On November 4, 2010, the Centers for Disease Control and Prevention (CDC) issued an alert to consumers and health professionals about an outbreak of E. coli O157:H7 in five states: Arizona, California, Colorado, New Mexico and Nevada. The alert was based on epidemiological evidence linking at least 25 E. coli O157:H7 illnesses in those states to a cheese product called “Bravo Farms Dutch Style Gouda Cheese” that the defendant manufactured and distributed to Costco Warehouses. Costco offered the cheese product for sampling and sale at the “cheese road show” held at certain Costco Warehouses, including the location at Christown Spectrum Mall in Phoenix, Arizona, from October 5 to November 1, 2010.
Further investigation by the CDC and various state and local health agencies demonstrated that 38 E. coli O157:H7 cases from Arizona, California, Colorado, New Mexico and Nevada in the outbreak shared an indistinguishable DNA fingerprint pattern. The fingerprint pattern has never been seen before in the PulseNet database, which is the national subtyping network made up of state and local public health laboratories and federal food regulatory laboratories.
In a remarkable move, U.S. marshals and Food and Drug Administration agents raided Bravo Farms and seized the gouda, along with piles of edam and blocks of white cheddar on January 27, 2011. Investigators seized more than 80,000 pounds of cheese with the intent of disposing of it as garbage. This development is remarkable because the FDA so rarely feels compelled to actually visit a food manufacturing facility and impound potentially contaminated food items. Typically, the manufacturer has long since disposed of the implicated food at the FDA’s request. It takes a rare combination of egregious manufacturing conditions and a lack of cooperation to induce such FDA action. With Bravo Farms, federal authorities reported:
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
Additionally, 15 of 24 cheese samples collected tested positive for Listeria monocytogenes, a pathogenic organism that can cause serious and sometimes fatal infections in children and the elderly. The samples came from four different types of Bravo Farms cheese, including cheddar, edam, gouda, and jack. And one sample, a cheddar cheese, tested positive for E. coli O157:H7. As a result of the multiple positive samples for pathogenic bacteria representing approximately four (4) months of production, on November 22, 2010, the California Department of Food and Agriculture 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.