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3
Adopting a Risk-Based Decision-Making Approach to Food Safety

As described in Chapter 2, the responsibilities of the U.S. Food and Drug Administration’s (FDA’s) new Office of Foods include providing executive leadership and management to all FDA food-related programs; directing the development of integrated strategies, plans, policies, and budgets to build the FDA’s food-related scientific and regulatory capacities and programs, including the recruitment and training of key personnel and the development of information systems (FDA, 2009); and exercising direct line authority over the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM). Its responsibilities include both short-term decision making in direct response to a food crisis and longer-term initiatives focused on sustained, continued improvement in food safety and public health. The former responsibility requires rapid decision making in cooperation with multiple regulatory partners, while the latter requires long-term strategic planning aimed at proactive activities that are based on data and risk-based prediction and prioritization. For example, the FDA’s responsibility during a foodborne illness outbreak would focus on identification of the source of contamination (product trace-back), initiation of regulatory action, and product recall. More proactive activities might involve conducting research to address crucial unknowns, undertaking formalized quantitative risk assessment, identifying candidate mitigation strategies to prevent repeat incidents, and ensuring the implementation of those strategies. Critical to both long- and short-term initiatives are improvements in cooperation with partners (see Chapters 4 and 7); efficient data collection, sharing, and analysis (Chapter 5); and communication with the public (Chapter 9).



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3 Adopting a Risk-Based Decision-Making Approach to Food Safety A s described in Chapter 2, the responsibilities of the U.S. Food and Drug Administration’s (FDA’s) new Office of Foods include provid- ing executive leadership and management to all FDA food-related programs; directing the development of integrated strategies, plans, poli- cies, and budgets to build the FDA’s food-related scientific and regulatory capacities and programs, including the recruitment and training of key personnel and the development of information systems (FDA, 2009); and exercising direct line authority over the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM). Its responsibilities include both short-term decision making in direct response to a food crisis and longer-term initiatives focused on sustained, continued improvement in food safety and public health. The former responsibility requires rapid decision making in cooperation with multiple regulatory partners, while the latter requires long-term strategic planning aimed at proactive activities that are based on data and risk-based prediction and prioritization. For example, the FDA’s responsibility during a foodborne illness outbreak would focus on identification of the source of contami- nation (product trace-back), initiation of regulatory action, and prod- uct recall. More proactive activities might involve conducting research to address crucial unknowns, undertaking formalized quantitative risk assessment, identifying candidate mitigation strategies to prevent repeat incidents, and ensuring the implementation of those strategies. Critical to both long- and short-term initiatives are improvements in cooperation with partners (see Chapters 4 and 7); efficient data collection, sharing, and analysis (Chapter 5); and communication with the public (Chapter 9). 

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 ENHANCING FOOD SAFETY Clearly, short- and long-term responsibilities coexist as the FDA seeks to both manage and prevent foodborne illness. As noted earlier, the FDA has often been criticized as responding reactively to food problems. Some- times, this type of action is necessary; the FDA has no choice but to react when a problem manifests itself. However, greater proactive efforts by the FDA would enhance food safety. This chapter presents a conceptual approach for the prioritization of activities and allocation of resources to support both short- and long-term FDA responsibilities for food safety. Accordingly, the chapter lays out the foundation for a proactive, risk-based food safety system. Succeeding chapters describe elements of such a system that are dependent on the success of the approach presented here. For instance, application of a risk-based approach at all levels of regulation is a prerequisite for harmonization of federal, state, and local food safety programs (Chapter 7). Similarly, effective cooperation and communication with diverse stakeholders will require that all levels of the FDA embrace a proactive, risk-based approach to food safety management and facilitate its implementation (Chapter 9). The committee did not conduct a comprehensive review of the details of all the risk-based activities of the FDA, such as the models utilized or factors considered in making individual decisions. The committee was provided with general information with regard to the FDA’s risk-based activities and describes its understanding of those activities in this chapter. In this discussion, the committee uses concrete examples of those activities and identifies gaps with respect to the extent to which they adhere to the attributes and steps of the recommended approach. Although the commit- tee concluded that those activities would have been enhanced by the use of a more extensive risk-based approach, in this and subsequent chapters the committee also recognizes that the FDA will face challenges in this regard. The committee identified challenges and courses of action to overcome them, for example, in hiring the appropriate personnel and coordinating data collection and sharing (Chapter 5), reorganizing the agency’s food safety research portfolio (Chapter 6), integrating FDA programs with those of state and local governments (Chapter 7), carrying out risk communica- tion and education (Chapter 9), and addressing organizational problems (Chapter 11). There is consensus that food safety programs and any approach to food safety reform must be both science- and risk-based. This view was first articulated in the 1998 Institute of Medicine (IOM)/National Research Council (NRC) report Ensuring Safe Food: From Production to Consump­ tion (IOM/NRC, 1998) and is also addressed by other reports of the IOM/NRC (IOM/NRC, 2003), the U.S. Government Accountability Office (GAO) (GAO, 2004a,b,c, 2005, 2007, 2008, 2009a,b), consumer groups (Consumers Union, 2008; Tucker-Foreman, 2009), and Congress (Becker,

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 ADOPTING A RISK­BASED DECISION­MAKING APPROACH 2008, 2009; Brougher and Becker, 2008). These reports have emphasized the importance of using the best available science to understand foodborne illness, including the identification of causative agents (chemicals, toxins, and microbes) and transmission pathways and the development of appro- priate surveillance systems. As the science base has developed, attention over the last decade has increasingly turned to its application within a risk- based framework, with the ultimate goal of improving public health. The term “risk-based” implies the existence of an underlying science base; how- ever, it goes a step beyond to encompass use of the tools of risk and decision analysis to create systems that optimize the ability to prevent and control foodborne illness and improve public health. This chapter focuses on how this type of risk-based system might be constructed and implemented to enable the FDA to deal more effectively with food safety problems. Ensuring Safe Food provides a rough description of the components necessary for the implementation of a risk-based system: . . . [It] require[s] 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 assess- ment and technical feasibility. . . . Thus, both the relative risks and benefits must be considered in allocating resources. (IOM/NRC, 1998, p. 93) Other documents have furthered the concept of risk-based food safety management. For example, a 2002 discussion paper issued by Resources for the Future1 states: If the primary objective of the food safety system is to reduce the burden of disease, success requires risk-based resource allocation. The food safety system must make the best possible use of its resources to reduce the dis- ease burden. This means focusing government effort on the greatest risks and the greatest opportunities to reduce risk, wherever they may arise. It means adopting the interventions—presumably some combination of research, regulation, and education―that will yield the greatest reduction in illness. (Taylor, 2002, p. 7) These previous documents go beyond the scope of traditional technical risk assessment by introducing such terms as “risk-based resource alloca- tion” and “relative risk and benefit.” In its deliberations, the committee recognized the need to address risk analysis in the broader context of regu- 1 See http://www.rff.org/rff/Documents/RFF-IB-02-02.pdf (accessed January 25, 2010).

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 ENHANCING FOOD SAFETY latory decision-making processes and risk governance (see, for example, IRGC, 2005, 2009) to manage food safety. The challenges and best practices for integrating science to support effective risk management decisions are widely recognized, as summarized by a recent NRC study (NRC, 2009a): The most effective decision support efforts are organized around six prin- ciples: begin with users’ needs; give priority to processes over products; link information producers and users; build connections across disciplines and organizations; seek institutional stability; and design processes for learning. Following these principles improves the likelihood of achieving the three main objectives of decision support: increased usefulness of infor- mation, improved relationships between knowledge producers and users, and better decisions. (NRC, 2009a, p. 67) In short, in a society with limited resources, decisions about allocation need to be made in a consistent manner and with the goal of maximizing benefits and reducing risks while considering associated costs. In the area of food safety, a process is needed for allocating resources based on public health data and information. Risk managers must consider a wide variety of factors in their decision-making process, including the needs and values of a diverse set of stakeholders, which may diverge even with respect to public health. These factors might include economic considerations, the control- lability of risk, and the population affected. The committee recognizes that such multidimensional comparisons are a highly challenging endeavor. However, the lack of such a systematic approach to risk-based decision making causes problems, from a decrease in public trust to unintended con- sequences in the marketplace, the environment, and society. In addition, the lack of such an approach may make a regulatory agency more vulnerable to political influences. The need to formally acknowledge the complexity of such decision making and then establish a transparent and systematic way to carry out the decision-making process is the subject of the next section. In addition, in Chapter 4, the committee elaborates further on the issue of how to select interventions. It should be noted that, while the committee concluded that providing the FDA with a stepwise process as a tool for making decisions is appropriate, the development of the FDA’s philoso- phy, including specific criteria and their weight, is a management decision beyond scope of this study. Thus in Chapter 4 (recommendation 4-2), the committees recommends that the FDA develop its philosophical approach by defining a strategy that delineates factors to consider (e.g., economic factors, public perception, environmental factors) and their weight.

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 ADOPTING A RISK­BASED DECISION­MAKING APPROACH A RISK-BASED APPROACH TO FOOD SAFETY MANAGEMENT Definitions Many groups have defined risk and risk characterization. For exam- ple, the World Health Organization’s (WHO’s) International Program on Chemical Safety defines risk as “the probability of an adverse effect in an organism, system, or (sub)population caused under specified circumstances by exposure to an agent” (IPCS, 2004). Others have expanded this defini- tion to include the fact that this probability can be expressed quantita- tively or qualitatively and that risk characterization includes a discussion of the significant scientific uncertainties in this information. Further, the committee agreed upon the following working definition for a risk-based approach: “a systematic means by which to facilitate decision making to reduce public health risk in light of limited resources and additional fac- tors that may be considered.” The committee identified the following as key attributes of a risk-based food safety system: (1) is proactive based on a strategic management plan; (2) is data driven; (3) is grounded in the principles of risk analysis; (4) employs analytical methods to rank risks based on public health impact; (5) incorporates deliberation with key food safety stakeholders; (6) considers factors such as consumer perception, public acceptance, market impacts, and environmental impacts in decision making when appropriate; (7) employs analytical methods to prioritize the allocation of limited resources to manage risk most effectively; (8) employs measures to evaluate the efficacy of the risk management program on a continuous basis; and (9) performs all of these functions in a systematic and transparent manner with the involvement of stakeholders. These attributes are further described in Box 3-1. A Conceptual Approach to Risk-Based Food Safety Management The risk-based system envisioned by the committee will entail analysis and prioritization at several distinct levels: • the formulation of a strategic plan that identifies outcomes/goals of the risk-based system, • broad-based risk ranking to identify the most important risks based exclusively on public health considerations, • the identification of additional data/information needs upon which prioritization of resources may be based, • the choice of intervention strategies and allocation of regulatory resources, and • the evaluation of outcomes.

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0 ENHANCING FOOD SAFETY BOX 3-1 Attributes of a Risk-Based Food Safety System A risk-based system is proactive and based on a strategic man- agement plan. Notwithstanding the need to respond to unforeseeable crises, risk activities should be planned in advance, an exercise that should include various stakeholders and be based on the knowledge gained from past experience with a vision of predicting food contamina- tion problems. Managing a crisis in the short term and implementing a well-developed strategic plan for managing food safety in the long term are equally important; attention to unanticipated outbreaks should not detract from implementation of the strategic plan. A risk-based system is data driven. Although expert opinion is a valu- able asset when there are uncertainties or data must be interpreted, a risk-based system should be grounded in science. That is, the collection, analysis, and interpretation of quality data, as well as data management, are essential tasks for the implementation of a risk-based system. A risk-based system is grounded in the principles of risk analy- sis. A risk-based system should be grounded in risk analysis, with risk assessment, risk communication, and risk management as the essen- tial basis for establishing a sound public health protection capability. If implemented appropriately, the system ideally provides a transparent, data-driven means by which to determine the extent of public health protection achieved as a result of different risk management actions, and therefore it provides a decision-making tool. This concept has worldwide support and has been applied for several decades by regulatory and public health agencies. A risk-based system employs analytical methods to rank risks based on public health impact. A risk-based system systematically ranks risks even if those risks differ in complexity and uncertainty. The development of analytical methods (models) that can assign numerical values to the various risks based on public health impact is the founda- tion of this activity. A risk-based system employs analytical methods to prioritize the allocation of limited resources to manage risk most effectively. The evaluation of intervention strategies is an essential element of risk management. Risk managers must consider multiple characteristics or

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 ADOPTING A RISK­BASED DECISION­MAKING APPROACH attributes of different risks and integrate these data for the purpose of prioritizing and making effective use of resources. In this manner, deci- sions are made by considering the food system as a whole, that is, with a systems-based approach. Important decision analysis tools that may be used in this process are feasibility, cost-effectiveness, and cost–benefit analyses. A major element of this activity is a clear statement of regula- tory philosophy and the use of a road map showing how decisions will be made regarding the mix of private responsibility, government incentives, and government regulation that will be used to manage different risks. A risk-based system considers other factors, such as consumer perception, cost, controllability, public acceptance, environmental effects, and market impacts, in decision making when appropri- ate. Risk mitigation strategies and public policy decision making are influenced by factors other than public health risk. These considerations should be formally communicated to stakeholders. A risk-based system employs measures to evaluate the efficacy of the risk management program on a continuous basis. An essential step in a risk-based system is evaluation of the efficacy of the system itself with respect to public health and other factors selected by decision makers. Evaluation of programs, always a daunting process, requires the identification of indicators by which to link interventions to public health outcomes. To collect and integrate food safety data so that attribution models can be built is a critical first step in this process. A risk-based system performs all of these functions in a system- atic and transparent manner with the involvement of stakeholders. Risk managers should develop a process for implementing a two-way communication approach whereby stakeholders have an opportunity to engage in the risk-based decision-making process. This approach should include input and access to discussions regarding the basis for decision making, as well as information about the uncertainties and variability of the underlying data. Likewise, a risk-based approach requires disclosure of all sources of information, comprehensive analysis, and transparency regarding the considerations taken into account in the decision-making process. In addition, independent peer review is fundamental to all scien- tific undertakings and critical for risk-based decision-making processes.

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 ENHANCING FOOD SAFETY Figure 3-1 depicts the cycle of risk prioritization and regulatory (inter- vention) activities that constitutes the basis of a risk-based food safety system. As the figure shows, the system encompasses six basic steps. These steps are outlined below and then discussed in detail, recognizing that they could be ordered differently and are likely to be taken iteratively. Step 1: Strategic Planning Step 2: • Identify Public Health Step 6: Public Health Risk Ranking Objectives Monitoring and R eview • Establish a Risk Management Plan • Develop or Select Tools for • Collect and Analyze Data on Public Health Risk Ranking • Establish Metrics to Measure Evaluation Measures Performance • Rank Risks Based on Public • Inter pret Data and Evaluate Health Outcomes Intervention Results • Report Results and Solicit • Deter mine Whether Public Feedback Health Objectives Are Being Met • Communicate the Results to Stakeholders • Review and Refine the Process as Necessary to Step 3: Accomplish Inter mediate Target ed Informat ion Outcomes and Public Health Gathering and Consideration Objectives so as to Achieve of Ot her Fact ors Continuous Improvement • Identify and Cons ider Additio nal Criteria for Decision Making Step 4: • Conduct Targeted Analysis and Select ion of Information Gathering Intervention(s) Step 5: • Identify Priority Risks for Design of an Intervention (Instrument) • Identify an Appropria te Level of Analysis Intervention Plan Protection for Each High- Priority Risk • Develop a Plan for • Identify Interven tion Options Implementing the • Identify the Type of Technical Selected Interven tions Analysis Needed to Evaluate • Allocate Resources and the Options Implement Interventions • Gather Information • Choose Interventio n Strategies • Report Results, Solicit Feedback , and Modify Intervention Strategies If Needed FIGURE 3-1 Steps in a risk-based food safety system (iterative between and within boxes).

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 ADOPTING A RISK­BASED DECISION­MAKING APPROACH Step 1: Strategic Planning 1. Identify public health objectives related to food safety in consulta- tion2 with stakeholders. 2. Establish a risk management plan (general and specific strategic plans for meeting public health objectives and for considering and choosing policy interventions to achieve those objectives). 3. Establish metrics with which to measure performance in consulta- tion with stakeholders. Step 2: Public Health Risk Ranking (Ranking of Hazards) 1. Develop or select tools (models, measures, or other) for public health risk ranking in consultation with stakeholders. 2. Rank risks based on public health outcomes. 3. Report results to stakeholders and solicit feedback. Step 3: Targeted Information Gathering on Risks and Consideration of Other Factors That May Influence Decision Making 1. Identify and consider additional criteria upon which risk-based decision making will be based (e.g., public acceptance, cost, con- trollability, environmental effects, market impacts) in consultation with stakeholders. 2. Conduct targeted information gathering. For each high-priority and/or uncertain risk, determine the need for collection of addi- tional information and implement accordingly: a. additional data collection (research, surveillance, survey, base- line data), and b. risk assessment (qualitative, quantitative, semiquantitative). assessment (qualitative, 3. Based on that additional information, identify priority risks for which intervention analysis is needed. Step 4: Analysis and Selection of Intervention(s) 1. Identify an appropriate level of protection for each high-priority risk, based on available data and in consultation with stakeholders. 2. Identify intervention options in consultation with stakeholders. 3. Identify the types of technical analysis, including but not limited 2 In this context, the term “consultation” means “discussions with other interested individu- als or groups to obtain advice.”

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 ENHANCING FOOD SAFETY to risk assessment, needed to evaluate the options; identify perfor- mance measures and the initial design of databases. 4. Gather the information necessary to conduct the technical analysis. 5. Choose intervention strategies for implementation using multi- criteria decision analysis. 6. Report results to stakeholders, solicit feedback, and modify inter- vention strategies if needed. Step 5: Design of an Intervention Plan 1. Develop a plan for implementing the selected interventions in con- sultation with stakeholders. 2. Allocate resources and implement interventions. Step 6: Monitoring and Review 1. Collect and analyze data on evaluation measures selected during strategic planning. 2. Interpret data and evaluate whether the interventions result in the desired intermediate outcomes. 3. Determine whether public health objectives are being met by using performance metrics developed in Step 1 (broad strategic planning). 4. Communicate the results to stakeholders. 5. Review and refine the entire process in an iterative manner as nec- essary to accomplish both intermediate outcomes and public health objectives so as to achieve continuous improvement over time. Further Description of the Proposed Approach to Risk-Based Food Safety Management Step : Strategic Planning Strategic planning, conducted at several different levels, is an essential element of a successful food safety program. The highest level of strategic planning involves the identification of long-term and broadly stated goals for protecting public health from the threats associated with food contami- nants, sometimes referred to as public health objectives. Perhaps the best example of such goals is those proposed for Healthy People (Box 3-2). These goals are considered national in scope and concern the entire food safety system, including components of the system not under FDA jurisdic- tion. In strategic planning, however, the FDA would also likely include agency-specific intermediate objectives, which might lead only indirectly to

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 ADOPTING A RISK­BASED DECISION­MAKING APPROACH BOX 3-2 Food Safety Goals Proposed for Healthy People 2020 Objectives Retained as Is from Healthy People 2010 FS HP2020–1: Reduce severe allergic reactions to food among adults with a food allergy diagnosis. FS HP2020–2: (Developmental) Improve food-employee food prepara- tion practices that directly relate to foodborne illnesses in retail food establishments. Objectives Retained but Modified from Healthy People 2010 FS HP2020–3: Reduce infections caused by key pathogens commonly transmitted through food. FS HP2020–4: Reduce infections associated with foodborne outbreaks due to pathogens commonly transmitted through food. FS HP2020–5: Prevent an increase in the proportion of nontyphoidal Salmonella and Campylobacter­ jejuni isolates from humans that are resistant to antimicrobial drugs. FS HP2020–6: Increase the proportion of consumers who follow key food safety practices. Objectives New to Healthy People 2020 FS HP2020–7: Reduce the number of outbreak-associated infections caused by food commodity group. FS HP2020–8: Reduce contamination of meat and poultry products by foodborne pathogens. FS HP2020–9: (Developmental) Increase the number of States that have prohibited sale or distribution of unpasteurized dairy products (as defined by FDA, unpasteurized liquid milk and cheeses aged <60 days). SOURCE: http://www.healthypeople.gov/hp2020/Objectives/TopicArea. aspx?id=22&TopicArea=Food+Safety (accessed October 8, 2010). improvements in public health. Examples of these sorts of objectives might be improved efficiency of inspections or reorganization of the FDA research function. While accomplishing these objectives might not lead directly to improvements in public health, achieving efficiencies that would ultimately enable improvements in public health would represent measurable move- ment toward increased safety of the U.S. food supply. Identification of the specific means by which the goals are to be achieved—for instance, defining the regulatory structures and the nature

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0 ENHANCING FOOD SAFETY BOX 3-5 Sources of Foodborne Disease Attribution Data Data on foodborne disease attribution generally come from three major sources: (1) outbreak reports, (2) case control studies, and (3) source tracking. Outbreak Reports: Outbreak investigations have traditionally served as the primary means of identifying food sources for pathogens. When outbreaks are carefully investigated, such data can be extremely valu- able. In the United States, however, almost all outbreak investigations are conducted by local health departments, which tend to be overworked and to lack either the laboratory or epidemiologic resources to identify a source. There are significant biases involved in the choice of which outbreaks get investigated (generally those that are large or involve an “interesting” pathogen), and the percentage of outbreaks reported and investigated ranges widely both among and within states. Outbreaks may also not be representative of routine foodborne disease cases: they generally represent a significant breakdown in food practices rather than the endemic pattern of transmission of pathogenic microorganisms. There are issues with timeliness as well: the U.S. Centers for Disease Control and Prevention tends to compile data from outbreak reports only on a sporadic basis, which often results in multiple-year gaps between reporting of national summary data. The United Kingdom has tended to rely on outbreak data in its food attribution/food safety efforts; however, its data collection is more standardized than that of the United States, without the wide variability in reporting from local health department to local health department (Batz et al., 2005). Case Control Studies: When FoodNet was first established, the impor- tance of food attribution in the calculation of food-specific incidence rates was recognized. Consequently, the system was designed to include ongoing case control studies to identify specific foods/food groups that might be consumed more commonly by ill persons infected with a specific resources will be needed for further characterization of foodborne disease attribution in support of risk-based food safety management. Simply knowing the proportion of the occurrence of a particular dis- ease that is associated with a specified hazard is not enough. For exam- ple, contamination and agent proliferation (and inactivation) can occur at all stages throughout the food chain. There is a need for attribution estimates across the chain—for example, what proportion of salmonel-

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 ADOPTING A RISK­BASED DECISION­MAKING APPROACH pathogen than by well controls. Under the FoodNet program, six case control studies have been conducted. While many have yielded useful epidemiologic data (Friedman et al., 2004; Marcus et al., 2007; Varma et al., 2007), it has become apparent that this is not an effective means to determine attribution percentages: it is expensive and labor intensive, and it yields only crude estimates of the relative contribution of various food categories to disease incidence. Concern has also been raised about possible biases inherent in the selection control process (which has generally involved random digit dialing techniques). Source Tracking: Food safety agencies in the Netherlands and Denmark have pioneered work in the source tracking of pathogens, that is, using molecular markers/typing to link human disease with animal sources. The process requires careful monitoring of isolates from food animals, with appropriate typing, and application of identical typing methods for human isolates. Data are then entered into models that permit real-time calculation of the relative public health impact of various food−pathogen combinations. These data have been used effectively, particularly in the Netherlands, to guide regulatory actions designed to deal with new and emergent problems in the national food safety system. However, this work has dealt almost exclusively with animal sources for pathogens; virtually no work has been done with pathogen contamination of produce, and produce generally has not been included in the source-tracking models. In the United States, some initial efforts were made to develop such a system, focusing primarily on salmonella. However, results have not been impressive, in part because of the incompatibility of data sets (and lack of data sharing). The U.S. Food and Drug Administration has sponsored intramural research on molecular-typing methods that might be utilized in these systems, but to date, efforts to develop appropriate risk models have not led to useful results. losis cases attributable to the consumption of contaminated leafy greens is associated with poor personal hygiene practices of food handlers versus preharvest contamination on the farm? Likewise, because agents can be transmitted by multiple routes, more defined data on transmission are needed—for instance, what proportion of human norovirus infections is attributable to foodborne routes as compared with person-to-person transmission? These are simply examples of important questions about

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TABLE 3-2 Summary of Approaches to Food Attribution  Approach Data Needs Advantages Limitations Examples Foodborne disease Coordinated surveillance Usually applied to multiple Assumes equivalence of pathogen- Batz et al., 2004; sureillance systems with similar foods and pathogens. specific contributions of each Adak et al., Based on the use data collection efforts Outbreak data are a food type to disease. Adequately 2005; DeWaal et of aggregate data throughout a specified measure of attribution at classifying multicomponent foods al., 2006 from epidemiologic location, region, or country. the point of consumption. is challenging. Serious gaps in investigation of Takes many years to Able to take into account databases exist. outbreaks. accumulate sufficient data. other routes of transmission Must include food vehicle (such as travel, contact information. with animals). Addresses a broad range of microbes and foods. Data are collected routinely on a national basis for a large number of pathogens over many years. Case control study Systematic review of Identification of sources of Classic weaknesses of case control Multiple Analytic epidemiologic published case control sporadic infections. Classic studies, including misclassification, examples, study that compares studies and case series to strengths of case control recall bias, limited resolution but specific diseased (cases) with identify relevant risk factors study design, including for commonly consumed foods, applications to nondiseased (controls) for disease; calculation of ability to explore multiple establishment of temporality. food attribution persons with respect population-attributable exposures (specific foods, Many cases required for adequate are sparse (see to previous exposures; risk to estimate relative food preparation practices, statistical power. Usually limited to EFSA, 2008) relative role of exposure importance of different cross-contamination, travel, a single microorganism rather than is determined by exposures. other risk factors). multiple agents. Expensive. comparing frequencies in cases and controls.

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Microbial subtyping Integrated, active Best suited to pathogens Usually applied to a single van Pelt et al., Based on a combination surveillance of most major that are clonally pathogen. In current use, but 2003; Hald et of strain typing collated sources (food, animals); disseminated through not well suited to organisms that al., 2004, 2007 with epidemiologic reliance on extensive the food chain. Useful have relatively unstable DNA. surveillance data and collection of representative in identifying original Does not take into account effects mathematical modeling; strains for comparison; reservoir and setting of other contamination risk underlying hypothesis is information on amount priorities for interventions factors (such as human handling, that control of ultimate of animal or food product when contamination occurs cross-contamination). Assumes reservoir (usually available for consumption. during production. equivalence of relative pathogen- occurring before specific contribution of each food harvest) will prevent type to disease. Expensive. Requires human exposure. extensive libraries of isolates from a range of foods or reservoirs. Quantitatie microbial Information on estimates Allows a high level of detail Serious data gaps. Substantial CFSAN/FSIS, risk assessment for parameters to use in with respect to specific food uncertainty (should be accompanied 2003 (Listeria Yields mathematically modeling and uncertainty commodities. Theoretically, by uncertainty analysis). Resource monocytogenes); derived estimates of distributions for estimates; can integrate data obtained intensive. Evers et al., risk. logic model of how from national surveillance 2008 parameters are related to programs. each other. Expert elicitation More explicit, structured, Best suited to filling in Subjective in nature. Potential Hoffmann et Experts combine quantitative methods data gaps. Able to combine for bias (based on respondent al., 2007a,b; and weigh data from (including well-calibrated information from multiple background, personal bias), Havelaar et al., different sources to methods and performance- sources (different experts although use of structured 2008 estimate attribution. based weighting) are with different knowledge approaches decreases bias. Best being used and are bases). methodological approaches increasing resolution and (calibrated, highly structured) transparency. require a high degree of expertise and are resource intensive.  SOURCE: NRC, 2009b.

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 ENHANCING FOOD SAFETY attribution that must be answered if food safety risks are to be under- stood and characterized. Foodborne disease attribution data and models are essential to support a risk-based food safety management approach. They directly support Steps 1 (strategic planning), 2 (public health risk ranking), and 6 (monitoring and review); they also support the other steps of the process indirectly. From a planning perspective, for example, risk ranking must be based on the hazard–food combinations that generate the greatest burden of disease and/or the most significant negative impact on public health. It is difficult to per- form such risk ranking without reliable foodborne disease attribution data. Similarly, it is difficult to evaluate and implement risk-based intervention approaches without knowing the most likely means by which a contaminant enters the food chain or which specific practices contribute to its proliferation and/or inactivation. Finally, in monitoring and reviewing the efficacy of risk management strategies that have already been implemented, it is necessary to determine whether public health objectives are being met. Attribution is a logical metric in this regard, perhaps the most important one, as a reduction in the burden of disease associated with a specific food–hazard combination provides the best evidence that interventions are working. The availability of comprehensive epidemiological attribution data also aids in transparency. In short, solid epidemiological attribution data form the cornerstone of risk- based prioritization, management, and evaluation. KEY CONCLUSIONS AND RECOMMENDATIONS The committee defined a risk-based food safety management system as “a systematic means by which to facilitate decision making to reduce public health risk in light of limited resources and additional factors that may be considered.” The committee went on to define the key attributes of such a system and produced a stepwise approach to its design. The committee recognizes that some of the variables to be considered in models used to rank risks from imported foods will be different from those considered for domestic foods. Variables for models used to rank intentional con- tamination will be different as well. However, the committee believes the recommended risk-based approach is broad enough to apply to all hazards, whether intentionally introduced or not, and to all foods, whether domesti- cally produced or imported. The committee recognizes that this compre- hensive risk-based approach is a relatively new concept that will take time and resources to implement. While the committee commends the FDA for recent steps taken and progress toward risk ranking and prioritization described in this chapter, the FPP falls short of providing a comprehensive vision for a risk-based food safety management system. Much of the agency’s current decision-

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 ADOPTING A RISK­BASED DECISION­MAKING APPROACH making process appears to be based on crisis management rather than a systematic preventive approach. Furthermore, although the FDA states in many of its documents that it operates under a risk-based framework, many of the attributes of a risk-based system that the committee regards as nec- essary (in particular, strategic planning, comprehensiveness, transparency, external review of risk assessment and intervention analysis programs, and risk communication) are not sufficient in the agency’s current approach. The resources (personnel, data, models) necessary to design and support a risk-based food safety management system are extensive, and the FDA does not have the human capacity, data infrastructure, or organization to sup- port such a function at the present time. The provision of these resources is essential to the success of the FDA’s future food safety risk management activities. The committee offers the following recommendations to enhance the management of food safety at the FDA. Recommendation 3-1: The type of risk-based food safety approach outlined by the committee in Box 3-2 should become the operational centerpiece of the 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 domes- tically 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 stra- tegic 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 sup- ported 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.

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 ENHANCING FOOD SAFETY The following recommendations encompass essential steps that need special attention in the implementation of a risk-based approach. 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 stra- tegic 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. REFERENCES Adak, G. K., S. M. Meakins, H. Yip, B. A. Lopman, and S. J. O’Brien. 2005. Disease risks from foods, England and Wales: 1996–2000. Emerging Infectious Diseases 11(3):365–372. Batz, M. B., S. A. Hoffmann, A. J. Krupnick, J. G. Morris, D. M. Sherman, M. R. Taylor, and J. S. Tick. 2004. Identifying the Most Significant Microbiological Foodborne Hazards to Public Health: A New Risk Ranking Model. Food Safety Research Consortium Discus- sion Paper No. 1. Resources for the Future, Washington, DC. http://www.rff.org/RFF/ Documents/FRSC-DP-01.pdf (accessed February 6, 2009). Batz, M. B., M. P. Doyle, G. Morris, Jr., J. Painter, R. Singh, R. V. Tauxe, M. R. Taylor, and D. M. Lo Fo Wong. 2005. Attributing illness to food. Emerging Infectious Diseases 11(7):993–999. Becker, G. S. 2008. U.S. Food and Agricultural Imports: Safeguards and Selected Issues. Washington, DC: Congressional Research Service. Becker, G. S. 2009. Food Safety on the Farm: Federal Programs and Selected Proposals. Wash- ington, DC: Congressional Research Service. Behn, R. D. 2003. Why measure performance? Different purposes require different measures. Public Administration Reiew 63(5):586–606. Bell, J. W. 2009. The USFDA and Ensuring Food Safety Perspectie of a Seafood Scientist. Pa- per presented at Institute of Medicine/National Research Council Committee on Review of the FDA’s Role in Ensuring Safe Food Meeting, Washington, DC, March 24, 2009. Belton, V., and T. J. Stewart. 2002. Multiple Criteria Decision Analysis: An Integrated Approach. Boston, MA: Kluwer Academic Publishers. Bevan, G., and C. Hood. 2006. Have targets improved performance in the English NHS? British Medical Journal 332(7538):419–422. Bird, S., C. S. David, V. T. Farewell, H. Goldstein,T. Holt, and P. C. Smith. 2005. Perfor- mance indicators: Good, bad, and ugly. Journal of the Royal Statistical Society Series A 168(Part 1):1–27. Brougher, C., and G. S. Becker. 2008. CRS Report for Congress: The USDA’s Authority to Recall Meat and Poultry Products. Washington, DC: Congressional Research Service.

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