The new Rule establishes requirements addressing common routes of microbial contamination, including agricultural water; biological soil amendments of animal origin; worker health and hygiene; equipment, tools, buildings, and sanitation; and domesticated and wild animals. Sprouts represent a distinct food safety concern. Between 1996 and 2020 in the United States, the FDA observed 52 reported outbreaks of foodborne illness associated with sprouts. The outbreaks resulted in at least 2700 cases of illness, 200 hospitalizations, and three deaths. Because the distinctive practices and conditions for growing sprouts present unique risks, the FDA established sprout-specific requirements in Subpart M (Sprouts) of the Produce Safety Rule. Sprout operations are subject to the Produce Safety Rule. The guidance also briefly discusses certain requirements (in Subparts E and O of the Rule relating to Agricultural Water and Records) of particular relevance to a sprout operation. Some of the material in this guidance relates to regulatory requirements of the Produce Safety Rule that are also covered in the draft “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Guidance for Industry.” The final guidance focuses specifically on insights drawn from the FDA’s experience with sprout operations, such as from inspections and sprout-associated foodborne illness outbreak investigations, and elaborates on how the broader records and cleaning and sanitizing standards in part 112 could apply to and be implemented in a sprout operation. @ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-standards-growing-harvesting-packing-and-holding-sprouts-human-consumption#:~:text=FDA%20has%20also%20issued%20the,address%20chemical%20or%20physical%20hazards.
FDA issued new guidance for standards for the growing, harvesting, packing, and holding of sprouts