Inspections, Compliance, Enforcement, and Criminal Investigations
Tiny Greens 5/5/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
• 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 site. An 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.
• Your response does not address the hose with the leaking valve under the lunch room sink.
• 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.