FDA Releases Recommendations for Sprout Production

FDA has released two guidance documents that outline recommendations for how sprout operations need to comply with the Produce Safety Rule.

The first is a guidance (2023 Final Guidance) that updates and finalizes some sections of the January 2017 Draft Guidance entitled “Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human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.” These sections include:

• Cleaning and sanitizing;
• Agricultural water in sprout operations;
• Seeds for sprouting;
• Environmental monitoring; and
• 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The second guidance (2023 Draft Guidance) re-issues certain sections of the January 2017 Draft Guidance and issues one new section for sprout operations as revised draft guidance. The following updated and new sections in the revised draft guidance are now available for comment: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); and
• Personnel qualifications, training, and hygienic practices.

The revised draft guidance is available for comment, and FDA has said it is particularly interested in receiving information about testing of spent sprout irrigation water or in-process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 E. coli, including test kit names. Comments can be submitted at regulations.gov.