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Executive Summary
Pages 1-12

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From page 1...
... is formulating risk assessments to identify important foodborne hazards; evaluate potential strategies to prevent, reduce, or eliminate those hazards; assess the effects of different mitigation strategies; and identify research needs. These risk assessments, in brief, empirically characterize the determinants of the presence or level of microbial contamination in vulnerable foodstuffs at various points leading up to consumption.
From page 2...
... Cross contamination which occurs when harmful bacteria in raw beef or its juices are spread to other foods through contact with cutting boards, utensils, and the like also accounts for illnesses. Among other known sources of infection are consumption of contaminated sprouts, lettuce, salami, and unpasteurized milk and fruit juice; swimming in or drinking contaminated water; and contact with the stools of infected animals or people.
From page 3...
... The rule addresses foodborne illness associated with meat and poultry products by focusing more attention on the prevention and reduction of microbial pathogens on raw products that can cause illness. FSIS is formulating microbial risk assessments to help to inform efficient riskmanagement policy decisions and identify future research needs.
From page 4...
... Because the report contains specific observations on numerous individual components of a complex assessment, it is not possible to cogently and concisely list all of the comments here. The sections below are a synopsis of the committee's major findings.
From page 5...
... The exclusive use of fecal prevalence also requires the assumption that most carcass contamination in later stages of processing occurs directly from the gastrointestinal tract of slaughtered animals, although circumstantial evidence suggests that the hide is also an important source. The decision to use fecal prevalence appears to have been necessitated by the paucity of information on other indicators.
From page 6...
... The committee observes that the lack of publicly available data regarding crucial steps in the slaughter process, the variability of the operations modeled in the module, and the potential unpredictability of the effects of some activities on contamination during slaughter and carcass fabrication complicate modeling and limit the module's forecasting capacity. The draft module relies heavily on the results of only one study (Elder et al., 2000)
From page 7...
... The committee observes, however, that cross contamination during preparation is an established, important risk factor; that the lack of data concerning its impact is no more severe than the lack of data for some other parts of the draft model; and that further attention to cross contamination will help to lay the groundwork for an analysis and better identify the data gaps that need to be filled by future research. The value of the risk assessment in informing public health policy and supporting regulatory interventions will be increased if it is able to factor in the effect of cross contamination on E
From page 8...
... Because non-0157:H7 serotypes contribute to the EHEC disease burden particularly as a cause of HUS the committee suggests that the decision to exclude these serotypes be revisited. If the final risk assessment is limited to 0157:H7, the committee recommends that this decision and its implications for the model be explicitly discussed in the "Hazard Characterization" chapter.
From page 9...
... A risk assessment is typically an effort directed at providing an estimate of risk through the collection of evidence and the application of mathematical tools, and the risk estimate is usually a dependent output of the model. The draft alters that arrangement by deriving the exposure assessment and the population risk estimates from separate sources and then inferring an E
From page 10...
... That will allow for a stable evidence base and provide for some limited validation of model estimates with epidemiologic data. If no independent data are available, a formal statistically based updating algorithm could be used.
From page 11...
... The committee suggests that the authors evaluate available empirical information related to possible correlations among the variables and, in the absence of relevant data, carefully consider whether independence assumptions are most appropriate for the model. General Comments Two unifying concepts underlie many of the committee's comments on the draft risk assessment.
From page 12...
... Center for Food Safety & Applied Nutrition Foodborne Pathogenic Microorganisms and Natural Toxins Handbook. vm.cfsan.fda.gov/~mow/chapl5.html, accessed March 14, 2002.


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