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  1. Economic Impact Analyses of FDA Regulations

Requirements for Additional Traceability Records for Certain Foods (Proposed Rule) Regulatory Impact Analysis

Summary:

The Food and Drug Administration (FDA) is issuing a proposed rule that would allow industry to more rapidly and effectively trace food products that cause illnesses back through the food supply system to the source and forward to determine recipients of the contaminated product. The proposed rule would only apply to foods we have designated for inclusion on the Food Traceability List. By allowing faster identification of contaminated foods and increasing rates of successful tracing completions, the proposed rule may result in public health benefits if foodborne illnesses directly related to those outbreaks are averted. This may also lead to more efficient use of FDA and industry resources needed for outbreak investigations by potentially resulting in more precise recalls and avoidance of overly broad market withdrawals and advisories for listed foods.

FDA has issued this proposed rule with two co-proposed options for how this rule would apply to retail food establishments.

  • Option 1 Full exemption: RFEs that employ 10 or fewer full-time equivalent employees (FTEs) would be exempt from the requirements of the rule.
  • Option 2 Partial exemption: RFEs that employ 10 or fewer FTEs would be exempt from the requirement to provide FDA, under specified circumstances, with an electronic sortable spreadsheet containing certain traceability information; however, they would be required to comply with all other aspects of the rule.

If finalized, full compliance with co-proposed Option 2 would have annualized costs of about $535 million per year at a seven percent discount rate and $513 million at a three percent discount rate over a 10-year period. Annualized public health benefits would be about $626 million per year at a seven percent discount rate and $640 million at a three percent discount rate.

Under co-proposed Option 1, full compliance would have annualized costs of about $411 million per year at a seven percent discount rate and $400 million at a three percent discount rate over a 10-year period. Annualized public health benefits would be about $567 million per year at a seven percent discount rate and $580 million at a three percent discount rate.

Requirement for Additional Traceability Requirements for Certain Foods PRIA document (PDF 975 KB)

Federal Register: 85 FR 59984, September 23, 2020

Docket: FDA-2014-N-0053

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