National Academies Press: OpenBook

Enhancing Food Safety: The Role of the Food and Drug Administration (2010)

Chapter: 5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System

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Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
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5
Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System

Information science—a term that refers to the collection, organization, storage, retrieval, exchange, interpretation, and use of information—and information technology (IT) are critical to the success of a risk-based decision-making system.1 If the U.S. Food and Drug Administration (FDA) is to implement a risk-based approach in fulfilling its regulatory mission, it must know what is happening in the arena it regulates; that is, data from the food enterprise must be appropriately collected, integrated, and analyzed. To allocate resources, understand and prevent food safety problems, and drive continual improvements in public health, a risk-based system requires accurate, reliable, secure, and timely information that is accessible, within appropriate limits, to all stakeholders in the food safety system. The importance of information to the food safety enterprise has been recognized by the White House Food Safety Working Group as one of the three principles guiding the development of a modern, coordinated food safety system: “High-quality information will help leading agencies know which foods are at risk; which solutions should be put into place; and who should be responsible” (FSWG, 2009, p. 3).

As described in this chapter, large quantities of data related to food safety are already being collected. Yet, as has been highlighted by others, the FDA is facing an information crisis and currently lacks the necessary infrastructure to efficiently process, manage, protect, integrate, analyze, and leverage the large volume of data to which it has access. This deficiency hampers the agency’s ability to achieve its mission and increases both costs

1

In this chapter, the terms “data” and “information” are used interchangeably.

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

and the likelihood of regulatory errors (FDA Science Board, 2007). Much of the data is “stovepiped” into stand-alone databases that are not accessible within and across government agencies, including the FDA (Taylor and Batz, 2008; FDA Science Board, 2009). A lack of resources, legal constraints, nonstandardized data collection, varied data formats, incompatible IT systems, a sense of ownership by the group that collects the data, and a culture that often uses publication rather than rapid information release as the basis for evaluating performance have been identified as contributing to the persistent problems with data sharing (Taylor and Batz, 2008; FDA Science Board, 2009). For example, the FDA apparently has the regulatory authority to require that all data be submitted electronically and to specify the format of these data submissions, but it may not have sufficient resources to implement such electronic standards (FDA Science Board, 2007). It has been noted that inspection reports are often handwritten and take a long time to enter into the electronic system, databases sometimes contain incorrect or contradictory information, and data analysis is slow (FDA Science Board, 2007; GAO, 2009). The Science Board has also stated that requirements need to be developed in conjunction with stakeholders who will be making the submissions. Finally, the FDA lacks the necessary tools to store, search, model, and analyze data (FDA Science Board, 2007).

Generating and providing timely access to the appropriate data is challenging for any food regulatory agency because of the complexity of data needs, coupled with the diverse types of information from multiple sources and scientific disciplines. Also, the committee recognizes the challenge for government officials to be expeditious about communicating with stakeholders while also ensuring accuracy. In some instances, moreover, depending on the nature of the data and the needs of the user, release to others may justifiably be delayed because of the time needed to either interpret data or mask confidential information. As explained later in the chapter, however, the committee found that some delays that occur in the current system are not justifiable.

Recognizing these challenges, moving forward with a risk-based food safety system will require the development of an integrated information infrastructure that provides a relatively uninhibited flow of high-quality, relevant information (see Chapter 3). In the context of this report, an integrated information infrastructure refers to one that is strategically designed to facilitate the systematic collection, integration, management, storage, analysis, interpretation, and communication of the information needed to support a risk-based food safety management system, and also one that has the flexibility and accessibility to meet the varied and changing information needs of a diverse set of users.

This chapter outlines the key types of data needed to support risk-based decision making. In addition, it briefly illustrates the breadth of food safety

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

data that are being collected by government and other parties as well as gaps and challenges in the collection of these data. A particular barrier to achieving an efficient, risk-based food safety system that is discussed extensively in the chapter is the lack of data sharing. Finally, the chapter describes the elements that are critical to designing and implementing an integrated information infrastructure that can support a risk-based food safety management system. These elements include strategic planning to assess data needs and plan study designs as well as data analysis and communication, mechanisms to allow for timely sharing of quality data, a modern IT infrastructure, and the human capacity to collect, analyze, manage, and communicate the data.

THE ROLE OF DATA IN A RISK-BASED FOOD SAFETY MANAGEMENT SYSTEM

At its core, the FDA is a public health agency, and the ultimate goal of protecting the public health should be its highest priority. To support the achievement of this goal, the FDA’s information infrastructure should provide a foundation for risk-based decision making in all aspects of food safety management.

Data will be needed to implement the steps in the risk-based approach delineated in Chapter 3. In strategic planning (Step 1 of the risk-based approach), the FDA will need access to high-quality and timely data to identify the key public health objectives on which its food safety program will be centered. At the highest level, these public health objectives will be consistent with national public health objectives, such as those articulated in Healthy People 2020, which include “reduc[ing] the number of outbreak-associated infections caused by food commodity group” (including dairy, fruits/nuts, and leafy vegetables)2 (HHS, 2009). However, the FDA will also pursue specific intermediate outcomes, such as the reduction of methyl mercury in foods, that will serve as the basis for its targeted risk management programs. The establishment of these objectives should be based on data acquired in the field, such as data on contamination or foodborne illness.

The process of public health risk ranking (Step 2) will also require data. For example, as discussed in Chapter 3, foodborne illness attribution models are crucial to public health risk ranking because they provide the bridge between public health impact and risk in the food continuum. However, developing such models requires a comprehensive data collec-

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

tion system that integrates data from various sources and harmonizes the categorization of foods, as well as the methods used to produce, process, and distribute those foods (NRC, 2009).

Data collection and subsequent analyses are the outcomes of Step 3 of a risk-based system (targeted information gathering). In carrying out this step, risk managers must identify and consider additional criteria upon which risk-based decision making will be based and, for each high-priority and/or uncertain risk, determine the need for collecting additional information. Such additional data may encompass virtually any (and all) of the data types noted below. These data then form the basis upon which intervention analysis (Step 4) can proceed, which may also involve the collection of even more information in an effort to evaluate the efficacy and feasibility of candidate control options.

Finally, data must be collected to measure the efficacy of specific interventions, the overall food safety system, and the risk-based approach in achieving national and agency-specific public health objectives (Step 6). Crucial to this process is the collection of information that can directly relate interventions to specific public health outcomes, including epidemiological data and associated attribution models.

Ultimately, the FDA’s purpose in collecting food safety data is to better understand the distribution and determinants of foodborne illness, prioritize the determinants based on their public health impact, and develop interventions for the determinants and thereby control foodborne illness. In fact, understanding the epidemiology of foodborne illness is necessary to support the ability to make informed, risk-based policy decisions and allocate food safety resources appropriately. In turn, a risk-based decision-making process will improve knowledge of the epidemiology of foodborne illness and drive continual improvements in public health. As defined by Last (1995, p. 62), epidemiology is “the study of the distribution and determinants of health-related states or events in specified populations, and the application of this study to control of health problems.” As noted by Havelaar and colleagues (2006, p. 9), “epidemiology is now largely a quantitative science that extensively uses statistical (associative) models to explore the relation between risk factors and disease.”

DATA NEEDS FOR A RISK-BASED SYSTEM

To meet the needs of a risk-based system, data would ideally be collected at each point along the food production continuum—on the farm, in processing, during distribution, at retail, and in the home. A variety of data sources can contribute to an understanding of the epidemiology of foodborne illness, including data collected through surveillance, behavioral studies, analytical research, and traditional epidemiological studies. The types of data collected

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

might include foodborne pathogen levels and transmission routes in animals, plants, food products, humans, and the environment; current industry and consumer practices, including behaviors and attitudes; and the efficacy of candidate intervention approaches at all phases of the continuum. There is also a need for epidemiological data to support estimates of the overall burden of foodborne illness and the proportion of such illness associated with specific vehicles (foods) and transmission routes (i.e., foodborne illness attribution). A regulatory agency might decide to include other factors in its risk-based approach as well, such as the costs and benefits of implementing specific interventions, even though those factors are not directly related to public health. These data types can be broadly categorized as behavioral, economic, food production, and surveillance data. The importance of each type of data for a risk-based system is discussed further in the following subsections. To maximize the utility of these diverse surveillance systems, there must be an integrated information infrastructure that, through strategic planning, facilitates informed data collection and promotes standards for data exchange. Effective collection of these types of data will require active research—including basic, population, and clinical research—as outlined in Chapter 6.

Behavioral Data

Behavioral data are critical to understanding routes of transmission, implementing intervention strategies to change behavior, developing risk communications, improving public health response, and evaluating interventions. As discussed in Chapter 9, behavioral data are ultimately essential for developing strategies that will enable the FDA to communicate effectively with diverse audiences under a wide range of circumstances and through multiple communication channels. For example, the attitudes, perceptions, and behaviors of the general public and food industry personnel can impact their compliance with recommended food safety interventions, such as safe food-handling practices (Medeiros et al., 2001; Pilling et al., 2008). Likewise, understanding the attitudes, perceptions, and behaviors of public health personnel—including physicians, laboratory personnel, and government officials—can help identify ways to improve public health response.

Economic Data

In a risk-based system, data on benefits and costs are combined for use in cost-effectiveness and cost–benefit analyses of alternative policy interventions. Economic data can be used to measure and understand several important dimensions of a risk-based food safety system. These data may

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

be thought of as measuring factors that affect the demand for safer food by individuals and by society as a whole on the one hand and factors that affect the supply of safer foods on the other. The demand for food safety arises in part from the costs of foodborne illness in terms of medical treatment, lost productivity due to mortality and morbidity, and other costs, such as loss of leisure time or burden on family members due to illness (Majowicz et al., 2004; Frenzen et al., 2005; Kemmeren et al., 2006; USDA/ERS, 2009). In addition to avoiding these costs, individuals or society may be willing to pay for (i.e., demand) improved safety based on the well-being or peace of mind associated with safer foods (Shogren et al., 1999). On the supply side, economic data can be used to measure the potential and actual costs of actions intended to supply safer foods, as well as to gain insight into incentives for countries and companies to invest in food safety. These data on incentives include domestic and international market impacts from the incidence of foodborne pathogens, from outbreak incidents in total, and as distributed across the supply chain. Examples of such impacts include the loss of market share by food producers in domestic markets due to the loss of reputation for safety and loss of export markets. Data that can help in understanding these effects include farm cash receipts, total value at retail, value of exports, value of imports, proportion of domestic consumption of food products produced domestically, and information on key export and import markets (Ruzante et al., 2009).

Food Production Data

To support risk-based decision making, the FDA needs to have information that relates to the production, processing, and storage of foods, including the size of the regulated industry and the distribution channels. For example, the FDA needs to understand current industry practices, including best practices, intervention strategies, and emerging technologies. The agency also needs to know the prevalence of foodborne pathogens throughout the food production, processing, and distribution chain. In fact, in support of the functions of the Office of Regulatory Affairs (ORA), including routine inspection activities, the FDA collects a large amount of data for both regulatory and nonregulatory purposes that may address these types of questions.

Data are also collected by the industry in support of safety control systems such as Hazard Analysis and Critical Control Points and routine microbiological monitoring. In addition, industry data collected by the academic and government research sectors are a rich source of information that can be used to estimate the prevalence and levels of pathogens and toxins in the food supply, evaluate the efficacy of intervention strategies, model risk and its mitigation, and identify consumer behaviors and market trends. All these data collected throughout the food production continuum

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

can be used to inform attribution and risk models, aid in the allocation of agency resources, and provide evidence of data gaps to inform future data collection efforts, among many other purposes.

Surveillance Data

For purposes of this report, “surveillance” refers to the ongoing, systematic3 collection and analysis of contaminant, public health, and molecular data throughout the farm-to-fork continuum for use in preventing and controlling foodborne illness. Surveillance is a critical component of a risk-based food safety system in that it improves overall understanding of the epidemiology of foodborne illness. Specifically, surveillance can be used to establish a baseline level of foodborne illness, identify goals for its reduction, and provide a means by which to measure the impact of interventions on its control. Given resource limitations, the risk-based approach recommended in this report is essential as a tool to prioritize surveillance efforts.

Animal, food, environmental, human, public health, molecular, and behavioral (see p. 151) surveillance are all needed to respond to food safety crises, monitor food safety outcomes, and assess the effectiveness of the food safety system. Surveillance of animal populations, the food supply, and the environment is almost always undertaken with an eye to identifying sources of contamination and their subsequent transmission from a food animal to product(s) that will ultimately be consumed by people. Surveillance of human populations is used to better characterize the burden of foodborne illness and identify the relative importance of particular exposures (e.g., foods, transmission routes). Public health surveillance provides important insights into current medical, laboratory, and general public health practices, such as reporting and outbreak investigations. Molecular surveillance systems, such as PulseNet and VetNet, combine the methods of molecular biology with those of epidemiology to establish associations between contaminated food and illness when they are separated in space or time.

GAPS AND CHALLENGES IN THE CURRENT DATA COLLECTION SYSTEMS

Implementing an effective risk-based system, and developing the foodborne illness attribution models needed to support such a system, will require a comprehensive information infrastructure that integrates data

3

In this context, the term “systematic” means that the surveillance is conducted in an orderly fashion, not haphazardly. For example, under certain circumstances, passive surveillance can be considered systematic, if it is conducted under some minimum established standards.

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

from various sources, harmonizes the data collected through the use of data standards, and finally analyzes, interprets, and disseminates those data in such a manner that they can be used to monitor and evaluate the overall food safety system. As evidenced by the following discussion, such a comprehensive system does not currently exist in the United States, compromising the FDA’s capacity to fulfill its mission of protecting public health from hazards transmitted through the food supply. Current efforts to develop a risk-based food safety system are significantly limited, despite the fact that vast amounts of food safety data are already being collected. In recent years, several studies have evaluated the state of the FDA’s science and information infrastructure and identified a number of problems (see Appendix B). While these problems have been well documented, it has been suggested that they persist because of a lack of commitment and inadequate investment that stem from legislative and policy inaction (FDA Science Board, 2007; Taylor and Batz, 2008).

A detailed description of the complexity and challenges of the data collection systems currently used to ensure food safety in the United States is given in the report Harnessing Knowledge to Ensure Safe Food: Opportunities to Improve the Nation’s Food Safety Information Infrastructure (Taylor and Batz, 20084). These challenges are discussed briefly below.

Fragmented Data Collection

The data needs of the nation’s food safety system are currently being met through a patchwork of diverse data collection systems and networks that generate vast amounts of food safety data (for an extensive review see Taylor and Batz, 2008). Often, the collection of data is not comprehensive or designed to support a risk-based approach. Table 5-1 illustrates the breadth of the salient data by listing examples of U.S. public health–related data collection programs and networks in which the FDA is the lead or participates. Table 5-2 shows examples of the systems currently used to collect the different types of data outlined in the previous section, including some of the systems listed in Table 5-1, as well as shortcomings of these systems identified by the committee.

As part of its food regulatory function, the FDA collects some data, including microbiological samples, for the food products it regulates. With coverage in every state and territory, the FDA’s field personnel and delegates are well positioned to generate and provide data that could be used in the agency’s risk-based decision making. However, because field personnel do not have a daily presence in the regulated facilities, the FDA has limited opportunities to collect data outside of its routine regulatory efforts. With

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

TABLE 5-1 Examples of U.S. Public Health–Related Data Collection Programs and Networks

Aflatoxin Testing Program

Under memorandums of understanding (MOUs), the U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) provides appropriate U.S. Food and Drug Administration (FDA) district offices with the results of aflatoxin analysis for domestic and imported peanuts, imported in-shell pistachios, and imported in-shell brazil nuts in lots that may be subject to action under the Federal Food, Drug, and Cosmetic Act (FDCA) and with an analysis certificate on any lot upon request. The FDA will also notify the Agricultural Marketing Service (AMS) of the criteria it will use concerning total aflatoxin levels in lots to determine whether they may be subject to action under the FDCA.

CAERS (CFSAN Adverse Events Reporting System)

The Center for Food Safety and Applied Nutrition (CFSAN) Adverse Events Reporting System (CAERS) team monitors all individual postmarketing surveillance adverse event reports related to CFSAN-regulated products. Reviewers in CFSAN’s program offices assess these reports and work closely with program experts and researchers throughout CFSAN and the FDA. CAERS tracks what products and ingredients may be harmful and conveys this information to industry, consumers, and other interested parties. The CAERS adverse event data permit CFSAN to do trend analysis on multiple adverse events and to track rarer product-related adverse events that may occur over several years.

CIFOR (Council to Improve Foodborne Outbreak Response)

CIFOR is a working group that seeks to improve performance and coordination among federal, state, and local agencies with respect to routine surveillance of foodborne illness, foodborne outbreak detection and response, laboratory methods for detecting and measuring foodborne pathogens, and foodborne illness prevention, communication, and education at the state and local levels. The council includes representatives of the U.S. Centers for Disease Control and Prevention (CDC), the FDA, USDA, the Association of Food and Drug Officials, the Association of Public Health Laboratories, the Association of State and Territorial Health Officials, the Council of State and Territorial Epidemiologists, the National Association of County and City Health Officials, the National Environmental Health Association (NEHA), and the National Association of State Departments of Agriculture. CIFOR also includes an industry workgroup composed of 16 leaders from food production, restaurant, and retail companies.

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

EHS-Net (Environmental Health Specialists Network)

EHS-Net is a CDC-coordinated collaborative forum of environmental health specialists who work with epidemiologists and laboratories to identify and mitigate environmental factors that contribute to foodborne illness and other disease outbreaks. Its goals include translating investigatory findings into improved food safety prevention efforts using a systems-based approach and strengthening relations among epidemiology, laboratory, and environmental health programs.

eLEXNET (Electronic Laboratory Exchange Network)

This web-based information network, coordinated by the FDA, allows federal, state, and local food safety officials to compare, share, and coordinate laboratory analysis findings. It is also the data capture and communication system for the Food Emergency Response Network (FERN). eLEXNET provides the necessary infrastructure for an early warning system that identifies potentially hazardous foods and enables health officials to assess risks and analyze trends.

Epi-Ready

This nationwide team-training initiative, led by CDC and NEHA, provides up-to-date foodborne illness outbreak investigation and surveillance training to public- and private-sector environmental health professionals, as well as other professionals who collaborate in conducting foodborne illness outbreak investigations.

Epi-X (Epidemic Information Exchange)

Run by CDC, Epi-X is a web-based surveillance communication tool for public health professionals. It enables public health professionals to access and share preliminary health surveillance information and notifies them rapidly of health events as they occur. Key features of Epi-X include scientific and editorial support, controlled user access, digital credentials and authentication, rapid outbreak reporting, and support for multijurisdictional peer-to-peer consultation.

FERN (Food Emergency Response Network)

FERN is a network of local, state, and federal food-testing laboratories that responds to emergencies involving biological, chemical, or radiological contamination of food. It provides a national surveillance capability designed to offer an early means of detecting threat agents in the American food supply, prepares the nation’s laboratories to respond to food-related emergencies, and offers surge capacity for responding to widespread, complex food contamination emergencies. FERN is coordinated by both the FDA and USDA/FSIS.

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

FoodNet (Foodborne Diseases Active Surveillance Network)

A collaboration among CDC, the FDA, USDA, and the ten states participating in CDC’s Emerging Infections Program, FoodNet has the goal of providing more accurate estimates of foodborne illness associated with pathogens by conducting active, population-based surveillance for foodborne illness cases at ten sites. FoodNet has contributed to the standardization of methods among laboratories and performs targeted case control studies to identify risk factors for pathogen-specific illnesses.

FoodSHIELD

FoodSHIELD’s mission is to support federal, state, and local government regulatory agencies and laboratories through web-based tools that enhance threat prevention and response, risk management, communication, asset coordination, and public education.

MDP (Microbiological Data Program)

MDP is a national foodborne pathogen database program implemented in 2001. Through cooperation with state agriculture departments and relevant federal agencies, MDP is meant to collect, analyze, and report data on foodborne pathogens for selected agricultural commodities. The FDA provides technical assistance to enhance methods used by MDP participants. Additionally, USDA/AMS informs the FDA of any positive pathogenic findings detected through MDP.

NARMS (National Antimicrobial Resistance Monitoring System)

NARMS was established in 1996 to monitor changes in the susceptibility of select bacteria to antimicrobial agents of human and veterinary importance among foodborne isolates collected from humans, animals, and retail meats. NARMS is a collaboration between three federal agencies including FDA’s Center for Veterinary Medicine (CVM), CDC and USDA. NARMS also collaborates with antimicrobial resistance monitoring systems in other countries, including Canada, Denmark, France, Mexico, the Netherlands, Norway, and Sweden, so that information can be shared on the global dissemination of antimicrobial resistant foodborne pathogens. Molecular fingerprints of select foodborne bacteria (Salmonella and Campylobacter) recovered via NARMS are deposited into the CDC PulseNet databank for use in identifying sources and spread of foodborne outbreaks. The information from NARMS forms the basis for public health recommendations for the use of antimicrobial drugs in both food producing animals and humans. NARMS data also are vital in disease outbreak investigations and can be used to help create treatment guidelines for foodborne pathogens, thereby ensuring better health outcomes.

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

OutbreakNet/NORS (National Outbreak Reporting System)

OutbreakNet is a national CDC-coordinated network of local, state, and federal public health officials who investigate outbreaks of enteric illness, including foodborne outbreaks. State OutbreakNet members report findings of their foodborne outbreak investigations to CDC through NORS, a national web-based reporting system that tracks foodborne, person-to-person, animal contact, waterborne, and norovirus outbreaks. Prior to NORS, states reported foodborne outbreaks through the Electronic Foodborne Outbreak Reporting System. In 2008, the FDA and CDC executed an MOU under which the FDA provides two contract employees to the OutbreakNet unit at CDC for the purpose of mining and analyzing CDC data to address the FDA’s policy and programmatic questions and support its regulatory mission and public health interventions. A plan of work was developed and implemented beginning in late fall 2008. Biannual reports are made to the FDA on progress in the plan’s implementation. Examples of topics being addressed are attribution of outbreaks due to raw milk and raw milk cheese versus all dairy and produce attribution classified by produce type.

PDP (Pesticide Data Program) and National Residue Program

Under USDA/AMS’s PDP, a collaboration with the U.S. Environmental Protection Agency (EPA), the FDA is notified of apparent food-related violations that are detected by PDP for follow-up, as warranted. Under USDA/FSIS’s National Residue Program, the FDA is notified of apparent residue violations in meat, poultry, and egg products for follow-up with the responsible firms. The FDA’s pesticide residue data are provided to and used by EPA to support EPA’s pesticide tolerance reassessments, required under the Food Quality Protection Act of 1996. When FDA pesticide residue findings indicate pesticide misuse (a violation of the Federal Insecticide, Fungicide, and Rodenticide Act, which is enforced by EPA), the FDA notifies EPA for follow-up as warranted. Currently, as mandated by the Food and Drug Administration Amendments Act of 2007, an MOU among the FDA, USDA’s AMS and FSIS, and the U.S. Department of Commerce is being developed so that AMS and FSIS pesticide residue monitoring data will be included in the FDA’s pesticide residue monitoring program.

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

PetNet

PetNet is a proposed network that would be developed by CVM to report disease outbreaks in companion animals or contamination incidents concerning pet food or animal feed. In March 2009, a working group—including representatives of CVM, CDC, USDA, the U.S. Department of Homeland Security, and public health and feed control officials from the states—was formed to combine expertise in epidemiology, veterinary medicine, emergency response, feed regulation, and laboratory analyses and charged with the development and implementation of PetNet. The target date for implementation is August 2010.

PulseNet (National Molecular Subtyping Network for Foodborne Disease Surveillance)

Established by CDC in collaboration with state public health laboratories, PulseNet is an early warning system for outbreaks of foodborne illness, consisting of a national network of public health laboratories that perform deoxyribonucleic acid (DNA) fingerprinting on foodborne bacteria. Comparison of DNA patterns permits analysts to connect cases to a common source.

Total Diet (TDS) Study

In this ongoing market basket survey, conducted by the FDA, samples of approximately 280 core foods in the U.S. food supply are collected and analyzed to determine levels of various contaminants (such as acrylamide and perchlorate) and nutrients in those foods. Data provided by the TDS have been used by regulatory agencies to estimate exposures to chemicals in foods, to perform risk assessments, and to establish policy.

VetNet

VetNet, a database maintained by USDA’s Agricultural Research Service (ARS), was modeled after PulseNet and serves as USDA’s pulsed-field gel electrophoresis (PFGE) pattern library. VetNet uses PFGE to subtype animal specimens submitted to NARMS and samples collected from federally inspected meat and poultry establishments for nontyphoidal Salmonella and Campylobacter. Combined data from VetNet and PulseNet could be used in outbreak investigations and surveillance efforts; however, data sharing issues have limited the usefulness of VetNet in this way. In 2007, an MOU among FSIS, ARS, and CDC was signed to help improve data sharing, but the effectiveness of this agreement has not been evaluated.

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

TABLE 5-2 Examples of Current Data Collection Systems and Associated Shortcomings

Type of Data

Examples of Current Data Collection Systems

Shortcomings

Behavioral (see Chapter 9)

Food Safety Survey

  • Government funding is not adequate.

  • Substantial delays are incurred because of the 1990 Paper Reduction Act, which includes unnecessary barriers to approval of study designs.

Economic

Only ad hoc collection of this type of data

  • Data often are not collected or are collected ad hoc to meet Office of Management and Budget requirements.

  • Estimates often have many uncertainties.

Food Production (nonregulatory, collected by industry)

Data on levels or presence of pathogens (or pathogen indicators) in ingredients

  • Industry is reluctant to share data for fear of regulatory action if a contaminant is found.

  • Industry fears that competitors will derive some advantage from the information shared.

  • The amount and type of data collected vary among and within sectors of the food industry.

  • Smaller producers, processors, etc. have limited ability to collect and analyze data.

  • Problems with using data may occur when data standards do not exist or are not followed.

  • The capability for electronic reporting of data is lacking.

Food Production (regulatory or nonregulatory, but collected by government)

Data collected by industry with regard to juice Hazard Analysis and Critical Control Points or low-acid canning process

  • Data collected at the state level are not utilized to drive a risk-based approach.

  • At the U.S. Food and Drug Administration (FDA), collection is led by the Office of Regulatory Affairs and based on an annual work plan. Participation of the FDA program centers with regard to data needs for a risk-based approach is questionable.

 

Data collected on traceability to comply with Bioterrorism Act

  • Data collection opportunities are minimal because of the low rate of inspection.

  • Problems with using data collected for regulatory purposes may occur if design or data standards are inadequate.

 

Selected pathogens in domestic and imported fresh produce

  • Adequate information technology systems with which to share and analyze data on a real-time basis are lacking.

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

Type of Data

Examples of Current Data Collection Systems

Shortcomings

Surveillance

Molecular-based

  • VetNet

  • PetNet

  • PulseNet (National Molecultar Subtyping Network for Foodborne Disease Surveillance)

  • Collection of data is especially lacking at the farm and retail levels.

  • VetNet consists of data on isolates obtained through the U.S. Department of Agriculture’s regulatory testing program for slaughter and processing establishments.

  • VetNet is not integrated with PulseNet, hindering the ability to use the data to develop attribution models.

  • PetNet is in development, and how it will be integrated with VetNet and PulseNet is unclear.

  • Clinical data, which would be useful for risk ranking, are not collected.

  • Data cannot be used to estimate the incidence of specific pathogens.

 

Contaminants

  • Aflatoxin testing

  • Pesticide Data Program

  • Total Diet Study

  • Microbiological Data Program

  • Most data are not collected routinely, except for some commodities (e.g., sprouts).

  • Very little data are collected on farms or retail establishments.

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

Type of Data

Examples of Current Data Collection Systems

Shortcomings

Surveillance

Acute clinical outcomes

  • Center for Food Safety and Applied Nutrition Adverse Events Reporting System

  • Foodborne Diseases Active Surveillance Network

  • Epidemic Information Exchange

  • Norovirus Outbreak

  • OutbreakNet

  • Resources for food safety vary by state and local jurisdiction.

  • There are no standard procedures, only guidelines, for investigating a local or multistate outbreak. Although guidelines often are followed as if they were legal standards, procedures and participation still vary by state and local jurisdiction.

  • Lack of communication between epidemiologists and laboratory analysts may delay investigations.

  • Communication between the FDA and relevant industries varies by state and local jurisdiction.

  • Etiology is not identified in more than 50% of outbreaks.

  • Data availability is often delayed by months or years.

  • The reporting rate to state or local departments varies because of various factors, including a lack of testing or reporting by physicians or others.

  • Although summaries are available from the U.S. Centers for Disease Control and Prevention, raw data are not easily accessible.

 

Long-term clinical outcomes

  • Identification of the long-term effects of foodborne illnesses is not routinely performed in the United States.

the exception of a few high-risk products, such as sprouts, the FDA generally has not required routine microbial surveillance of the foods over which it has jurisdiction.

Molecular-based surveillance of microbial pathogens in foods is sparse, particularly at the farm and retail levels. Laboratory and personnel resources have not been made available for such testing and surveillance, and the FDA has lacked the analytic capability to utilize such data optimally even if they were collected. As part of the 1997 Food Safety Initiative, the FDA did conduct companion microbiological surveys of selected imported and domestic produce to examine the prevalence of selected foodborne pathogens. While the results of these surveys were used to guide regulatory activities, they could not be used in quantitative risk assessment because of

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

the low rate of contamination and the lack of quantitative and molecular subtyping data.

In addition to relying on its own data collection, the FDA utilizes data collected by systems (e.g., National Molecular Subtyping Network for Foodborne Disease Surveillance [PulseNet], OutbreakNet, Foodborne Diseases Active Surveillance Network [FoodNet]) managed by other groups, such as the U.S. Centers for Disease Control and Prevention (CDC). These systems, which collect data through nationwide passive or active surveillance in several sentinel sites that are representative of the whole population (IOM, 2003), are starting to address problems associated with the collection of human epidemiological surveillance data.

PulseNet is an example of a notable, albeit still imperfect, improvement in the coordination and sharing of laboratory data among states and federal agencies to conduct nationwide surveillance of foodborne pathogens. The system has been instrumental in recognizing national outbreaks by linking small numbers of cases in different states, which by themselves might not have been further investigated, to similar small clusters in other states. While other federal agencies have established companion data collection systems for animal and food isolates (e.g., VetNet), data sharing between these systems and PulseNet is inconsistent. Further, different methodologies for subtyping, naming, and classifying isolate patterns have complicated the FDA’s ability to use data from these other systems even if they were to be fully accessible. As a result, it has not been possible to date to use molecular data to track specific pathogens from farm to table to patient. If PulseNet is to continue to play a significant role in the monitoring of disease occurrence, significant, ongoing funding must be committed to modernizing the system. For example, pulsed-field gel electrophoresis, the technology that serves as the basis for PulseNet, is increasingly antiquated.

OutbreakNet, another CDC system, also relies on information from state and local health departments and works in partnership with PulseNet. Foodborne outbreak reporting is useful for analyzing long-term trends for pathogens not captured in other surveillance systems and for providing summaries of outbreaks (IOM, 2003). OutbreakNet has played a pivotal role in the identification of several national, multistate outbreaks, including the 2006 E. coli O157:H7 outbreak associated with spinach. Recognizing the limitations of state and local data and their importance to the efficacy of nationwide foodborne illness and outbreak surveillance, the Institute of Medicine has recommended enhancements to the outbreak investigation and reporting of state and local health departments (IOM, 2003).

Unlike passive surveillance systems, CDC’s FoodNet is an active population-based surveillance system that has improved foodborne illness estimates, contributed to the standardization of methods among laboratories, and identified risk factors for pathogen-specific illnesses through its

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

targeted case control studies. In addition, FoodNet is particularly advantageous for capturing data on illnesses that are underrepresented in passive surveillance systems. For example, Campylobacter or Vibrio infections rarely appear in outbreaks and often are not reportable (IOM, 2003). Even so, FoodNet has its own limitations. For example, case ascertainment is costly and currently neither rapid nor real-time, and the sentinel site approach restricts the system’s geographic scope. It is also well recognized that large numbers of cases are not identified because those affected often do not seek medical attention. If medical attention is sought, the physician frequently does not order a stool culture, or, if a stool culture is ordered, the laboratory that receives the specimen may fail to screen for the pathogen that infected the individual. FoodNet attempts to quantify underreporting of foodborne illness through regular telephone-based community surveys as well as periodic surveys of physicians and laboratories.

Regulatory agencies, such as the FDA, are highly dependent on human disease surveillance systems, which in turn depend on data provided by state and local health departments. Reporting practices, the intensity of foodborne illness investigations, and the criteria for deciding which outbreaks to investigate depend on local interests and resources, resulting in foodborne illness reporting rates that can vary more than ten-fold among states in any given year (CDC, 2009). As a result, disease surveillance data available to the FDA are often inconsistent in quality and timeliness. Reporting in general is slow, requiring weeks to months for data to be transmitted from the local to the state to the federal level. Consequently, summary data are posted and published intermittently, often many months or years after a reporting period ends. For example, CDC’s 2007 Summary of Notifiable Infectious Diseases was not made available publicly until 2009. Further, because of the variability in reporting by the states, summary data cannot provide reliable estimates of disease prevalence. The lack of standardization in the collection and analysis of data and diverse state and local government capabilities have limited both the utility of these surveillance systems and the speed with which the FDA has been able to respond to recent outbreaks. Moreover, while data on public health practices among the general public, physicians, and clinical laboratories are critical to risk-based decision making, such data are collected only sporadically and usually do not include surveillance of the public health practices of federal, state, and local government agencies (e.g., reporting practices). The committee concluded that, if the FDA is to utilize state and local government data more reliably, standardization of state and local food safety programs will be necessary (see Chapter 7).

Clearly, numerous data collection systems that generate large quantities of data with direct applicability to food safety already exist. These systems were created largely in response to specific needs and often put in place with

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

no strategic forethought as to how the data would be analyzed and/or leveraged, through integration, to achieve the goals of the broader food safety system. Once established, data collection systems frequently have become institutionalized, even if the data being collected are of questionable quality and utility. When new questions arise, there is a tendency to try to retrofit existing systems to address them. While this approach may meet short-term data needs, it often compromises the ability to evaluate trends over time and limits the generalizability and interpretability of the data overall. In some cases, data collection systems simply do not exist (e.g., surveillance for the long-term health effects of foodborne illness) or are sparse (e.g., behavioral data). Some types of data, particularly those generated by industry, have been particularly difficult to acquire and will remain so until mechanisms that can overcome these challenges are put in place.

Lack of Data Sharing Among Government Entities

A wide variety of government entities collect data on food-associated hazards to humans and animals, but significant barriers to sharing those data have been extensively documented (Taylor and Batz, 2008). One barrier is federal and state laws, regulations, and policies that sometimes restrict the sharing of data among government entities because of such concerns as the protection of patient privacy, trade secrets, and confidential business information. These laws, regulations, and policies vary markedly among—and sometimes even within—different federal agencies. Personnel from government agencies performing field investigations frequently lack a firm understanding of the laws, regulations, and policies of their own agencies (and those of their partners), and this lack of knowledge often hampers coordination of efforts and leads to excessive withholding of information.

The failure of government entities to share food safety data sufficiently within the bounds of the law appears to result not only from a misunderstanding of legal obligations but also in part from institutional culture. This observation is illustrated by the sometimes tense relationship between the FDA and CDC. The two agencies agree (in theory) that they should share all information with each other. They have entered into a memorandum of understanding (MOU) (MOU 225-03-8001) that states the following:

Although there is no legal requirement that FDA and CDC exchange information in all cases, FDA and CDC agree that there should be a presumption in favor of full and free sharing of information between FDA and CDC. As sister public health agencies within the Department of Health and Human Services, there are no legal prohibitions that preclude FDA or CDC from sharing with each other most agency records in the possession of either agency. (FDA, 2003)

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

The committee learned, however, that the actual relationship between the FDA and CDC falls far short of fulfilling this presumption of full and free data sharing (Morse, 2009; Osterholm, 2009). In response to written questions about information sharing between the agencies, the Center for Food Safety and Applied Nutrition (CFSAN) provided the following statement:

To determine what foods may be responsible for causing outbreaks, FDA relies in part on epidemiological data from the [CDC] which, in large part, relies on the states. CDC redacts confidential private patient information from these data, as required by federal privacy laws, but otherwise there are no legal constraints to the sharing of this information between CDC and FDA because there is a signed confidentiality [MOU] between the two agencies that allows for the free exchange of information. However, sometimes there are delays in FDA’s receiving epidemiological data from CDC because the states need to supply CDC with the data and CDC needs time to compile the data, redact any confidential patient information, and analyze, [sic] and interpret these data before sharing.5

CFSAN’s response illustrates the real and perceived barriers to information sharing between CDC and the FDA. CDC appears to have informed the FDA that “federal privacy laws” require CDC to redact confidential patient information before providing data to the FDA. This redaction of information delays data sharing; at worst, it prevents or delays the FDA’s use of the information to protect public health. Federal law does not require such redaction. The relevant statute, the Privacy Act, 5 U.S.C. 552a,6 prohibits federal agencies from disclosing any personal record without the consent of the person to whom the record pertains, but it contains an explicit exception for disclosures “to those officers and employees of the agency which maintains the record who have a need for the record in the performance of their duties.” CDC and the FDA, as sister agencies within the U.S. Department of Health and Human Services (HHS), fall within this exception.7 Of course, none of this is to suggest that patient-identifying information should be shared between the agencies when there is no need

5

Personal communication, Chad Nelson, FDA, July 25, 2009.

6

The Privacy Act of 1974, 5 U.S.C. § 552a(b)(1); The Health Privacy Rule of the Health Insurance Portability and Accountability Act would not normally limit CDC’s authority to share data with anyone because CDC is not a “covered entity” subject to that rule.

7

The Privacy Act incorporates the definition of the term “agency” from the Freedom of Information Act, which in turns defines “agency” as “any executive department, military department, Government corporation, Government controlled corporation, or other establishment in the executive branch of the Government (including the Executive Office of the President), or any independent regulatory agency [emphasis added].” The Privacy Act of 1974, 5 U.S.C. § 552a(f)(1).

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

to do so. But sharing of confidential information is appropriate when redaction by CDC would unduly delay the transmission of essential information to the FDA in an emergency situation or would completely deny the FDA information it needs to protect the public health. Consequently, it is important for the agencies to understand that such redaction by CDC is not legally required.

The MOU between CDC and the FDA (MOU 225-03-8001) appears to assume that such confidential information may be shared between the agencies, and it establishes a mechanism for doing so. For “routine requests for information,” the agency seeking the information need only demonstrate, in writing, why it needs the requested information, and the responding agency “should only decide not to share information in response to [such] a request if it has credible information and a reasonable belief that the requesting agency may not be able to comply with applicable laws or regulations governing the protection of non-public information or with the principles or procedures set forth in this MOU.” With respect to “emergency requests for confidential information,” the MOU sets forth more flexible and expeditious procedures, which include oral requests. The MOU explicitly cites “a foodborne illness outbreak” as its one example of “emergency circumstances” (FDA, 2003).

CFSAN’s quoted response to the committee’s written questions suggests that CDC fails to live up to the MOU’s presumption of “full and free sharing of information” not only because of real or perceived legal limitations but also, as suggested above, because of its institutional culture. The response states that CDC withholds food safety data from the FDA until it “analyzes” and “interprets” the data. There is no legal requirement or public health justification for such a delay. The perception among some witnesses questioned by the committee was that CDC employees are reluctant to disseminate data, even to a sister agency, if early release of those data might compromise their academic publishing opportunities.

The committee understands, but was unable to verify, that some states may have data-sharing agreements with CDC that prohibit CDC from sharing confidential data it has obtained from the states with additional parties, perhaps even sister federal agencies such as the FDA. If such provisions do in fact exist, in the new climate of a closer working relationship between federal and state food safety authorities, greater sharing of information and the development of ways to share information within the bounds of confidentiality would be beneficial. To the extent that state laws prohibit the sharing of confidential information with federal agencies altogether, even when such sharing is necessary to protect the public health, reassessing such laws to permit the creation of a truly cooperative and integrated food safety system would be warranted.

Problems also appear to exist with respect to information sharing

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
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between the FDA and the U.S. Environmental Protection Agency (EPA), which, unlike CDC, is not a sister agency within HHS. CFSAN reported to the committee that during the 2008 incident involving the melamine contamination of dairy powder imported from China, the EPA declined to share the results of a melamine exposure assessment with the FDA because that assessment “contained confidential commercial information not disclosable outside of EPA.”8

There is also evidence of substantial constraints and delays in the flow of food safety information from the FDA to state and local governments. The FDA’s responses to the committee’s questions on data sharing identify several federal laws that restrict what food safety information it can share with state and local authorities. These laws include the following:

  • The Trade Secrets Act, 18 U.S.C. 1905, prohibits any federal agency employee from divulging “in any manner or to any extent not authorized by law any information coming to him in the course of his employment or official duties … which information concerns or relates to the trade secrets, processes, operations, style of work, or apparatus, or to the identity, confidential statistical data, amount or source of any income, profits, losses, or expenditures of any person, firm, partnership, corporation, or association.”9

  • Section 301(j) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 331(j), prohibits “revealing, other than to the Secretary or officers or employees of the Department, or to the courts when relevant in any judicial proceeding under this Act, any information acquired under authority of [an enumerated list of FDCA sections] concerning any method or process which as a trade secret is entitled to protection….”10

  • The Privacy Act, 5 U.S.C. 552a, prohibits federal agencies from disclosing any personal record without the consent of the person to whom the record pertains.

The restrictions on data sharing established by these laws are not necessarily as sweeping as they appear at first glance, however. For example, the Trade Secrets Act applies only to disclosures “not authorized by law,” and the FDA could by regulation “authorize” its employees to share various types of information vital to food safety, provided it has been granted the requisite authority by Congress to do so. Section 301(j) of the FDCA applies, on its face, only to trade secrets and not to confidential commer-

8

Personal communication, Chad Nelson, FDA, July 25, 2009.

9

The Trade Secrets Act, 18 U.S.C. § 1905.

10

The Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 331(j).

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

cial information that does not qualify as a trade secret.11 Consequently, this provision appears to bar FDA officers and employees from sharing information concerning food formulas and manufacturing processes, for example, but not from sharing distribution data needed to conduct traceback/trace-forward activities. The Privacy Act contains a number of potentially relevant exceptions, the most important of which is the “routine use” exception. Under this provision,12 an agency can disclose a record containing information about an individual without that individual’s consent if the disclosure is for a “routine use” defined by regulation. An agency may define the disclosure of a record as a “routine use” if the disclosure is for any “purpose which is compatible with the purpose for which [the record] was collected.”13 Each agency thus has broad discretion under the Privacy Act to decide when it is appropriate to disclose personal information.

These federal laws clearly present real obstacles to information sharing between the FDA and state and local governments. One possible method for facilitating such communications in light of these legal restrictions is through the liberal use of commissioned officials in state and local governments. According to its regulations, the FDA may share “data otherwise exempt from public disclosure” with “state and local government officials commissioned pursuant to 21 U.S.C. 372(a),” which states that:

[t]he Secretary is authorized to conduct examinations and investigations for the purposes of this Act … through any health, food, or drug officer or employee of any State, Territory, or political subdivision thereof, duly commissioned by the Secretary as an officer of the Department.

The FDA is understandably concerned that state and local officials

11

The FDA’s own regulations draw a distinction between a “trade secret” on the one hand and “commercial or financial information that is privileged or confidential” on the other. According to the regulations,

[a] trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationship between the trade secret and the productive process). 21 CFR 20.61(a)

By contrast,

[c]ommercial or financial information that is privileged or confidential means valuable data or information which is used in one’s business and is of a type customarily held in strict confidence or regarded as privileged and not disclosed to any member of the public by the person to whom it belongs. (21 CFR 20.61(b))

12

21 U.S.C. 552a(b)(3) (incorporating by reference 21 U.S.C. 552a(a)(7) and 21 U.S.C. 552a(e)(4)(D)).

13

21 U.S.C. 552a(a)(7).

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

with whom it shares confidential information will disclose that information inappropriately. Under 21 CFR 20.84, commissioned officials are “subject to the same restrictions with respect to the disclosure of such data and information as any other [FDA] employee.” Nevertheless, CFSAN, in its answers to the committee’s questions, noted that “due to their sunshine [openness] laws, certain states are unable to keep such information confidential, which limits FDA’s ability to share such information.”

With regard to the provision of information by state and local governments to the FDA, CFSAN told the committee that:

[t]here are legal restrictions on the sharing by state and local governments of epidemiological data that may contain patient information that is considered confidential. This occurs with every outbreak investigation…. We understand that these restrictions derive from state and federal patient privacy laws….14

Federal law may in fact limit information sharing by state and local government entities in at least some instances. For example, the FDA public information regulations, 21 CFR 20.63(b), state that:

[t]he names and other information which would identify patients … should be deleted from any record before it is submitted to the [FDA]. If the [FDA] subsequently needs the names of such individuals, a separate request will be made.15

The committee does not know whether this regulation has prevented or delayed the sharing of vital food safety information by state and local governments with the FDA.

One oft-cited federal statute that, regardless of perception, does not in fact appear to greatly inhibit the sharing of food safety information between state and local governments and the FDA is the Health Insurance Portability and Accountability Act (HIPAA). The HHS Privacy Rule implementing HIPAA, 45 CFR Part 160 and Part 164, Subparts A and E, applies only to “covered entities” specified in the statute, namely “health plans,” “healthcare clearinghouses,” and “healthcare providers.”16 Many state and local agencies possessing epidemiological data do not fall within any of these categories. To the extent that a state or local agency is a “covered entity,” the Privacy Rule contains an explicit public health exception that would

14

Personal communication, Chad Nelson, FDA, July 25, 2009.

15

21 CFR 20.63(b).

16

The Health Insurance Portability and Accountability Act of 1996, Public Law 104-191, section 1172.

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

apply in the context of a food safety emergency.17 HIPAA prevents the disclosure only of patient-identifying information, so even when the statute applies, it does not prohibit the dissemination of appropriately redacted data (although the redaction process may cause delay). However, it should be noted that state privacy laws may present a greater barrier to the sharing of food safety information by state and local governments. They may cover more types of entities and impose more stringent privacy requirements than does HIPAA.18

Access to Industry Data

Many food companies have carefully designed science-driven food safety systems that produce a substantial amount of data that would be of great value for risk-based decision making. Industry has, however, been reluctant to share its data with the FDA. Barriers that limit the ease with which data from industry could flow to the FDA include the proprietary nature of such data, the absence of an appropriate information infrastructure to manage the data, and potential regulatory ramifications, the latter of which is often cited as the most significant concern. In short, the FDA has generally not been successful in accessing industry data, and although the concept periodically arises as a point of discussion, the agency has made no coordinated effort to overcome the barriers involved.

MOVING FORWARD: DESIGNING AND IMPLEMENTING AN INTEGRATED INFORMATION INFRASTRUCTURE

Designing and implementing the integrated information infrastructure necessary to support a risk-based food safety system will require an investment in information science, as well as an infrastructure that improves data availability and quality and facilitates data standardization, harmonization, and analysis. In 2007, the FDA Science Board recommended that the agency collaborate with other government agencies to develop data standards and large-scale sustainable data-sharing infrastructures that would allow the timely integration and analysis of data critical to the agency’s mission (FDA Science Board, 2007). Such an investment would reduce data gaps and facilitate risk-based decision making while improving communication, the integration of business processes, and interoperability. In the committee’s

17

45 CFR 164.512(j). See also 45 CFR 164.512(f) (law enforcement exception).

18

HIPAA itself does not limit how strictly states may protect patient privacy. The HIPAA Privacy Rule, by its own terms, does not preempt state law regarding the privacy of patient health information to the extent that the state law is more stringent than the federal regulations (45 CFR 160.203(b)). Moreover, some state laws may impose patient privacy limitations on state and local government entities not covered by HIPAA.

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

opinion, key elements necessary to initiate the transition to an integrated information infrastructure include (1) strategic data collection, (2) the accessibility of data, (3) the availability of a modern IT system, and (4) the analytic capacity to design and maintain the system as well as to analyze, interpret, and disseminate data generated by the system. These elements are discussed briefly below. Chapter 11 examines potential organizational changes to ensure that these elements are in place.

Strategic Data Collection

Accurate, reliable, secure, and timely data are the backbone of any risk-based decision-making system. The types of data collected and the methods employed in data collection should, ultimately, be driven by the specific objectives and goals of the system. The data that could be collected are virtually endless, making the strategic planning process critical. Strategic planning is readily applicable to data collection and analysis; in fact, it is necessary for the development of an integrated information infrastructure. The strategic plan must address the following:

  • the goals and ultimate uses of the data (attribution, public health response, development of targeted interventions);

  • the types of data needed to achieve those goals;

  • an assessment of what data are currently being collected, as well as their limitations and appropriateness;

  • the data issues and gaps that must be addressed to achieve the stated goals;

  • the priorities for collecting additional data;

  • the data collection methods and standards necessary for accessing, integrating, and analyzing the various sources of data;

  • the analytic capabilities necessary for collecting, integrating, and analyzing the data; and

  • the performance metrics that will be used to evaluate the data collection and analysis system, including a quality assurance system.

The first step in the strategic planning process should be a comprehensive inventory and review of existing data collection systems without regard for interinstitutional boundaries. Each data collection system should be reviewed by FDA and non-FDA scientists to evaluate its relevance, funding, productivity, and programmatic benefits as they relate to the agency’s mission. Such an approach would provide valuable information for the strategic planning process and would, in essence, make data collection part of the set of risk management tools available for agency use. To be effective, the strategic planning process will require input from multiple federal,

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

state, and local government agencies, as well industry and nongovernmental organizations (NGOs).

Data collection should not be performed simply for its own sake. Decisions on data collection systems and the exact nature of the data to be collected must be driven by the needs of the underlying risk-based decision-making process. As discussed further in Chapter 11, the development of appropriate and cost-effective data collection systems should, ideally, be done in collaboration with other agencies and departments involved in work with food safety, potentially through a single, unified center focused on data collection and analysis. Data collection systems should be developed and evaluated within the risk-based decision-making process outlined in this report. In the absence of a single food agency, it will be challenging to formulate a strategic vision for developing and implementing the integrated information infrastructure necessary to support a risk-based food safety system. The FDA can and should take an active leadership role in the development and implementation of a system that is designed to suit its needs in the years to come.

Access to Data

Many different groups collect food safety data for different purposes that could be valuable to the regulatory mission of the FDA. The system should leverage data collected for a variety of purposes by various federal, state, and local government agencies, as well as by the food industry, the academic sector, and NGOs. To this end, it is essential that data be accessible to all stakeholders in a timely manner. The FDA’s ability to effectively identify, investigate, and respond to food safety issues—including outbreaks, emerging pathogens, and the choice of intervention strategies—is dependent on timely access to quality data that are often collected by others.

As described above, substantial barriers to data sharing must be addressed before a risk-based system can be implemented effectively. Relevant government agencies should examine whether they currently withhold more food safety information than is required by law, and they should correct any current misunderstandings of the law. The FDA should take a leadership role in implementing the recommendations of Taylor and Batz (2008) for improving access to currently available data necessary to fulfill its mission. Chapter 11 outlines some approaches, such as a centralized risk-based analysis and data management center, that might alleviate some of the barriers to data sharing mentioned in this section. Regardless of the establishment of these approaches, many of the actions suggested below will still be needed to overcome data-sharing barriers. To the extent that legal changes are needed to allow sufficient data sharing, especially in the case of emergencies, Congress should consider amending the law.

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

To facilitate the sharing of food safety data relevant to protecting the public health, the Secretary of HHS should publish guidelines, including answers to frequently asked questions, concerning data sharing between different HHS agencies. In addition, the FDA and CDC should jointly provide training to their food safety employees regarding the actual limits on such data sharing imposed by federal law. There would be some benefit in having FDA and CDC employees present at the same training sessions. This training should address in detail the data-sharing MOU entered into by the two agencies. The FDA should also assist state and local food safety agencies regarding the provision of such training to state and local employees. Further, the FDA should, as recommended elsewhere in this report, consider greatly expanding the use of its commissioning authority to create a cadre of state and local commissioned officers throughout the nation, which, in addition to increasing the size of the agency’s inspectional force, would facilitate data sharing between the FDA and state and local governments. Entering into formal data-sharing agreements with other federal agencies with which the FDA has shared or might share food safety information (e.g., EPA) is also advisable. In terms of legal barriers to sharing data, the FDA should determine whether federal law preempts state openness laws with respect to information provided to FDA-commissioned state and local officers and, if necessary, ask Congress to revise the relevant statutes and regulations to ensure that the agency can share confidential data without concern that those data will later be made public under state openness laws. The FDA should also determine whether its public information regulations, such as 21 CFR 20.63(b), have prevented or delayed state and local governments’ sharing of vital food safety information with the agency. If necessary, the regulations should be revised to permit state and local governments, as well as other entities, to submit records to the FDA in emergency situations or when there is a legitimate need without first redacting patient-identifying information.

In terms of accessibility of industry data, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 gives the FDA access to industry records only when they are related to food that “presents a threat of serious adverse health consequences or death to humans or animals.”19 In Chapter 10, the committee recommends that the FDCA be amended to require that every food facility prepare a food safety plan and that this plan and its implementation records be made available to FDA inspectors. The FDA should identify the kinds of industry data that are needed for risk-based decision making and develop mechanisms for collecting and ensuring the quality of those data. The FDA should also

19

Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), Public Law 107-188, 107th Cong., 2nd sess. (January 23, 2002).

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

consider regulatory changes, to the extent necessary to ensure food safety, that would authorize it to release some trade secret and confidential commercial information under the Trade Secrets Act. To help promote the trust and cooperation of industry, advances in tracking, masking, and analyzing information should be explored to enable the FDA and its partners to protect such information while sharing information that specifically helps protect public health.

Information Technology and Personnel Needs
Information Technology

A critical component of the implementation of a risk-based decision-making system is the underlying technology necessary for the collection, processing, and delivery of information. The inability to collect, integrate, and deliver information can result in inefficient use of resources, redundancy, ineffective information sharing, and delayed or inappropriate regulatory decision making, all of which impact public health (FDA Science Board, 2007; GAO, 2009). The ability to access, integrate, and analyze numerous and varied data sources depends on the development, harmonization, evaluation, and adoption of an electronic data exchange environment that supports data standards.

Several recent reports have found critical gaps in the FDA’s centralized IT infrastructure, which has been described as obsolete, redundant, and unstable (FDA Science Board, 2007; GAO, 2009). In 2007, the FDA Science Board described the agency’s IT situation as “problematic at best—and at worst it is dangerous” (FDA Science Board, 2007, p. 5).The FDA’s IT workforce has been deemed insufficient to meet the agency’s needs (FDA Science Board, 2007). Further, the FDA’s IT infrastructure lacks the necessary backup systems to provide continuity of operation in case of system failures (FDA Science Board, 2007). During the 2006 spinach-related outbreak, for example, failures in the FDA’s e-mail system contributed to delays in responding to the outbreak (FDA Science Board, 2007).

Recent evidence suggests that the FDA is making progress, albeit slowly, in improving its information infrastructure (FDA Science Board, 2009). In 2008, the agency began an effort to consolidate its IT infrastructure and centralize its IT management with the creation of the Office of Information Management (GAO, 2009). As of this writing, the development of a comprehensive strategic plan for this office was under way and was expected to be completed by the end of fiscal year 2009 (GAO, 2009). Progress appears to have been made on developing an IT architecture design and on building the foundation for data standards and harmonization (FDA Science Board, 2009). Several initiatives to modernize the FDA’s information infra-

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

structure and IT systems have been undertaken, with the Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting (PREDICT) model as a relevant example (see Chapter 3 and Appendix E). Workforce assessments have also been undertaken. Further, the FDA has established a Bioinformatics Board to oversee the agency’s IT investments, as well as Business Review Boards for each of the core business areas that are responsible for the day-to-day oversight of IT projects. It has also created a project management office, developed criteria for evaluating prospective projects, and documented project monitoring and control processes.

Despite this recent progress, however, substantial challenges remain, including centralizing IT, developing a scientific computing infrastructure, addressing information security issues, and conducting strategic human capital planning. Of particular concern are the lack of a detailed, comprehensive strategic IT plan and the agency’s segmented approach to developing its enterprise architecture. For example, the FDA started building PREDICT, a component of its enterprise architecture, without having a detailed plan or establishing priorities for the development of the overall enterprise architecture (FDA Science Board, 2009). Such an approach is contrary to the concepts outlined in this report and may ultimately result in a fragmented enterprise architecture that is incompatible with future systems.

The committee agrees with the recommendations in the FDA Science Board report. The committee emphasizes the importance of the development of a modern IT infrastructure and investment in the FDA’s IT workforce (see section below regarding Personnel Needs) to meeting the agency’s public health objectives and implementing its overall strategic plan.

Personnel Needs

The problems of fragmented data collection systems and inaccessibility of data are compounded by an inadequate pool of scientific personnel that can, even in times of emergency, effectively collect, manage, analyze, interpret, and disseminate the data to which they have access. Several reports have noted the problem of insufficient staff, as well as inadequate recruitment and retention and the failure to make an investment in professional development (FDA Science Board, 2007). Recently, the U.S. Government Accountability Office (GAO) recommended that the agency manage its workforce strategically by determining the critical skills and competencies needed to fulfill its mission, analyzing the gaps between current skills and future needs, and developing strategies for filling those gaps (GAO, 2009). While the FDA has increased its training budget and is conducting workforce assessments (FDA Science Board, 2007, 2009), however, it has not yet addressed the bulk of these GAO recommendations.

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

The FDA is underutilizing its field personnel. For example, field assignments could be used for the collection of data (e.g., who uses a specific piece of equipment in processing frozen peas) or the analysis of samples (e.g., a statistically representative sampling of bagged salads for microbiological analysis). Prior to 1994, ORA’s Minneapolis Center for Microbiological Investigation conducted analyses in the field for the FDA; however, this dedicated function no longer exists. Given the agency’s limited inspection capacity, most efforts of the inspectional force are dedicated to performing legally required inspectional duties.

As mentioned in Chapter 3, one way to meet the FDA’s analytical personnel needs would be to create functional teams in support of the risk-based approach. In this case, for example, a surveillance team would be responsible for interacting with other federal agencies and state and local jurisdictions and for managing centralized epidemiological databases supporting modeling efforts. Such a group would include statisticians, epidemiologists, microbiologists, behavioral scientists, economists, risk analysts, biomathematical modelers, database managers, IT personnel, risk managers, and other experts as needed. Also, the agency should start implementing the above-mentioned GAO recommendation to address its IT human resource needs (GAO, 2009). Chapter 11 describes approaches for consolidating data and risk analysis, such as a centralized risk-based analysis and data management center that would meet the needs of all agencies with responsibilities for food safety. As outlined in Chapter 11, the committee sees clear potential advantages to the creation of such a center that would have access to food safety data from multiple agencies, the analytical capacity to deal with these data, and the ability to disseminate results of its analyses to agencies for policy development. Even with such a center, however, the FDA will need to maintain a core of experts in all the disciplines noted above.

KEY CONCLUSIONS AND RECOMMENDATIONS

Decisions on data collection systems and the characteristics of the data to be collected must be driven by the needs of the underlying risk-based decision-making process. The FDA has not adequately assessed and articulated its data needs. The agency currently lacks the capability to collect and integrate the data needed for effective implementation of a risk-based approach to food safety. For example, it lacks a dedicated cadre of analytical personnel to design, implement, and manage the collection of and analyze, interpret, and disseminate the data needed to support a risk-based system. It lacks a group of epidemiologists, statisticians, and data analysts that can work with risk modelers, analysts, and managers to support risk-based decisions about food safety.

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

In terms of sharing data with other relevant partners (e.g., CDC, the U.S. Department of Agriculture, the food industry), it appears that the legal regime now in place would permit a substantial increase in such data sharing. However, nonlegal obstacles, both technological (e.g., inadequate IT) and cultural (e.g., unnecessary delays in sharing data or a lack of trust), continue to limit the sharing of data among partners. To protect the public health, federal, state, and local agencies and industry must share more food safety information, and share it more rapidly, than is now the case.

In support of a risk-based approach driven by data, the committee makes the following recommendations.

Recommendation 5-1: Data collection by the FDA should be driven by the recommended risk-based approach and should support risk-based decision making. It is critical that the FDA evaluate its food safety data needs and develop a strategic plan to meet those needs. The FDA should review existing data collection systems for foods to identify data gaps, eliminate systems of limited utility, and develop the necessary surveillance capabilities to support the risk-based approach. The FDA should formulate and implement a plan for developing, harmonizing, evaluating, and adopting data standards. The FDA should also establish a mechanism for coordinating, capturing, and integrating data, including modernization of its information technology systems. To coordinate, capture, and integrate data, the FDA could lead the implementation of a multiagency food safety epidemiology users group as outlined by Taylor and Batz (2008). The centralized risk-based analysis and data management center proposed in recommendation 11-3 in Chapter 11 could serve the functions of data storage and analysis in support of a risk-based approach. Mechanisms should also be instituted to build trust with industry and, in partnership, collect and analyze industry data.


Recommendation 5-2: The FDA should evaluate its personnel needs to carry out its roles in collecting, analyzing, managing, and communicating food safety data. The agency should establish an analytical unit with the resources and expertise (i.e., statisticians, epidemiologists, behavioral scientists, economists, microbiologists, risk analysts, biomathematical modelers, database managers, information technology personnel, risk managers, and others as needed) to support risk-based decision making.


Recommendation 5-3: The FDA should evaluate statutes and policies governing data sharing and develop plans to improve the collection and sharing of relevant data by all federal, state, and local food safety agencies. For example, in collaboration with other food safety agencies, the

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

FDA should develop and implement technologies and procedures that will ensure confidentiality and facilitate data sharing. Congress should consider amending the law, to the extent that legal changes are needed, to allow sufficient data sharing among government agencies.

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Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
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USDA/ERS (U.S. Department of Agriculture/Economic Research Service). 2009. Foodborne Illness Cost Calculator: Assumption Details and Citations for Salmonella. Washington, DC: USDA. http://www.ers.usda.gov/data/FoodBorneIllness/salmAssumptionDescriptions.asp?Pathogen=Salmonella&p=1&s=4683&y=2006&n=1397187 (accessed January 30, 2009).

Suggested Citation:"5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
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Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems.

Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more.

Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety 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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