With Compliance Dates Looming, FDA Publishes Draft Guidance for Sprouts

FDA has issued, for public comment, a draft guidance to help sprout operations meet new standards designed to help keep sprouts free of contamination and safe for consumers to eat. 

Sprout operations have new requirements under the Produce Safety Rule mandated by the FSMA Sprouts present a unique risk because the conditions under which they are typically produced are also ideal for the growth of bacteria that cause foodborne illnesses. Between 1996 and July 2016 there were 46 reported outbreaks associated with sprouts in the United States, accounting for 2474 illnesses, 187 hospitalizations, and three deaths.

The largest covered sprout operations must be in compliance with all applicable provisions of the Produce Safety Rule by January 26, 2017, while covered sprout operations that are small and very small businesses have compliance dates of January 26, 2018 and January 28, 2019, respectively.

The Produce Safety Rule requires, among other things, that covered sprout operations take measures to prevent the introduction of dangerous microbes into seeds or beans used for sprouting, test spent sprout irrigation water (or, in some cases, in-process sprouts) for the presence of certain pathogens, test the growing, harvesting, packing and holding environment for the presence of the Listeria species or Listeria monocytogenes, and take corrective actions when needed.

Overall, the Produce Safety Rule sets science-based standards for the safe growing, harvesting, packing, and holding of fruits and vegetables on farms (for produce for human consumption). There are specific provisions in the rule that build on previous guidances regarding sprouts, but they now carry the force and effect of law.

The draft guidance will be available for public comment for 180 days starting January 19, 2017. The FDA will consider all comments before completing a final version. Submit electronic comments to http://www.regulations.gov. Comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For more information, see

• Draft Guidance for Industry: Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations
• FSMA Final Produce Safety Rule