Recent Recalls Provide Insight in Avoiding Future Contaminations

The recent massive recall of food products containing peanuts and other peanut ingredients distributed by the Peanut Corporation of America (PCA) offers several insights into steps the food industry can take to avoid future contaminations and recalls. The recall also highlights the fact that the industry must take responsibility for safeguarding our nation’s food supply, because the U.S. Food and Drug Administration (FDA) currently lacks the resources to do so.

The PCA recall, which began in the fall of 2008 with the recall of millions of dollars worth of peanuts and peanut ingredients contaminated with Salmonella, is the largest food recall in American history. The resulting outbreak of illness due to Salmonella contamination sickened more than 700 people in 46 states and killed at least nine people. The recall led to federal investigations and several Congressional hearings, and resulted in PCA filing for bankruptcy protection while being charged with knowingly introducing contaminated peanut products into U.S. interstate commerce.

Aside from the human toll, PCA’s distribution of contaminated product into the U.S. food supply chain has had an undetermined effect on the hundreds of food processing facilities that incorporated PCA’s ingredients into finished products that were then distributed widely throughout the United States. As discussed below, testimony given at Congressional oversight hearings, as well as federal investigations into the recall, have helped to determine what caused the contamination and what can be done to prevent a recall of this magnitude from occurring again.

Know Your Suppliers

While it may seem that food processors should be able to identify the sources of the food ingredients coming into their facilities, federal investigators found that they cannot. Earlier this year, the Office of Inspector General (OIG) at the Department of Health and Human Services conducted an investigation into traceability in the food supply chain to gauge compliance with the FDA’s records maintenance requirements, enacted pursuant to the Bioterrorism Act. The records maintenance rule requires food manufacturers to maintain records that identify the immediate previous source, immediate subsequent recipient, and transporter(s) of their products.

Though the records maintenance requirements have been in effect for more than three years, the OIG found that most food manufacturers and distributors that were investigated could not identify the suppliers (or recipients) of their products. In particular, the investigation found that 59% of facilities in the study did not comply with the FDA’s records maintenance requirements. (See “Traceability in the Food Supply Chain,” Department of Health and Human Services, Office of Inspector General, March 2009, available at In addition, one quarter of the food facilities involved in the study were not even aware that they were supposed to be able to trace product from their suppliers.

The investigation also revealed that of the 40 selected food products traced through the supply chain, only five could be traced all the way through the supply chain at each stage, although the facilities that likely handled the products could be identified for about 31 out of the 40 products. The findings of the OIG investigation help to explain why some food firms, particularly smaller firms not aware of compliance obligations under the FDA’s rules, continued to conduct recalls associated with PCA product well into the spring of 2009.

As the OIG investigation and the PCA recall demonstrated, a food processor’s ability to identify the ingredient source quickly is essential to identifying potentially contaminated product. This is especially true in situations in which firms source bulk ingredients from several suppliers—ingredients that are then commingled into a common bin. In fact, the investigation found that one key factor that hindered the ability to trace product through the supply chain was the mixing of product from several suppliers. The FDA’s records maintenance requirements clearly state that the source of each shipment that enters a common bin must be recorded.

Audit Your Suppliers

After a food firm is able to identify all of its suppliers fully, the next step is to audit the suppliers. There are several ways to complete supplier audits. One common practice is to hire a third party auditor to conduct periodic investigations and audits of the supplier’s facility and operations.

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