Adequate, nutritious, safe food is essential to human survival, but food can also cause or convey risks to health and even life itself. Although estimates vary widely, there is agreement that foodborne illness is a serious problem. In the United States, as many as 81 million illnesses (Archer and Kvenberg, 1985) and up to 9,000 deaths (CAST, 1994) per year have been attributed to food-related hazards. Estimates of the annual cost of medical treatment and lost productivity vary widely, from $6.6 billion to $37.1 billion from seven major foodborne pathogens (Buzby and Roberts, 1997).
The nation's agriculture and food marketing systems have evolved to provide food to a growing and increasingly sophisticated population. Complex processes built on advances in science and technology have been developed to evaluate and manage the risks associated with the changing nature of the food supply. Well-established systems control many food risks, but serious hazards to public health remain.
PURPOSE AND SCOPE OF THE STUDY
As a result of the continuing concern about the food safety system in the United States, Congress commissioned the National Academy of Sciences, through the Agricultural Research Service of the US Department of Agriculture (USDA), to undertake the study that resulted in this report. The charge to the committee was twofold. The committee was asked to (1) assess the effectiveness of the current system to ensure safe food, and (2) provide recommendations on scientific and organizational changes needed to increase the effectiveness of the
food safety system. Over a 6 month period, the committee held three meetings as well as two open forums where agency representatives and relevant stakeholders discussed the food safety system. The committee reviewed many documents, including reports on how other countries are reshaping their systems.
This report summarizes the committee's review of food safety in the United States by (1) describing the current US system for food safety and the changing nature of concerns which it encounters, (2) outlining an effective food safety system, (3) identifying the ways in which the current food safety system is inadequate, and (4) providing recommendations to move toward the scientific foundation and organizational structure of a more effective food safety system.
Protecting the safety of food requires attention to a wide range of potential hazards. Food safety is not limited to concerns related to foodborne pathogens, toxicity of chemical substances, or physical hazards, but may also include issues such as nutrition, food quality, labeling, and education. While the scope of this study includes all of these components, this committee's immediate concern focuses on food-related hazards.
1. The Current US Food Safety System
The US food supply is abundant and affordable and is judged by many to present an acceptable level of risk to health. The system has evolved from one that provided consumers with minimally processed basic commodities that were predominantly for home preparation to today's system of highly processed products designed either to be ready-to-eat or to require minimal preparation in the home. As a result of many technological advances, the food system has progressed dramatically from traditional food preservation processes such as salting and curing to today's marketplace with frozen ready-to-eat meals and take-out foods. Likewise, distribution systems for foods have changed greatly.
While these developments have provided the American consumer with a wide array of food products with a high degree of safety, a more diverse food supply carries additional risks as well as benefits. The availability of new food choices such as ''minimally processed" vegetable products (for example, prebagged and chopped leaf lettuce mixes) presents new risks for microbial contamination. The globalization of the food system brings food from all parts of the world into the US marketplace, and with it the potential for foodborne infection or other hazards not normally found in the United States.
The current US food safety system has many of the attributes of an effective system. The nature of food safety concerns has changed due to past successful efforts to control the use of unidentified or misrepresented food ingredients and problems with the appearance and wholesomeness of food products; microbiological and chemical hazards now present new and in some cases increasingly serious challenges which cannot be detected using traditional inspection methods. The introduction of Hazard Analysis Critical Control Point (HACCP) monitoring systems in meat, poultry, and seafood products is an
example of the introduction of science-based process control methodology into food safety regulation and enforcement.
Many Americans now eat in ways that increase risk, including consuming more raw or minimally processed fruits and vegetables and eating fewer home prepared meals. A smaller number of food processing and preparation facilities provide food to increasingly larger numbers of US consumers, enhancing the extent of harm that can arise from any one incident. Simultaneously, increasing numbers of Americans have compromised immune systems because of age, illness, or medical treatment. The development of genetically modified foods and modified macronutrients are two examples of new products or technologies that require new ways of evaluating the safety of substances added to the food supply.
The federal government has usually addressed these developments by adding new structures and processes or adjusting old ones. These incremental adjustments have created a number of inefficiencies and apparent conflicts within the system. Some have been addressed (for example, pesticides have been exempted from the Delaney clause's ban on carcinogens), but others remain. USDA is obligated by statute to maintain the system of continuous onsite factory inspection by government inspectors that has been the hallmark of meat and poultry regulation. The Food and Drug Administration (FDA), meanwhile, with a more varied industry to regulate, has relied on selective monitoring, in which far fewer inspectors periodically visit settings where food is produced, processed, or stored to verify compliance with or to uncover violations of its requirements. A result is that in some cases inspectors from these two agencies oversee food processing in the same processing facility at the same time due to the different enabling statutes. Agencies are at times precluded by statute from implementing monitoring or enforcement practices that are based in science.
The size and complexity of the US food system require significant involvement of government at all levels-federal, state, and local; of the food industry-ranging from the producer to food server; of universities; of the news media; and, most importantly, of the consumer, to address adequately the multitude of issues that arise in ensuring safe food. At the federal level, the efforts are currently fragmented, with at least 12 agencies1 involved in the key functions of safety: monitoring, surveillance, inspection, enforcement, outbreak management, research, and education. Efforts to coordinate federal activities have intensified over the last two years with the National Food Safety Initiative. There are over 50 memoranda of agreement between various agencies related to food safety. The recent proposal to create a Joint Food Safety Research Institute
between USDA and FDA is an obvious outgrowth of such efforts. Notwithstanding these relatively recent activities, however, there still exist significant barriers to full integration.
Summary Findings: The Current US System for Food Safety
- Has many of the attributes of an effective system;
- is a complex, inter-related activity involving government at all levels, the food industry from farm and sea to table, universities, the media, and the consumer;
- is moving toward a more science-based approach with HACCP and with risk based assessment
- is limited by statute in implementing practices and enforcement that are based in science;
- is fragmented by having 12 primary federal agencies involved in key functions of safety: monitoring, surveillance, inspection, enforcement, outbreak management, research, and education; and
- is facing tremendous pressures with regard to:
emerging pathogens and ability to detect them;
maintaining adequate inspection and monitoring of the increasing volume of imported foods, especially fruits and vegetables; maintaining adequate inspection of commercial food services and the increasing number of larger food processing plants; and
the growing number of people at high risk for foodborne illnesses.
2. An Effective Food Safety System
The committee defines safe food as food that is wholesome, that does not exceed an acceptable level of risk associated with pathogenic organisms or chemical and physical hazards, and whose supply is the result of the combined activities of Congress, regulatory agencies, multiple industries, universities, private organizations, and consumers. The mission of a food safety system should be stated as an operational charge that uses and reflects that definition. After reviewing the missions presented by some of the lead federal agencies involved in the US food safety system, the committee defined an overall mission as follows:
The mission of an effective food safety system is to protect and improve the public health by ensuring that foods meet science-based safety standards through the integrated activities of the public and private sectors.
Attributes of an Effective Food Safety System
The attributes of a model food safety system can be summarized in five major components. First, it should be science-based, with a strong emphasis on risk analysis, thus allowing the greatest priority in terms of resources and activity to be placed on the risks deemed to have the greatest potential impact (see Box ES-1). Adjusting effort to risk depends on being able to identify hazards, evaluate the dose-response characteristics of the hazards, estimate or measure exposures, and then determine the likely frequency and severity of effects on health resulting from estimated exposure. Hazards are properties of substances that can cause adverse consequences. Hazards associated with food include microbiological pathogens, naturally occurring toxins, allergens, intentional and unintentional additives, modified food components, agricultural chemicals, environmental contaminants, animal drug residues, and excessive consumption of some dietary supplements. In addition, improper methods of food handling and preparation in the home can contribute to increases in other hazards.
The limited resources available to address food safety issues direct that regulatory priorities be based on risk analysis, which includes evaluation of prevention strategies where possible. This approach enables regulators to estimate the probability that various categories of susceptible persons (for example, the elderly, or nursing mothers) might acquire illness from eating specific foods and thereby allows regulators to place greater emphasis and direct resources on those foods or hazards with the highest risk of causing human illness. Risk analysis provides a science-based approach to address food safety issues. Comprehensive human and animal disease surveillance must be an integral part of any risk analysis in order to estimate exposure.
The second component in a model system is to have a national food law that is clear, rational, and comprehensive, as well as scientifically based on risk. Scientific understanding of risks changes, so federal food safety efforts must be carried out within a flexible framework. US regulatory agencies are moving toward science-based HACCP programs2. This is a major step toward a science based system, but other steps remain critical. An ideal system would be preventive and anticipatory in nature, and thus designed with integrated national surveillance and monitoring along with education and research required to support these activities woven into the fabric of the system. A reliable and accurate system of data collection, processing, evaluation, and transfer is the foundation for scientific risk analysis. Research should have both applied and basic components and be targeted at the needs of producers, processors, consumers, and regulatory decision-makers and other scientists.
BOX ES-1. What Is the Meaning of Science-Based?
A science base for ensuring safe food encompasses many elements. When utilized, these elements improve the ability to identify, reduce, and manage risks; minimize occurrence of foodborne hazards; gather and utilize information; enhance knowledge; and improve overall food safety. Several examples of science-based actions that have been implemented in the US food safety system that are readily recognized as positive elements of the system include:
While the approaches above are important successful science-based tools in food production and processing, these are only examples of implementation of the scientific basis for food safety. An effective food safety system also integrates science and risk analysis at all levels of the system, including food safety research, information and technology transfer, and consumer education.
Third, a model food safety system should also have a unified mission and a single official who is responsible for food safety at the federal level and who has the authority and the resources to implement science-based policy in all federal activities related to food safety. This would allow for effective and consistent regulation and enforcement. Similar risks require similar planning, action, and response. Thus the intensity, nature, and frequency of inspection should be similar for foods posing similar risks. A central voice is critical to effective marshaling of all aspects of the food safety system to create a coordinated response to foodborne disease outbreaks. Control of resources is also critical in
order to encourage movement toward science-based food safety provisions and to ensure that research and education are targeted toward efforts that will produce the greatest benefit for a given cost of improving food safety.
The fourth essential feature of an ideal federal food safety system is that it be organized to be responsive to and work in true partnership with nonfederal partners. These include state and local governments, the food industry, and consumers. The food safety system must function as an integrated enterprise. It must be agile, fluid, connected, integrated, and transparent, with well-defined accountability and responsibility for each partner in the system. It must frame approaches to risk management that recognize the importance of public perception of risks as well as assessments conducted by experts.
Finally, an effective food safety system must be supported by funding adequate to carry out its major functions and mission-to promote the public's health and safety. Moving toward science-based risk analysis as the underpinning of the system should allow reallocation of resources to areas identified as critical to an integrated, focused effort to ensure safe food.
Summary Findings: An Effective Food Safety System
- Should be science-based with a strong emphasis on risk analysis and prevention thus allowing the greatest priority in terms of resources and activity to be placed on the risks deemed to have the greatest potential impact;
- is based on a national food law that is clear, rational, and scientifically based on risk;
- includes comprehensive surveillance and monitoring activities which serve as a basis for risk analysis;
- has one central voice at the federal level which is responsible for food safety and has the authority and resources to implement science-based policy in all federal activities related to food safety;
- recognizes the responsibilities and central role played by the non-federal partners (state, local, industry, consumers) in the food safety system; and
- receives adequate funding to carry out major functions required.
3. Where Current US Food Safety Activities Fall Short
Statutory revision is essential to the development and implementation of an effective and efficient science-based food safety system. Major aspects of the current system are in critical need of attention in order to move toward a more effective food safety system. Food safety in the United States lacks integrated Congressional oversight, allocation of funding based on science, and sustained political support. Statutory impediments interfere with implementation of a more effective food safety system. More than 35 primary statutes regulate food safety. Statutory revision is essential to the development and implementation of an effective and efficient science-based food safety system. The meat and poultry inspection laws mandate a form of compliance monitoring that is largely
unrelated to the magnitude or the types of risks that are now posed by those foods. This diverts efforts and perhaps resources from actual risks and other hazards. Inconsistent food statutes often inhibit the use of science-based decision-making in activities related to food safety, including lack of jurisdiction to evaluate food-handling practices in countries of origin for some types of imported foods.
The federal government response to food safety issues is too often crisis-driven. Management decisions, emphasis, and agency culture are driven by the primary concerns of each agency and special initiatives. One result is fragmentation, which causes a lack of coordination and consistency among agencies in mission, food safety policies, regulation, and enforcement. The fact that some agencies have dual responsibilities (regulation of the quality of food products while marketing them via promotional activities) makes their actions more vulnerable to criticism regarding possible conflicts of interest and may bias their approach to food safety.
In addition to fragmented and overlapping authorities, federal activities are not well-integrated with state and local activities. This results in overlapping responsibilities, gaps in responsibilities, and inefficiencies. Although FDA recommended minimum food-handling standards in a Food Code issued in 1993, the Code has not been adopted in its entirety by most state and local authorities. Surveillance efforts currently in place (such as FoodNet) have been designed to provide data representative of national trends with regard to seven indicator foodborne pathogens yet are not designed to identify trends within smaller geographic areas or communities. Similarly, there are conflicts between US requirements and those of other nations and international bodies. These inadequacies have serious implications for both food imports and food exports.
The multi-faceted federal framework of the US food safety system lacks direction from a single leader who can speak for the government when confronting food safety issues and providing answers to the public. There is no single voice in the government to communicate with stakeholders regarding food safety issues. The lack of clear leadership at the federal level impedes the federal role in the management of food safety. Leadership is needed to set priorities, deploy resources, and integrate a consistent policy into all levels of the system.
A significant impediment to moving toward a science-based food safety system is the lack of adequate emphasis on and integration of surveillance activities that provide timely information on current and potential foodborne disease and related hazards. This timely information is critical if the food safety system is to move from a mode of reaction to prevention. FDA's lack of resources to maintain adequate inspection and monitoring of commercial food facilities and of fresh fruits and vegetables, both domestic and imported, using statute-driven methods of monitoring and enforcement, increases the threat of foodborne disease and related hazards in the food supply.
The committee found that the resource base for research and surveillance was not adequate to achieve the goals identified as necessary for an effective system. Furthermore, there is not an adequately coordinated effort on the scale
required to analyze risk and respond to the challenges of the changing nature of American food hazards related to increases in consumption of imported foods and of food eaten outside the home.
With respect to consumer education, the committee found two major problems: in some instances, consumer knowledge is inadequate or erroneous; and even where knowledge is adequate, it often fails to influence behavior.
Summary Findings: Where the US Food Safety System Falls Short
- Inconsistent, uneven and at times archaic food statutes that inhibit use of science-based decision-making in activities related to food safety, including imported foods;
- a lack of adequate integration among the 12 primary agencies that are involved in implementing the 35 primary statutes that regulate food safety;
- inadequate integration of federal programs and activities with state and local activities;
- absence of focused leadership: no single federal entity is both responsible for the government's efforts and given the authority to implement policy and designate resources toward food safety activities;
- lack of similar missions with regard to food safety of the various agencies reviewed;
- inadequate emphasis on surveillance necessary to provide timely information on current and potential foodborne hazards;
- resources currently identified for research and surveillance inadequate to support science-based system;
- limited consumer knowledge, which does not appear to have much impact on food-handling behavior; and
- lack of nationwide adherence to appropriate minimum standards.
4. Conclusions and Recommendations Needed to Improve the US Food Safety System
Given the concerns outlined above, the committee came to three primary conclusions:
An effective and efficient food safety system must be based in science.
To achieve a food safety system based on science, current statutes governing food safety regulation and management must be revised.
To implement a science-based system, reorganization of federal food safety efforts is required.
To accomplish these objectives, the committee recommends that the following measures be taken regarding the scientific and organizational changes needed to improve the US food safety system:
Base the food safety system on science.
The United States has enjoyed notable successes in improving food safety. One example is the joint government-industry development of low-acid canned food regulations, based on contingency microbiology and food engineering principles, that has almost eliminated botulism resulting from improperly processed commercial food. Similarly, the passage of the 1958 Food Additives Amendment to the Food, Drug, and Cosmetic Act of 1938 was a "technology forcing" event that improved the evaluation of the safety of added and natural substances and reduced the risks associated with the use of food additives. In a like manner, the Delaney clause of that amendment resulted in increased attention to carcinogenic substances in the food supply. With increasing knowledge, many rational, science-based regulatory philosophies have been adopted, some of which rely on quantitative risk assessment. Adoption of such a science-based regulatory philosophy has been uneven and difficult to ensure given the fragmentation of food safety activities, and the differing missions of the various agencies responsible for specific components of food safety. This philosophy must be integrated into all aspects of the food safety system, from federal to state and local.
Congress should change federal statutes so that inspection, enforcement, and research efforts can be based on scientifically supportable assessments of risks to public health.
Limitations on the resources available to address food safety issues require that food safety activities operate with maximal efficiency within these limits. This does not require full-scale, cost-benefit analysis of each issue, but it does require that costs, risks, and benefits be known with some precision. Thus, where feasible, regulatory priorities should be based on risk analysis which includes evaluation of prevention strategies where possible. The greatest strides in ensuring food safety from production to consumption can be made through a science-based system that ensures that surveillance, regulatory, and research resources are allocated to maximize effectiveness. This will require identification of the greatest public health needs through surveillance and risk analysis, and evaluation of prevention strategies. The state of knowledge and
technology defines what is achievable through the application of current science. Public resources can have the greatest favorable effect on public health if they are allocated in accordance with the combined analysis of risk assessment and technical feasibility. However, limiting allocation of resources to only those areas where high priority hazards are known can create a significant problem: other hazards with somewhat lower priority but with a much greater probability of reduction or elimination might not be addressed due to limited resources. Thus both the marginal risks and marginal benefits must also be considered in allocating resources.
Not all agencies responsible for monitoring the safety of imported food are authorized to enter into agreements with the governments of exporting countries in order to reciprocally recognize food safety standards or inspection results. Uniform or harmonized food safety standards and practices should be established, and officials allowed to undertake research, monitoring, surveillance, and inspection activities within other countries. This should permit inspection and monitoring efforts to be allocated in accordance with science-based assessments of risk and benefit. Changes in federal statute that would foster and enhance science-based strategies are shown in Box ES-2.
BOX ES-2. Changes in Federal Statutes that Would Foster and Enhance Science-based Strategies
Congress and the administration should require development of a comprehensive national food safety plan. Funds appropriated for food safety programs (including research and education programs) should be allocated in accordance with science-based assessments of risk and potential benefit.
Changes in statutes or organization should be based on a rational, well-developed national food safety plan formulated by current federal agencies charged with food safety efforts and with representation from the many stakeholders involved in ensuring safe food. Such a plan, as shown in Box ES-3, should serve as the blueprint for strategies designed to determine priorities for
funding, to determine what the needs are, and to ensure that they are incorporated into activities and outcome evaluation.
BOX ES-3. The National Food Safety Plan Should
To implement a science-based system, Congress should establish, by statute, a unified and central framework for managing federal food safety programs, one that is headed by a single official and which has the responsibility and control of resources for all federal food safety activities, including outbreak management, standard-setting, inspection, monitoring, surveillance, risk assessment, enforcement, research, and education.
The committee was asked to consider organizational changes that would improve the safety of food in the United States. During the 6 months of active review of information and deliberation, the committee identified characteristics needed in an organizational structure that would provide for an improved focus for food safety in the United States. The committee found that the current fragmented regulatory structure is not well-equipped to meet the current challenges. The key recommendation in this regard is that in order for there to be successful structure, one official should be responsible for federal efforts in food safety and have control of resources allocated to food safety.
This recommendation envisions an identifiable, high-ranking, presidentially-appointed head, who would direct and coordinate federal activities and speak to the nation, giving federal food safety efforts a single voice. The structure created, and the person heading it, should have control over the resources Congress allocates to the food safety effort; the structure should also have a firm foundation in statute and thus not be temporary and easily changed by political agendas or executive directives. It is also important that the person heading the structure should be accountable to an official no lower than a cabinet secretary and, ultimately, to the President.
Many members of the committee are of the view that the most viable means of achieving these goals would be to create a single, unified agency headed by a single administrator—an agency that would incorporate the several relevant functions now dispersed, and in many instances separately organized, among three departments and a department-level agency. However, designing the precise structure and assessing the associated costs involved are not possible in the time frame given the committee, nor were they included in its charge. The committee did discuss other possible structures; while it ruled out some, it certainly did not examine all possible configurations and thus the examples provided in Box ES-4 are only illustrative of possible overall structures that could be considered.
BOX ES-4 Some Examples of Possible Organizational Structures to Create a Single Federal Voice for Food Safety
The committee does not believe that the type of centralized focus envisioned can be achieved through appointment of an individual with formal coordinating responsibility but without legal authority or budgetary control for food safety, a model similar to a White House-based 'czar'. Nor, in the committee's view, can this goal be achieved through a coordinating committee similar to that currently provided via the National Food Safety Initiative. In evaluating possible structures, the committee realized that past experience with other structures or
reorganizations, including the creation of new agencies, such as the Environmental Protection Agency (EPA), should inform any final judgment. Further, it is quite possible that other models may now exist in government that can serve as templates for structural reform. Whether or not a single agency emerges, the ultimate structure must provide for not just delegated responsibility, but also for control of resources and authority over food safety activities in the federal government.
Congress should provide the agency responsible for food safety at the federal level with the tools necessary to integrate and unify the efforts of authorities at the state and local levels to enhance food safety.
This report specifically addresses the federal role in the food safety system, but the roles of state and local government entities are equally critical. For integrated operation of a food safety system, officials at all levels of government must work together in support of common goals of a science-based system. The federal government must be able to ensure nationwide adherence to minimal standards when it is deemed appropriate. The work of the states and localities in support of the federal mission deserves improved formal recognition and appropriate financial support. Statutory tools required to integrate state and local activities regarding food safety into an effective national system are shown in Box ES-5.
BOX ES-5. The Statutory Tools Required to Integrate Local and State Activities Regarding Food Safety into an Effective National System
MOVING TOWARD A MODEL SYSTEM
It is recognized that these recommendations will need significant review and discussion. The committee focused on the need for a centrally managed federal system to ensure coordination and direction in food safety programs and policy, and to serve as a single voice with authority and resources to suggest and implement legislation. It had insufficient time to review all the possible organizational structures that could accomplish this goal. A successor study could focus on this. Of critical importance, though, are the first two recommendations: the first, to base the system on science, and the second, that of rewriting the current patchwork of federal food statutes that in many cases do not serve to ensure a scientifically supportable and risk-based food safety system, and certainly prevent it from being more cost effective. Regardless of the organizational structure chosen, a revamped federal food statute is critical to being able to reallocate resources toward risks that have or will have the greatest significance to the public's health. Implementation of these recommendations should not be looked at as a cost-cutting measure, but rather as a way to design a well-defined integrated system to ensure safe food. This system may well be able to demonstrate effectively a need for additional resources to address important and specific problems. Although the National Food Safety Initiative properly seeks to alleviate problems inherent in the present decentralized structure, experience indicates that any ad hoc administrative adjustments and commitments to coordination will not suffice to bring about the vast cultural changes and collaborative efforts needed to create an integrated system.
Changing hazards associated with food and changing degrees of acceptance of risk are factors that impact the nation's ability to protect public health and ensure safe food. Risk acceptance and foodborne hazards will continue to change and evolve with new technologies and consumer demands. Federal food safety efforts must be designed to deal with those changes. This report is not a comprehensive and all-inclusive discussion of these issues. Adoption of the recommendations in this report will not end the effort to make food safer. They should, however, contribute to ensuring the safety of our food while providing a blueprint for a truly integrated system.