A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration (2011) / Chapter Skim
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4 Case Study of a Targeting Decision
4 Case Study of a Targeting Decision
Pages 66-91
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From page 66... ...
. The extent of FDA oversight is variable and ranges from relatively little public oversight of some products, such as fresh vegetables, to a highly regulated system for others, such as canned foods.
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From page 67... ...
That general decision problem is too large to be undertaken as a case study, so a much simplified decision context and evaluation were selected. Rather than considering all the different options for what types of food could be inspected, this case study considers only three specific food categories: leafy greens, shrimp, and canned foods.
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From page 68... ...
CHARACTERIZING THE PUBLIC-HEALTH CONSEQUENCES Data on foodborne illnesses are generally available from the Centers for Disease Control and Prevention (CDC) , but estimating the number of illnesses caused by the food categories evaluated in this case study required additional data and various assumptions.
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From page 69... ...
population that consume product) Populations of Children under 5 years old, the elderly, and the immunosuppressed are more susceptible and suffer more severe concern effects from foodborne illnesses; pregnant women are of special concern for specific pathogens, such as Listeria.
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From page 70... ...
from 1.3 million (0 to 2 million) from unspecified agents unspecified agents Personal Degree to which a person 40-50% of cases of foodborne 10-15% of cases of foodborne 45-60% of cases of foodborne illnesses controllability can eliminate or reduce illnesses from leafy greens could illnesses from shrimp could be from commercially canned foods could his or her own risks be eliminated or reduced by eliminated or reduced by be eliminated or reduced by personal through voluntary personal action by the consumer personal action by the consumer action by the consumer actions Ability to Ability of informed 3% or fewer of all cases of 3-5% of all cases of foodborne About 50% of cases of botulism from detect adverse institution to detect foodborne illness caused by illness caused by shrimp could commercial canned foods could be health effects population-level effects leafy greens could be detected be detected and successfully detected; 3% or fewer of all other associated with product and successfully attributed.
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From page 71... ...
Although the greens are often shipped directly from the field, they may be mixed and repackaged by processors before being shipped to retail and food-service outlets. Fresh leafy greens are often consumed raw with little preparation, and the shift toward fresh products has increased the associated food-safety risk because products consumed raw have not been treated with heat or other kill steps.
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From page 72... ...
Figure 4-1 illustrates the general approach taken by the committee. Annual Number of Cases of Foodborne Illnesses Associated with Leafy Greens As noted above, the committee used three primary sources to estimate the annual number of cases of foodborne illness caused by leafy greens.
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From page 73... ...
FIGURE 4-1 General approach used by the committee to estimate annual number of deaths and other adverse effects associated with leafy greens.
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For the low estimate, no foodborne illnesses from unspecified agents were attributed to leafy greens. Best Estimate.
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From page 75... ...
. Lacking any data to the contrary, the committee assumed that leafy greens were just as likely to be consumed at home as away from home, so at least 27% of leafy greens consumed are prepared outside the home, and at least 27% of the cases of foodborne illnesses from leafy greens are not personally controllable by the individual consumer.
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From page 76... ...
Given the uncertainty surrounding consumer knowledge and the ability to remove contamination, the committee estimated that 55-70% of those preparing leafy greens at home have practical control over the risks. Given the estimate that 73% of cases of foodborne illnesses from leafy greens result from home preparation, about 40-50% of the total cases of illnesses from leafy greens are personally controllable.
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From page 77... ...
in the private sector, and the effectiveness of the activities is reflected in the overall rates of foodborne illnesses from leafy greens. In this framework, the ability to mitigate refers to the ability to manage, reduce, or otherwise control any adverse health effects of the products being evaluated, assuming that such effects occur and are detected.
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From page 78... ...
population size of 310 million yields the estimates of the exposed population shown in Table 4-1. As described above in the discussion of leafy greens, infants and young children, older people, and immunosuppressed populations are more susceptible to foodborne illnesses generally and are more likely to suffer more severe effects if they do contract the illnesses.
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From page 79... ...
(2007) provided estimates of the percentages of cases of foodborne illness from specific pathogens attributable to seafood (that is, seafood was one of the food categories evaluated in the expert-elicitation study)
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At most 20% of the total number of cases of foodborne illnesses from shrimp are potentially controllable by individual action on the basis of the percentage of shrimp consumed at home. Following the same logic described for leafy greens, the committee assumes that 60-80% of those consuming shrimp at home have sufficient knowledge to be able to reduce the likelihood of foodborne illnesses, resulting in an estimate that about 10-15% of all cases of foodborne illnesses from shrimp are personally controllable, that is, could be avoided by the actions of individual consumers.
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From page 81... ...
(2011a) and the specific pathogens associated with shrimp, the committee estimated that about 3-5% of foodborne illnesses caused by shrimp would be detected.
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From page 82... ...
Considering both fresh and frozen shrimp and the estimated ability to mitigate adverse health effects of consumption of leafy greens and canned foods described elsewhere in this case study, the committee estimated the ability of institutions to mitigate adverse health effects of shrimp consumption to be 10-50%. Commercial Canned Foods According to the Economic Research Service (ERS)
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From page 83... ...
Accordingly, those groups are highlighted as populations of special concern. Mortality and Morbidity Commercially canned foods have rarely been linked to documented deaths in the United States.
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For the best estimate, the committee assumed that 10% of botulism cases could be attributed to commercially canned foods.
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Numbers of deaths, severe health effects, less severe health effects, and adverse quality-of-life health effects were then calculated according to the general method used for leafy greens. Personal Controllability As with the other food categories discussed, people theoretically have the ability to eliminate their personal risks of foodborne illnesses from commercially canned foods by avoiding the use of canned foods entirely.
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From page 86... ...
(2011a) , the committee estimated that about half the cases of botulism poisoning from commercially canned foods would be detected, and less than 3% of all other types of foodborne illnesses from canned foods would be detected.
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From page 87... ...
USING THE RISK CHARACTERIZATION TO SUPPORT DECISION-MAKING A review of Table 4-1 reveals a clear "ranking" of the three food categories in terms of the number of foodborne illnesses associated with each: domestic leafy greens appear to cause substantially more illnesses than do shrimp, and both appear to cause far more illnesses than do commercially canned foods. Other factors, however, also differ between the food categories and could be relevant to decision-makers and policy-makers.
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From page 88... ...
For example, if FDA were considering a high-level decision about whether to focus newly available inspection resources on leafy greens, shrimp, or commercially canned foods, the risk characterization developed here would provide information on the current levels of adverse health effects associated with each category and on where the maximum potential for risk reduction exists. Deciding how to allocate the resources would require additional analysis and more detailed understanding of how the resources would be used.
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From page 89... ...
2007. Using expert elici tation to link foodborne illnesses in the United States to foods.
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From page 90... ...
2011a. Foodborne illness acquired in the United States- major pathogens.
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From page 91... ...
Case Study of a Targeting Decision 91 USDA (U.S. Department of Agriculture)
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