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Pages 1-18

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From page 1...
... State and local governments have the main responsibility for food produced or sold within their borders. The major FDA offices with responsibility for food safety are the Office of the Commissioner, the Office of Foods, the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, the Office of Regulatory Affairs, and the National Center for Toxicological Research.
From page 2...
... It then presents conclusions concerning the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. 3 For example, these include a change in administration, the formation of the White House Food Safety Working Group, and the FDA's establishment of a new Office of Foods with oversight and authority over the two FDA centers that regulate food -- the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine.
From page 3...
... The FPP Strategic planning is an essential element of a food safety program and should precede the design and implementation of a risk-based approach to food safety management. At a broad level, strategic planning entails identifying public health goals (e.g., reducing the number of infections caused
From page 4...
... Although the balancing of diverse risks, benefits, and costs is challenging, the lack of a systematic, risk-based approach to facilitate decision making can cause problems ranging from a decrease in public trust to the occurrence of unintended consequences to society, the environment, and the marketplace. Moreover, to carry out all its food safety responsibilities and ensure continuity of everyday operations, the FDA needs to have sufficient staff working on food issues to ensure that routine functions continue even when a crisis occurs.
From page 5...
... The FDA's surveillance role is supported by its research capacity, which gives the agency an opportunity to fill data gaps and address uncertainties to help refine its risk-based decision making. The FDA's current food safety research program appears to be fragmented and poorly managed, lacking strategic planning and coordination of research that is conducted intramurally and at the five extramural research centers.
From page 6...
... Step 2: Public Health Risk Ranking (Ranking of Hazards)
From page 7...
... One barrier to improved efficiency is that the FDA's food programs lack direct authority over the work of inspectors, resulting in potential substantial delays in policy implementation in the field. Nor have inspection procedures been reviewed for efficiency or consis
From page 8...
... The FDA should envision risk communication not only as consultation with stakeholders at various steps of the risk-based process, but also as a form of policy intervention to achieve objectives in its strategic plan. The FDA's risk-based food safety management system must incorporate effective risk communication and food safety education for consumers and those who could impact public health through their professions, such as public health officials.
From page 9...
... Hence, the importance of in-depth analysis and planning of such changes cannot be overemphasized. RECOMMENDATIONS The committee's deliberations resulted in suggested directions for improving food safety management (Box S-3)
From page 10...
... Food Safety Management • pply the recommended risk-based approach to the management of A all food hazards. • ddress the lack of resources (e.g., data infrastructure, human A c apacity)
From page 11...
... Recommendation 3-2: The FDA should develop a comprehensive strategic plan for development and implementation of a risk-based food safety management system. The agency should also develop internal operating guidelines for the conduct of risk ranking, risk assessment, risk prioritization, intervention analysis, and the devel opment of metrics with which to evaluate the performance of the system.
From page 12...
... , and other countries' governments. Recommendation 4-2: The FDA should develop a comprehensive strategy for choosing the level and intensity of policy interventions needed for different food safety risks.
From page 13...
... Following this review and with consideration of the agency's broad strategic plan, the FDA should examine the relevance and allocation of its research resources by using public health risk ranking and prioritization. Future research should address the most pressing public health issues and directly support further characterization of risk and selection, implementa tion, and evaluation of interventions.
From page 14...
... These efforts could be expanded by establishing a competitive extramural research funding program. Integrating Federal, State, and Local Food Safety Programs Recommendation 7-1: The FDA should utilize the surveillance, inspection, and analytic systems and resources of state and local governments in a fully integrated food safety program.
From page 15...
... If this approach is uti lized, the FDA should set minimum standards for such auditors and audits, with oversight and implementation being assigned to an accreditation and standards body. Improving Food Safety and Risk Communication Recommendation 9-1: In its effort to integrate risk communication into the recommended risk-based food safety management system, the FDA should play a leadership role in coordinating the educa tion of the food industry, the public, clinical health professionals, and public health officials at all government levels.
From page 16...
... Modernizing Legislation Recommendation 10-1: Congress should consider amending the Federal Food, Drug, and Cosmetic Act to provide explicitly and in detail the authorities the FDA needs to fulfill its food safety mis sion. The following are the most critical areas in which Congress should enact amendments: mandatory reregistration of food facili ties and FDA authority to suspend registrations for violations that threaten the public health, mandatory preventive controls for all food facilities, FDA authority to issue enforceable performance stan dards, mandatory adoption by the FDA of a risk-based approach to inspection frequency and intensity, expansion of the FDA's access to records, FDA authority to mandate recalls, and FDA authority to a A tabletop discussion is a focused practice activity that places the participants in a simu lated situation requiring them to function in the capacity that would be expected of them in a real event.
From page 17...
... To achieve this goal, and as a potential intermediate step toward the creation of a single food safety agency, the committee recommends the establishment of a centralized risk-based analysis and data management center. This center should be provided with the staff and supporting resources necessary to conduct rapid and sophisticated assessments of short- and long-term food safety risks and of policy interventions, and to ensure that the comprehensive data needs of the recommended risk-based food safety management system are met.


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