Achieving the Vision of an Efficient Risk-Based Food Safety System
Preceding chapters have presented a variety of recommendations aimed at improving the U.S. Food and Drug Administration’s (FDA’s) food safety–related activities. Box 11-1 lists some of the areas in which the committee found that significant improvements are warranted. In formulating its recommendations, the committee emphasized the need for the FDA to move toward a risk-based approach to food safety. Recognizing that many enhancements (e.g., leadership commitment, staff retention, strategic planning) can be realized without structural changes, the committee initially formulated its recommendations in the context of the FDA’s current food safety management structure. Subsequently, however, the committee concluded that while some recommendations pertain only to the FDA’s functions and operations, success in implementing many others will be achieved only through cooperation with partners that play important roles in maintaining food safety. As the study progressed and the committee’s ideas matured, it became clear that the effectiveness of the FDA’s food safety programs will not be fully realized without organizational changes both in the structure of the agency itself and across the multiple government agencies and departments with food safety responsibilities.
Such changes will not occur without strong leadership with a clear vision for reform and the capacity (i.e., resources) and authority to implement the changes effectively. Leadership should direct change and be authorized to redirect resources and bring in new personnel with the appropriate expertise. The agency leaders with responsibility for implementing the changes must also have the appropriate support at high levels of governmental oversight. At the same time, not just high-level management but also
Selected Proposed Improvements in the U.S. Food and Drug Administration’s (FDA’s) Food Safety Management Highlighted Throughout This Report
the entire team tasked with facilitating agency changes must have the necessary vision, understanding, and experience to implement those changes. Further, since many FDA food safety activities are inextricably linked to those of other agencies with food safety jurisdiction (federal, state, and local) (see Table 2-1 in Chapter 2), coordination and collaboration with these agencies will be essential. As discussed in Chapter 3, moreover, change cannot occur without careful prior planning and substantial investments in physical, human, and financial resources. Finally, the need for strong leadership implies that appropriate legislative authority must be given to the agency (see Chapter 10).
For more than a decade, various organizations, consumer groups, and individuals have recommended organizational changes in the U.S. food safety system, with the goal of increasing its efficiency and enhancing the public health (IOM/NRC, 1998; GAO, 2004, 2005a, 2007, 2008; Gombas, 2009; Halloran, 2009; IOM, 2009; Plunkett, 2009; Scott, 2009; Waldrop, 2009).1 Furthermore, governments in other countries
have reorganized and adapted their food safety systems to reflect current circumstances (GAO, 2005b). More recently, in congressional testimony on federal oversight of food safety and the FDA’s Food Protection Plan (FPP), Lisa Shames, the U.S. Government Accountability Office’s director of natural resources and environment (GAO, 2008), stated that:
it is important to note that FDA is one of 15 federal agencies that collectively administer at least 30 laws related to food safety. This fragmentation is a key reason we designated federal oversight of food safety as a high-risk area. Two agencies have primary responsibility—FDA is responsible for the safety of virtually all foods except for meat, poultry, and processed egg products, which are the responsibility of the United States Department of Agriculture (USDA). In addition, among other agencies, the National Marine Fisheries Service in the Department of Commerce conducts voluntary, fee-for-service inspections of seafood safety and quality; the Environmental Protection Agency regulates the use of pesticides and maximum allowable residue levels on food commodities and animal feed; and the Department of Homeland Security is responsible for coordinating agencies’ food security activities. This federal regulatory system for food safety, like many other federal programs and policies, evolved piecemeal, typically in response to particular health threats or economic crises. (GAO, 2008, p. 3)
As of this writing, change is already under way, as evidenced by the creation of the White House Food Safety Working Group (FSWG) in March 2009. The FSWG was formed by the Obama Administration to address the critical need for cooperation across the spectrum of federal food safety agencies (FSWG, 2009a). Chaired by the Secretaries of the U.S. Department of Health and Human Services and USDA, the FSWG “will coordinate with other agencies and senior officials to advise the President on improving coordination throughout the government, examining and upgrading food safety laws, and enforcing laws that will keep the American people safe” (FSWG, 2009a). According to Agriculture Secretary Thomas J. Vilsack:
The Working Group will be an important tool for gathering ideas as to how we can strengthen the food safety system to be more accountable and accessible to the public it protects, flexible enough to quickly resolve new safety challenges that emerge, and able to meet the robust needs of our rapidly changing world. (HHS, 2009)
In an effort to foster transparency and openness, the FSWG has invited public participation and is focusing on five basic principles similar to those in the FDA’s FPP:
Respond rapidly to outbreaks and facilitate recovery.
Expand risk-based inspection and enforcement.
Focus on prevention.
Target resources effectively.
Strengthen surveillance and risk analysis. (FSWG, 2009b)
The FSWG proposes to strengthen federal coordination by clarifying responsibilities, improving accountability, and modernizing current statutes. Thus its establishment is, at the time of this writing, a critical first step toward a comprehensive overhaul of the U.S. food safety management system, with the FDA as a key player (FSWG, 2009b).
The committee strongly supports the direction being taken by the FSWG. It is concerned, however, that these efforts remain piecemeal. A review of the FSWG website reveals little activity since the group’s inception, and its membership is unclear. To be effective, the FSWG must include experts with the depth of background in food safety needed to understand the multitude of issues facing those agencies charged with food safety oversight. Increased transparency and stakeholder participation would strengthen and enhance the role of the FSWG as the leader in planning and implementing the comprehensive overhaul needed to optimize the U.S. food safety management system. The remainder of this chapter addresses issues relevant to reorganization and resource allocation within the FDA and approaches to the unification of food safety activities across the multiple agencies and departments with food safety responsibilities.
ISSUES RELEVANT TO REORGANIZATION AND RESOURCE ALLOCATION
Barriers to Change Within the FDA
As outlined in Chapter 2, FDA responsibilities relative to the nation’s food supply lie within multiple centers and units. As it currently stands, there are deep-seated and fundamental differences in the cultures within the various FDA units. Historical differences in mission, financing, legal authorities and responsibilities, and institutional traditions have led to disparate perspectives on food safety issues among these units (Bell, 2009; Osterholm, 2009). A good example is the differing visions for the Center for Food Safety and Applied Nutrition (CFSAN) and the Office of Regulatory Affairs (ORA). Past studies (Glavin, 2008) have also noted the conflicts inherent in the FDA’s dual roles of law enforcement and protection of the public health. Policy setting for FDA food and feed regulation has historically resided with CFSAN (formerly the Bureau of Foods) and the Center for Veterinary Medicine (CVM), respectively, which are headed by a director. On the other hand, enforcement of policies and regulations is
carried out by ORA, which is headed by an associate commissioner. Much of ORA’s organizational culture is focused on its law enforcement role. CFSAN and CVM employees, on the other hand, are not law enforcement officers (Givens, 2009). Thus, ORA investigators can request data while they conduct an inspection, and these data may be helpful in guiding regulatory decisions that affect the public health. On the other hand, if these data reveal policy violations, they can also become the basis for regulatory action against a food facility. This possibility could contribute to hesitancy on the part of industry to share potentially important data with the FDA (see Chapter 5).
Historically, ORA district offices sought approval from CFSAN (or the Bureau of Foods) for legal action when sufficient evidence existed, in the opinion of CFSAN scientists/administrators, to support such action. Over time, more authority was ceded to the ORA regions/districts to take action on specific findings without center approval or concurrence. Establishing field research centers and strengthening support for ORA laboratories as part of ORA’s “revitalization strategies” were perceived by some as usurping what was traditionally a function of CFSAN scientists (Swann, 1993; Glavin, 2008). The relationship between the two centers has reportedly varied over time with changes in personnel and personal relationships among leaders within the offices of the director at CFSAN and the associate commissioner for regulatory affairs, as well as at lower echelons within each organization.
A related problem that derives from this division of roles at the FDA is that inspectors under the jurisdiction of ORA have responsibilities for more than one type of FDA-regulated product. As a result, the agency has imprecise data on the proportion of field resources dedicated to food safety (Givens, 2009; Solomon, 2009). This situation appears to be due to the policy that individual inspectors are not assigned to specific types of facilities (foods, drugs, devices, cosmetics) but handle a variety of establishments in their jurisdictions (Givens, 2009). Although maintaining a workforce with diverse training in foods, drugs, devices, and cosmetics purportedly provides the agency with flexibility, the committee argues that it results in an inspection force that may not have sufficient expertise in food safety (see Chapter 8) (Givens, 2009; Wagner, 2009).
In summary, the separation of the public health and enforcement roles within the FDA and the lack of clarity about their overlap have resulted in a situation in which CFSAN and CVM, the agency’s food and feed policy arms, have little direct authority over the FDA’s activities in the field. This lack of direct authority hampers the FDA’s ability to prioritize such activities as inspections, the collection of data necessary to drive a risk-based food safety management system, and even the implementation of new or updated CFSAN policies. These are essential activities that are central to the
FDA’s success in managing food safety with a risk-based approach; implementing many of the recommendations in this report will not be feasible if these problems persist.
Efficient Use of Resources
Among other factors, the organizational structure at the FDA contributes to a setting in which the utilization of available resources is often less than ideal. This report has pointed to various areas in which such operational inefficiencies exist at the FDA; two particularly important areas are discussed below.
One area of concern for the committee that has also been highlighted by others (GUIRR/NAS, 2009) is the lack of coordination of the nation’s food safety and defense research portfolios. Within the FDA, in the absence of a strong organizational focus with a well-defined strategic plan, food safety–related research has evolved into a poorly integrated network of research centers, institutes, and laboratories (see Chapter 6). The ORA laboratories play into this issue; their work is focused on enforcement, but with appropriate agency restructuring, they could well be a critical source of data to support risk-based food safety management. As part of any organizational restructuring, changes to the agency’s research portfolio (and laboratory functions) will be necessary, including reallocation of irrelevant or poorly performing initiatives and identification of future resources needed to support risk-based efforts.
Data infrastructure issues are a second area of critical importance with respect to resource allocation and internal reorganization. Underlying virtually all of the recommendations made in this report is the fundamental need for reliable data to guide the decision-making process. Reliable data must be appropriate (fit-for-purpose), complete, available, and representative of all sectors and stakeholders (Bell, 2009; Osterholm, 2009; Plunkett, 2009; Scott, 2009). As described in Chapter 5, there are many technical, cultural, and perhaps even legal barriers to meeting such data needs, including inadequate information technology (IT) infrastructure, cultures that discourage the sharing of data, and delays or lack of collaboration in sharing data due to misunderstandings about legal constraints. Also, the lack of high-quality personnel to carry out the collection, analysis, and management of data has been highlighted in this report as a barrier to good data infrastructure and management (Chapter 5). At the most basic level, the FDA must give top priority to the development of robust IT systems that can accommodate the data available from multiple partners; such systems must be designed to collect the right data in the right format to facilitate risk-based decision making. In any internal FDA reorganization, an applied statistician and an IT/data manager with experience in developing and maintaining
large databases must be included in the top management group, and their respective divisions must have access to the necessary resources and work collaboratively to create a modern data management system.
Current Approaches to Internal FDA Reorganization
As this report is being written, the FDA has initiated internal reorganization plans that would integrate the food safety functions of, CFSAN and CVM. The committee is encouraged by, and strongly supportive, of the creation of the Office of Foods with authority over CFSAN and CVM (see Chapter 2). However, this consolidation will not resolve concerns associated with the separation of the enforcement and public health roles of ORA and the centers, respectively. In fact, based on the problems discussed above, the committee concluded that if the FDA is to accomplish its food safety mission efficiently, its food programs should have complete authority over field activities related to the foods it regulates. The committee is also concerned about how the plans currently being developed will deal with structuring the agency’s research mission and with addressing the IT and data management deficiencies highlighted in this report.
UNIFICATION OF FOOD SAFETY ACTIVITES ACROSS MULTIPLE AGENCIES AND DEPARTMENTS
In keeping with its statement of task, the committee did not conduct an in-depth review of the whole food safety system and responsible government agencies. Nor has the committee considered or evaluated the pros and cons of all potential organizational changes that might address the current challenges reviewed in this report. The committee does believe, however, that certain key organizational changes described below would enhance the ability of the FDA, and the federal government in general, to ensure food safety.
The committee concludes that focusing attention on risk-based priorities, workforce development, and the integration of activities currently scattered among many poorly coordinated agencies would result in a marked increase in efficiency throughout the system. While the resource and organizational issues to be addressed may appear to be daunting in the short term, it is highly likely that well-designed components of an integrated food safety system would, in the long run, save money and improve the public health.
Similar sentiments have been expressed by government officials in other countries that have recently reorganized their food safety systems (see Appendix C). Although evaluations of the outcomes of these reorganizations are still in progress, officials in each country believe that the final bal-
ance will be a positive one. In addition to improvements in efficiency, such as less overlap in inspections and more consistent and timely enforcement of laws and regulations, some countries cite areas that should result in savings, such as reduced duplication of inspections and lower costs associated with administrative personnel (GAO, 2005b).
There are well-documented difficulties inherent in any internal restructuring of government agencies, difficulties that are magnified when such efforts involve reorganizing across agencies and departments that have traditionally operated independently. The committee is aware that any reorganization efforts directed at the food safety system will require careful planning and may require stepwise implementation. Regardless of the final structure of the food safety system, it must include data management and analytical functions that will ensure that the data needs of a risk-based food safety system are met. The approaches described below reflect what could be an evolutionary process in which the first step—creation of a centralized risk-based analysis and data management center—leads toward accomplishing the more challenging goal of a unified food safety agency.
Creation of a Centralized Risk-Based Analysis and Data Management Center
A risk-based food safety system requires the analytical capacity to assess food safety risks and policy interventions and the ability to access data from a broad array of sources. To meet these needs, the committee envisions the establishment of a centralized center with risk-based analysis and data management functions. The need for data to support a scientific basis for decision making has been articulated by the White House FSWG as well as a variety of other public and private groups (Taylor and Hoffman, 2001; GAO, 2004, 2005a; Taylor and Batz, 2008). The proposed center would serve as an information hub or broker that would streamline data collection from a variety of sources to support a risk-based approach. Such data might include epidemiological and farm-to fork surveillance data collected at the national level; inspectional, laboratory, and epidemiological data collected at the state and local levels; supporting food safety data, such as industry surveillance and academic research findings; and other relevant data related to food safety and food defense.
Establishment of a centralized food safety data management function would be an important step toward the implementation of a risk-based approach to food safety management. However, the act of collating and organizing data does not necessarily mean that the right data have been collected or that the data will be used appropriately. Therefore, this center also needs to house the analytic capacity, including the appropriate scientific and technical expertise, to identify (in consultation with the relevant agen-
cies) specific data needs, ensure that data are collected in an appropriate manner, and analyze the data with the clear goal of supporting risk-based food safety decision making.
The committee envisions several advantages to the establishment of such a centralized risk-based analysis and data management center. On the analytical side, having such a center responsible for all food safety data, irrespective of agency, would go a long way toward developing the much-needed capacity that is currently lacking. The center’s independence from a specific regulatory agency would not preempt any agency’s prerogative to develop its own approach to food safety management, but would eliminate the need for each agency to develop its own comprehensive expertise in risk and decision analysis. This in turn would reduce interagency competition for available scientific resources (including personnel), reduce redundancy, harmonize analytical methods, and increase efficiency. Specifically, because the agencies involved would not have competing analytic groups, the center concept would ensure a consistent technical approach to surveillance, data analysis, and modeling. On the data management side, the centralized nature of this body would help overcome some of the current barriers to data acquisition and transfer, keeping in mind that additional actions needed to overcome the data sharing barriers identified in Chapter 5 would have to be considered during the center’s establishment. The ability of such a center to promote communication, collaboration, and sharing of data among government agencies is central to its value.
Positioning the risk-based analysis and data management center as a free-standing (independent) entity that is not directly answerable to any one regulatory agency would also result in a scientifically credible source of unbiased data and analytic capacity. This model is consistent with the need for separation of the risk management and assessment functions, which is central to the assurance that risk-based decision making is objective and not influenced to support a predetermined policy or political agenda (NRC, 1983, 1996). Further, within such a structure, it may be easier to recruit and retain scientists and maintain the interactive and multidisciplinary scientific base essential to the functioning of such an organization. Although it is important to stress that this center should be independent from political influence, it is also essential that the strategic plan for the center be developed to address the needs of the regulatory food safety agencies. The term “independent” in this context means free from political influence but accountable to the public health needs and mission of the regulatory agencies. In Europe, quasi-governmental research institutes (such as the National Institute for Public Health and the Environment in the Netherlands or the European Food Safety Authority) serve the dual purposes of functioning as a hub for national data collection and providing the independent scientific and analytical expertise necessary to support policy decision
making. The proposed center could be established as an entity in its own right or as a step toward the ultimate establishment of a single, unified food safety agency.
Creation of a Single, Unified Food Safety Agency
For well over a decade, many responsible suggestions have been made that the major elements of the U.S. food safety system would be more effective and efficient if many of the core activities of multiple agencies were consolidated into a single food agency (IOM/NRC, 1998; National Commission on the Public Service, 2003; GAO, 2005b; IOM, 2009). The committee concluded that, to effect the risk-based approach and actions proposed in this report, a unified food safety agency will ultimately be essential. Such an agency would have overall authority for all aspects of the risk-based food safety system outlined in Chapter 3, from planning and data collection to policy and regulatory development, including oversight of all food safety inspections. Its functions would be supported by the centralized risk-based analysis and data management center described above; in fact, the unified entity would be responsible for this center.
Establishment of a single food safety agency would certainly be challenging. It would require reorganization of various federal agencies and buy-in from several congressional committees to facilitate changes to many food safety–related laws and regulations (IOM/NRC, 1998; GAO, 2004). Given the jurisdictional and political ramifications, an immediate and total reorganization of this magnitude probably is not feasible. Nonetheless, it is the consensus of this committee that core federal food safety responsibilities should ultimately reside within a single entity having a unified administrative structure, a clear mandate, a dedicated budget, and above all, full responsibility for oversight of the entirety of the safety of the nation’s food supply.
KEY CONCLUSIONS AND RECOMMENDATIONS
The committee is confident that the recommendations offered in this report constitute a series of actions that would enhance the FDA’s food programs and their ability to ensure food safety now and in the future. The committee is encouraged by changes already occurring in the FDA’s food programs, such as the establishment of the Office of Foods in 2009. However, the committee has not been persuaded that the consolidation of responsibility represented by the establishment of this office will resolve issues associated with the current separation of the FDA’s food safety–related enforcement and public health roles and the lack of authority of CFSAN and CVM over inspection and enforcement. In addition, food safety in the
United States today is managed by multiple government agencies, hampering the efficiency and effectiveness of the overall food safety system.
Efficiency in working toward the common goal of ensuring food safety and the public health will be greatly enhanced if the recommendations in this report are implemented in the context of the organizational changes outlined in this chapter. The committee realizes that there are many potential avenues to the evolution and implementation of those organizational changes and that there are serious barriers to overcome. Hence, the importance of in-depth analysis and planning of the implementation process cannot be overemphasized. With regard to the overall organization and functioning of the FDA, the committee makes the following recommendations.
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.
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