Source - Food & Beverage Litigation And Regulatory Update | Issue 813

GAO: FDA Should Finalize Plans to Implement New Traceability Rule

The Government Accountability Office (GAO) has recommended that the U.S. Food and Drug Administration (FDA) finalize its plans for implementing a rule that would aim to help trace the sources of outbreaks of foodborne illness. In developing the 2022 rule, FDA established a list of certain foods requiring enhanced recordkeeping, setting a compliance date of January 20, 2026. Entities handling items on the list will be required to maintain certain records, including a traceability plan, at certain points in the item’s supply chain.

As of October 2023, FDA had not yet finalized or documented an implementation plan, according to FDA officials. GAO found that components of such a plan could help address challenges stakeholders identified in preparing for the rule’s compliance deadline, include more information on nonfederal regulators’ roles in the inspection process and FDA’s enforcement strategy and needed resources. “By finalizing and documenting an implementation plan, FDA will have better assurance it is well positioned to make progress toward its regulatory goals and address the various challenges that stakeholders identified to achieving compliance by the deadline,” GAO said. The U.S. Department of Health & Human Services agreed with the recommendation.

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