As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Rhodes Legacy Inc. DBA Sun Sprouts
A food firm in Nebraska is on notice from the FDA after an inspection of their sprouting operation. The inspection was prompted by epidemiological and traceback evidence to an outbreak of human infections with Salmonella Typhimurium linked to their food firm.
On Feb. 28, 2023, the Centers for Disease Control and Prevention (CDC) announced that the multistate outbreak of Salmonella Typhimurium infections linked to Sun Sprouts-brand alfalfa sprouts grown by SunSprout Enterprises was over.
The CDC reported a total of 63 illnesses, with 10 people requiring hospitalization. Illnesses were reported in eight states with the last illness onset on Feb. 2, 2023. States with cases included Arizona (1), Iowa (6), Kansas (6), Missouri (9), Nebraska (26), New Hampshire (1), Oklahoma (1) and South Dakota (13).
In a May 10, 2023, warning letter, the FDA described a Dec. 28, 2022, through Jan. 6, 2023, inspection of Sun Sprouts’ sprouting operation in Omaha, NE.
The FDA’s inspection found serious violations of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption regulation and resulted in the issuance of an FDA Form 483.
Produce Safety Rule violations
During the inspection, FDA investigators observed the following significant violations of the Produce Safety Rule:
1. The firm failed to meet the requirement to test spent sprout irrigation water from each production batch of sprouts for E. coli O157:H7 and Salmonella spp. or, if such testing is not practicable, test each production batch of sprouts at the in-process stage (i.e., while sprouts are still growing) for E. coli O157:H7 and Salmonella spp., in accordance with the requirements. Specifically, they stated that they do not conduct spent sprout irrigation water testing or in-process testing for their spicy sprout blend, their broccoli sprouts or their sunflower shoots. Further, they stated they have not conducted any testing on their spicy sprout blend, their broccoli sprouts or their sunflower shoots since April of 2022. From April 21, 2022, to Dec. 23, 2022, the firm produced their spicy sprout blend (redacted) times, their broccoli sprouts (redacted) times and their sunflower shoots (redacted) times. The firm sold these sprouts without conducting spent sprout irrigation water testing or any in-process testing.
In the firm’s written response to the FDA 483, dated Jan. 12, 2023, they explained that they will be following a new SOP for testing sprouts grown at their facility. The SOP they provided, “SOP XX-1 Irrigation water testing for Special blends and other sprouts (redacted),” lists the following sprouts and notes that the list can change at any time: gourmet, spicy, broccoli, and sunflower. The SOP says to collect and test water sample for sprouts grown (redacted). However, they did not provide any documentation to demonstrate they have implemented and are following this procedure—i.e., they did not provide any documentation to demonstrate that they are testing spent sprout irrigation water from each production batch of sprouts for E. coli O157:H7 and Salmonella spp.
2. The firm did not test the spent sprout irrigation water (or sprouts) from each production batch of sprouts for Salmonella spp. using either (1) the method of analysis described in “Testing Methodologies for E. coli O157:H7 and Salmonella species in Spent Sprout Irrigation Water (or Sprouts),” Version 1, Oct. 2015, FDA or (2) a scientifically valid method that is at least equivalent to this method of analysis in accuracy, precision, and sensitivity, as required. Specifically, on Nov. 22, 2022, following PCR analysis, they received a presumptive positive test result for Salmonella spp. in their spent sprout irrigation water from lot 4211 of alfalfa sprouts. Neither the firm nor their third-party laboratory conducted a culture confirmation test on the presumptive positive sample by using a method of analysis described in the “Testing Methodologies for E. coli O157:H7 and Salmonella species in Spent Sprout Irrigation Water (or Sprouts),” Version 1, Oct. 2015 or a scientifically valid method that is at least equivalent to this method of analysis in accuracy, precision, and sensitivity, as required. Rather, the firm collected a new sample of spent sprout irrigation water for lot 4211 on Nov. 22, 2022, and submitted it for analysis. Following the new sample showing a negative analysis result for Salmonella spp., they released the product for shipment into interstate commerce to their customers, including ones located in Kansas, Iowa, and Missouri. Because the samples were collected from the same production batch as the presumptive positive, that batch should be considered presumptive positive. A negative test result does not negate a previous positive test result from the same batch.
At the close of the inspection, they submitted their updated protocol on handling positive lab testing results, identified as “SOP XX. PROCEDURE FOR POSITIVE LAB,” to FDA investigators. As written, this procedure indicates that if they receive a presumptive positive result, they will treat a presumptive positive as a true positive and, among other things, destroy all affected products, quarantine and discontinue use of the seed, notify seed suppliers, and clean and sanitize equipment. The adequacy of this corrective action will be evaluated during FDAs next inspection.
3. The firm did not clean and sanitize food contact surfaces that they use to grow, harvest, pack, or hold sprouts before contact with sprouts or seeds or beans used to grow sprouts, as required. Specifically, on Jan. 4, 2023, FDA investigators observed significant filth on the irrigation nozzles for their mister. These nozzles are food contact surfaces used to water their sprouts growing (redacted). Water from the misters comes into contact with the harvestable portion of the sprouts that they grow ((redacted)). They stated the nozzles were last cleaned (redacted) prior to Jan. 4, 2023.
In their written response to the FDA 483, dated Jan. 12, 2023, the firm attached a cleaning schedule for the mister nozzles (“Mister Nozzle Cleaning Schedule”). In the procedure, Mister Nozzle Cleaning Schedule, the misters would be cleaned (redacted). During FDA inspection, they told investigators that the observed filth on the misters were from (redacted) of use since the previous cleaning. As the visible filth was observed on the misters after (redacted) of use, this indicates that cleaning and sanitizing their mister nozzles on a (redacted) quarterly basis (i.e., every (redacted)), as identified in their written response, is not adequate to comply with requirements.
4. The firm did not meet the requirement that at least one supervisor or responsible party for their farm must have successfully completed food safety training at least equivalent to that received under standardized curriculum recognized as adequate by FDA, as required. FDA, in cooperation with the Illinois Institute of Technology’s Institute for Food Safety and Health, created the Sprout Safety Alliance to help sprout producers identify and implement best practices in the safe production of sprouts. During FDA inspection, they explained to FDA investigators that neither them nor a supervisor has successfully completed at least the equivalent of the standardized curriculum, food safety training for sprouts growers (Sprouts Safety Alliance Training). Additionally, none of their employees have successfully completed at least the equivalent of the standardized curriculum, food safety training for sprouts growers (Sprouts Safety Alliance Training).
The full warning letter can be viewed here.
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