Sprout operations have new requirements under the rule mandated by the Food Safety Modernization Act.
FDA said it presents a unique risk because of production conditions (time, temperature, water activity, pH and available nutrients) ideal for growth of bacteria that cause foodborne illnesses.
Most often the seeds
Between 1996 and July 2016 there were 46 outbreaks associated with sprouts in the US, accounting for 2,474 illnesses, 187 hospitalizations and three deaths.
In outbreaks associated with sprouts, epidemiological investigations often identify the most likely source as seeds used for sprouting but poor sanitation and unhygienic practices can also contribute to contamination.
Seed contamination can occur at the farm, conditioner, supplier or at the sprout operation.
They should be stored off the floor, away from walls and in conditions to prevent bacterial growth and help pest control inspection.
Electronic or written comments on the guidance can be submitted until July 24.
The agency published guidance to reduce the risk of Listeria monocytogenes in ready-to-eat foods earlier this month.
The guidance does not cover best practices or requirements outside the Produce Safety Rule such as address chemical or physical hazards.
It is not legally binding and alternative approaches can be used if they satisfy requirements of the regulations.
The Produce Safety Rule requires covered sprout operations take measures to prevent introduction of dangerous microbes into seeds or beans used for sprouting, test spent sprout irrigation water for certain pathogens and test the growing, harvesting, packing and holding environment for Listeria species or Listeria monocytogenes.
The Sprout Safety Alliance (SSA), made up of industry, academia, and federal, state and local food protection agencies, has developed a curriculum and training programs for the sprout production community.
It is funded by grant from FDA to the Illinois Institute of Technology’s Institute for Food Safety and Health (IIT IFSH).
Large covered sprout operations must be in compliance by January 26 and for small and very small businesses by January 26, 2018 and January 28, 2019, respectively.
The guidance covers sprout production, seed receipt and storage, initial seed rinse, seed treatment to reduce microorganisms, pre-germination seed soak, germination and growth, harvest, wash/drain and cool, packing and storage and distribution.
Many steps in sprout production, such as rinsing and soaking seed, irrigating sprouts and washing finished product, involve water.
Certain uses of “agricultural water” (including sprout irrigation water) are subject to a microbial water quality requirement of no detectable generic E. coli per 100ml.
The Produce Safety Rule requires testing of spent sprout irrigation water (or in-process sprouts) from each production batch during germination and growth for E. coli O157:H7 and Salmonella species.
FDA recommends cleaning and sanitizing of food contact surfaces in sprout operations at least daily.
Food contact surfaces include trays or drums used for sprouting; interior surfaces of containers used for seed rinsing, treatment, and pre-germination soaking; and counters in contact with sprouts during packing.
The agency advised verification of sampling of recently cleaned and sanitized surfaces to monitor effectiveness.
“Some of these tests, which include bioluminescence, adenosine triphosphate (ATP), and protein-based technologies, provide rapid results and allow for follow-up or intensified cleaning and sanitizing activities if results are above established thresholds.
“Another option is to quantify aerobic plate counts (APC) of a surface to directly monitor viable microbial populations, the results of which could also be used to indicate where to target sampling of Listeria spp. or L. monocytogenes as part of environmental monitoring.”