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Enhancing Food Safety: The Role of the Food and Drug Administration
Domestic food safety systems in exporting countries may vary from excellent to nonexistent. Potable water may not be available for irrigation; waste and sewage treatment may be absent or inadequate. Nevertheless, many exporting countries that lack domestic food safety programs are willing to do what they can to ensure export markets for their products, including employing food safety measures to satisfy importing country requirements if doing otherwise could cause problems or a loss of market access.
While no importing country is able to examine all imported foods for all possible chemical residues and contaminants, microbiological pathogens, and physical hazards, many importing countries have achieved excellent imported food safety records by focusing resources on higher-risk foods and preventive mechanisms and confronting food-related public health problems when they occur. As discussed in this appendix, import programs for food safety can employ many methodologies to foster safer imports and provide incentives for foreign producers/food importers to comply with importing country requirements. Just as imported food presents different food safety challenges from those encountered with domestically produced foods, so, too, do they require a different paradigm for regulation.
The FDA’s overall foods program is distinct in several respects from the agency’s other public health regulatory program areas. First—with the exception of food and color additive approvals and premarket notification for certain foods—foods under FDA jurisdiction, whether produced within or outside the United States, do not require premarket approval. Thus, the foods program overall is generally a postmarket program. A second difference is that the foods regulatory program, to date, is not supported in any way by user fees, while all agency premarket approval programs are, as well as all agency export certificate programs, except for foods. Thus the foods program, at present, is totally dependent on congressional appropriations. Third, whereas most of the FDA’s other centers generally have regulatory autonomy over their respective product areas, the Center for Food Safety and Applied Nutrition (CFSAN) must interface with other federal departments and agencies, as well as the 50 states, to ensure consistent and comprehensive coverage of the entire U.S. food supply at all levels. While the regulatory roles of U.S. food safety partners are well delineated, smooth operation of the U.S. food control system requires constant communication to ensure that the roles mesh efficiently. Finally, the foods program differs from other FDA programs in that, by volume of product and number of consignments, the realm for regulatory oversight is vast. These four differences are important to remember and fundamental in considering potential improvements in the FDA’s foods program because one needs to understand