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Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water (Final Regulatory Impact Analysis)

The final rule replaces the microbial water quality criteria and uniform testing provisions for pre-harvest agricultural water used in direct application on non-sprout covered produce in the 2015 produce safety final rule with provisions for annual pre-harvest agricultural water assessments in which farms using pre-harvest agricultural water for non-sprout covered produce will holistically evaluate potential hazards that may impact their water systems and implement risk-reduction measures to reduce the potential for contamination of covered produce or food contact surfaces. We analyze the rule relative to a primary baseline of pre-harvest agricultural water microbial quality criteria and testing provisions in the 2015 produce safety final rule and relative to an alternate baseline of no pre-harvest agricultural water provisions. We quantify benefits to the public from a reduction in foodborne illnesses. Additional (non-quantified) benefits include those related to recalls averted increased flexibility in comprehensively evaluating potential hazards associated with pre-harvest agricultural water. We quantify costs to farms from reading the rule, conducting pre-harvest agricultural water assessments, mitigation, and recordkeeping. We estimate that the annualized benefits over 10 years will range from $-29.4 million to $51.0 million at a 7 percent discount rate, with a primary estimate of $10.1 million, and from $-30.3 million to $52.4 million at a 3 percent discount rate, with a primary estimate of $10.3 million. The annualized costs will range from $6.7 million to $26.0 million at a 7 percent discount rate, with a primary estimate of $17.7 million, and from $6.8 million to $25.6 million at a 3 percent discount rate, with a primary estimate of $17.5 million.

Regulatory Impact Analysis

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water (Final Regulatory Impact Analysis) (PDF 744KB)

Federal Register: 89 FR 37448
Publication Date: 5/6/2024
Docket: FDA-2021-N-0471

 
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