Assuming that the likelihood of a farm causing illness is proportional revenues and that smaller farms are not relatively riskier than larger farms, we estimate a total reduction in benefits of roughly 47,000 illnesses that would not be prevented, equivalent to reduction of $28 million in benefits annually as compared to the $25,000 limit.
FDA has not selected this alternative because, although the cost savings to industry are relatively substantial, we tentatively conclude that the potential additional 47,000 illnesses that would result from increasing the minimum threshold for coverage are too great to justify this option.
The proposed limit of $25,000 accounts for only 1.3 percent of covered produce, representing an estimated 26,000 illnesses per year, increasing the threshold to $50,000 would represent substantial public health impact, nearly doubling the number of preventable illnesses that would not be avoided.
FDA requests comment on the appropriate threshold values to define the limits on farm size for coverage in the proposed rule, as well as supporting data and other information.
Quantifying the benefits of the proposed rule
We welcome comment on the potential benefits of the rule, and we particularly request any information that would permit FDA to more accurately quantify the likely benefits of the proposed provisions for individual commodities or for groups or classes of commodities.
The primary benefit of the provisions in this rule would be an expected decrease in the incidence of illnesses relating to produce from microbial contamination.
For the purpose of this analysis, we develop a conceptual framework that describes how implementing this rule would likely reduce the level of foodborne illness. Estimating the rule’s foodborne illness reduction benefits would require the following: (1) baseline risk of foodborne illness attributable to FDA-regulated produce under the scope of this rule; (2) a measure of lost health as measured by morbidity and mortality effects attributable to foodborne illness; (3) value of lost health due to foodborne illness; (4) the changes from baseline food production practices due to the rule; and (5) the effectiveness of the preventive controls.
1. Baseline Risk of Foodborne Illness
a. Foodborne Illness Attributable to Produce from Microbial Contamination
We estimate that there are 2.68 million illnesses per year associated with produce that would be covered by this rule and that these illnesses cost $1.6 billion per year. We expect that the proposed rule would eliminate some portion of these illnesses and costs.