Regulatory Impact Analysis: produce safety rule - The Packer

Regulatory Impact Analysis: produce safety rule

01/11/2013 03:19:00 PM
Tom Karst

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.

To estimate the number of baseline illnesses attributable to produce from microbial contamination only, we begin with only those outbreaks we can directly attribute to FDA-regulated produce from microbial contamination.

In total, there are 4,257 illnesses from 22 separate outbreaks that are linked to produce RACs other than sprouts for the years 2003-2008; this data represents only reported and laboratory confirmed illnesses from outbreaks.

The data span of 2003-2008 is utilized for this analysis because it represents the most current, and comprehensive data available. We are unable to look at years beyond 2008, because the full outbreak data, from CDC, has not been completely collected, sorted, cleaned, and made available for public use.

We do not go back further in the data, because there are regulations in the industry that took effect prior to these dates, and we want to look at a baseline estimate with all current regulations in place and functioning. Additionally, collection methods by both FDA and CDC have improved vastly in recent years, and data further back may be more subject to underreporting biases. This data is directly from an FDA database generated from outbreak investigations and reports (Ref.36).

We note that, because of the infrequency of accrue due to the mitigation of produce related illness in other countries due to improvements in the safety of U.S. exports or produce grown and consumed in other countries on farms covered by the proposed rule. A rough estimate of costs can be found in the Unfunded Mandates section. outbreaks, using a short time period may overstate the riskiness of a particular commodity if it happened to have an outbreak during the period evaluated. If additional data are available from the CDC at the final rule stage we will add it to the analysis. In addition, both 2003 and 2008 had unusually high numbers of illnesses caused by produce, relative to illnesses in adjacent years. We seek comment on whether and how use of our chosen time period may affect the results of our analysis and whether it would be more appropriate to use a different period of analysis.

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