By way of background, the Produce Safety Rule under FDA’s Food Safety Modernization Act implemented new requirements applicable to sprout operations.  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.  FDA reports that 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.

Today, the FDA released a draft guidance to help sprout operations meet the new standards set forth under the Produce Safety Rule designed to help keep sprouts free of contamination and safe for consumers to eat.  In general, 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).  The Produce Safety Rule requires, in relevant part, 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.

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

The draft guidance will be available for public comment for 180 days following its imminent publication in the Federal Register.  Comments received within this time frame will be considered in the development of the final version of the guidance document.