FDA Issues Draft
Guidance to Help Sprout Operations Comply with FSMA Produce Safety Rule
January 19, 2017
Dear Colleagues,
The U.S. Food and Drug
Administration (FDA) today issued for public comment a draft guidance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 (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
that accounted 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.
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The draft guidance will be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 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 additional information,
please visit the website below:
Constituent
Update, “FDA Announces Draft Guidance to Help Sprout Operations Comply with
Produce Safety Rule:”
http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm536958.htm
Draft
Guidance for Industry:
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm510578.htm
Federal
Register Notice:
https://www.federalregister.gov/documents/2017/01/23/2017-01128/guidance-compliance-with-and-recommendations-for-implementation-of-the-standards-for-the-growing
This message is being
broadcast by the Division of Communications in the FDA's Office of Regulatory
Affairs (ORA).
Thank you,
FDA/ORA
Office of Communications and Quality Program Management
Division of Communications
Mailbox: DivComm-ORA@fda.hhs.gov
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