In late 2010, the CDC reported that thirty-eight persons infected with E. coli O157:H7 were reported from five states. The number of ill persons identified in each state was as follows: AZ (19), CA (3), CO (11), NM (3) and NV (2). There have been 15 reported hospitalizations, 1 case of hemolytic uremic syndrome (HUS), and no deaths. In response to this outbreak and subsequent inspections, Bravo Farms recalled all of its cheeses. The action followed laboratory testing by the California Department of Food and Agriculture that reveals the presence of Listeria monocytogenes and E. coli O157:H7 in cheese samples.
Now, the FDA has filed an action against Bravo (actually its cheese) and is in the process of seizing it (See Complaint). It appears, according to recently filed Court documents, that when the FDA investigators conducted an inspection of Bravo Farms, LLC between November 4 and December 1, 2010 (See Inspection). FDA investigators observed the following insanitary conditions whereby food may have become contaminated with filth or whereby food may have been rendered injurious to health:
a. Plant buildings and structures are not of suitable size, construction, and design to facilitate maintenance and sanitary operations for food-manufacturing purposes. Employees must travel from the in-process area directly through the finished product areas without sufficient controls to prevent cross-contamination, and uncovered in-process materials are transported outside of the building, exposed to the open environment.
b. Adequate measures under the conditions of manufacturing and handling are not being taken to destroy or prevent the growth of undesirable microorganisms particularly those of public health significance, to prevent the food from being adulterated within the meaning of the Act. The firm lacks the controls necessary to assure that cheese manufactured from raw (unpasteurized) milk is aged for the minimum requirement of 60 days.
c. Equipment containers and utensils used to convey, hold, or store raw materials, work-in-progress, rework, or food, are not handled and maintained during manufacturing or storage in a manner that protects against contamination. The firm utilizes the same equipment for young (unaged) cheese and aged cheese, without assuring proper cleaning and sanitization to prevent cross contamination.
d. Effective measures are not being taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. At least fifty (50) flies were observed in the processing areas of the firm, a rabbit was seen leaving the room in which packaging material for finished is stored, and gaps were observed around doors leading into the processing area.
e. The facility is not constructed in such a manner that drip or condensate does not contaminate food, food-contact surfaces, or food-packaging materials. Condensate was observed directly over an uncovered vat of in-process cheese.
f. Employees are not washing hands thoroughly and sanitizing if necessary to protect against contamination with undesirable microorganisms in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated. An employee was observed dipping his hands in the utensil sanitizing bath and the proceeding to mix in-process cheese with his bare hands, and an employee scratched his chin under his beard cover and then mixed the milled cheese with his bare hands without washing or sanitizing his hands.
FDA investigators collected environmental samples from within the Bravo Farms production facility. A sample collected from a food contact surface was found positive for Listeria monocytogenes, a pathogenic organism which can cause serious and sometimes fatal infections in children and the elderly.
CDFA collected finished product samples from Bravo Farms, LLC and analyzed those samples for E. coli O157:H7 and L. monocytogenes. Fifteen (15) of the twenty-four (24) samples were found positive for L. monocytogenes. These samples represent four types of cheese produced by the firm: Cheddar, Edam, Gouda, and Jack. The positive samples come from cheese produced over four (4) month time period. One CDFA sample of cheddar cheese was found positive for E. coli O157:H7. This sample was analyzed by FDA using pulsed field gel electrophoresis (PFGE) and found to be indistinguishable from the E. coli O157:H7 strain associated with the outbreak.
As a result of the multiple positive samples for pathogenic bacteria representing approximately four (4) months of production, on November 22, 2010, CDFA imposed a quarantine on all types, varieties and flavors of cheese manufactured, handled, or packaged by Bravo Farms, LLC and ordered a recall of all cheese distributed by Bravo Farms, LLC.
Therefore, the Federal Court issued a Warrant to seize the cheese to prevent further distribution of the cheese (See Warrant).
See my five part series on raw milk and the “60 day rule” – Part 1, Part 2, Part 3, Part 4 and Part 5, as well as Outbreaks, illnesses and recalls linked to raw (unpasteurized) and pasteurized dairy products, United States, 2010. Lets See what the LA Times has to say on the topic: