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