Produce Sprouts
  • The final rule includes new requirements to help prevent the contamination of sprouts, which have been frequently associated with foodborne illness outbreaks. Sprouts are especially vulnerable to dangerous microbes because of the warm, moist and nutrient-rich conditions needed to grow them.
  • Between 1996 and 2014, there were 43 outbreaks, 2,405 illnesses, and 171 hospitalizations, and 3 deaths associated with sprouts, including the first documented outbreak of Listeria monocytogenes associated with sprouts in the United States. Requirements specific to sprouts include, for example: ◦Taking measures to prevent the introduction of dangerous microbes into or onto seeds or beans used for sprouting, in addition to treating seeds or beans that will be used for sprouting (or relying on prior treatment by the seed/bean grower, distributor, or supplier with appropriate documentation).

◦  Testing of spent sprout irrigation water from each production batch of sprouts, or in-process sprouts from each production batch, for certain pathogens. Sprouts cannot be allowed to enter commerce until it is ascertained that these required pathogen test results are negative.

◦  Testing the growing, harvesting, packing and holding environment for the presence of Listeria species or Listeria monocytogenes.

◦  Taking corrective actions if spent sprout irrigation water, sprouts, and/or an environmental sample tests positive.

  • In January 2017, FDA issued a draft guidance to help sprout operations comply with the applicable requirements in the Produce Safety rule.
  • The first compliance date for the largest sprout operations began on January 26, 2017.
  • Draft Guidance for Industry: Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human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.