FDA publishes rule for production of sprouts

The FDA has released its final food safety guidance for producers of sprouts, a food that has been linked to several outbreaks in recent years.

The document details recommendations on how sprout operators can comply with the sprout portion of the 2011 Food Safety Modernization Act, which establishes science-based standards for safe produce production and harvest.

Topics covered in the final guidance on sprout production include cleaning, sanitization, use of agricultural water, seeds for sprouting, environmental monitoring, and recordkeeping. 

The Food and Drug Administration has also released a revised draft of a second guidance document that includes a section on testing spent sprout irrigation water for pathogens.

Between 1996 and 2020, the FDA reported 52 foodborne illness outbreaks linked to sprouts, which are produced in conditions ideal for pathogen growth. The outbreaks involved various organisms, including Salmonella, Listeria, and E.coli. The events led to at least 2,700 infections, 200 hospitalizations, and 3 deaths.

Investigations of the outbreaks often showed that contaminated seeds were the contamination source, but other factors were also discovered. Those factors included poor sanitation and unhygienic production practices in sprout production facilities.

The first guidance document released yesterday, the 2023 Final Guidance, updates and finalizes the following sections of the January 2017 Draft Guidance entitled Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human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The second guidance (2023 Draft Guidance) re-issues certain sections of the January 2017 Draft Guidance and issues one new section for sprout operations as revised draft guidance. The following updated and new sections in the revised draft guidance are now available for comment: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 

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