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Trust & Consequences

Fri, 08/28/2009 - 5:01am
Phyllis Entis, MSc., SM (NRCM)

Peanut butter probably killed Clifford Tousignant, a 78-year old Korean War veteran. It most likely killed Shirley Almer, and seven other people, too.

These nine victims did not die as the result of a peanut allergy. They were infected with Salmonella Typhimurium. As were more than 700 other people, who managed to survive the nausea, vomiting, fever and diarrhea that resulted from eating contaminated peanut butter.

The outbreak began in September 2008. The initial cases, however, escaped notice for more than a month. It was early November before CDC spotted a pattern of illnesses reported by several different states, all due to an unusual strain of Salmonella Typhimurium. CDC enlisted the assistance of state and local health officials across the country to trace the source of the outbreak.

The investigation bore its first fruit when Minnesota's "Team Diarrhea" isolated the Salmonella strain from an opened jar of King Nut peanut butter, found in the kitchen of a nursing home where several residents had been infected. Connecticut confirmed the link by recovering the outbreak strain from an unopened jar of King Nut peanut butter stored in a distributor's warehouse.

With the cooperation of King Nut, CDC and FDA traced back the contaminated peanut butter to the Blakeley, Georgia processing plant owned by Peanut Corporation of America ("PCA"). FDA and Georgia inspectors descended on the Blakeley plant in early January 2009. The investigators uncovered numerous violations, and found Salmonella in the plant environment. They also discovered that PCA shipped some of its peanut products to its Plainview, Texas subsidiary.

FDA soon learned that PCA had never registered the Plainview peanut plant with the Texas Department of State Health Services. The plant had been operating for three years without ever having been inspected. Once again, federal and state investigators found numerous sanitary violations on visiting the Plainview facility. And they recovered the outbreak strain of Salmonella Typhimurium from a batch of peanut meal that PCA had shipped from the Georgia facility to the Texas plant.

PCA supplied peanut butter and other peanut products to more than 100 food processors, including Kellogg Co. In January 2009, while the FDA was immersed in its investigation of PCA's production plants, the agency received several complaints from consumers who had developed salmonellosis after eating Kellogg's Austin and Keebler brand peanut butter crackers. These crackers - made with PCA's peanut butter - were contaminated with the Salmonella Typhimurium outbreak strain.

Kellogg immediately recalled its Austin and Keebler crackers. And, as the scope of the contamination became manifest, the initial flurry of recall notices issued by PCA's dozens of customers became a blizzard that lasted through most of the winter.

The US food safety system is based on trust. Consumers rely on government regulators to police the food industry. FDA, USDA and state agencies trust food processors to follow Good Manufacturing Practices. Food companies, such as Kellogg, trust the validity of Certificates of Analysis provided by their ingredient suppliers - or trust third-party auditors to keep those suppliers on track.

If trust is misplaced at any point, the system is put at risk. Multiple lapses can lead to catastrophic system failure - just as happened when Peanut Corporation of America distributed Salmonella-contaminated peanut products to its customers throughout the United States.

What went wrong at Peanut Corporation of America?
The Georgia PCA facility had a history of violations uncovered during previous state inspections; the Texas facility never even registered with the state as a food processing plant, and never was inspected - until it was too late.

PCA chose to close its eyes to food safety problems. Salmonella-positive lab results simply triggered a re-test, or were ignored completely. PCA shipped peanut products to its customers before the company received lab test results, and did not recall shipments that tested Salmonella-positive. The company lied to government inspectors, lied to its customers, and lied to consumers about its Salmonella contamination problem.

What went wrong at Kellogg?
Kellogg relied on independent, third-part audits carried out by the American Institute of Baking ("AIB") to verify that PCA was meeting Kellogg's ingredient microbiological safety standards. In fact, these audits were anything but independent.

PCA paid AIB registration fees so that the company's QC Managers could attend the Institute's annual training courses. PCA named AIB as the "independent" auditor required under the peanut supplier's agreement with Kellogg. PCA paid for - and received advance notice of - the audits. The last AIB audit of PCA's Georgia facility, which took place in March 2008, was arranged three months in advance.

What went wrong with the regulators?
PCA registered its Plainview, Texas peanut facility with FDA, as required by federal law. The company also registered with the Texas Comptroller of Public Accounts. But PCA never notified the Texas Department of State Health Services ("DSHS") that it was carrying out food processing operations in Plainview. As a result, DSHS - under contract with FDA to carry out food plant inspections on behalf of the federal government - never visited PCA's Texas facility until after FDA identified Plainview's connection to the national Salmonella outbreak.

The Georgia Department of Agriculture, also under contract with FDA, inspected PCA's Blakeley plant nine times in three years. Based on the time spent on site, these inspections were cursory, at best. Each plant visit lasted no more than four hours, and was carried out by a single inspector; most inspections were less than three hours long. The last state inspection, carried out in October 2008, uncovered only two violations.

PCA was under no legal obligation to release its lab test results to regulators. It's no surprise, therefore, that the company chose not to advise the Georgia inspector of Salmonella-positive lab reports, dating as far back as June 2007. That information only came to light during FDA's outbreak investigation.

PCA's President, Stewart Parnell, didn't set out deliberately to poison his customers, any more than a drunk driver sets out to crash his car. Triggering a deadly food poisoning outbreak was, undoubtedly, the farthest thing from his mind. But choices have consequences, and Parnell chose to ignore the warning signs of a deeply embedded Salmonella contamination in his production plant.

Parnell's unwise decisions precipitated a deadly nationwide Salmonella outbreak, a series of food recalls that cost the food industry more than $1 billion, and the bankruptcy of Peanut Corporation of America.

To read more from Phyllis Entis, visit her blog at http://efoodalert.blogspot.com or pick up a copy of her book, "Food Safety: Old Habits, New Perspectives" (ASM Press).

COMMENTS

Ms. Entis is being irresponsible when she is implying that Kellogg did anything wrong. They did nothing wrong. Third party audits are an acceptable means of verifying compliance; it is proper that the audits be scheduled in advance. What did AIB find? If they did a poor job auditing, then it is AIB's fault, not Kellogg's. Of course Kellogg paid for the audit; audits are not free! Perhaps Ms. Entis does not know much about manufacturing businesses and that a government regulatory agency serves a different function than a third party auditor. Attending training is a proper way to learn what is expected to be included in a site's quality control system, and is not, as she implies, a conflict of interest.
-Kevin Bachar

Have a comment? Email it to karen.langhauser@advantagemedia.com

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