| Public Health Service Food and Drug Administration |
Seattle District |
Department of Health and Human ServicesOctober 19, 2011
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 12-01
Nadine P. Scharf
President and Owner
Evergreen Fresh Sprouts, LLC
P.O. Box 786
Moyie Springs, Idaho 83845
WARNING LETTER
Dear Mrs. Scharf:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your sprout growing facility located at 488 Settlers Lane, Moyie Springs, Idaho on June 22-29, 2011, and July 1, 2011. This inspection was conducted as a result of an outbreak of human infections of Salmonella Enteritidis. Collaborative investigative efforts of local, state, and federal public health and regulatory agencies linked this outbreak to Evergreen Produce brand alfalfa sprouts and spicy sprouts. The sprouts were distributed to various customers in Idaho, Montana, Washington State, and possibly to retailers in neighboring states. As of July 6, 2011, this outbreak sickened approximately 25 people in five states between April 12, 2011, and July 5, 2011.
On June 29, 2011, FDA hand delivered a FDA Requested Recall letter to you requesting that you immediately initiate a recall of all varieties and all package sizes of alfalfa and spicy sprouts grown and distributed by your firm and sold under the Evergreen Produce brand. We acknowledge your cooperation in recalling your alfalfa and spicy sprouts from the marketplace, and voluntarily disposing your alfalfa seeds, and in-process and finished alfalfa and spicy sprouts in your facility.
During the inspection, FDA collected several finished products including alfalfa and spicy sprouts, and environmental samples from your facility. We notified you on July 25, 2011, that our laboratory analyses of the samples did not yield Salmonella. Although our samples did not yield Salmonella, our investigators documented insanitary conditions and practices that may have contributed directly or indirectly to contamination of your sprouts with pathogens. 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)] because 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 and practices were observed:
1. Employees may have cross-contaminated the sprouts as evidenced by:
a. Employees handled hoist controls and resumed working directly with sprouts in the Bubbler Tank and the Bean Harvester Tank in the Green (Sprout) Room without washing and sanitizing or changing their gloves.
b. Employees left the production area and building without removing their gloves or aprons and upon return worked directly with sprouts without sanitizing or changing their gloves or aprons.
c. An employee donned a production apron by lowering it to the floor, where it touched the floor, and then stepped into it. Although the apron had touched the floor, the employee did not sanitize the apron prior to working directly with sprouts.
The unsanitized surfaces described above may harbor pathogens. Employees that contact these surfaces and then work with food, may have cross-contaminated the food.
2. Sprouts may have been cross contaminated as evidenced by:
a. The waterlines mounted along the ceiling in the Green (Sprout) Room and directly above open uncovered vats of in-process germinated sprouts were visibly unclean and had what appeared to be mold or algae growth. Dripping condensate from the waterlines fell onto the sprouts.
b. Dirt and condensate build-up on the water lines mounted along the ceiling and above the germinated bean sprouts in the Bean Room.
c. Dirt and sprout residue on the ceiling area above the open Bean Harvester Tank located in the Green (Sprout) Room and the open Bean Soak Tank in the Bean Room.
d. The fan guards on the oscillating fan were dirty and the fan was blowing directly onto in-process bean sprouts awaiting spin drying in the Green (Sprout) Room.
e. The cooling blower unit of your refrigerated truck used to deliver finished sprouts was covered with dirt and dust.
f. Pools of standing water on the floor of the Green (Sprout) Room and the Bean Room. Employees indicated that these floor drains were inoperable. Employees that handled sprouts walked through these pools then throughout the production and packaging areas, the employee break room, and the restroom. Standing water may serve as a reservoir of pathogens as well as a route of contamination. Employees and equipment may contaminate the sprouts or food contact surfaces through splashing.
3. Food contact surfaces were insanitary as evidenced by:
a. Residues of bean spouts inside the bean harvester tank and in the harvester and residues of seed hulls inside the spin bucket after your production employees identified the equipment as having been cleaned and ready to use.
b. The pitchfork used on finished sprouts was stored in a visibly dirty bucket.
Food contact surfaces must be thoroughly cleaned and sanitized to avoid serving as a source and route of filth and pathogens in food.
The above items are not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with the applicable laws and regulations administered by FDA. You should take prompt action to correct these violations. Failure to do so may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.
Please notify this office in writing within fifteen (15) working days of receipt of this letter describing the specific steps you have taken to correct the noted violations and to prevent these violations or other similar violations from occurring again. Include documentation of the corrective actions you have taken to date. If your planned corrections will occur over time, please state the reason for the delay and include a timetable for implementation of those corrections.
During the inspection, our investigators provided you a copy of the Guidance for Industry: Reducing Microbial Food Safety Hazards for Sprouted Seeds, and Guidance for Industry: Sampling and Microbial Testing of Spent Irrigation Water During Sprout Production, both dated October 27, 1999. In cooperation with FDA, University of California at Davis also developed of series of videos related to sprout safety (http://postharvest.ucdavis.edu/libraries/video/). These documents are considered guidance and are designed to assist you in complying with the Food, Drug, and Cosmetic Act. If you plan to implement an alternative approach to treating seed and testing spent irrigation water that will provide comparable assurances of detecting and controlling pathogenic bacteria in your sprouts, please provide a copy of your sampling schedule and testing method to the address below.
Please send your reply to the U.S. Food and Drug Administration, Attention: Peter C. Chow, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have questions regarding this letter, please contact Mr. Chow at 425-483-4766.
Sincerely,
/s/
Charles M. Breen
District Director
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