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2 The Food Safety System: Context and Current Status
Pages 35-72

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From page 35...
... /National Research Council (NRC) report Ensuring Safe Food: From Production to Consumption (IOM/NRC, 1998)
From page 36...
... These include changes in the food production landscape, climate change, changing consumer perceptions and behaviors, globalization and increased food importation, the role of labor−management relations and workplace safety, heightened concern about bioterrorism, increased levels of pollution in the environment, and the signing of international trade agreements. Changes in the Food Production Landscape In addition to constant changes in food production and substantial growth in the number of food facilities (the number regulated by the U.S.
From page 37...
... . Climate Change Climate change is doubly relevant to the food enterprise: not only may climate change affect food yields, but food production may contribute to climate change by releasing a substantial amount of greenhouse gases, such as carbon monoxide and nitrogen monoxide (Stern, 2007)
From page 38...
... . Recent foodborne illness outbreaks have further increased consumer awareness about food safety; in fact, a majority of consumers believe foodborne illnesses are a serious or very serious worry (FSIS, 2002; Hart Research Associates/Public Opinion Strategies, 2009)
From page 39...
... Specifically, ensuring that workers have access to appropriate sanitary facilities, providing adequate sick leave, and making hand washing a critical control point are vital to controlling many hazards in the food supply. For example, if farm laborers in the field are not provided with adequate sanitary facilities, there will be increased opportunity for crop exposure to
From page 40...
... Regulation and oversight of all phases of the food supply chain by all levels of government can help enhance food safety by identifying situations in which work procedures need improvement or workers need training. Cooperation between the FDA and labor regulatory agencies such as the National Institute for Occupational Safety and Health and the Occupational Safety and Health Administration would appear to warrant exploration.
From page 41...
... A recent report, however, found that the national residue program is not accomplishing its mission of monitoring the food supply for harmful residues (USDA, 2010a)
From page 42...
... A recent analysis suggests that foreign food producers may be at a disadvantage when they want to export to the United States because they need to comply with costly requirements under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, such as providing prior notice of shipment (GAO, 2004a; Boisen, 2007) .1 As the volume of imported foods continues to rise, such international agreements are becoming more important and must be considered in any discussion of enhancing food safety in the United States.
From page 43...
... OVERVIEW OF THE CURRENT FOOD SAFETY SYSTEM Although the FDA's role in ensuring safe food needs to be reviewed in the context of the U.S. national food safety system, for brevity the discussion in this section is limited to information that pertains to the FDA and is needed as context for the reminder of this report.
From page 44...
... • Through the U.S. Marshals Service, seizes unsafe food products not yet in the marketplace, as ordered by courts.
From page 45...
... EPA/OECA Office of Responsible for inspection/enforcement of pesticide Enforcement regulations, including the misuse of pesticides. and Compliance Assistance EPA/OPPTS Office of Responsible for risk assessment of pesticide residues in Prevention, food, pesticide registration.
From page 46...
... Also enforces food safety laws governing domestic and imported food, except meat and poultry, by inspecting food production establishments and food warehouses and collecting and analyzing samples for physical, chemical, and microbial contamination; reviewing the safety of food and color additives before marketing; reviewing animal drugs for the safety of animals that receive them and humans who eat food produced from the animals; monitoring the safety of animal feed used for food-producing animals; developing model codes and ordinances, guidelines, and interpretations and working with states to implement them in regulating milk and shellfish and retail food establishments, such as restaurants and grocery stores (e.g., the model Food Code, a reference for retail outlets and nursing homes and other institutions on how to prepare food to prevent foodborne illness) ; establishing good food manufacturing practices and other production standards, such as plant sanitation and packaging requirements and Hazard Analysis and Critical Control Points (HACCP)
From page 47...
... USDA/ARS Agricultural Provides data for food products and contaminants Research Service (fruits and vegetables, dairy products, eggs/egg products, meat/poultry, seafood, grain/rice/related products, imported foods, animal drugs/feeds, and pesticide residues) to support risk assessment by the Food Safety and Inspection Service (FSIS)
From page 48...
... . Also enforces food safety laws governing domestic and imported meat and poultry products by • inspecting food animals for diseases before and after slaughter; • inspecting meat and poultry slaughter and processing plants; • with USDA's Agricultural Marketing Service, monitoring and inspecting processed egg products; • collecting and analyzing samples of food products for microbial and chemical contaminants and infectious and toxic agents; • establishing production standards for the use of food additives and other ingredients in preparing and packaging meat and poultry products, plant sanitation, thermal processing, and other processes; • making sure all foreign meat and poultry processing plants exporting to the United States meet U.S.
From page 49...
... Because of Information USDA's responsibility for food safety and inspection, Center NAL comprehensively collects works addressing foodborne illness, food toxicology, and food inspection. In addition, in support of USDA's close relationship and regulatory role with the food industry, NAL collects information on the food industry and technology, including food irradiation and biotechnology.
From page 50...
... ; • using advisory and enforcement actions to protect the health of their citizens, including placing embargoes on (i.e., stopping the sale of) unsafe food products manufactured, transported, or dis tributed within state borders; • providing safety training and education to food establishment per sonnel and industry as requested; • preparing for and participating in food recall events and foodborne outbreak investigations independently or with the FDA and other federal agencies (this may include ordering recalls of contaminated foods within state borders and taking enforcement actions against firms within state borders)
From page 51...
... . The FDA is required to oversee the safety of all food products with the exception of meat, poultry, and some egg products.
From page 52...
... . In some fundamental respects, the law under which the FDA must ensure the safety of 80 percent of the nation's food supply4 remains unchanged since 1938, despite the dramatic changes in food production, processing, and distribution that have taken place since (as discussed earlier in this chapter)
From page 53...
... Office of Policy, Planning, and Budget Office of Women's Health Office of Legislation Office of the Chief Office of the Commissioner Counsel Office of the Counselor to the Commissioner Office of the Administrative Law Judge Office of the Chief of Staff Office of Special Office of External Medical Programs Affairs Office of Equal Office of Office of the Office of Employment Office of Foods International Chief Scientist Administration Oppor tunity & Diversity Programs Management Center for National Center for Center for Center for Office of Center for Center for Food Safety Center for Drug Devices and Biologics Regulator y Veterinary Tobacco and Applied Toxicological Evaluation Radiological Evaluation Affairs Medicine Products Nutrition Research and Research Health Research FIGURE 2-1 Organization of the U.S. Food and Drug Administration.
From page 54...
... According to CFSAN's mission statement, "CFSAN, in conjunction with the agency's field staff is responsible for promoting and protecting the public's health by ensuring that the nation's food supply is safe, sanitary, wholesome, honestly labeled, and cosmetic products are safe and properly labeled." Specific responsibilities include • safeguarding the nation's food supply by making sure products are safe, • conducting activities in conjunction with ORA and other groups within the agency, and • ensuring that food is free of contaminants (FDA, 2009c; Fraser, 2009)
From page 55...
... The administration justified the budget request with reference to investments that would strengthen the safety and security of the food supply chain, including enhancements to the system needed as a result of recent food safety events, the dramatic growth in food imports, and changes in food processing and distribution practices. Among the priorities mentioned in the budget justification were the creation of a food safety system that would integrate federal and state programs, the development of preventive controls, increased frequency of domestic and foreign inspections, improved laboratory capacity and food surveillance, and enhanced information technology (IT)
From page 56...
... . Incorporated in the FY 2011 budget for the FDA's food programs is approximately $194 million in user fees, which has been proposed by Congress for registration of food facilities, reinspection, and food and feed export certification.
From page 57...
... For example, in 1992, as a result of concern expressed by FDA leadership about the ability of the agency's food programs to address emerging food safety issues, the FDA (1) conducted a management study of CFSAN'S programs and activities, (2)
From page 58...
... The ultimate goal was to maintain a strong and flexible food safety system as new public health challenges continued to emerge. In 2007, the Office of Food Protection was established under the commissioner's oversight to develop an agencywide, visionary strategy for food protection and serve as a liaison to HHS on food protection issues.
From page 59...
...  THE FOOD SAFETY SYSTEM: CONTEXT AND CURRENT STATUS BOX 2-1 Responsibilities of the Office of Foods • rovides executive leadership and management to all U.S. Food and P Drug Administration (FDA)
From page 60...
... In 1997, after a series of serious foodborne outbreaks, President Clinton announced a request for $43.2 million to fund a nationwide early-warning system for foodborne illness, increase seafood safety inspections, and to expand food safety research, training, and education. In addition, the Secretary of Agriculture, the Secretary of HHS, and the Administrator of the EPA were directed to identify specific steps to improve the safety of the nation's food supply (FDA/USDA/EPA/CDC, 1997)
From page 61...
... . Imported Foods As discussed earlier, a significant portion of the nation's food supply -- and more than 75 percent of its seafood -- comes from abroad; however, the FDA inspects less than 2 percent of imported foods (GAO, 2004c; FDA Science Board, 2007)
From page 62...
... . Occasionally it will inspect farms, but almost exclusively during periods of crisis (FDA Science Board, 2007)
From page 63...
... Facilities can go as long as 10 years without an inspection, and the rate of inspection has declined by 78 percent in the past 35 years (FDA Science Board, 2007)
From page 64...
... . Without a sufficient number of inspectors and inspections, the agency cannot ensure the safety of the food supply (FDA Science Board, 2007)
From page 65...
... The Science Board's report stated that basic research programs and risk assessments would determine pressing risks to the food supply so that the agency's limited funds could be used for targeted research to address those risks (FDA Science Board, 2007)
From page 66...
... . An example of how IT problems contribute to inefficiency is the significant duplication of effort among the agencies responsible for ensuring safe food discussed above.
From page 67...
... In the following chapters, the committee encourages the FDA to continue with its recent initiatives and plans and to delineate a course of action that will enable it to become more efficient at carrying out its food safety responsibilities. REFERENCES Abbot, J
From page 68...
... 2007. Food Protection Plan: An Integrated Strategy for Protecting the Nation's Food Supply.
From page 69...
... 1992. Food Safety and Quality: Uniform, Risk­Based Inspection System Needed to Ensure Safe Food Supply.
From page 70...
... . 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.
From page 71...
... 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. NCTR (National Center for Toxicological Research)
From page 72...
... Journal of Food Protection 66:130–161. Schmidt, J


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