The FDA, the CDC and state and local public health officials in September 2012 began investigating a multi-state outbreak of Salmonella Bredeney infections eventually linked to peanut butter made by Sunland Inc. of Portales, New Mexico.
According to the Center for Disease Control and Prevention (CDC), as of November 8, 2011, a total of 41 persons infected with the outbreak strain of Salmonella Bredeney have been reported from 20 states. The number of ill persons identified in each state is as follows: Arizona (1), California (7), Connecticut (3), Illinois (1), Louisiana (1), Massachusetts (3), Maryland (1), Michigan (1), Minnesota (1), Missouri (2), Nevada (1), New Jersey (2), New Mexico (1), New York (2), North Carolina (2), Pennsylvania (2), Rhode Island (1), Texas (5), Virginia (2), and Washington (2). Among persons for whom information is available, illness onset dates range from June 14, 2012, to September 21, 2012. Ill persons range in age from less than 1 year to 79 years, with a median age of 6 years. Sixty-three percent of ill persons are children under the age of 10 years. Sixty percent of ill persons are male. Among 36 persons with available information, 10 (28%) patients reported being hospitalized. No deaths have been reported.
Testing conducted by the New Jersey Department of Health, Virginia Division of Consolidated Laboratory Services, and Washington State Department of Agriculture laboratories isolated the outbreak strain of Salmonella Bredeney from opened jars of Trader Joe’s Valencia Creamy Peanut Butter collected from case-patients’ homes.
On September 20, FDA, the CDC and the state of California briefed Trader Joe’s on the status of the investigation, and the company voluntarily removed the suspected product from their store shelves. Trader Joe’s has also posted a customer advisory on their internet page and initiated a recall.
On September 23, FDA and CDC briefed Sunland Inc. on the status of the investigation and the company voluntarily recalled the almond butter and peanut butter products that were manufactured on the same product line as Trader Joe’s Valencia Creamy Salted Peanut Butter between May 1 and September 24, 2012.
On October 4, Sunland Inc. expanded its ongoing recall to include all products made in the Sunland nut butter production facility between March 1, 2010 and September 24, 2012. The company added 139 products to the recall, bringing the total number of products recalled by Sunland Inc. to 240. On October 12, Sunland Inc. expanded its ongoing recall to include raw and roasted shelled and in-shell peanuts sold in quantities from 2 ounces to 50 pounds which are within their current shelf life or have no stated expiration date.
On October 5, the FDA announced that environmental samples taken in the Sunland Inc. nut butter production facility showed the presence of Salmonella. Subsequent analysis determined that Salmonella Bredeney with a DNA fingerprint that is the same as the outbreak strain was present in the samples. Additionally, FDA analysis confirmed that peanut butter made in the Sunland nut butter facility showed the presence of Salmonella with a DNA fingerprint that is the same as the outbreak strain of Salmonella Bredeney. Testing conducted by the Washington State Department of Agriculture laboratory isolated the outbreak strain from an opened jar of Trader Joe’s Valencia Creamy Peanut Butter collected from a case-patient’s home.
As part of the continuing investigation, the FDA also inspected the Sunland Inc. production facilities, which include a building in which peanuts are processed and a separate building in which nut butters are made. On October 13, FDA announced that testing has found the presence of Salmonella in raw peanuts from the peanut processing facility. Environmental samples taken from this building showed the presence of Salmonella.
The FDA has now made the observations from its recent inspection of Sunland Inc. publicly available. This inspection was conducted between September 17 and October 16, 2012, and became part of the investigation of the Salmonella Bredeney outbreak linked to peanut butter made by Sunland Inc.
During this inspection investigators found that conditions in the company’s facility, the company’s manufacturing processes, and the company’s testing program for Salmonella may have allowed peanut butter that contained Salmonella to be distributed by the company. The FDA found that between June of 2009 and August of 2012, Sunland Inc. had distributed, or cleared for distribution, portions of 11 lots, or daily production runs, of peanut or almond butter after its own testing program identified the presence of at least one of nine different Salmonella types (Arapahoe, Bredeney, Cerro, Dallgow, Kubacha, Mbandaka, Meleagridis, Newport, and Teddington) in those lots. Two of these lots showed the presence of the outbreak strain of Salmonella Bredeney.
Five product samples collected and analyzed by FDA from Sunland Inc. showed the presence of Salmonella, but had not been identified as containing Salmonella by Sunland Inc.’s internal testing. Among those products were peanut butter and shelled raw peanuts. Two of these samples showed the presence of the outbreak strain of Salmonella Bredeney. Additionally, during its inspection of the plant in September and October 2012, the FDA found the presence of Salmonella in 28 environmental samples. Three of these samples showed the presence of the outbreak strain of Salmonella Bredeney.
Additionally, investigators found that employees improperly handled equipment, containers, and utensils used to hold and store food. Employees handling peanut products wiped gloved hands on street clothes and other times failed to wash their hands or change gloves. There were no hand washing sinks in the peanut processing building production or packaging areas and employees had bare-handed contact with ready-to-package peanuts.
There were no records documenting the cleaning of production equipment. The super-sized bags used by the firm to store peanuts were not cleaned despite being used for both raw and roasted peanuts. There was a leaking sink in a washroom which resulted in water accumulating on the floor, and the plant is not built to allow floors, walls and ceilings to be adequately cleaned.
Finally, investigators found that raw materials were exposed to potential contamination. Raw, in-shell peanuts were found outside the plant in uncovered trailers. Birds were observed landing in the trailers and the peanuts were exposed to rain, which provides a growth environment for Salmonella and other bacteria. Inside the warehouse, facility doors were open to the outside, which could allow pests to enter.
Marler Clark, The Food Safety Law Firm, is the nation’s leading law firm representing victims of Salmonella outbreaks. The Salmonella lawyers of Marler Clark have represented thousands of victims of Salmonella and other foodborne illness outbreaks and have recovered over $600 million for clients. Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation. Our Salmonella lawyers have litigated Salmonella cases stemming from outbreaks traced to a variety of foods, such as cantaloupe, tomatoes, ground turkey, salami, sprouts, cereal, peanut butter, and food served in restaurants. The law firm has brought Salmonella lawsuits against such companies as Cargill, ConAgra, Peanut Corporation of America, Sheetz, Taco Bell, Subway and Wal-Mart.