Enhancing Food Safety The Role of the Food and Drug Administration (2010) / Chapter Skim
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11 Achieving the Vision of an Efficient Risk-Based Food Safety System
11 Achieving the Vision of an Efficient Risk-Based Food Safety System
Pages 305-318
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From page 305... ...
can be realized without structural changes, the committee initially formulated its recommendations in the context of the FDA's current food safety management structure. Subsequently, however, the committee concluded that while some recommendations pertain only to the FDA's functions and operations, success in implementing many others will be achieved only through cooperation with partners that play important roles in maintaining food safety.
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Further, since many FDA food safety activities are inextricably linked to those of other agencies with food safety jurisdiction (federal, state, and local) (see Table 2-1 in Chapter 2)
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. For more than a decade, various organizations, consumer groups, and individuals have recommended organizational changes in the U.S.
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From page 308... ...
Department of Health and Human Services and USDA, the FSWG "will coordinate with other agencies and senior officials to advise the President on improving coordination throughout the government, examining and upgrading food safety laws, and enforcing laws that will keep the American people safe" (FSWG, 2009a)
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food safety management system. The remainder of this chapter addresses issues relevant to reorganization and resource allocation within the FDA and approaches to the unification of food safety activities across the multiple agencies and departments with food safety responsibilities.
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From page 310... ...
This lack of direct authority hampers the FDA's ability to prioritize such activities as inspections, the collection of data necessary to drive a risk-based food safety management system, and even the implementation of new or updated CFSAN policies. These are essential activities that are central to the
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. The ORA laboratories play into this issue; their work is focused on enforcement, but with appropriate agency restructuring, they could well be a critical source of data to support risk-based food safety management.
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In fact, based on the problems discussed above, the committee concluded that if the FDA is to accomplish its food safety mission efficiently, its food programs should have complete authority over field activities related to the foods it regulates. The committee is also concerned about how the plans currently being developed will deal with structuring the agency's research mission and with addressing the IT and data management deficiencies highlighted in this report.
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From page 313... ...
Such data might include epidemiological and farm-to fork surveillance data collected at the national level; inspectional, laboratory, and epidemiological data collected at the state and local levels; supporting food safety data, such as industry surveillance and academic research findings; and other relevant data related to food safety and food defense. Establishment of a centralized food safety data management function would be an important step toward the implementation of a risk-based approach to food safety management.
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From page 314... ...
The center's independence from a specific regulatory agency would not preempt any agency's prerogative to develop its own approach to food safety management, but would eliminate the need for each agency to develop its own comprehensive expertise in risk and decision analysis. This in turn would reduce interagency competition for available scientific resources (including personnel)
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From page 315... ...
Nonetheless, it is the consensus of this committee that core federal food safety responsibilities should ultimately reside within a single entity having a unified administrative structure, a clear mandate, a dedicated budget, and above all, full responsibility for oversight of the entirety of the safety of the nation's food supply. KEY CONCLUSIONS AND RECOMMENDATIONS The committee is confident that the recommendations offered in this report constitute a series of actions that would enhance the FDA's food programs and their ability to ensure food safety now and in the future.
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Implementing this recommendation would resolve issues associated with the separation between the agency's enforcement functions and larger public health roles and responsibilities, and ensure a well-trained field workforce with specialized expertise in food safety and risk-based principles of food safety management. Recommendation 11-2: There is a compelling need to elevate and unify the nation's food safety enterprise so that the FDA and relevant sister agencies can better ensure a safe food supply.
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From page 317... ...
Paper pre sented at Institute of Medicine/National Research Council Committee on Review of the FDA's Role in Ensuring Safe Food Meeting, Washington, DC, March 24, 2009. GUIRR/NAS (Government-University-Industry Research Roundtable of the National Academy of Sciences)
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Paper presented at Institute of Medicine/National Research Council Committee on Review of the FDA's Role in Ensuring Safe Food Meeting, Washington, DC, March 24, 2009. Waldrop, C
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