A Salmonella Sun Sprouts warning letter was sent to that company by the FDA after an outbreak, which happened from December 2022 to January 2023, linked to those raw sprouts sickened at least 63 people in eight states. The case count by state was: Arizona (1), Iowa (6), Kansas (6), Missouri (9), Nebraska (26), New Hampshire (1), Oklahoma (1), and South Dakota (13). Ten people were hospitalized.
The FDA inspected the sprouting operation of Rhodes Legacy Inc. doing business as Sun Sprouts, because of the outbreak. FDA’s traceback investigation identified the brand’s alfalfa sprouts as a likely source of illnesses in that outbreak.
The inspection revealed “serious violations of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption regulation (Produce Safety Regulation or PSR), Title 21, Code of Federal Regulations, Part 112 (21 CFR Part 112).” The sprouts are adulterated within the meaning of the law, since they have been rendered injurious to health. A Form FDA-483 was issued.
The significant violations include failing to meet the requirement to test sprout irrigation water from each production batch of sprouts for Salmonella and E. coli O157:H7. The company stated they did not conduct spent sprout irrigation water testing or in-process testing for the spicy sprouts blend, broccoli sprouts, or sunflower shoots. These products were sold without any in-process testing.
In January 2023, the company said they will follow a new SOP for testing sprouts, but they did not provide any documentation to demonstrate that they are testing the water.
The company did not test spent sprout irrigation waster or sprouts from each production batch of sprouts for Salmonella using either of the two acceptable scientific methods. On November 22, 2022, the company received a presumptive positive test for Salmonella in the water from lot 4211 of alfalfa sprouts. No culture confirmation test was conducted; instead, the company collected a new sample of spent sprout irrigation water for that lot and submitted it for analysis, which was negative. The product was then released for shipment.
The company did not clean and sanitize food contact surfaces used to grow, harvest, pack or hold sprouts before contact with sprouts or seeds or beans used to grow sprouts. On January 4, 2023, investigators “observed significant filth on the irrigation nozzles” for the mister. Nozzles are food contact surfaces, and water from misters comes into contact with harvestable portions of the sprouts.
Finally, the company did not meet the requirement that at least one supervisor or responsible party must have successfully completed food safety training. And none of the employees have successfully completed at least the equivalent of the standardizes curriculum, food safety training for sprout growers.