of its recommendations (e.g., the factors to consider when assessing interventions) are within the purview of the FDA, especially since the agency’s food safety program functions in the context of its overall responsibilities for food, which, for example, also include a nutrition program.
Recognizing that many enhancements can be realized without structural changes (through, for example, leadership commitment, staff retention, strategic planning), the committee initially deliberated its recommendations in the context of the current food safety management structure. As the study progressed and the committee’s ideas matured, it became clear that there were many reasons to call for a single food agency, including the fact that a risk-based approach should encompass all foods and hazards. This is not a new idea, but it is one that is fraught with challenges that the committee recognizes. To overcome these challenges and to maintain public health as the ultimate goal, the committee formulated a stepwise process for achieving a single food safety system and ensuring maintenance of the day-to-day operations necessary to protect the public health. In formulating its own recommendations, the committee also took into account many recommendations made by other groups and individuals to enhance food safety, some of which the committee explicitly supports. (Appendix B presents a sampling of past recommendations from other sources.) The committee also specified what legislative changes would be required to implement its recommendations.
Finally, the committee was asked, if feasible, to provide cost estimates for implementing its recommendations. However, because essential supporting information was not always accessible and the committee faced time constraints, the evidence needed to address this question in detail was lacking. The committee did consider cost and resource issues in a general sense in all of its deliberations by drawing on the experience of members who formerly held senior leadership positions at the FDA.
ORGANIZATION OF THE REPORT
This report is divided into three parts. Part I sets the stage for understanding and improving the FDA’s role in the food safety system. Chapter 2 assesses the current system with respect to how well it has fulfilled its public health mission in the face of the significant changes in the food enterprise discussed briefly above; it also contains a summary of organizational and functional challenges at the FDA. The committee used previous NRC and IOM reports, as well as reports by the agency itself, GAO, industry, and consumer organizations, to document these challenges.
Each chapter in Parts II and III is dedicated to explaining the com-
mittee’s understanding of the essential functions of a food safety regulatory agency; these chapters also include the committee’s recommendations. Part II presents the committee’s vision of a food safety system defined by a risk-based decision-making approach. Chapter 3 details the attributes of such an approach and identifies the infrastructure needed for its implementation, such as personnel and analytical capacity. It also presents an account of the science needed to build a risk-based system, including data analysis and laboratory research. Chapter 4 outlines the types of governance models that might be appropriate for managing food safety and explains the importance of defining the responsibilities of the various parties involved in food safety (e.g., industry, state and local governments).
Part III describes what is necessary to implement the food safety system proposed in Part II. Chapters 5 and 6, respectively, address the creation of the necessary data surveillance and research infrastructures. Chapter 7 describes state and local food safety programs nationwide and calls for their harmonization and integration with the programs of the federal government to achieve a seamless food safety program. Chapter 8 addresses the issue of how to enhance the efficiency of food inspections. Chapter 9 examines the critical issue of communicating about food safety and risks with those who can impact public health through their food safety–related conduct at home (consumers) or at work (e.g., personnel in industry and the health professions). Chapter 10 is dedicated to legislative needs for an enhanced food safety system. Finally, Chapter 11 sets forth the organizational changes needed to achieve the committee’s vision of an efficient risk-based food safety system.
Appendixes B–G can be found on the inserted CD. They include the agendas of all public meetings (Appendix A), recommendations of selected past reports (Appendix B), a brief description of food safety systems in the United States and other countries (Appendix C), two commissioned papers on food defense and food importation (Appendixes D and E, respectively, prepared at the committee’s request by outside experts and used as background for the committee’s deliberations), a sampling of selected FDA research (Appendix F), the FPP (Appendix G), a glossary and a list of acronyms and abbreviations (Appendixes H and I, respectively), and biographical sketches of the committee members (Appendix J).
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