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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 (Proposed Rule)

The Food and Drug Administration (FDA) is, for non-sprout covered produce, proposing to extend 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 would 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 proposed rule, using a 3 (7) percent discount rate over 10 years, would be from $404 ($382) million to $392 ($370) million, resulting in a savings of $12 million. The total annualized benefits to consumers, discounted at 3 (7) percent over 10 years, would decrease by $108 ($109) million from $1.033 billion ($983 million) to $925 ($874) million. All estimates are in 2016 dollars. This comes out to approximately a 3% decrease in costs, and approximately an 11% decrease in benefits as compared to the produce safety regulation. Using a 3 (7) percent discount rate, the proposed rule would have negative annualized net benefits of $96 ($97) million.

Regulatory Impact Analysis

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E; Proposed Rule (Proposed Rule) RIA (PDF - 164KB)

Federal Register: September 13, 2017

Docket: FDA–2011–N–0921