Responding to an Outbreak of Salmonella Bredeney: A Collaboration Between the FDA, CDC, and State Health Partners

BACKGROUND:  

In September 2012, the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the New Mexico Environmental Department investigated an outbreak of illnesses caused by Salmonella Bredeney associated with consumption of Trader Joe’s Valencia Creamy Salted Peanut Butter  (PB) manufactured by Sunland, Inc. of Portales, New Mexico.

METHODS:  

Epidemiology: A total of 42 persons infected with the outbreak strain were reported from 20 states; 61% of cases were children <10 years old. Of 33 case-patients who completed the food exposure questionnaire, 78% reported shopping at different locations of Trader Joe’s, a major grocery chain; 100% of the cases purchased PB produced by a single manufacturer, Sunland, Inc.

Laboratory: FDA and state partners collected product samples at the manufacturer, retail locations, and case patient’s homes; additionally, FDA collected environmental samples at the manufacturer. S. Bredeney with a PFGE pattern matching the outbreak strain was isolated from opened jars of PB from case-patients’ homes, as well as from retained products and the environment at the firm.  In addition, Salmonella Cerro, Meleagridis, Anatum, Mbandaka, and Kiambu were isolated from the manufacturer’s environment.

RESULTS:  

Investigation: Sunland, Inc. was identified as the sole contract manufacturer of the implicated PB. CDC, FDA, and the states collaborated with both Trader Joe’s and Sunland, Inc. to promptly recall implicated products. The FDA investigated Sunland, Inc., collecting samples, records, and production information from the firm. Investigators found multiple GMP deficiencies and determined that the firm’s internal controls were insufficient to prevent shipment of contaminated product. As a result of FDA’s investigational findings, the initial recall was later expanded to include multiple other products.

CONCLUSIONS:  

Conclusion: The combination of laboratory, investigational, and epidemiologic findings led to the rapid recall of the implicated PB and subsequent expansion to additional Sunland, Inc. products. Based on the firm’s history of violations, FDA took the additional step of suspending Sunland, Inc.’s registration to prevent additional contaminated product from reaching consumers. The collaboration between CDC, FDA, state and local public health officials, and industry partners led to prompt removal of the product and prevention of additional illnesses.