A combination of epidemiological analysis and laboratory testing by state officials in Minnesota and Connecticut, the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC) have enabled FDA to confirm that the sources of the outbreak of illnesses caused by Salmonella Typhimurium are peanut butter and peanut paste produced by the Peanut Corporation of America (PCA) at its Blakely, Georgia processing plant.
Peanut butter is sold by PCA in bulk containers ranging in size from five (5) to 1,700 pounds. The peanut paste is sold in sizes ranging from 35-pound containers to product sold by the tanker container. Neither of these products is sold directly to consumers.
However, through its investigation, FDA has determined that PCA distributed potentially contaminated product to more than 100 consignee firms, for use as an ingredient in hundreds of different products, such as cookies, crackers, cereal, candy and ice cream.
FDA initiated an inspection of PCA’s Blakely plant on January_9 shortly after learning that this firm might be linked to the ongoing Salmonella outbreak. FDA finished its inspection on January_27. A list of problems observed by FDA investigators during their inspection is available at this link: http://www.fda.gov/ora/frequent/default.htm. An amendment to the original list was issued on February 5, 2009. This list is not a final agency determination regarding compliance. The deficiencies observed indicate that the plant was not compliant with Current Good Manufacturing Practices required by the FDA. These deficiencies are related to cleaning programs and procedures as well as failure to implement steps to mitigate Salmonella contamination in the facility.
On January_28, PCA issued an expanded voluntary recall of all peanuts and peanut products processed in its Blakely, Georgia facility since January 1, 2007. The expanded recall includes all peanuts (dry and oil roasted), granulated peanuts, peanut meal, peanut butter and peanut paste. All of the recalled peanuts and peanut products were made only at the company’s Blakely, Georgia facility.
On January 30, 2009 FDA confirmed that a criminal investigation of PCA is underway.
In the course of gathering information during an investigation, it is sometimes necessary that FDA refine reports and other documents based on new facts that are discovered or further provided by records or by the firm. On January_27, 2009, after an inspection that began on January_9, 2009, FDA Investigators issued form FDA-483 to management of the Peanut Corporation of America. The inspection involved sampling, documentation collection, and included a heavy focus on information needed to document and support product recall activities. After a more detailed review of the many records provided during this inspection, FDA determined that certain information provided by PCA management during the inspection was not consistent with the subsequent analysis of the company’s records. On February 5, 2009, FDA issued the amended FDA-483 to now cover this information and additional details about the private laboratory testing.
Based on statements from the firm’s management during the inspection, FDA’s investigators recorded in the original FDA-483 that the firm had shipped products after having received a positive Salmonella test for the lot, followed by a negative Salmonella test for the lot. Having scrutinized many records related to the firm’s testing and shipping of lots, the investigators have amended their recorded observations to present the variety of testing and shipping circumstances reflected by the firm’s records.
It is important to note that for all lots identified in the FDA-483 (original and amended), the firm received positive Salmonella test results for the products shipped. For example, in some situations the firm received a positive Salmonella test result, followed by a later negative result, and then shipped the products. In some other situations, the firm shipped the products before it had received the positive test results. For these, sometimes the firm received a subsequent negative test, and sometimes no additional testing appears to have been done.
FDA has been working with the company and purchasers of PCA’s peanut butter and peanut paste to identify affected products and facilitate their removal from the market. FDA and state officials have visited in excess of 1,000 firms who purchased PCA products. Now, the same type of work is continuing and includes the additional products in the expanded recall.
Companies nationwide that received product made by PCA have issued voluntary recalls of their products. As FDA gathers additional information about these products, the list of recalled products is expected to expand. FDA has created a searchable database for these products, which can be found at http://www.accessdata.fda.gov/scripts/peanutbutterrecall/index.cfm. The list is updated frequently.
Product recalls include some pet food products that contain peanut paste that was made by PCA. While the risk of animals contracting salmonellosis is minimal, there is risk to humans from handling these products. It is important for people to wash their hands–and make sure children wash their hands–before and, especially, after feeding treats to pets. Further information for consumers is located in the Frequently Asked Questions section located on this web site. The pet food products are also included in the searchable data base of recalled products.
Source: U.S. Food and Drug Administration, USA