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Summary

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

1

Unless otherwise indicated, the term “food” refers to both food and animal feed.

2

The U.S. Department of Agriculture’s Food Safety and Inspection Service is primarily responsible for the safety of meat, poultry, and unshelled egg products. The FDA shares responsibility for the safety of alcoholic beverages with the Alcohol and Tobacco Trade Bureau of the Department of the Treasury. The FDA shares jurisdiction with state and local governments over food in interstate commerce. State and local governments have the main responsibility for food produced or sold within their borders. The major FDA offices with responsibility for food safety are the Office of the Commissioner, the Office of Foods, the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, the Office of Regulatory Affairs, and the National Center for Toxicological Research.



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Summary P roviding 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 1 Unless otherwise indicated, the term “food” refers to both food and animal feed. 2 The U.S. Department of Agriculture’s Food Safety and Inspection Service is primarily responsible for the safety of meat, poultry, and unshelled egg products. The FDA shares responsibility for the safety of alcoholic beverages with the Alcohol and Tobacco Trade Bureau of the Department of the Treasury. The FDA shares jurisdiction with state and local governments over food in interstate commerce. State and local governments have the main responsibility for food produced or sold within their borders. The major FDA offices with responsibility for food safety are the Office of the Commissioner, the Office of Foods, the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, the Office of Regulatory Affairs, and the National Center for Toxicological Research. 

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 ENHANCING FOOD SAFETY 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. STUDY APPROACH To conduct this study, a 13-member committee with extensive experi- ence 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. CONCLUSIONS 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. 3 For example, these include a change in administration, the formation of the White House Food Safety Working Group, and the FDA’s establishment of a new Office of Foods with over- sight and authority over the two FDA centers that regulate food—the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine.

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 SUMMARY BOX S-1 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 oppor- tunities 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 recom- mendations, as feasible. Specifically, the committee will: • valuate the FDA Plan in light of past reports directed at strengthen- E ing food safety including, but not limited to Ensur­ing Safe Food fr­om Pr­oduction to Consumption (IOM/NRC, 1998), Scientific Cr­iter­ia to Ensur­e Safe Food (IOM/NRC, 2003), the 2007 FDA Science Board report, and relevant GAO reports; • dentify strengths and weaknesses of the FDA Plan, factors that I may limit its achievement, and needed revisions or additions; and • dentify and recommend enhancements in FDA’s tools and capac- I ity that are needed to implement a comprehensive plan and assure a risk-based preventive system, including in the areas of new regulatory tools and statutory authority; research mandate; resources required for research, scientific and technical infrastruc- ture, standard setting, inspection, and enforcement; integration of programs with other regulatory and public health agencies involved in food safety surveillance, research and regulation at federal, state and local levels; expansion of FDA’s international presence and international regulatory information exchange; and changes in organizational and leadership structures on food safety within the Department of Health and Human Services. The FPP 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 iden- tifying public health goals (e.g., reducing the number of infections caused

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 ENHANCING FOOD SAFETY by specific foods), identifying tools for attaining those goals (e.g., research, education activities), and developing measures with which to evaluate suc- cess. 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 market- place. 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-

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 SUMMARY 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 com- ponent 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 inten- sity 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 summa- rized 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, man- age, 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 intramu- rally 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 investiga- tion, have long been important contributors to the U.S. food safety system.

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 ENHANCING FOOD SAFETY BOX S-2 A Recommended Risk-Based Approach Step 1: Strategic Planning 1. dentify public health objectives related to food safety in consultation I with stakeholders. 2. stablish a risk management plan (general and specific strategic E plans for meeting public health objectives and for considering and choosing policy interventions to achieve those objectives). 3. stablish metrics with which to measure performance in consultation E with stakeholders. Step 2: Public Health Risk Ranking (Ranking of Hazards) 1. evelop or select tools (models, measures, or other) for public health D risk ranking in consultation with stakeholders. 2. ank risks based on public health outcomes. R 3. eport results to stakeholders and solicit feedback. R Step 3: Targeted Information Gathering on Risks and Consideration of Other Factors That May Influence Decision Making 1. dentify and consider additional criteria upon which risk-based decision I making will be based (e.g., public acceptance, cost, controllability, envi- ronmental effects, market impacts) in consultation with stakeholders. 2. onduct targeted information gathering. For each high-priority and/or C uncertain risk, determine the need for collection of additional informa- tion and implement accordingly: a. dditional data collection (research, surveillance, survey, baseline a data); and b. isk assessment (qualitative, quantitative, semiquantitative). r 3. ased on that additional information, identify priority risks for which B intervention analysis is needed. 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.

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 SUMMARY Step 4: Analysis and Selection of Intervention(s) 1. dentify an appropriate level of protection for each high-priority risk, I based on available data and in consultation with stakeholders. 2. dentify intervention options in consultation with stakeholders. I 3. dentify the types of technical analysis, including but not limited to risk I assessment, needed to evaluate the options; identify performance measures and the initial design of databases. 4. ather the information necessary to conduct the technical analysis. G 5. hoose intervention strategies for implementation using multicriteria C decision analysis. 6. eport results to stakeholders, solicit feedback, and modify interven- R tion strategies if needed. Step 5: Design of an Intervention Plan 1. evelop a plan for implementing the selected interventions in consul- D tation with stakeholders. 2. llocate resources and implement interventions. A Step 6: Monitoring and Review 1. ollect and analyze data on evaluation measures selected during C strategic planning. 2. nterpret data and evaluate whether interventions result in the desired I intermediate outcomes. 3. etermine whether public health objectives are being met by using D performance metrics developed in Step 1 (broad strategic planning). 4. ommunicate results to stakeholders. C 5. eview and refine the entire process in an iterative manner as nec- R essary to accomplish both intermediate outcomes and public health objectives so as to achieve continuous improvement over time. 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 allocat- ing 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 inspec- tors, resulting in potential substantial delays in policy implementation in the field. Nor have inspection procedures been reviewed for efficiency or consis-

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 ENHANCING FOOD SAFETY 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 Commu- nication 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 sepa- ration of responsibilities in the FDA’s food programs. Food safety in the United States is managed by many government agen- cies. The ability of the FDA, and the government in general, to succeed in

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 SUMMARY 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. RECOMMENDATIONS The committee’s deliberations resulted in suggested directions for improving food safety management (Box S-3) and specific recommenda- tions for overcoming deficiencies in the food safety system (Box S-4). LOOKING FORWARD Although food safety is the responsibility of everyone, from produc- ers 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.

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0 ENHANCING FOOD SAFETY BOX S-3 Suggested Directions for Improving the U.S. Food and Drug Administration’s (FDA’s) Food Safety Management • pply the recommended risk-based approach to the management of A all food hazards. • ddress the lack of resources (e.g., data infrastructure, human A c apacity) and organization for the implementation of a risk-based food safety management system. • dentify metrics with which to measure the effectiveness of interven- I tion strategies and the food safety system as a whole. • efine the roles of the various parties sharing responsibility for food D safety, and develop a roadmap with defined criteria for the level and intensity of policy interventions and plans to evaluate them. • evelop a strategic plan to identify data needs for a risk-based D a pproach, and establish mechanisms to coordinate, capture, and integrate the data. Remove barriers to the practical utilization of data to support a risk-based system, including problems with data sharing and gaps in analytical expertise within the FDA. • onduct strategic planning and coordination of the FDA’s food safety C research portfolio. • ntegrate food safety programs at the federal, state, and local levels, I with the ultimate goal of utilizing all food surveillance, inspectional, and analytical systems as part of the national food safety program. • ddress the existence of barriers to improving the efficiency of inspec- A tions, such as the inefficiency of inspection procedures and the fact that the FDA’s food programs do not have direct authority over the work of inspectors. • ontinue development of a single source of authoritative government C information on food safety, safe food practices, foodborne illnesses and risks, and crisis communications. • reate a centrally controlled plan for communicating with one voice C with all affected parties during food safety crises. • odernize the legislative framework to give the FDA the necessary M legal authority to perform its role in ensuring the safety of FDA- r egulated foods. • mplement organizational changes that would greatly enhance the I ability of the FDA to succeed in ensuring food safety.

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 SUMMARY BOX S-4 Recommendations 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 oper- ational 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 devel- opment 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 continued

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 ENHANCING FOOD SAFETY BOX S-4 Continued 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 coor- dinating, 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 recom- mendation 11-3 in Chapter 11could 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.

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 SUMMARY Recommendation 5-2: The FDA should evaluate its personnel needs to carry out its roles in collecting, analyzing, managing, and commu- nicating food safety data. The agency should establish an analytical unit with the resources and expertise (i.e., statisticians, epidemiolo- gists, behavioral scientists, economists, microbiologists, risk ana- lysts, 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 poli- cies governing data sharing and develop plans to improve the col- lection 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 technolo- gies 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 shar- ing 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, implementa- tion, 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 medi- cal 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 ini- tiatives; hiring of new staff in critical areas and, where appropriate, retraining of existing staff; and identification of future resource continued

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 ENHANCING FOOD SAFETY BOX S-4 Continued 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 con- tinue to utilize alternative funding mechanisms (e.g., cooperative agreements, university-based centers, contracts) based on a com- petitive, 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 prereq- uisite to such integration, the FDA should work with the states and localities to harmonize their programs by providing adequate stan- dards 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 evo- lutionary 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, audit- ing, 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 establish- ment of such a system, an outside panel should review the potential legal and cultural roadblocks to streamlining inspections and revise the Inves­ tigations Oper­ations Manual so as to enhance efficiency and protection of the public health. As a prerequisite for a risk-based inspection system,

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 SUMMARY 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 territo- ries and tribes). The FDA should maintain a cadre of inspectors for several critical tasks, such as auditing inspections, providing spe- cialty 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 evolu- tionary fashion, with intermediate goals and associated performance measures. Recommendation 8-3: The FDA should fully consider the implica- tions 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 uti- lized, 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 educa- tion 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- continued

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 ENHANCING FOOD SAFETY BOX S-4 Continued 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 agen- cies, 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 stake- holders 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 per- sonnel, and consumers with respect to food safety, paying specific attention to knowledge about demographic groups that are particu- larly susceptible to food risks. In making critical decisions about risk communication to implement recom- mendations 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. Modernizing Legislation 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 mis- sion. The following are the most critical areas in which Congress should enact amendments: mandatory reregistration of food facili- ties 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 stan- dards, 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 a A tabletop discussion is a focused practice activity that places the participants in a simu- lated situation requiring them to function in the capacity that would be expected of them in a real event.

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 SUMMARY 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 spe- cialized 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 rel- evant 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 estab- lishment 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 politi- cal forces and influence as possible and accountable to the public health needs and mission of the regulatory agencies.

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