FDA Finalizes Draft Guidance for Sprout Operations under the Produce Safety Rule, Releases Certain Sections as Revised Draft Guidance

The US Food and Drug Administration (FDA) released two guidance documents that outline recommendations for how sprout operations may comply with the Produce Safety Rule.

The first is a guidance (2023 Final Guidance) that updates and finalizes the following sections of the January 2017 Draft Guidance entitled Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human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
  • Recordkeeping

The second guidance (2023 Draft Guidance) re-issues certain sections of the January 2017 Draft Guidance and issues one new section for sprout operations as revised draft guidance. The following updated and new sections in the revised draft guidance are now available for comment: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

These 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 The revised draft guidance is available for comment, and we are particularly interested in receiving information about testing of spent sprout irrigation water or in-process sprouts that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 E. coli, including test kit names (as applicable).

To Submit Comments

Comments can be submitted at any time at Regulations.gov or to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 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 Comments on the revised draft guidance should be submitted to the Federal Register within 180 days to ensure they are considered during development of the final guidance.

For More information

2023 Final Sprout Guidance

2023 Draft Sprout Guidance

Federal Register Notice

FSMA Final Produce Safety Rule