6
Conclusions and Recommendations

Congress commissioned the National Academy of Sciences, through the US Department of Agriculture's (USDA) Agricultural Research Service, to undertake the study that resulted in this report. The charge to the committee was to perform two main tasks: assess the current US food safety system and its effectiveness in addressing the continually changing concerns about food safety; and provide recommendations on scientific and organizational changes needed to ensure an effective food safety system for the present and future generations.

The effectiveness of efforts to ensure the safety of food for US consumers is not solely, perhaps not even primarily, the responsibility of the federal government. An effective food safety system depends on the collective efforts of food producers, processors, transporters, suppliers, preparers, retailers, and handlers; of officials at the local, state, and federal levels; and of consumers who select and prepare food. There are three overriding conclusions that the committee came to as a result of its deliberations:

    I.  

    An effective and efficient food safety system must be based on science.

    II.  

    To achieve a food safety system based on science, current statutes governing food safety regulation and management must be revised.

    III.  

    To implement a science-based system, reorganization of federal food safety efforts is required. 



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    6 Conclusions and Recommendations Congress commissioned the National Academy of Sciences, through the US Department of Agriculture's (USDA) Agricultural Research Service, to undertake the study that resulted in this report. The charge to the committee was to perform two main tasks: assess the current US food safety system and its effectiveness in addressing the continually changing concerns about food safety; and provide recommendations on scientific and organizational changes needed to ensure an effective food safety system for the present and future generations. The effectiveness of efforts to ensure the safety of food for US consumers is not solely, perhaps not even primarily, the responsibility of the federal government. An effective food safety system depends on the collective efforts of food producers, processors, transporters, suppliers, preparers, retailers, and handlers; of officials at the local, state, and federal levels; and of consumers who select and prepare food. There are three overriding conclusions that the committee came to as a result of its deliberations: I.   An effective and efficient food safety system must be based on science. II.   To achieve a food safety system based on science, current statutes governing food safety regulation and management must be revised. III.   To implement a science-based system, reorganization of federal food safety efforts is required. 

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    The committee's recommendations focus on two main areas. The first addresses the scientific basis of prudent, cost-effective food safety regulation. The second addresses the legal framework and management structure within which the scientific basis should be developed and deployed. The committee presents these recommendations as an integrated, mutually reinforcing package. Specifically, the committee believes that the development and, critically, the use of a scientifically supportable foundation for regulation is not likely to be achieved within the current scattered organization of federal food safety programs, where responsibility is dispersed, budgets are separate, a unified mission is lacking, and no single official has formal or public overall responsibility and authority for performance. More study is needed to determine the best organizational plan for a centrally unified framework for managing the federal system. The committee's recommendations do not assume that the only way to improve food safety is to create a single responsible agency. The committee also recognizes that designing the details of a centrally managed federal system will generate controversy and will in any case take time. Moreover, it should be emphasized that many of the specific elements of its recommendations can and should be implemented without waiting for the creation of a centrally managed federal system. The committee emphasizes the urgency of reform,1 both scientific and organizational. Threats to the safety of food consumed by Americans are ubiquitous and, whether or not the threats are growing, they are certainly changing. Diverse observers of the food safety system, including entities attached to both Congress and the White House, have been calling attention to specific gaps and deficiencies for more than a decade (see Appendix B for a description of previous proposals related to changes in organizational structure). Responsive legislative and administrative actions along the lines of those recommended are long overdue. Scientific Recommendations Recommendation I: Base the food safety system on science. The United States has enjoyed notable successes in improving food safety. An example of these is the joint government-industry development of low-acid 1   During the I month period in which the final committee meeting was held (June, 1998), national public health officials in the US reported three major outbreaks involving collectively more than 7,000 reported cases of food-related illness. It is assumed that many more cases of food-related illnesses occurred during this time period as most foodborne illnesses are either unreported or unrecognized as part of an outbreak.

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    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 Cosmetics 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. With increasing knowledge, many rational, science-based regulatory philosophies have been adopted, some of which rely on quantitative risk assessment. Adoption of this 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. The greatest strides in ensuring food safety from production to consumption can be made through a scientific risk-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. 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. It is important to recognize that limiting allocation of resources to only those areas where high priority hazards exist can create another problem: other hazards with somewhat lower priority but with a much greater probability of reduction or elimination will not be addressed due to limited resources. Thus, both the relative risks and benefits must be considered in allocating resources. Recommendation IIa: Congress should change federal statutes so that inspection, enforcement, and research efforts can be based on scientifically supportable assessments of risks to public health. At a minimum, Congress should legislatively modify the provisions of the Meat Inspection Act and the Poultry Products Inspection Act that are now understood to require physical inspection of each animal carcass and thereby force resources to be allocated in a fashion that is not calibrated to risk. Adequate resources should be made available for the implementation of the Hazard Analysis Critical Control Point (HACCP) system by the USDA and the Food and Drug Administration. Resource allocations should be subject to revision and adjustment as assessments of risk change. Implementing a food safety system based on risk assessment will require a new level of flexibility in statutory directives to permit

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    responsiveness to advances in science and technology that underlie the food system and food safety efforts. BOX 6-1. Changes in Federal Statutes that Would Foster and Enhance Science-Based Strategies ·   Eliminate continuous inspection system for meat and poultry and replace with a science-based approach which is capable of detecting hazards of concern; ·   mandate a single set of science-based inspection regulations for all foods; and ·   mandate that all imported foods come from only countries with food safety standards deemed equivalent to US standards. Recommendation IIb: 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. The National Food Safety Plan should: •   Include a unified, science-based food safety mission; •   integrate federal, state, and local food safety activities; •   allocate funding for food safety in accordance with science-based assessments of risk and potential benefit; •   provide adequate and identifiable support for research and surveillance to: —   monitor changes in risk or potential hazards brought on by changes in the food supply or consumption patterns, and —   improve the capability to predict and avoid new hazards; increase monitoring and surveillance efforts to improve knowledge of the incidence, seriousness, and cause-effect relationships of foodborne disease and related hazards; address the additional and distinctive efforts required to ensure the safety of imported foods; recognize and provide support for the burdens imposed on state and local authorities that have primary front-line responsibility for the regulation of food service establishments; and address consumers' behaviors related to safe food-handling practices.

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    Rationale for Recommendations Related to a Science-Based System The greatest strides in ensuring food safety from production to consumption can be made through a scientific risk-based system that ensures that surveillance, regulatory, and research resources are allocated to maximize effectiveness. That will require identification of the greatest public health needs and greatest opportunities for improvement through prevention, surveillance and risk analysis. 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. Both risks and scientific understanding of risks change, so federal efforts must be carried out within a flexible framework. US regulatory agencies are moving toward science-based HACCP programs. The committee found evidence that current resources might be inadequate both to continue traditional inspection and to implement HACCP systems fully. A glaring defect in the present system is that substantial resources are directed to problems that do not have the greatest human health impact (for example, carcass-by-carcass organoleptic [primarily visual and odor detection] inspection of meat and poultry). The elimination of continuous inspection for meat and poultry would not necessarily end all ante- or postmortem inspections of carcasses, if HACCP programs were appropriately developed and implemented. Such programs would have to include appropriate methods to identify diseased animals, which might require some level of carcass inspection as identified by hazard analysis. Current understanding of the magnitude of the problem of foodborne disease and the importance of the relevant hazards is incomplete and in many cases inaccurate. Furthermore, there is a lack of scientific resources and structure to address the gaps and inaccuracies. Effective and adequate monitoring, surveillance, and research to characterize risk are required to improve the allocation of resources and to develop the knowledge and technology needed to manage hazards that pose the greatest risk. The committee found many instances in which the resource base for research and surveillance was not adequate to achieve the critical goals discussed. There is not an adequately coordinated effort on the scale required to analyze the risks and respond to the challenges presented by the changing nature of American food hazards related to increases in consumption of imported foods and in meals eaten away from home. It is also important that any national plan directly address the safety of imported food. 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 or practices should be encouraged, and officials allowed to undertake research, monitoring,

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    surveillance, or inspection activities within other countries. This should permit inspection and monitoring efforts to be allocated in accordance with science based analyses of risk and benefit. The committee found two major problems with respect to consumer education: in some instances, consumer knowledge is inadequate or erroneous; and even where knowledge is adequate, it often fails to influence behavior. A task force to examine approaches to and resources for consumer education is required. Role of Risk Analysis The cornerstone of a science-based system of food safety is the incorporation of the results of risk analysis into all decisions regarding resource allocation, programmatic priorities, and public education activities. Risk assessment integrates data on exposure to harmful agents and dose-response relationships to estimate the risk of developing illness from eating specific foods. The growing acceptance of the principles of risk assessment has also led to its use beyond regulatory standard-setting. It is now possible to use comparisons of risk to inform and set priorities for risk management. Risk-based priorities enable resources to be so allocated as to protect public health and to attack the worst problems and/or those most amenable to change first. Resources Required for Research To move from a reactive mode of research based on responses to food safety crises to a preventive mode in which newly emerging hazards are identified, or, if possible, prevented, and potential methods for containment evaluated, the federal agency(ies) responsible for food safety regulation will need authority to direct the allocation of funds for food safety research. Intramural and extramural research priorities should be focused on both short and long-term hazard prevention and on advancing understanding of foodborne pathogens and other food-related hazards; research results should then be integrated into the standard-setting and regulatory program. Selection of research priorities should be based on identification of the greatest potential areas for foodborne risks and assessment of the likely contributions of research findings to the prevention of illness and the improvement of regulatory performance. In addition to research targeted at immediate regulatory needs, there should continue to be a federally supported, long-term, strategic research program. It should have both applied and basic components and be targeted at the needs of producers, processors, consumers, and nonregulatory and regulatory scientists.

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    Recommendations to Implement a Science-Based System Through Organizational Changes Recommendation IIIa: 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 look at organizational changes that would improve the safety of food in the United States. In the time available for information gathering and deliberation, the committee identified characteristics needed in an organizational structure that would improve 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 committee's key recommendation is that to achieve a structure that can implement a science based system, one official should be responsible for federal efforts in food safety and have control of the resources allocated to food safety. This recommendation contemplates a structure that would have 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 easily subject to changes in political agendas. It is also important that the person heading the structure should be accountable to an official no lower than a cabinet-level secretary, and ultimately, to the President. 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 Recommendation IIIb: 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

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    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. BOX 6-2. Statutory Tools Required to Integrate Local and State Activities Regarding Food Safety into an Effective National System ·   Authority to mandate adherence to minimal federal standards for products or processes, ·   continued authority to deputize state and local officials to serve as enforcers of federal law, ·   funding to support, in whole or in part, activities of state and local officials that are judged necessary or appropriate to enhance the safety of food, ·   authority given to the federal official responsible for food safety to direct action by other agencies with assessment and monitoring capabilities, and ·   authority to convene working groups, create partnerships, and direct other forms and means of collaboration to achieve integrated protection of the food supply. Rationale for Organizational Recommendations Centralized and Unified Federal Framework The committee believes that the creation of a centralized and unified federal framework is critical to improve the food safety system. Many members of the committee are of the view that the most viable means of achieving the goal would be 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, in the time frame given the committee, it was not possible to determine whether this is the only sound approach or whether the costs of achieving it would be too high. Nor was it the committee's charge to resolve these issues. The committee did discuss some possible structures; while it ruled out some, it certainly did not examine all possible configurations and thus the examples provided below are only illustrative of possible overall structures that could be considered. The committee does not believe that the type of centralized

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    focus envisioned can be achieved through the 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. Experience indicates that any ad hoc administrative adjustments and commitments to coordinate will not suffice to bring about the cultural changes and collaborative efforts needed to create an integrated system. 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, should inform any final judgment. Further, it is quite possible that other models may now exist in government that can serve as templates for an improved structure. It thus proposes that a sequential, detailed examination of specific organizational changes be a major component of future study, in keeping with the Congressional appropriations language. BOX 6-3. Some Examples of Possible Organizational Structures to Create a Single Federal Voice for Food Safety ·   A Food Safety Council with representatives from the agencies with a central chair appointed by the President, reporting to Congress and having control of resources, ·   designating one current agency as the lead agency and having the head of that agency be the responsible individual, ·   a single agency reporting to one current cabinet-level secretary, and ·   an independent single agency at cabinet level. NOTE: These examples are provided for illustrative purposes and many other configurations are possible. It is strongly recommended that future activities be directed toward identifying a feasible structure that meets the criteria outlined. Integration of Food Safety Efforts 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 the food safety system, officials at all levels of government must work together in support of common goals. The federal government must be able to ensure nationwide adherence to minimal standards. The work of the states and localities in support of the federal mission deserves better formal recognition and appropriate financial support.

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    Similarly, the increased demand of US consumers for year-round availability of fruits and vegetables and the internationalization of the food supply generally have created an increased need for regulatory inspection and control of imported foods. Rationalization of an expanded system of import controls should be based on risk analysis and rely on greatly increased cooperation with US trading partners. The food industry, from production to delivery, must be included in the planning and implementation of comprehensive food safety efforts. Consumers also have the crucial responsibility of knowing and practicing safe food-handling procedures to protect themselves and their families. Government officials should develop and support partnerships and joint activities with the food industry and with consumers in pursuit of the goal of combating foodborne illness and related hazards.