As of April 20, 2015 the CDC reported a total of ten patients infected with several strains of Listeria reported from four states: Arizona (1), Kansas (5), Oklahoma (1), and Texas (3). Illness onset dates ranged from January 2010 through January 2015. All ten patients were hospitalized. Three deaths were reported from Kansas. After those illnesses and deaths were linked to Blue Bell products, the FDA launched an investigation on the three manufacturing facilities in Texas, Oklahoma and Alabama. What likely formed the basis of the criminal investigation is that Listeria was isolated from non-food contact areas within the Broken Arrow, Oklahoma processing room and kitchen and from non-food contact surfaces of production equipment. These included 5 samples in 2013, 10 samples in 2014, 1 sample in January, and 1 sample in February of 2015. In addition, environmental samples collected by the FDA on March 24, 2015 and March 25, 2015 tested positive for Listeria. In addition, total coliform greater than 20 Colony Forming Units (CFUs)/mL was identified in finished product, in process product batches, and raw ingredients in 6 samples during April 2014, 8 samples during January 2015, 23 samples during February 2015, and 10 samples during March 2015. A CFU is a unit used to estimate the number of viable bacteria or fungal cells in a sample. Viable is defined as the ability to multiply via binary fission under the controlled conditions. So, Blue Bell knew there were positive bacterial tests in one of its plants, and in products, over an extended period of time that likely contributed to the outbreak. Here are the highlights of the FDA plant investigations in 2015:
Observation #1: Failure to manufacture and package foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.
Observation #2: Failure to perform microbial testing where necessary to identify sanitation failures and possible food contamination.
Observation #3: The procedure used for cleaning and sanitizing of equipment and utensils has not been shown to provide adequate cleaning and sanitizing treatment.
Observation #4: Failure to provide running water at a suitable temperature for cleaning equipment, utensils and food-packaging materials.
Observation #5: The plant is not constructed in such a manner as to prevent drip and condensate from contaminating food, food-contact surfaces, and food-packaging materials.
Observation #6: Employees did not wash and sanitize hands thoroughly in an adequate hand-washing facility after each absence from the work station and at any time their hands may have become soiled or contaminated.
Observation #7: Failure to store cleaned and sanitized portable equipment in a location and manner which protects food-contact surfaces from contamination.
Observation #8: All reasonable precaution are not taken to ensure that production procedures do not contribute contamination from any source.
Observation #9: The design of equipment does not allow proper cleaning and maintenance.
Observation #10: Failure to hold foods which can support the rapid growth of undesirable microorganisms at a temperature that prevents the food from becoming adulterated.
Observation #11: Failure to have smoothly bonded or well maintained seams on food contact surfaces, to minimize accumulation of food particles and organic matter and the opportunity for growth of microorganisms.
Observation #12: Failure to take apart equipment as necessary to ensure thorough cleaning.
Observation #1: Failure to manufacture foods under conditions and controls necessary to minimize the potential for growth of microorganisms.
Observation #2: The procedure used for cleaning and sanitizing of equipment has not been shown to provide adequate cleaning and sanitizing treatment.
Observation #3: The plant is not constructed in such a manner as to prevent condensate from contaminating food and food-contact surfaces.
Observation #4: Failure to clean food-contact surfaces as frequently as necessary to protect against contamination of food.
Observation #5: Failure to wear beard covers in an effective manner.
Observation #6: Failure to maintain buildings in repair sufficient to prevent food from becoming contaminated.
Observation #1: Failure to perform microbial testing where necessary to identify possible food contamination.
Observation #2: Suitable outer garments are not worn that protect against contamination of food and food contact surfaces.
Observation #3: Failure to maintain food contact surfaces to protect food from contamination by any source, including unlawful indirect food additives.
Observation #4: The design and materials of equipment and utensils does not allow proper cleaning.
Observation #5: All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source.
Observation #6: Employees did not wash and sanitize hands thoroughly in an adequate hand-washing facility at any time their hands may have become soiled or contaminated.
Observation #7: The plaint is not constructed in such a manner as to prevent condensate from contaminating food-contact surfaces.
Observation #8: Non food-contact equipment in manufacturing areas is not constructed so that it can be kept in a clean condition.
There is little wonder why a Listeria outbreak happened and why Blue Bell’s plants were shuttered and why there is now a criminal investigation.