Federal Register #FDA2025N4250

FDA Requests Public Comment on Food Traceability Recordkeeping Requirements

The Food and Drug Administration (FDA), under the Department of Health and Human Services, is seeking public comment on a proposed information collection related to food traceability records. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - No OEMs or commercial vendors are mentioned, as this is a regulatory information collection notice, not a procurement. - Products/Services Requested: - Public comments and recommendations regarding the establishment, maintenance, and availability of records for certain foods - Focus on traceability records for foods on the Food Traceability List (FTL), as required by 21 CFR part 1, subparts J and S - Unique/Notable Requirements: - Applies to entities that manufacture, process, pack, hold, receive, distribute, transport, or import food in the U.S. - Requires maintaining records for two years - Documentation of critical tracking events and supply chain activities - Ability to request exemptions or waivers under certain circumstances - Aims to improve FDA's ability to respond to and contain threats from contaminated food

Description

The Food and Drug Administration (FDA) is proposing to collect additional traceability records for certain foods to improve the ability to respond to and contain threats of serious adverse health consequences or death from contaminated food. The collection supports regulations requiring persons who manufacture, process, pack, hold, receive, distribute, transport, or import food in the United States to establish and maintain records identifying sources and recipients of food. The FDA requests written comments including recommendations by July 13, 2026. This effort is part of compliance with the Paperwork Reduction Act of 1995 and aims to enhance public health protections through improved food traceability.

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