SoyNut Butter E. coli Outbreak Leads to Suspension Order Amid List of Violations at Dixie Dew
The E. coli investigation that led to the recall of SoyNut Butter Company’s I.M. Healthy SoyNut Butters and I.M. Healthy Granola products is ongoing. In the course of the investigation, the recall expanded to include Dixie Diner’s Club brand Carb Not Beanit Butter and 20/20 Lifestyle Yogurt Peanut Crunch Bars. The source of the outbreak has been confirmed through both post-illness interviews in what is termed a “trace-back” investigation, and epidemiological evidence finding the strain of E. coli in product that was found in the victim’s homes. As part of the investigation, I.M. Healthy brand SoyNut Butter was collected from victim’s homes of ill people and from retail locations.
The outbreak pathogen turned out to be the most common form of Shiga toxin-producing E. coli, or “STEC”. The strain was identified as O157:H7. The exact same train of O157:H7 has been identified in 30 victims of E. coli in 12 states: The states include Arizona 4, California 5, Florida 1, Illinois 1, Massachusetts 1, Maryland 1, Missouri 1, New Jersey 1, Oregon 9, Virginia, 2, Washington 2, and Wisconsin 1.
The first illness was reported on or about January 4, 2017, and illnesses continued to be identified through at least March 13, 2017. The victims range in age from only 1 to 57 years, with the majority being children (there is a mean age of 8). Twenty-four of 29 victims whose age is known are younger than 18 years. Among ill people, 59% are male.
12 victims have been hospitalized, with 3 in 4 of those developing hemolytic uremic syndrome (HUS), a very serious condition that can lead to kidney failure or death. Fortunately, there have been no fatalities in this outbreak.
According to the CDC, the product was eaten in homes and at childcare centers, schools, and other institutions that served a variety of I.M. Healthy brand SoyNut Butter, I.M. Healthy brand granola, Dixie Diner’s Club brand Carb Not Beanit Butter, or 20/20 Lifestyle Yogurt Peanut Crunch Bars. The large number of children is common in outbreaks associated with peanut butter.
A Suspension Order was issue to Dixie Dew’s in response to the outbreak, and until it is lifted, no food product may leave the facility for sale or distribution.
According to FDA investigators, there was a “failure to perform microbial testing where necessary to identify possible food contamination” at Dixie Dew’s. In addition, the Form 483 inspection and suspension order identified the following:
- investigators observed grossly insanitary conditions that cause your firm’s soy nut butter products to be adulterated;
- food contact surfaces, floors, walls, and ceilings in the soy nut butter processing and packaging rooms were heavily coated with soy nut butter build-up from previous production runs.
- firm does not routinely wash and sanitize smaller pipes, pipe fittings, gaskets, seals, “or the rubber _____ plug” when broken down following a production run;
- firm does not conduct a kill step for SoyNut Butter product remaining in your firm’s mixing kettle leftover from a production run;
- plant Manager stated, up to _____ may remain in the kettle overnight or weekend prior to resuming production. You and your Plant Manager stated the kettle is shut off when product remains in the kettle overnight and/or over the weekend;
- plant manager and maintenance supervisor reported your _____ machine, used for fine mixing of the SoyNut Butter and ________, routinely shuts off during processing. Your Plant Manager stated this occurs one to two times per day and, this problem has persisted for approximately 15 years despite repeated maintenance intended to correct the problem;
- firm monitors the SoyNut ______ with a ______ thermometer, but plant manager stated he has never verified the accuracy of this instrument;
- you and your plant manager report,your temperature probe and chart recorder, initially engineered to verify and record _____ of product in the large mixing kettle, is not functioning properly and has not been used for well over a year.
For more information about the SoyNut Butter E. coli outbreak or to speak to an E. coli lawyer, call 1-888-335-4901,