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FDA Failed to Follow Up on 2004 Peanut Butter Contamination

Inspector visited ConAgra plant but agency dropped the ball
At least four deaths blamed on subsequent Salmonella outbreak

By Joseph S. Enoch
ConsumerAffairs.com

October 19, 2007

• FDA Failed to Follow Up on 2004 Peanut Butter Contamination • Peter Pan Returning To Store Shelves • Consumers Still Getting Sick From Tainted Peanut Butter • Fourth Peanut Butter Death Reported • Peanut Butter Recall Extended to Products Made as Early as 2004 • Peanut Butter Scare Stirs Congress • Consumers Left Holding the Peanut Butter Jar • Earlier Peanut Butter Contamination Kept Quiet • Peanut Butter Developed as a Health Food • Third Death Blamed on Peanut Butter • Peanut Butter Recalls Spread to Ice Cream & Desserts • FDA Says Peanut Butter Salmonella Outbreak Is "Ongoing" • Salmonella Confirmed in Peanut Butter • Second Death Linked To Tainted Peanut Butter • Death Linked To Tainted Peanut Butter • ConAgra Recalls Tainted Peanut Butter as Complaints Mount • FDA Widens Peanut Butter Warning • Reports of Peanut Butter-Borne Illness Increase • FDA Warns of Salmonella in Peanut Butter --- • Consumer Complaints about Peanut Butter --- • Salmonella: What It Is • More about Food Safety ...

The Salmonella peanut butter outbreak that is blamed for killing at least four and sickening hundreds early last year, was not the first instance of a Salmonella outbreak in a batch of Peter Pan peanut butter for the ConAgra Foods company.

Nor did it come as a surprise to the U.S. Food and Drug Administration (FDA), which had failed to follow up on earlier problems at the plant that produced the contaminated peanut butter.

Documents obtained by ConsumerAffairs.com through a Freedom of Information Act request reveal that ConAgra discovered “microbial problems” in October 2004.

In February 2005, the FDA sent inspector Jackie Douglas to ConAgra's Sylvester, Ga. plant, which produces Peter Pan and Great Value peanut butters, to investigate an anonymous claim of insect infestation, poor in-plant sanitation, equipment maintenance and quality control.

The FDA also had received five complaints from consumers who said they found plastic, hair, rice and mouse droppings in the peanut butter.

'Micro hold'

Although Douglas found the plant to be in compliance with applicable codes, the plant managers informed her that there was a “micro hold” in October 2004, in which some of the plant's peanut butter was destroyed as a result of lab tests.

"Management verbally reported that each day's production is tested in-house for Salmonella and coliforms prior to release of the production for sale," Douglas noted in her inspection report. "Firm acknowledged that there was some production in October that did not meet product specifications and was put on micro hold, and was subsequently destroyed. However, management would not report the exact reason for the hold, nor the amount of product affected."

The plant managers informed Douglas that the details of that micro hold would be made available to the FDA if they filed a written request.

The FDA never did request that information, ConAgra spokeswoman Stephanie Childs said.

FDA dropped the ball

If the FDA had folowed through, it would have discovered that the micro hold was the result of Salmonella, Childs said. She wasn't sure how much peanut butter was destroyed, but she said the product manufactured the day the Salmonella was discovered was destroyed as well as an unspecified number of days before and after.

The FDA made no further inquiries until two years later when the Centers for Disease Control informed the FDA that more than 200 consumers had been infected with Salmonella, possibly as a result of eating Peter Pan peanut butter.

FDA spokeswoman Catherine McDermott gave unresponsive answers to ConsumerAffairs.com's questions and a follow up e-mail and phone call to the agency's press office were not returned.

A month after the initial recall, ConAgra and the FDA issued press releases announcing that the recall would be expanded to October 2004.

"We were reaching back to custumers who might on an off-chance still have that product in storage or on shelf," Childs said. "I think there was some confusion behind the intent of that FDA press release. But our intent from the very beginning was to recall 100 percent of product made there."

Childs said it was a coincidence that the company announced an extension to its recall back to October 2004, the same month the company destroyed unknown batches of peanut butter that contained Salmonella.

Excessive moisture

In both Salmonella outbreaks, ConAgra scientists are not entirely sure what caused them. But they largely blame excessive moisture, Childs said.

The October 2004 outbreak was possibly a result of peanut shells from one distributor that may have been exposed to too much hurricane weather. It's also possible that sugar stored in a damaged shed may have been exposed to rain, the company said.

The February 2007 recall was possibly the result of the plant's faulty sprinkler system or a leak in the roof.

"We have procedures in place to clean up after that; stop production, get rid of product that may have been impacted by those kinds of scenarios and to start fresh," Childs said. "But we think there must have been some salmonella after our cleanup and that that lead to the unintentional contamination of the product later on."

Despite the cleanups, micro holds and ConAgra's in-house Salmonella testing, their product sickened hundreds of consumers whose doctors reported it to the CDC and likely many thousands more.

ConsumerAffairs.com has received 205 related complaints. Many of those complaints involved multiple illnesses among family members.

Was the problem sporadic?

"Yes, we have these regular testing procedures. Yes, we regularly hold the product," Childs said. "But our experts believe that either the salmonella count was either too low to detect or that it was sporadic enough that our testing procedures could not detect it."

The plant tests one jar per line per hour, Childs said.

The FDA has levied no fines against ConAgra and the agency's investigation is ongoing. A manager at the Health and Human Services Freedom of Information Office said it will likely be "many months" before the FDA finishes its investigation.

Back on shelves

Peter Pan returned to store shelves in August and Childs said the company has made extra efforts to ensure the product is safe.

"We fully renovated the plant, worked with food safety experts to modify product testing and further separated raw ingredients from any finished product," Childs said.

By the time Peter Pan returned to stores, the Centers For Disease Control and Prevention said that 628 people in 47 states have been affected by salmonella poisoning from the tainted peanut butter.

While most of the product has been pulled from store shelves, health officials say some of the recalled jars may still be in consumers’ pantries. The recalled peanut butter can be identified by the product code beginning with 2111 on the lid.

While the CDC does not officially attribute any deaths to the outbreak, families of at least four elderly consumers have told ConsumerAffairs.com that their loved ones died after eating tainted peanut butter. Their deaths are not counted, officials say, because no autopsies were performed.

Eighty-one-year-old Rosie Haskins died February 26. Her family reported to ConsumerAffairs.com that a partially eaten jar of peanut butter was found in her room. The jar had the telltale 2111 stamped on the lid.

Another death reported to ConsumerAffairs.com was that of 85-year-old Mary Halstead of West Virginia. She died after her son made her a peanut butter sandwich -- her favorite food.

"Dumb old me, I made her a peanut butter sandwich at home and brought it to her at the hospital, because it was just about the only thing she wanted to eat," Larry Halstead, her son, said. "In no time, she got just 100 percent worse." Halstead said his mother then became semi-comatose and died.

Two other deaths have been unofficially attributed to the tainted peanut butter.

An elderly Chicago-area man, George Baldwin, was said to be in relatively good health just before his death from complications of food poisoning, shortly after he ate a peanut butter sandwich.

"He puts the peanut butter on toast, eats the toast, in six hours he develops fever, nausea, diarrhea and vomiting -- all of which are signs of salmonella poisoning," Baldwin family attorney Don McGarrah said.

A 76-year old Pennsylvania woman, Roberta Barkay of Philadelphia, died in January from complications of food poisoning, and family members contend she too ate peanut butter shortly before her death. The family has hired an attorney who has filed suit against the manufacturer, ConAgra.

While new cases of peanut butter-related salmonella have tapered off, the CDC is warning consumers to be careful. The agency says consumers should carefully examine peanut butter jars on kitchen shelves to make sure the product is not included in the recall.

“This outbreak demonstrates the potential for widespread illness from a broadly distributed contaminated product, one that had not previously been implicated in a food-borne illness outbreak in the United States,” the CDC said in a statement.

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