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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Tiny Greens 5/5/11


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863


May 5, 2011
William R. Bagby, Jr.
Tiny Greens
2314 North Highcross Road
Urbana, Illinois 61802
Dear Mr. Bagby:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your sprouting facility located at 2314 North Highcross Road, Urbana, Illinois on December 20, 2010 through January 28, 2011. 
This inspection was conducted as a result of an epidemiological and traceback investigation that linked a Salmonella enterica serotype (b)(5) outbreak to sprouts grown in your facility. This outbreak sickened approximately (b)(5) states between November 1, 2010 and February 9, 2011. During the inspection, FDA collected several environmental samples from your facility.  One sample, (b)(5), included subsamples collected from the aqueous runoff of a compost pile outside of your facility. One such subsample from this sample yielded a strain of Salmonella that was indistinguishable from the outbreak strain, as determined through Pulse Field Gel Electrophoresis (PFGE). We have included a copy of the PFGE results with a comparison of those taken from a cluster of cases (see attachment 1).
During our inspection, we documented conditions and practices that are likely to have contaminated your product with the Salmonella outbreak strain. Accordingly, the sprouts grown in your facility 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 been contaminated with filth or rendered injurious to health. You can find the Act through links on FDA’s homepage at www.fda.gov.
The following insanitary conditions were observed:

• Run-off water from the compost pile was pooling into a drain along the walkway 11 feet from the entrance to the greenhouse. The subsample that yielded the Salmonella outbreak strain was taken from this siteAn employee entered the compost area to dump production waste. After walking through the compost pile and water that had pooled along the walkway, the employee returned to the production area wearing the same clothing and boots that he had worn outside.  In addition, two employees pushed a cart containing trays of alfalfa sprouts from the sprouting area, (b)(4), out through the greenhouse exit. After walking and wheeling the cart through the compost pile, the employees returned to the production area with the cart, wearing the same clothing and boots that they had worn outside. The employees did not clean or disinfect their boots or the cart at any time between these two activities.

• The sink employees use to wash their hands in the lunch room before entering the production area had a hose with a valve on its end that was leaking water onto the floor where there was a substantial amount of foot traffic. Organic matter, in conjunction with wet conditions, such as those observed in your facility, foster the growth of Salmonella and other pathogens. 

• An employee placed a screen from a shaker table on the floor and rinsed it with a hose. This operation was performed within 2 inches of open trays of germinated sprouts. Aerosol water droplets from the water stream onto the floor were splashing into the trays of germinated sprouts.

• Germination drum plexi-glass doors were stored on the drum frames less than 12 inches from the floor. The drum closest to the greenhouse door had all four doors stored in this manner. Water and debris from the floor was observed splashed onto the doors. The doors were not cleaned prior to installation on the germination drum.

• Sprouts were unloaded from the germination drums into white perforated pails on dollies. When the dollies were rolled to the table for placing the sprouts in trays, water from the rotating wheels on the floor was observed splashing up on the perforated pails with access to the sprouts.

We acknowledge your letter dated February 6, 2011, discussing your proposed corrective actions. We note that documentation of your corrective actions was not included with your response. Your proposed corrective actions are also inadequate for the following reasons:
• You state that boots and galoshes worn in the production area will no longer be allowed outside the building, but you do not state that you are taking any precautions to ensure that carts wheeled  through the outdoor compost area will be cleaned prior to entering the production area, to prevent pathogens from getting onto the production area floor where they may be splashed onto sprouts.

• Your response does not address the hose with the leaking valve under the lunch room sink.

The adequacy of the corrective actions you submitted will be further assessed at our next inspection. 
This letter is not intended to include an exhaustive list of the violations at your facility. It is your responsibility to ensure compliance with applicable food safety laws and regulations administered by FDA. You should investigate and determine the causes of the violations and take prompt actions to correct them to bring your products into compliance. Failure to promptly correct these violations may result in legal action without further notice including, but not limited to, seizure and injunction.
In addition to the violations discussed above, we have the following comments:

• We observed that micro-greens were being grown using the compost you generate at your facility. We acknowledge that in your letter dated February 6, 2011, (b)(4). Because the pathogen implicated in the outbreak that occurred between November 1, 2010 and February 9, 2011 was isolated from run-off from your compost, we strongly recommend that all compost you use to grow food is treated with a scientifically valid process to kill pathogens, and that you have an adequate monitoring program to verify your process. You may find additional guidance related to the storage of composted materials in FDA’s Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, which is available at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/


• At the inspection, FDA recommended that you change your method of seed treatment because your practice is not in accordance with the label directions and you do not have evidence that your practice is equivalent to the label directions. In your letter dated February 6, 2011, you proposed that (b)(4). Because the drums rotate, we do not consider it to be possible that the drums will stay evenly filled and therefore it will not be possible to ensure sufficient immersion of the seeds in the sanitizer. You may find it helpful to consult FDA’s guidance document, Guidance for Industry: Reducing Microbial Food Safety Hazards for Sprouted Seeds, which includes information on recommended seed treatment methods, including means of ensuring seed contact time with appropriate sanitizers and is available at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/

GuidanceDocuments/ProduceandPlanProducts/ucm120244.htm. You may also find it helpful to watch the training videos jointly developed by the California Department of Public Health and the FDA to assist the industry in producing safer sprouts. These videos are available at: http://postharvest.ucdavis.edu/Pubs/video-library.shtml#Sprouts.

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or other, similar, violations, from occurring again.  Include documentation of the corrective actions you have taken.  If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Please send your reply to the Food and Drug Administration, Attention: Rosemary Sexton, Compliance Officer, at the address above. If you have any questions regarding any issues in this letter, please contact Ms. Sexton at 312-596-4225 or rosemary.sexton@fda.hhs.gov.
Scott MacIntire
District Director