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Debate about fundamental reform of the nation’s food safety system is often oversimplified and reduced to a debate about whether we should form a single food regulatory agency. I believe that the long-term success of the system requires unification of the existing agencies, but not for abstract “good government” or organizational neatness reasons.
Organizations exist to achieve objectives, and organizational structure, whether in government or elsewhere, should follow function. What do we want the federal government’s food safety program to achieve? What are the attributes of a food safety system that can succeed in achieving it? What needs to be done legislatively and organizationally to have such a system? By addressing these questions, we can build a model for the future of the food safety system and understand the role and value of organizational change.
Objectives of the Food Safety System
The functional attributes and organizational structure of the food safety system should reflect the system’s important objectives. Three objectives stand out for me:
• Reducing Foodborne Disease in the United States. This is the most fundamental objective. Foodborne disease is a significant public health problem. The Centers for Disease Control and Prevention (CDC) estimates that known microbial pathogens alone cause 5,000 deaths, 325,000 hospitalizations, and 79 million illnesses annually (Mead et al., 1999). Virtually all of these illnesses are preventable if the right measures are taken at each appropriate step across the farm-to-table spectrum to prevent, minimize, and remove harmful contamination. No one intervention at any one point on the spectrum will by itself be adequate, but the collaborative and cumulative efforts of food producers, processors, distributors, retailers, and consumers can virtually eliminate foodborne disease. It’s important to recognize that the ultimate capacity to make food safe rests in these private hands but government has a responsibility—and it should be government’s first objective— to reduce foodborne disease as much as is reasonably possible through research, regulation, and education.
• Maintaining Public Confidence in Food Safety and the Food Supply. Public confidence in food safety is a public good. It supports consumers in choosing diverse and healthy diets, unconstrained by food safety concerns. It creates a receptive environment for new food technologies. And it is what people want. People want the peace of mind that comes from knowing their food is safe, and peace of mind comes from knowing that government and those involved commercially in the food system have done everything it is reasonably possible to do to make the food safe.
• Exerting International Leadership on Food Safety. It is important for both public health and economic reasons that the U.S. be capable of exerting international leadership on food safety. Much of the U.S. food supply is imported from countries whose standards of food hygiene are not as high as ours, and important segments of the U.S. agricultural and food industry increasingly rely on exports for their economic sustainability and growth. In today’s global food system, in which World Trade Organization (WTO) agreements have an important impact on the standards that govern both food imports and exports, the U.S. must be an international food safety leader.
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Attributes Required to Achieve the Objectives
Broadly speaking, the food safety system must have four key attributes to achieve its objectives:
Prevention. This is a core value in public health and, logically, the only way to reduce the burden of foodborne disease. The principle of prevention should thus be built into the food safety system.
The Hazard Analysis and Critical Control Points (HACCP) approach provides an accepted framework for this purpose. It calls for the food producer or processor to take responsibility for identifying potential hazards in its system, designing and implementing controls to prevent or minimize the hazards, and validating and continuously monitoring the effectiveness of the controls. The preventive principles of HACCP have applications across the farm-to-table food safety spectrum and are being applied to varying degrees on a voluntary basis. Their application as a regulatory tool is limited, however, to seafood, meat, poultry, and juice, where it has been adopted through case-by-case rulemaking processes relying on broad statutory definitions of “adulteration.”
Current U.S. food safety laws provide no mandate to build a preventive, farm-to-table food safety system. The Federal Food, Drug, and Cosmetic Act of 1938, which the Food and Drug Administration administers, is by design a largely reactive enforcement statute. It empowers FDA to remove harmful or potentially harmful food from the market through court enforcement action but does not direct or explicitly empower FDA to mount a comprehensive strategy to prevent foodborne disease. The meat and poultry inspection laws, whose conceptual roots are more than a century old, mandate carcass-by-carcass and daily inspection by the U.S. Dept. of Agriculture’s Food Safety and Inspection Service (FSIS) in slaughter and processing plants. In-plant inspection is important, but these laws force FSIS to focus virtually all of its resources on that one activity and largely ignore the many points on the farm-to-table spectrum where risks may arise and be prevented.
Accountability. This is a core function of all regulatory programs. In consumer protection regulation, the standard rationale for regulation is that the marketplace fails to provide the degree of the public good (in this case, food safety) that people want and are willing to pay for and that the good can be provided through the establishment of regulatory standards to which companies can be held accountable. Regulatory accountability substitutes for accountability the market does not adequately provide.
In the case of food safety, people seek assurance that the producers, processors, and purveyors of food are doing everything reasonably possible to make the food safe and thereby protect consumers from illness. Government responds by setting standards on behalf of the public and holding companies accountable for meeting the standards.
This principle of accountability is well established and works well in the case of chemical hazards through pre-market approval systems and the enforcement of tolerances, which together constitute food safety performance standards for the chemicals they cover.
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The principle of accountability is less well-established for microbial hazards, which account for virtually all known cases of foodborne disease. In contrast to chemicals, there are no provisions in current law that provide explicitly for microbial performance standards. When FSIS mandated HACCP for all meat and poultry plants in 1996, it used its general adulteration and inspection authority to establish performance standards for Salmonella. The objectives and concepts underlying the standards are explained in the preamble to the HACCP/pathogen reduction rule (FSIS, 1996). The standards were intended to induce reductions in the incidence of Salmonella contamination in slaughter and raw ground meat processing plants based on the public health judgment that a reduction in the incidence of pathogenic microbial contamination at this first point of entry into food would, in conjunction with HACCP and other elements of a broader pathogen reduction strategy, help prevent foodborne disease. The regulatory concept was that, without the performance standards, there would be no accountability through the regulatory process for reducing pathogens.
The performance standards have been effective in inducing pathogen reduction, with FSIS reporting that the incidence of Salmonella contamination has been cut substantially since the standards were adopted. For example, in the large plants that slaughter nearly all of the chickens Americans consume, the prevalence of Salmonella-contaminated carcasses has declined nearly 50%, from 20% prior to enactment of HACCP and the Salmonella standards to 10.3% in the most recent report (FSIS, 2000). Although it is too soon to draw definitive conclusions, CDC has reported declines in foodborne disease, which it attributes in part to the FSIS HACCP/pathogen reduction rules (Ostroff, 2000).
Nevertheless, the standards have been opposed by some in the meat industry, which recently won a court ruling (Supreme Beef Processors, Inc. v. USDA, 5th Cir. 2001) that the agency lacked legal authority under the current statutes to establish and enforce the standard as it applied to ground beef. It is unclear whether the court’s reasoning would extend to the Salmonella standards as they apply to slaughter plants. It is clear, however, that without the standards there is no direct accountability through the regulatory system to reduce Salmonella contamination.
Integration. In 1998, a committee of the National Academy of Sciences (NAS) issued a report documenting the multiplicity of differing food safety statutes and the fact that at least 12 federal agencies play important roles in food safety regulation and research (NIM/NRC, 1998). The committee called for modernization and unification of the food safety laws and the lodging of responsibility for leading and managing the federal food safety program in a single accountable official.
The NAS committee’s analysis and recommendations reflect the fact that reducing the burden of foodborne disease requires an integrated, holistic approach across the farm-to-table spectrum. A similar conclusion was reached and well documented in a recent report, “Emerging Microbial Food Safety Issues—Implications for Control in the 21st Century,” issued by the Institute of Food Technologists (IFT, 2002). The highly virulent pathogen Escherichia coli O157:H7 originates in the gut of cattle but, with manure as its vehicle, spreads throughout the food supply, contaminating meat, fresh produce, juice, and other foods. Effective preventive control of this problem will require research and strategically chosen regulatory and educational interventions at multiple points in the chain of food production, distribution, and consumption. Yet neither FDA nor FSIS has the statutory authority or practical mandate to forge an integrated strategy to reduce the burden of foodborne disease from this pathogen—a strategy that puts the research, regulatory, and educational tools of government to work in a coherent farm-to-table effortto minimize the risk of illness from E. coli O157:H7.
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The same can be said of the other major microbial pathogens, whose presence and behavior in the food supply rarely respect the statutory and organizational boundaries between FDA and FSIS. Under President Clinton’s Food Safety Initiative and with the current concern about food bioterrorism, the agencies are working more closely together than before, but no one person is in charge of and accountable for carrying out comprehensive, preventive strategies for reducing foodborne disease. The result is that less gets done to reduce disease than optimally could get done.
Risk-Based Resource Allocation. The food safety system must make the best possible use of its resources to reduce foodborne disease. This means focusing government effort on the greatest risks and the greatest opportunities to reduce risk, wherever they may arise. It means adopting the interventions— presumably some combination of research, regulation, and education—that will yield the greatest reduction in illness. The IFT report cited above documents scientifically why this is true.
The current system does not work this way, in part because of the lack of accepted decision tools for prioritizing food safety risks and opportunities for risk reduction (Taylor and Hoffmann, 2001). Risk-based resource allocation also is precluded by the way the carcass-by-carcass and daily inspection mandates of the meat and poultry laws drive resource allocation. These mandates result in FSIS employing about 7,600 inspectors and consuming about $800 million to regulate meat, poultry, and processed eggs products, while FDA has a total field staff of 1,700 for all of its food programs, including inspectors, laboratory technicians, and administrative staff (GAO, 2001). This allocation would be defensible if the risk were heavily concentrated in the products FSIS regulates, but CDC says that about 85% of the cases of illness reported to it for which a food source was known were associated with FDAregulated food products. The multiyear database of foodborne disease outbreaks (instances of multiple cases of disease associated with a common cause) compiled by the Center for Science in the Public Interest (CSPI, 2001) suggests that 80% of outbreaks may be linked to FDA-regulated foods.
Poultry slaughter inspection is a glaring example of how food safety resources are misallocated and cost effectiveness is lost. More than 15 years ago, NAS concluded that the statutorily mandated poultry slaughter inspection, which involves about two seconds of visual inspection for every one of the 7 billion chickens produced annually in the U.S., makes little contribution to food safety because it does not address Salmonella and other bacteria that cause disease. Yet FSIS must spend more than $200 million and use 3,000 government inspectors to do this work (Moss, 2001). Without question, these resources could be used better elsewhere in the regulatory system to reduce foodborne disease.
FDA has taken a step toward risk-based resource allocation with its annual adoption of “CFSAN Program Priorities” (FDA, 2002). An initiative of Joseph Levitt, Director of FDA’s Center for Food Safety and Applied Nutrition, this document outlines how CFSAN plans to target its efforts in the coming year. This approach should be applied across the entire food safety system for strategic as well as annual planning, with increasingly rigorous assessment and ranking of system-wide risks and the flexibility to deploy resources accordingly.
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The Need for Legislation
The current food safety laws undermine all four attributes of a successful food safety system:
• There is no express statutory mandate to systematically build prevention into the system, from farm-to-table.
• Accountability for reducing microbial pathogens through adoption of performance standards or other measures is not expressly provided for under current law and is in legal jeopardy with the Supreme Beef case.
• Integration is blocked by the patchwork of food safety laws that govern the food safety system and the resulting, fragmented organizational structure, which divides responsibility and accountability for the success of the government’s program. •
•Risk-based resource allocation is impossible when outdated laws mandate misallocation of food safety resources, and no one is in charge of resource allocation across the entire system.
These features of the current system are a threat to its success. It is difficult to argue that the system is doing everything it reasonably can to prevent foodborne disease when it wastes significant resources on antiquated inspection activities and perpetuates misalignment of resources in relation to risk.
Public confidence is fragile in an age of instant communication and close scrutiny of government programs, as European food safety agencies learned following the disclosures of scientific and institutional failures to protect the public adequately or meet public expectations in the cases of bovine spongiform encephalopathy (BSE), E. coli, and biotech foods. With luck, the U.S. will not encounter crises of confidence in food safety on that order, but the system is vulnerable today to the reality that it is not doing everything it reasonably could to prevent illness.
America’s international leadership on food safety also should not be taken for granted. It is jeopardized by FDA’s lack of resources and clear statutory authority to educate and inspect overseas producers and to require them to produce in accordance with U.S. standards. It is also jeopardized by the inability of the U.S. to bring to international harmonization discussions a single voice and consistent approaches to food safety within our own borders.
Key Elements of Legislation
For the food system to achieve its objectives in the long term, comprehensive legislative reform is required. Congress should replace the existing food safety laws with a unified law covering the entire food supply. Rather than just providing legal and regulatory tools, the new law should spell out the objectives of the government’s food safety system and provide a clear mandate and policy direction for the system. The key elements of the law should include:
• A mandate and authority to pursue systematic prevention of foodborne disease from the farm to the table through HACCP-based process control or other preventive strategies. The law should make HACCP mandatory for all processing operations, unless exempted, and direct that preventive steps be taken throughout the system where appropriate and effective to help reduce foodborne disease.
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• A mandate and authority to establish performance standards or other objective criteria as tools of accountability for achieving acceptable food safety results. Performance standards or other tools of accountability are essential to make HACCP or other preventive strategies effective in improving food safety and preventing disease.
• A requirement for a national food safety plan that looks at the food supply as a whole, sets priorities, and adopts holistic strategies to prevent disease. The plan would be revised and reissued every year with data on accomplishments, progress, and problems. The plan would be a vehicle for ensuring that the food safety system operates in a focused, integrated way and making the system accountable for achieving its objectives.
• A mandate to build and finance food safety partnerships with state and local authorities based on nationally uniform food safety standards and clearly defined roles for the states as part of a national food safety system. The states play a critical food safety role, especially at the retail level, but the federal–state relationship is not well defined or financed. The goal should be to enlist the states in partnerships that help ensure that the country’s aggregate food safety resources are used optimally to prevent disease.
• A mandate and authority for risk-based resource allocation. The law should direct that the government’s resources for food safety research, regulation, and education be deployed in the manner most likely to maximize reduction in foodborne disease. This would require repealing the current FSIS inspection mandate and substituting a modernized mandate for the entire farm-to-table food safety system that would ensure an adequate resource base for inspection but require that the inspection resource be distributed and used in the manner most likely to contribute to disease reduction.
• Modern enforcement tools, including enhanced authority to oversee imported food. The enforcement tools and import authorities available to FDA and FSIS are not consistent, and, because the statutes are old, they lack some of the basic tools required to deal with today’s problems, such as detention and recall authority, records access, establishment registration, and civil penalty authority. FDA also needs new authority to inspect overseas food producers and hold imports to the same standards as domestically produced food.
• A mandate to implement food safety education programs as part of the disease prevention strategy. Research is required to determine what works to change individual behavior, but education for commercial food handlers and consumers should be an integral part of the food safety system.
• A mandate to represent the U.S. food safety system and exert leadership in the international arena. The food safety agencies have no statutory mandate or adequate budget for participation in international activities, such as Codex Alimentarius Commission and the WTO. This leads to uncertainty about who represents U.S. food safety interests internationally and, by default, a prominent role for trade agencies, which lack a food safety mission, expertise, and credibility.
• A research mandate. A modernized food safety system will require research and data collection on many subjects, including the incidence and causes of foodborne disease, tools for risk ranking and resource allocation, new food safety technologies and prevention strategies, and consumer behavior.
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Organizational form should follow function. It is evident that change in the function and mandate of the food safety system on the order outlined here would require organizational change. We would need instead a single food safety agency to devise and implement an integrated, national food safety plan, set priorities, allocate resources, and be held accountable for the results. Anyone who has managed in government knows that these leadership and management functions cannot be performed effectively by committee or through coordination. They require an organizational and leadership structure that is designed around and capable of accomplishing the newly defined food safety mission.
The single food safety agency should include FSIS; the food regulatory functions of FDA, including CFSAN, the Center for Veterinary Medicine, and the food portion of FDA’s field resource; and the food safety aspects of the Environmental Protection Agency’s pesticide program. It would not be necessary to consolidate all the food safety research activities of the federal government, since most of them have specialized functions unrelated to the broad public health mission of the food safety agency, but the agency should have its own research mandate and budget. CDC’s foodborne disease surveillance program could also remain separate as an independent source of information on emerging problems and on whether the food safety agency is achieving its disease prevention objectives. However, the unified agency should take on all of the food regulatory functions now at FSIS and FDA, including the food labeling and nutrition functions.
The placement of the single agency within the federal government is an important and controversial issue. External food system stakeholders (industry and consumer alike) have strong and diverse views. Within government, neither USDA nor the Dept. of Health and Human Services (HHS) would welcome “losing” its food safety function to the other, which is one reason they have traditionally resisted organizational change. This stalemate could be resolved by establishing the new agency outside any existing department, like EPA. This would be justified by the importance of the food safety function of the government and the benefit of being insulated from the competing priorities and political interests of the existing departments. The alternative would be to consolidate the food safety functions within one of the existing departments.
HHS and USDA each have their strengths and weaknesses as homes for the food safety agency. Food safety regulation should be seen as a public health function of the government and thus its natural home is in the government’s health department, HHS. Historically, however, food regulation has been a low-profile, low-priority function within HHS and FDA. USDA’s strength is that food and the success of the food system are at the heart of its mission. Thus, food safety is a highprofile issue at USDA. USDA’s weakness as a home for food safety is that the department’s primary role is to promote and protect the interests of U.S. agriculture, which creates a fundamental conflict of interest because it forces the Secretary of Agriculture to balance her food safety responsibilities with her economic and promotional functions.
If it is not possible to create an agency outside the existing departments the better option is to place a consolidated food safety agency at HHS. To ensure that food safety receives due attention, the head of the agency should be appointed by and report directly to the secretary of HHS.
A Political Reality Check
The politics of change are always daunting. Major statutory and organizational changes normally come only in response to extraordinary leadership from a president or influential member of Congress or in response to a real or perceived crisis. Food safety will likely be no different.
The ideas in this article are thus offered with a healthy sense of reality about the uncertain prospects for near-term change. This is okay. Fundamental change in the mandate and structure of our food safety system should take time. We must be mindful of and carefully manage the disruptions and other costs associated with any major transition. But a political catalyst for change will come. When that happens, it will be important to have thought about the subject in advance and be ready to make changes that prepare the system for success in this new century.
by Michael R. Taylor
The author, formerly Administrator of the U.S. Dept. of Agriculture’s Food Safety and Inspection Service and Deputy Commissioner for Policy at the Food and Drug Administration, is Director and Senior Fellow, Risk, Resource, and Environmental Management Div., Resources for the Future, 1616 P St., N.W., Washington, D.C. 20036.
Based on a paper presented during the Institute of Food Technologists’ Second International Food Safety and Quality Conference and Expo, Atlanta, Ga., February 20–22, 2002
CSPI. 2001. Outbreak alert! Closing the gaps in our federal food safety net. Center for Science in the Public Interest, Washington, D.C. (www.cspinet.org/reports/outbreak_alert/index.htm).
FDA. 2002. FY 2002 CFSAN program priorities. Food and Drug Admin., Washington, D.C.
FSIS. 1996. Pathogen reduction; Hazard Analysis and Critical Control Point (HACCP) systems; Final rule. Food Safety and Inspection Service, U.S. Dept. of Agriculture, Fed. Reg. 61: 38806.
FSIS. 2000. Backgrounder, Progress report on Salmonella testing of Raw meat and poultry products. Food Safety and Inspection Service, U.S. Dept. of Agriculture (www.fsis.usda.gov/OA/background/salmtest5.htm).
GAO. 2001. Food safety—Overview of federal and state expenditures. GAO-01-177. General Accounting Office, Washington, D.C.
IFT. 2002. Emerging microbiological food safety issues— Implications for control in the 21st century. Inst. of Food Technologists, Chicago, Ill. (www.ift.org).
Mead, P.S., Slutsker, L., Dietz, V., McCaig, L.F., Bresee, J.S., Shapiro, C., Griffin, P.M., and Touxe, R.V. 1999. Food-related illness and death in the United States. Emerging Infectious Disease 5: 606-625.
Moss, A. 2001. Personal communication, Office of the Under Secretary for Food Safety, U.S. Dept. of Agriculture, Washington, D.C.
NIM/NRC. 1998. “Ensuring Safe Food From Production to Consumption.” Natl. Academy Press, Washington, D.C.
Ostroff, S.M. 2000. Statement of Associate Director for Epidemiologic Science, Natl. Center for Infectious Diseases, Centers for Disease Control and Prevention, before the Agriculture, Nutrition and Forestry Committee, U.S. Senate, Sept. 20 (www.cdc.gov/washington/legislative/09202000.htm).
Taylor and Hoffmann. 2001. Redesigning food safety. Issues in Science and Technology 24: 26.