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  1. Economic Impact Analyses of FDA Regulations

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E (Final Rule) Regulatory Impact Analysis

The Food and Drug Administration (FDA) is, for non-sprout covered produce, extending the compliance date for all of the provisions of Subpart E to four years after the relevant farm’s compliance date for all other provisions of the produce safety regulation (which varies based on establishment size).  This means that covered farms producing non-sprout covered produce will have an additional two years to comply with certain agricultural water provisions, compared to the originally-published compliance dates in the produce safety regulation; and an additional four years to comply with the remaining agricultural water provisions, compared to the originally-published compliance dates in the produce safety regulation.  The total annualized cost decrease of this final rule, using a 3 (7) percent discount rate over 10 years, will be from approximately $291 ($265) million to $280 ($254) million, resulting in a savings of approximately $12 ($10) million.  The total annualized benefits to consumers, discounted at 3 (7) percent over 10 years, will decrease by approximately $104 ($96) million from approximately $800 ($740) billion to $696 ($644) million. All estimates are in 2017 dollars. Using a 3 (7) percent discount rate, the final rule will have negative annualized net benefits of approximately $92 ($86) million.

Regulatory Impact Analysis

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E (Final Rule) (PDF - 183KB)

Federal Register: 84 FR 9706, March 18, 2019

Docket: FDA-2011-N-0921

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