The U.S. Food and Drug Administration (FDA) has announced two updates for Food Safety Modernization Act (FSMA) rules, including the finalization of a draft guidance for sprout operations under the Produce Safety Rule (PSR). FDA also updated the FAQ for its Food Traceability Final Rule to include information on inspections and FDA’s Product Tracing System.
Sprout Operations Under PSR
FDA released two guidance documents that outline recommendations for how sprout operations may comply with PSR. The first guidance updates and finalizes the following sections of a January 2017 draft guidance, titled, Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations:
- Cleaning and Sanitizing
- Agricultural Water in Sprout Operations
- Seeds for Sprouting
- Environmental Monitoring
The second guidance re-issues certain sections of the January 2017 draft guidance and issues one new section for sprout operations as a revised draft guidance. The following updated and new sections in the revised draft guidance are available for comment:
- Equipment, Tools, and Buildings
- Sampling and Testing of Spent Sprout Irrigation Water (or In-Process Sprouts)
- Personnel Qualifications, Training, and Hygienic Practices.
The chosen sections have been revised to align with information in other relevant guidance documents, incorporate additional information and comments received by the agency, and better consolidate and organize information within the guidance. The revised draft guidance is available for comment. FDA is particularly interested in receiving information about testing of spent sprout irrigation water or in-process sprouts that sprout operations are currently conducting for non-O157:H7 pathogenic Escherichia coli, including test kit names (as applicable).
Comments can be submitted at any time electronically at Regulations.gov or by mail to: Dockets Management Staff (HFA-305), FDA, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All written comments should be identified with the docket number FDA-2017-D-0175 and with the title of the guidance document. Comments on the revised draft guidance should be submitted to the Federal Register within 180 days of publication to ensure they are considered during the development of the final guidance.
Food Traceability FAQ Updates
FDA also recently updated its Food Traceability FAQ to provide additional information about FDA’s Product Tracing System and to explain how the agency intends to conduct initial inspections beginning in 2027. The agency also answered questions that provide clarity about which foods are covered under the rule and which ones are not.
The Food Traceability Final Rule was published in November 2022, establishing traceability recordkeeping requirements for persons who manufacture, process, pack, or hold foods included on the Food Traceability List (FTL). The rule was designed to facilitate faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses. The agency established January 20, 2026 as the compliance date, and does not intend to begin routine inspections until 2027.