Thursday, January 26, 2017

FDA Releases Draft Guidance to Assist Sprout Operations Comply with FSMA

FDA released a draft guidance to help sprout operations comply with FSMA regulations. 

The issue with sprouts is that the same conditions that allow the sprouts to grow from seeds also allows bacteria present on the seed to grow, and if these are pathogenic bacteria and the sprouts are eaten raw, then illnesses can occur.  One of the keys is sanitizing the beans before beginning the sprouting process to eliminate any pathogenic bacteria.

FDA Constituent Update
FDA Announces Draft Guidance to Help Sprout Operations Comply with Produce Safety Rule
Constituent Update
January 19, 2017

The U.S. Food and Drug Administration today issued for public comment a draft guidance to help sprout operations meet new standards designed to help keep sprouts free of contamination and safe for consumers to eat.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 FDA Food Safety Modernization Act. 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 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 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The draft guidance will be available for public comment for 180 days starting January 19, 2017.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 Comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

Additional Information
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

No comments:

Post a Comment