Enhancing Food Safety The Role of the Food and Drug Administration (2010) / Chapter Skim
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5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System
5 Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System
Pages 147-180
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From page 147... ...
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.
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From page 148... ...
. 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.
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From page 149... ...
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.
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From page 150... ...
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.
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From page 151... ...
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.
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From page 152... ...
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.
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From page 153... ...
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 or derly fashion, not haphazardly.
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From page 154... ...
. 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: Opportuni ties to Improe the Nation's Food Safety Information Infrastructure (Taylor and Batz, 20084)
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From page 155... ...
CIFOR (Council to CIFOR is a working group that seeks to improve performance Improve Foodborne and coordination among federal, state, and local agencies with Outbreak Response) 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.
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From page 156... ...
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 Run by CDC, Epi-X is a web-based surveillance Information Exchange)
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From page 157... ...
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.
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From page 158... ...
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.
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From page 159... ...
PulseNet (National Established by CDC in collaboration with state public health Molecular Subtyping laboratories, PulseNet is an early warning system for outbreaks Network for Foodborne of foodborne illness, consisting of a national network of public Disease Surveillance) health laboratories that perform deoxyribonucleic acid (DNA)
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From page 160... ...
• 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.
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From page 161... ...
• Total Diet Study • Microbiological Data Program continued
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From page 162... ...
Centers for Disease Control and Prevention, raw data are not easily accessible. Long-term clinical • Identification of the long-term effects of outcomes foodborne illnesses is not routinely performed in the United States.
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From page 163... ...
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)
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From page 164... ...
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)
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From page 165... ...
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)
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From page 166... ...
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.
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From page 167... ...
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)
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From page 168... ...
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.
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From page 169... ...
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.
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From page 170... ...
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)
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From page 171... ...
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)
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From page 172... ...
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)
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From page 173... ...
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.
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From page 174... ...
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.
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From page 175... ...
. Recent evidence suggests that the FDA is making progress, albeit slowly, in improving its information infrastructure (FDA Science Board, 2009)
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From page 176... ...
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)
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From page 177... ...
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.
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From page 178... ...
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 agen cies. For example, in collaboration with other food safety agencies, the
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From page 179... ...
2007. FDA Science and Mission at Risk.
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From page 180... ...
2008. Harnessing Knowledge to Ensure Food Safety: Opportu nities to Improe the Nation's Food Safety Information Infrastructure.
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