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  1. Economic Impact Analyses of FDA Regulations

Fish and Shellfish; Canned Tuna Standard of Identity and Standard of Fill of Container RIA

RIA Executive Summary

We estimate benefits of the proposed rule, if finalized.  We estimate ongoing annual cost savings ranging from approximately $4 million to $15.9 million at a 3 percent discount rate, and approximately $3.9 million to $15.8 million at a 7 percent discount rate.  Our primary annualized estimates are approximately $7.9 million at both the 3 percent and 7 percent discount rates.  The primary estimate of the present value of total cost savings in the 10 years following any final rule that may be issued based on the proposed rule is $67.6 million at a 3 percent rate of discount and $55.4 million at a 7 percent rate of discount.  Manufacturers and consumers may benefit from other provisions of the proposed rule, if finalized, but these impacts are harder to quantify.

The costs of the proposed rule, if finalized, are associated with costs to industry for reading and understanding the rule, training employees on new requirements, and the purchase of new equipment.  These are one-time costs that industry incurs immediately after any final rule that may be issued based on this proposed rule passes its compliance date.  When annualized over a period of 10 years, we estimate these costs range from approximately $3,800 to $6,000 at a 3 percent discount rate, and approximately $4,500 to $7,100 at a 7 percent discount rate.  Our primary annualized estimates are approximately $4,900 at a 3 percent discount rate and $5,800 at a 7 percent discount rate.  The primary estimate of total costs in the 10 years following any final rule that may be issued based on this proposed rule is $41,600 at a 3 percent discount rate and $40,600 at a 7 percent discount rate.

Regulatory Impact Analysis

Fish and Shellfish; Canned Tuna Standard of Identity and Standard of Fill of Container RIA

Federal Register: Hyperlinked FR Notice

Publication Date: 8/25/2023

Docket: FDA-2016-P-0147 

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