February 4, 2009
Recall of Peanut-Containing Products
February 4, 2009
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. 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, FDA confirmed that FDA’s Office of Criminal Investigations is involved in a Justice Department investigation of PCA.
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.
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.
Major national brands of jarred peanut butter found in grocery stores are not affected by the PCA recall.
FDA and CDC recommendations for consumers include:
Consumers are urged to check FDA’s web site to determine which products have been recalled and will be recalled in the coming days.
Any product that is on the recall list should be disposed of in a safe manner. Consumers are also urged to wash their hands after handling potentially contaminated products.
If consumers are unsure whether a peanut-containing product is potentially contaminated, they should avoid consuming it or feeding it to their pet until they obtain more information regarding the product.
Persons who think they may have become ill from eating peanut products are advised to consult their health care providers.
Stop selling recalled products.
For Directors of Institutions and Food Service Establishments
Ensure that they are not serving recalled products.
Inform consumers about whether their products could contain peanuts or peanut products from the Peanut Corporation of America (PCA). If a manufacturer knows its products do not contain peanuts or peanut products from PCA, it may wish to provide this information to consumers. For specific guidance: Guidance for Industry: Product Recalls, Including Removals and Corrections
The FDA will closely monitor these events by continuing to work with the firms on the details of their actions, conducting follow-up audits and inspections, monitoring the progress of the firms’ actions, working with state and local regulatory authorities, and notifying our foreign regulatory counterparts of products that have now been confirmed as having been distributed internationally.
FDA has collaborated with the Centers for Disease Control and Prevention (CDC) and public health officials in various states to investigate the multi-state outbreak of human infections due to Salmonella Typhimurium. An epidemiological investigation by the Minnesota Department of Health isolated and tested subsamples from an open five-pound container of King Nut peanut butter obtained at a nursing home where three patients were sickened by the outbreak strain of Salmonella Typhimurium. The Minnesota Health officials found the peanut butter contained the same strain of Salmonella Typhimurium associated with the illnesses linked to the outbreak.
Because it is always possible that the open container was contaminated by someone or something else in the environment, the FDA and the states began testing unopened containers of the same brand of peanut butter. King Nut distributes peanut butter manufactured by the PCA to institutional facilities, food service industries, and private label food companies in several states.
On January 19, 2009, testing by the Connecticut Department of Health of an unopened container of King Nut peanut butter showed that it too contained the same strain of Salmonella Typhimurium associated with illnesses linked to the outbreak. The fact that the Salmonella Typhimurium was confirmed in an unopened container of peanut butter indicates that peanut butter originating from the processing plant was contaminated. FDA has initiated inspections at the direct consignees of PCA and King Nut and continues to follow the distribution points for products.
The FDA has no evidence to suggest that the Salmonella Typhimurium contamination originated with any manufacturing facility other than PCA. The PCA facility in Blakely, Georgia is not operating at this time and the company has recalled all peanuts and peanut products produced there from January 1, 2007, to the present.
The FDA and food manufacturers are working to identify products that may be affected, and to track the ingredient supply chain of those products to facilitate their removal from the marketplace.
Posted by handh at February 4, 2009 9:03 PM