Providing nutritious, abundant, and safe food requires the efforts of many partners that together make up today’s complex and evolving food system.1 Since 1906, the U.S. Food and Drug Administration (FDA) and its predecessor agencies have regulated foods, among other products. Today the agency has oversight of approximately 80 percent of the U.S. food supply.2
Although there have been prior efforts to identify needed improvements in food safety, recent multistate foodborne illness outbreaks have again highlighted a food safety system that is not always effective in protecting the public health. The FDA has been criticized as responding only reactively to food safety problems and neglecting its preventive functions. With these concerns in mind, in 2008 Congress requested that the FDA contract with the National Academies for a comprehensive study of gaps in the FDA’s food safety system. While the responsibility for addressing these challenges
does not lie solely with the FDA, the focus of this report is on enhancing that agency’s food programs, specifically those devoted to food safety.
To conduct this study, a 13-member committee with extensive experience in FDA food programs and policies, food law and regulations, risk analysis and communication, economics, epidemiology, monitoring and surveillance, food microbiology and toxicology, feed issues, and state food programs was convened. The committee gathered information through six meetings, statements in response to specific queries to the FDA, and public documents.
As requested (Box S-1), the committee reviewed the FDA’s 2007 Food Protection Plan (FPP), a road map aligned with the agency’s strategic plan, but it also worked to identify additional tools and capacities to improve food safety. Since the publication of the FPP, organizational and leadership changes in the federal government3 have altered the U.S. food safety scene. In this new environment, the committee envisioned the FPP as a point of departure but focused its attention on providing the FDA with concrete guidance in various areas of concern, including the need to implement a risk-based food safety management system.
The committee left many of the details of the implementation of its recommendations to the FDA, especially since food safety is just one of the agency’s many responsibilities. The committee considered cost and resource issues in a general sense by drawing on the experience of members who formerly held senior leadership positions at the FDA. Because essential information was not always accessible, however, the committee lacked the full evidence base needed to address these issues in detail.
This section presents the committee’s main conclusions. It begins with a brief review of the FPP, which is evaluated throughout the report as appropriate. It then presents conclusions concerning the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management.
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:
Strategic planning is an essential element of a food safety program and should precede the design and implementation of a risk-based approach to food safety management. At a broad level, strategic planning entails identifying public health goals (e.g., reducing the number of infections caused
by specific foods), identifying tools for attaining those goals (e.g., research, education activities), and developing measures with which to evaluate success. The FDA’s strategic plan for food safety management should explain its risk-based regulatory philosophy and the factors it will weigh in making decisions about the prioritization of efforts, allocation of resources, and selection of interventions. At a specific level, all of the risk-based activities discussed in the report (e.g., data collection) should be undertaken only after strategic planning.
The FPP (Appendix G) presents the FDA’s general philosophy on food safety, focusing on three core elements: (1) prevention, (2) intervention, and (4) response. It also outlines the following four cross-cutting principles: (1) focus on risks over a product’s life cycle, (2) target resources to achieve maximum risk reduction, (3) address both unintentional and deliberate contamination, and (4) use science and modern technology systems.
The committee concluded that while the FPP can serve as a platform for initiating a transformation at the FDA, it lacks sufficient detail on which to base policy decisions on prevention and risk. For example, it does not provide specific strategies to achieve the actions proposed. Moreover, terms such as “risk” and “risk-based approaches” are not adequately defined in the FPP; thus they do not clearly elucidate the FDA’s philosophy and can be misunderstood. The committee concluded that the FPP needs to evolve and be supported by the type of strategic planning described in this report.
Adopting a Risk-Based Decision-Making Approach to Food Safety
In a food safety system, decisions about resource allocation need to be made consistently in order to maximize benefits and reduce risks while also considering costs. Food safety risk managers must consider a wide variety of concerns in their decision making, including the needs and values of diverse stakeholders, the controllability of various risks, the size and vulnerabilities of the populations affected, and economic factors. Although the balancing of diverse risks, benefits, and costs is challenging, the lack of a systematic, risk-based approach to facilitate decision making can cause problems ranging from a decrease in public trust to the occurrence of unintended consequences to society, the environment, and the marketplace. Moreover, to carry out all its food safety responsibilities and ensure continuity of everyday operations, the FDA needs to have sufficient staff working on food issues to ensure that routine functions continue even when a crisis occurs.
The committee examined concrete examples of the FDA’s risk-based activities and identified gaps. Although the FDA is to be commended for embracing classic tools of risk assessment and management, it currently lacks a comprehensive, systematic vision for a risk-based food safety sys-
tem. Many of the attributes necessary for such a system, including strategic planning, transparency, and formalized prioritization processes, are lacking in the agency’s approach to food safety management. The FDA also has made only limited progress toward establishing performance metrics for measuring improvements in food safety.
Food safety is a shared responsibility of industry, retailers, consumers, and government agencies, and determining their roles is an important component of strategic planning. Regulators also must establish a systematic means of evaluating, selecting, and designing interventions to address high-priority risks. The FDA lacks a clear regulatory philosophy for assigning responsibility and a comprehensive strategy for choosing the level and intensity of interventions, as well as the extensive resources necessary to design and support a comprehensive risk-based food safety management system.
The risk-based approach recommended by the committee is summarized in Box S-2.
Creating a Data Surveillance and Research Infrastructure
Data form the foundation of a risk-based decision-making approach, and vast amounts of such data are being collected by the government, industry, and academia. However, the FDA has not adequately assessed its data needs and lacks a systematic means by which to collect, analyze, manage, and share data. Barriers to the availability and utilization of data to support a risk-based approach include a lack of data sharing, the absence of a comprehensive data infrastructure, and limited analytical expertise within the FDA.
The FDA’s surveillance role is supported by its research capacity, which gives the agency an opportunity to fill data gaps and address uncertainties to help refine its risk-based decision making. The FDA’s current food safety research program appears to be fragmented and poorly managed, lacking strategic planning and coordination of research that is conducted intramurally and at the five extramural research centers. Many basic questions, such as the size and scope of the FDA’s research program and the appropriate balance between basic and applied research, need to be addressed before the program can be supportive of a risk-based approach. In particular, inadequate attention is given to research aimed at determining the efficacy and value of specific food safety management policies.
Integrating Federal, State, and Local Government Food Safety Programs
Food safety activities of state and local (including territorial and tribal) governments, including inspection, surveillance, and outbreak investigation, have long been important contributors to the U.S. food safety system.
A Recommended Risk-Based Approach
Step 1: Strategic Planning
Step 2: Public Health Risk Ranking (Ranking of Hazards)
Step 3: Targeted Information Gathering on Risks and Consideration of Other Factors That May Influence Decision Making
However, these activities are not fully integrated so that duplication is minimized. Integration will require harmonization so that all programs and functions related to food safety meet a minimum set of standards. The FDA has standards in place that, if broadened and implemented properly, could serve as the basis for this harmonization. As with the federal system, state and local efforts should be built on a risk-based approach.
Step 4: Analysis and Selection of Intervention(s)
Step 5: Design of an Intervention Plan
Step 6: Monitoring and Review
Enhancing the Efficiency of Inspections
For years, the inspectional capacity and efficiency of the FDA have been criticized as inadequate. Although mindful of potential gains from allocating more resources to the FDA’s inspection system, the committee focused on increasing the system’s efficiency. One barrier to improved efficiency is that the FDA’s food programs lack direct authority over the work of inspectors, resulting in potential substantial delays in policy implementation in the field. Nor have inspection procedures been reviewed for efficiency or consis-
tency with a risk-based approach. The committee concluded that exploring alternative models for the inspection of food facilities (e.g., delegating some inspection activities to state and local governments, accepting third-party auditing of food facilities) could lead to gains in efficiency.
Improving Food Safety and Risk Communication
Risk communication is integral to risk-based food safety management. The FDA should envision risk communication not only as consultation with stakeholders at various steps of the risk-based process, but also as a form of policy intervention to achieve objectives in its strategic plan. The FDA’s risk-based food safety management system must incorporate effective risk communication and food safety education for consumers and those who could impact public health through their professions, such as public health officials. The FDA should continue to use the advice of the Risk Communication Advisory Committee; below the committee offers several other recommendations to enhance risk communication.
Modernizing Legislation to Enhance the U.S. Food Safety System
Since 1938, Congress has occasionally amended the Federal Food, Drug, and Cosmetic Act (FDCA) to enhance the FDA’s power to fulfill its food safety mission. In some fundamental respects, however, the law under which the FDA must ensure the safety of 80 percent of the nation’s food has remained unchanged since 1938—despite the dramatic changes in food production and distribution patterns that have taken place. Those food safety provisions of the FDCA that are broad delegations of power rather than specific grants of authority have led to the FDA’s vulnerability to court challenges and, consequently, the agency’s reluctance to take action. This deficiency in the food safety system needs to be remedied.
Achieving the Vision of an Efficient Risk-Based Food Safety System
The committee is confident that the risk-based approach recommended in this report would enhance the FDA’s ability to ensure food safety now and in the future. Nonetheless, the committee recognizes that this approach will not work optimally under the current organizational structure of the food safety system. The committee is encouraged by the establishment of the Office of Foods in 2009, but it has not been persuaded that this single consolidation step will resolve the important problems related to the separation of responsibilities in the FDA’s food programs.
Food safety in the United States is managed by many government agencies. The ability of the FDA, and the government in general, to succeed in
ensuring food safety through the development of a risk-based food safety management system would be greatly enhanced if the recommendations in this report were implemented in the context of organizational changes, such as the integration of activities currently scattered among poorly coordinated agencies. There are many potential avenues of organizational reform and many serious barriers to overcome. Hence, the importance of in-depth analysis and planning of such changes cannot be overemphasized.
The committee’s deliberations resulted in suggested directions for improving food safety management (Box S-3) and specific recommendations for overcoming deficiencies in the food safety system (Box S-4).
Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. The committee hopes that this report provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.
Suggested Directions for Improving the U.S. Food and Drug Administration’s (FDA’s) Food Safety Management
Toward a Risk-Based Approach
Recommendation 3-1: The type of risk-based food safety approach outlined by the committee in Box S-2 should become the operational centerpiece of the U.S. Food and Drug Administration’s (FDA’s) food safety program. This approach should be embraced by all levels of management and should serve as the basis for food safety decision making, including prioritization of resources dedicated to all agency functions (e.g., inspections, promulgation of regulations, research). This approach should be applied to all domestically produced and imported foods and to all food-related hazards, whether due to unintentional or intentional (i.e., with intent to harm) contamination. The FDA should work with local, state, and national regulatory partners to facilitate the incorporation of these principles into their programs.
Recommendation 3-2: The FDA should develop a comprehensive strategic plan for development and implementation of a risk-based food safety management system. The agency should also develop internal operating guidelines for the conduct of risk ranking, risk assessment, risk prioritization, intervention analysis, and the development of metrics with which to evaluate the performance of the system. The strategic plan and guidelines should include descriptions of data, methodologies, technical analyses, and stakeholder engagement. Further, the strategic plan and all guidelines for the risk-based system should be fully supported by the scientific literature and subjected to peer review. When appropriate, the FDA should adopt guidelines already established by other federal agencies or international organizations.
Recommendation 3-3: The FDA, in collaboration with partners, should identify metrics with which to measure the effectiveness of the food safety system, as well as its interventions. The FDA should include these metrics, and plans for any related data collection, as part of strategic planning. The metrics should have a clearly defined link to public health outcomes.
Recommendation 3-4: The FDA should identify expertise needed to implement a risk-based approach. This includes training current
and/or hiring new personnel in the areas of strategic planning; management of data; development of biomathematical models and other tools for risk ranking, prioritization, intervention analysis, and evaluation; and risk communication.
Sharing the Responsibility
Recommendation 4-1: To ensure food safety, the FDA should develop a plan for defining the extent of and form for sharing responsibilities with the states, the private sector, third parties (e.g., independent auditors), and other countries’ governments.
Recommendation 4-2: The FDA should develop a comprehensive strategy for choosing the level and intensity of policy interventions needed for different food safety risks. Criteria for choosing the level and intensity of policy interventions and a plan for evaluating the selected interventions should be developed with transparency, stakeholder participation, and clear lines of communication.
Creating a Data Surveillance Infrastructure
Recommendation 5-1: Data collection by the FDA should be driven by the recommended risk-based approach and should support risk-based decision making. It is critical that the FDA evaluate its food safety data needs and develop a strategic plan to meet those needs. The FDA should review existing data collection systems for foods to identify data gaps, eliminate systems of limited utility, and develop the necessary surveillance capabilities to support the risk-based approach. The FDA should formulate and implement a plan for developing, harmonizing, evaluating, and adopting data standards. The FDA should also establish a mechanism for coordinating, capturing, and integrating data, including modernization of its information technology systems. To coordinate, capture, and integrate data, the FDA could lead the implementation of a multiagency food safety epidemiology users group (see Chapter 5). The centralized risk-based analysis and data management center proposed in recommendation 11-3 in Chapter 11 could serve the functions of data storage and analysis in support of a risk-based approach. Mechanisms should also be instituted to build trust with industry and, in partnership, collect and analyze industry data.
Recommendation 5-2: The FDA should evaluate its personnel needs to carry out its roles in collecting, analyzing, managing, and communicating food safety data. The agency should establish an analytical unit with the resources and expertise (i.e., statisticians, epidemiologists, behavioral scientists, economists, microbiologists, risk analysts, biomathematical modelers, database managers, information technology personnel, risk managers, and others as needed) to support risk-based decision making.
Recommendation 5-3: The FDA should evaluate statutes and policies governing data sharing and develop plans to improve the collection and sharing of relevant data by all federal, state, and local food safety agencies. For example, in collaboration with other food safety agencies, the FDA should develop and implement technologies and procedures that will ensure confidentiality and facilitate data sharing. Congress should consider amending the law, to the extent that legal changes are needed, to allow sufficient data sharing among government agencies.
Creating a Research Infrastructure
Recommendation 6-1: The FDA should have a food safety research portfolio that supports the recommended risk-based approach. To this end, the agency’s current food safety research portfolio should undergo a comprehensive review. Following this review and with consideration of the agency’s broad strategic plan, the FDA should examine the relevance and allocation of its research resources by using public health risk ranking and prioritization. Future research should address the most pressing public health issues and directly support further characterization of risk and selection, implementation, and evaluation of interventions. In addition, research should be coordinated to prevent duplication of effort, especially for cases in which research efforts are better suited to the academic or medical sector.
Recommendation 6-2: Implementation of recommendation 6-1 requires reorganization of the FDA’s research portfolio, including reallocation of resources from irrelevant or poorly performing initiatives; hiring of new staff in critical areas and, where appropriate, retraining of existing staff; and identification of future resource
needs to support risk-based food safety management. Although the committee recognizes the difficulty of transferring scientists from one research focus to another, the FDA should foster an environment of fluidity in which teams of scientists can be formed with ease to address different research initiatives as necessary.
Recommendation 6-3: Keeping in mind that the FDA will not be able to address all important research needs, the agency should continue to utilize alternative funding mechanisms (e.g., cooperative agreements, university-based centers, contracts) based on a competitive, peer-review process. These efforts could be expanded by establishing a competitive extramural research funding program.
Integrating Federal, State, and Local Food Safety Programs
Recommendation 7-1: The FDA should utilize the surveillance, inspection, and analytic systems and resources of state and local governments in a fully integrated food safety program. As a prerequisite to such integration, the FDA should work with the states and localities to harmonize their programs by providing adequate standards and overseeing their implementation, beginning with those states that meet such standards. Standardization and integration of state and local food safety programs should be conducted in an evolutionary fashion, with intermediate goals and associated performance measures. The White House Food Safety Working Group should make integration of federal and state food regulatory programs a priority and provide leadership to the already established Integrated Food Safety System Steering Committee. The agency should provide training, auditing, and oversight of state and local programs and should facilitate nationwide implementation of the recommended risk-based approach.
Enhancing the Efficiency of Inspections
Recommendation 8-1: The FDA should work toward an inspection system in which the frequency and intensity of inspection of each facility are based on risk, with minimum standards for the frequency and intensity of inspection of all facilities. To support the establishment of such a system, an outside panel should review the potential legal and cultural roadblocks to streamlining inspections and revise the Investigations Operations Manual so as to enhance efficiency and protection of the public health. As a prerequisite for a risk-based inspection system,
the FDA should update its Good Manufacturing Practices, including those for medicated animal feed, now and hereafter as necessary.
Recommendation 8-2: As alternative regulatory models emerge, the FDA should evolve toward conducting fewer inspections, instead delegating inspections to the states and localities (including territories and tribes). The FDA should maintain a cadre of inspectors for several critical tasks, such as auditing inspections, providing specialty expertise, developing training and instructional materials for inspectors, identifying and evaluating new inspection techniques, and serving as a backup corps in situations of special need. In preparation for this move, the FDA should review and update curricula specific to general food inspections as well as to particular types of inspections (e.g., seafood Hazard Analysis and Critical Control Points). Agency employees with responsibility for auditing inspections by others should also be provided with specific training. An FDA-sponsored food safety certification program should be established whereby inspectors become certified as they meet agency standards. The agency should include in its budget a line item to fund state contracts and partnerships to help the states move toward and maintain full certification. Plans for implementation of the suggested changes should proceed in an evolutionary fashion, with intermediate goals and associated performance measures.
Recommendation 8-3: The FDA should fully consider the implications of accepting inspection data from an auditing program in which third-party auditors would inspect facilities for compliance with food safety regulatory requirements. If this approach is utilized, the FDA should set minimum standards for such auditors and audits, with oversight and implementation being assigned to an accreditation and standards body.
Improving Food Safety and Risk Communication
Recommendation 9-1: In its effort to integrate risk communication into the recommended risk-based food safety management system, the FDA should play a leadership role in coordinating the education of the food industry, the public, clinical health professionals, and public health officials at all government levels. The FDA could carry out its leadership role in educating industry personnel, health pro-
fessionals, and public health officials by seeking authority to mandate the setting of training standards, preparing training materials, certifying trainers, and providing technical support for the interpretation of policies and for the implementation of the risk-based approach.
Recommendation 9-2: In collaboration with other federal agencies, the FDA should continue efforts to develop a single source of authoritative information on food safety practices, foodborne illness and risks, and crisis communications. The FDA, with other federal agencies, should develop a coordinated plan for communicating in one voice with all affected parties during crises so that stakeholders receive timely, clear, and accurate information from a single recognizable source.
Recommendation 9-3: The FDA should improve its understanding of the knowledge and behavior of industry, health professions personnel, and consumers with respect to food safety, paying specific attention to knowledge about demographic groups that are particularly susceptible to food risks.
In making critical decisions about risk communication to implement recommendations 9-1, 9-2, and 9-3, the FDA should explore new mechanisms (e.g., tabletop discussions,a public forums, consultations) for expanding its use of strategic partnerships and collaborations.
Recommendation 10-1: Congress should consider amending the Federal Food, Drug, and Cosmetic Act to provide explicitly and in detail the authorities the FDA needs to fulfill its food safety mission. The following are the most critical areas in which Congress should enact amendments: mandatory reregistration of food facilities and FDA authority to suspend registrations for violations that threaten the public health, mandatory preventive controls for all food facilities, FDA authority to issue enforceable performance standards, mandatory adoption by the FDA of a risk-based approach to inspection frequency and intensity, expansion of the FDA’s access to records, FDA authority to mandate recalls, and FDA authority to
identify countries with inadequate food safety systems and to ban all imports from such countries.
Realizing the Vision of an Efficient Food Safety System
Recommendation 11-1: The committee recommends that the FDA’s Office of Foods have complete authority over and responsibility for all field activities for FDA-regulated foods, including inspection, sampling, and testing of foods. Implementing this recommendation would resolve issues associated with the separation between the agency’s enforcement functions and larger public health roles and responsibilities, and ensure a well-trained field workforce with specialized expertise in food safety and risk-based principles of food safety management.
Recommendation 11-2: There is a compelling need to elevate and unify the nation’s food safety enterprise so that the FDA and relevant sister agencies can better ensure a safe food supply. The committee recognizes that organizational change to enhance the effectiveness and efficiency of the nation’s food safety system as a whole is an evolutionary process that would require careful analysis, planning, and execution. With this in mind, the committee recommends that the federal government move toward the establishment of a single food safety agency to unify the efforts of all agencies and departments with major responsibility for the safety of the U.S. food supply.
Recommendation 11-3: Regardless of the evolution of the food safety system, an integrated, unimpeded, and centralized approach to risk-based analysis and data management is required to enhance the FDA’s and the broader federal government’s ability to ensure a safe food supply. To achieve this goal, and as a potential intermediate step toward the creation of a single food safety agency, the committee recommends the establishment of a centralized risk-based analysis and data management center. This center should be provided with the staff and supporting resources necessary to conduct rapid and sophisticated assessments of short- and long-term food safety risks and of policy interventions, and to ensure that the comprehensive data needs of the recommended risk-based food safety management system are met. This center should be as free from external political forces and influence as possible and accountable to the public health needs and mission of the regulatory agencies.