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  1. Economic Impact Analyses of FDA Regulations

Requirements for Additional Traceability Records for Certain Foods: Compliance Date Extension RIA (Proposed Rule)

The Food and Drug Administration is proposing to extend the compliance date for the final rule “Requirements for Additional Traceability Records for Certain Foods” (the Food Traceability Rule) due to concerns about the amount of time affected entities will need to implement the requirements of the rule. If finalized this rule would extend the compliance date by 30 months from January 20, 2026 to July 20, 2028.

The benefits of this proposed rule comprise the foregone benefits associated with extending the compliance date of the Food Traceability Rule by 2.5 years. The costs of this proposed rule comprise the cost savings associated with extending the compliance date of the Food Traceability Rule by 2.5 years. We estimate that the annualized benefits over 20 years would range from -$260 million to -$7 million, with a primary estimate of -$91 million, using a 3 percent discount rate and from -$322 million to -$8 million, with a primary estimate of -$112 million, using a 7 percent discount rate. The annualized costs would range from -$227 million to -$3 million, with a primary estimate of -$54 million, using a 3 percent discount rate and from -$308 million to -$5 million, with a primary estimate of -$73 million, using a 7 percent discount rate.

Regulatory Impact Analysis

Requirements for Additional Traceability Records for Certain Foods: Compliance Date Extension (Proposed Rule) (PDF- 386KB)

Federal Register: 90 FR 38084
Publication Date: 08/06/2025 
Docket: FDA-2014-N-0053  
 

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