- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameMichael J Rhodes
- Rhodes Legacy Inc DBA Sun Sprouts
13315 A Street
Omaha, NE 68144-3642
- Issuing Office:
- Division of Human and Animal Food Operations West II
Date: May 10, 2023
Ref: CMS Case# 651402
Dear Mr. Rhodes:
The U.S. Food and Drug Administration (FDA) inspected your sprouting operation, located at 13315 A Street, Omaha, Nebraska, from December 28, 2022, through January 6, 2023. FDA conducted this inspection because sprouts grown at your sprouting operation were linked by epidemiological and traceback evidence to an outbreak of human infections with Salmonella Typhimurium. The FDA, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, investigated a multistate outbreak of Salmonella Typhimurium infections. FDA’s traceback investigation identified Sun Sprouts brand alfalfa sprouts grown by SunSprout Enterprises as a likely source of illnesses in this outbreak.
Our 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). Based on our inspectional findings, we have determined that your sprout products are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health. In addition, failure to comply with the PSR requirements promulgated under Section 419 of the Act [21 U.S.C. § 350h] is a prohibited act under section 301(vv) of the Act [21 U.S.C. § 331(vv)]. You can find the Act and FDA’s regulations through internet links in FDA's home page at http://www.fda.gov.
At the conclusion of our inspection, we issued to you a Form FDA-483, Inspectional Observations (FDA 483), listing the observations found at your sprouting operation during our inspection. We received your written responses on January 12, 2023, and January 26, 2023 to the FDA-483, Inspectional Observations. We address your responses below.
Produce Safety Rule Violations
During the inspection, FDA investigators observed the following significant violations of the Produce Safety regulation, 21 CFR Part 112:
1. You 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 of 21 CFR 112.147, as required by 21 CFR 112.144(b), using a method described in 21 CFR 112.153(a). Specifically, you stated that you do not conduct spent sprout irrigation water testing or in-process testing for your spicy sprout blend, your broccoli sprouts or your sunflower shoots. Further, you stated you have not conducted any testing on your spicy sprout blend, your broccoli sprouts or your sunflower shoots since April of 2022. From April 21, 2022, to December 23, 2022, you produced your spicy sprout blend (b)(4) times, your broccoli sprouts (b)(4) times and your sunflower shoots (b)(4) times. You sold these sprouts without conducting spent sprout irrigation water testing or any in-process testing.
In your written response to the FDA 483, dated January 12, 2023, you explain that you will be following a new SOP for testing sprouts grown at your facility. The SOP you provided, “SOP XX-1 Irrigation water testing for Special blends and other sprouts (b)(4),” 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 (b)(4). However, you did not provide any documentation to demonstrate you have implemented and are following this procedure—i.e., you did not provide any documentation to demonstrate that you are testing spent sprout irrigation water from each production batch of sprouts for E. coli O157:H7 and Salmonella spp.
2. You 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, October 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 by 21 CFR 112.153(a). Specifically, on November 22, 2022, following PCR analysis, you received a presumptive positive test result for Salmonella spp. in your spent sprout irrigation water from lot 4211 of alfalfa sprouts. Neither you nor your 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, October 2015 or a scientifically valid method that is at least equivalent to this method of analysis in accuracy, precision, and sensitivity, as required by 21 CFR 112.153(a). Rather, you collected a new sample of spent sprout irrigation water for lot 4211 on November 22, 2022, and submitted it for analysis. Following the new sample showing a negative analysis result for Salmonella spp., you released the product for shipment into interstate commerce to your 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, you submitted your updated protocol on handling positive lab testing results, identified as “SOP XX. PROCEDURE FOR POSITIVE LAB,” to our investigator. As written, this procedure indicates that if you receive a presumptive positive result, you 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 our next inspection.
3. You did not clean and sanitize food contact surfaces that you use to grow, harvest, pack, or hold sprouts before contact with sprouts or seeds or beans used to grow sprouts, as required by CFR 112.143(b). Specifically, on January 4, 2023, our investigators observed significant filth on the irrigation nozzles for your mister. These nozzles are food contact surfaces used to water your sprouts growing (b)(4). Water from the misters comes into contact with the harvestable portion of the sprouts that you grow ((b)(4)). You stated the nozzles were last cleaned (b)(4) prior to January 4, 2023.
In your written response to the FDA 483, dated January 12, 2023, you attached a cleaning schedule for the mister nozzles (“Mister Nozzle Cleaning Schedule”). In the procedure, Mister Nozzle Cleaning Schedule, the misters would be cleaned (b)(4). During our inspection, you told our investigators that the observed filth on the misters were from (b)(4) of use since the previous cleaning. As the visible filth was observed on the misters after (b)(4) of use, this indicates that cleaning and sanitizing your mister nozzles on a (b)(4) quarterly basis (i.e., every (b)(4)), as identified in your written response, is not adequate to comply with the requirements of 21 CFR 112.143(b).
4. You did not meet the requirement that at least one supervisor or responsible party for your farm must have successfully completed food safety training at least equivalent to that received under standardized curriculum recognized as adequate by FDA, as required per 21 CFR 112.22(c). 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 our inspection, you explained to our investigators that neither you 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 your employees have successfully completed at least the equivalent of the standardized curriculum, food safety training for sprouts growers (Sprouts Safety Alliance Training).
In your written response to the FDA 483, dated January 12, 2023, you stated your intention to complete part one and part two of the Sprout Safety Alliance Growers Training by the end of the calendar year. You attached your receipt for purchase of the course in your January 26, 2023, written response. The adequacy of your corrective action will be evaluated during the next inspection.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you with an opportunity to address them. Failure to adequately address this matter may result in legal action by the FDA without further notice, including, without limitation, seizure and/or injunction.
In addition to the above, we offer the following comments:
- Your SOP titled “Sprouts Protocol for Hold & Release Testing” states, “Once lab receives the samples they will do a composite testing of the water samples. No more that [sic] the water from (b)(4) will be consolidated into a single sample of water to be tested.” This method, known as pooling, refers to the practice of combining samples from multiple growing units to create one sample for testing. When utilizing this sampling strategy, in the event of a pathogen positive or presumptive positive test, that result is applicable to all lots pooled, in the absence of additional separate testing.
Please notify FDA in writing, within fifteen (15) working days from your receipt of this letter, of the specific steps that you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your response should be sent to U.S. Food and Drug Administration, Attention: Andrew A. Hoopes, Compliance Officer, 8050 Marshall Drive, Suite 205, Lenexa, KS 66214. If you have questions regarding this letter, please contact Compliance Officer Hoopes at (515) 244-0480 ext. 1002 or via e-mail at: firstname.lastname@example.org.
LaTonya M. Mitchell, Ph.D.
Program Division Director
Office of Human and Animal Food Operations
West Division II