Friday, April 4, 2014

The 2007 Peanut Butter Salmonella Outbreak - Criminal Investigation Still Ongoing

The Peter Pan Peanut Butter Salmonella Outbreak is a great case study in how Salmonella can contaminate a low moisture, ready-to-eat food.  In this case, CDC reported indicated over 400 cases  linked to peanut butter that had become contaminated due to "inadvertent moisture got into the production process", or a leaky roof.

Although this case is seven years old, it is not over yet for the parent company, ConAgra.  According to a story in the Atlantic Business Chronicle, the plant underwent an investigation in 2011by the Justice Department for criminal wrongdoing.  The company and the US Attorney's office are still in negotiations regarding the investigation, where it is possible that this "will likely involve a misdemeanor criminal disposition under the Food, Drug & Cosmetics Act."

The Chronicle reports that the company has spent $25 million in connection to the investigation.  This is in addition to the 10's of millions spent on upgrading the plant and the 50 to 60 million for the recall itself.  And of course there is the loss in sales over that time period.

Atlantic Business Chronicle
2007 peanut butter recall hanging over ConAgra

David Allison
Editor- Atlanta Business Chronicle
Apr 1, 2014

Seven years after a recall of peanut butter made at a Georgia plant, federal investigations are still hanging over the head of ConAgra Foods Inc.

ConAgra in February 2007 recalled all Peter Pan and Great Value peanut butter beginning with product code 2111 after the Food and Drug Administration issued a warning linking 288 cases of foodborne illness in 39 states to consumption of types of Peter Pan peanut butter. ConAgra manufactured "Peter Pan" and "Great Value" brands that were possibly contaminated with Salmonella at a single processing plant in Sylvester, Ga.

ConAgra reported it believed peanut butter may have been contaminated at the Sylvester plant when inadvertent moisture got into the production process and brought to life dormant Salmonella in raw peanuts or peanut dust.

Following the recall, investigators searched the plant. The U.S. Attorney's office in Georgia and the Consumer Protection Branch of the Department of Justice launched a formal investigation in 2011.

ConAgra (NYSE: CAG) reported today that it spent a total of $25 million in 2012 and 2013 in connection with the investigations.

"We have been and continue to be engaged in ongoing discussions with the U.S. Attorney's office and the Department of Justice in regard to the investigation," ConAgra reported today. "We are pursuing a negotiated resolution, which we believe will likely involve a misdemeanor criminal disposition under the Food, Drug & Cosmetics Act."

Based in Omaha, Neb., ConAgra is one of North America’s largest packaged food companies.

 Multistate Outbreak of Salmonella Serotype Tennessee Infections Associated with Peanut Butter --- United States, 2006--2007
In November 2006, public health officials at CDC and state health departments detected a substantial increase in the reported incidence of isolates of Salmonella serotype Tennessee. In a multistate case-control study conducted during February 5--13, 2007, illness was strongly associated with consumption of either of two brands (Peter Pan or Great Value) of peanut butter produced at the same plant. Based on these findings, the plant ceased production and recalled both products on February 14, 2007. The outbreak strain of Salmonella Tennessee subsequently was isolated from several opened and unopened jars of Peter Pan and Great Value peanut butter and from two environmental samples obtained from the plant. New case reports decreased substantially after the product recall (Figure 1). As of May 22, 2007, a total of 628 persons infected with an outbreak strain of Salmonella serotype Tennessee had been reported from 47 states since August 1, 2006 (Figure 2). Local and state public health officials in multiple states, with assistance from CDC and the Food and Drug Administration (FDA), are continuing to investigate this outbreak caused by peanut butter, a new food source for salmonellosis in the United States. All remaining jars of Peter Pan or Great Value peanut butter with a product code beginning with 2111 should be discarded.

 Public health officials in PulseNet (the molecular subtyping network for foodborne disease surveillance) and OutbreakNet (the network of public health epidemiologists who investigate foodborne illnesses nationwide) have been investigating this outbreak and attempting to identify the mechanism of initial contamination. The investigation began in November 2006, when public health officials in PulseNet noted a substantial increase in the number of isolates of the outbreak strain of Salmonella serotype Tennessee; throughout 2005 and most of 2006, these isolates were reported to PulseNet at a rate of one to five per month, whereas in October 2006, 30 isolates were reported. Pulsed-field gel electrophoresis (PFGE) patterns of Salmonella Tennessee strains isolated from patients were uploaded from state health department databases to CDC databases. Three closely related patterns* were determined to be associated with this outbreak.

 A case was defined as infection with Salmonella Tennessee with a PFGE pattern matching one of the three outbreak patterns in a person residing in the United States with symptom onset on or after August 1, 2006 (or, if onset date unknown, Salmonella Tennessee isolated on or after August 1, 2006). The median age of patients was 52 years (range: 2 months--95 years); 73% were female. Symptoms of infection included diarrhea (72%), abdominal cramps (65%), fever (43%), and dysuria (45%). Symptom onset dates were known for 481 of 628 patients and ranged from August 1, 2006 to April 23, 2007 (Figure 1). Twenty percent of patients were hospitalized; no deaths were attributed to Salmonella infection. Sixty-one percent of isolates were from stool specimens, 35% from urine specimens, and 4% from other specimens.

 The initial investigation indicated that cases were not clustered geographically, and patient interviews conducted during November--December 2006 by state and local officials from OutbreakNet did not reveal a common food exposure. Officials in multiple states then interviewed 26 patients in January 2007 using a standard food-consumption survey instrument of approximately 200 items. Interviews indicated that 48% of the patients had eaten turkey (excluding delicatessen-sliced turkey) and 85% had eaten peanut butter during the week before illness onset, higher proportions than would be expected from food-consumption surveys of the U.S. population (1).
In February 2007, a case-control study with 65 patients and 124 controls was conducted to identify the food item associated with illness; the majority of interviews were completed by state and local health departments and were coordinated by CDC. For the study, a case was defined as infection with the outbreak strain of Salmonella Tennessee in a person aged >18 years with a history of diarrhea. Controls were well adults from the patient's community who were matched by geographic location. Controls were identified using a reverse online telephone directory that when given an address provided telephone numbers for residences in the same extended neighborhood as the patients. The median ages for the patients and controls were 53 and 58 years, respectively. Patients were more likely than controls to have eaten peanut butter (81% versus 65%, matched odds ratio [mOR] = 1.9, 95% confidence interval [CI] = 0.8--5.2), to have eaten peanut butter more than once a week (66% versus 40%, mOR = 3.5, CI = 1.4--9.9), and to have eaten either Peter Pan or Great Value peanut butter (67% versus 13%, mOR = 10.9, CI = 3.8--43.0). Neither the consumption of other peanut butter brands nor consumption of turkey products was associated with illness.

 Epidemiologic data suggesting Peter Pan brands of peanut butter as the possible source of the outbreak were provided to FDA officials on February 13, 2007. The following day, FDA issued a health alert to consumers indicating that they should not eat Peter Pan or Great Value peanut butter with a product code beginning with 2111, both of which were manufactured in a single facility in Georgia operated by ConAgra Foods. ConAgra Foods voluntarily recalled the products, destroyed existing products in their possession, and temporarily halted production pending further investigation.
New case reports decreased substantially after the February 14 recall (Figure 1). Investigation of the cases is ongoing to determine whether persons are still eating peanut butter from contaminated lots.
Subsequent laboratory testing of leftover peanut butter from patients was performed at state public health laboratories and CDC. Salmonella Tennessee with a PFGE pattern matching one of the outbreak strains was isolated from 21 opened and unopened peanut butter jars with production dates ranging from July 2006 to December 2006. These jars were collected from patients in 13 states (Arkansas, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Minnesota, New York, Oklahoma, Pennsylvania, South Carolina, and Tennessee); two of the PFGE strains were isolated from these peanut butter samples. FDA isolated Salmonella Tennessee from 13 unopened jars of Peter Pan and Great Value peanut butter with production dates ranging from August 2006 to January 2007 and from two plant environmental samples. Peanut butter from the Georgia plant was exported to 70 countries. No confirmed cases linked to this outbreak have been reported from other countries, although several possibly related cases have been investigated.
The source of the peanut butter contamination is unknown. FDA is investigating the plant operations, including heating temperatures, to determine the mechanism.
Reported by: Salmonella Tennessee Outbreak Investigation Team. Local and state health departments. Div of Foodborne, Bacterial, and Mycotic Diseases, National Center for Zoonotic, Vector-Borne, and Enteric Diseases, CDC.

 Editorial Note:
Approximately 2,500 Salmonella serotypes can cause salmonellosis, an illness characterized by diarrhea, fever, and abdominal cramps, typically 12--72 hours after infection (2). Salmonella Tennessee infections are rare, and the source of most of these infections is unknown. An average of 52 Salmonella Tennessee cases were reported to the National Salmonella Surveillance System† each year during 1995--2004, representing 0.1% of all reported Salmonella strains (3). Only one other outbreak of Salmonella Tennessee infection with an identified food source, contaminated powdered milk, has been reported to CDC (4). In addition to causing gastrointestinal symptoms, certain serotypes, including Salmonella Tennessee, are more likely than other serotypes to infect the urinary tract. The percentage of patient Salmonella Tennessee isolates from urine specimens increased from 15% during 1995--2004 to 27% during 2005--2006. Because urinary tract infections are more common among females, the high proportion of isolates from urine in this outbreak might explain the high percentage of identified cases among females (3,5).
This is the first reported outbreak of a foodborne illness caused by peanut butter consumption in the United States. Outside the United States, one outbreak implicating peanut butter, caused by Salmonella serotype Mbandaka, was reported from Australia in 1996 (6). In addition, an outbreak of Salmonella serotype Agona infection in four countries was associated with consumption of a peanut-butter--coated snack produced in Israel (7,8).
Peanuts can become contaminated with salmonellae during growth, harvest, or storage, and the organisms are able to survive high temperatures in a high-fat, low-water--activity environment (9). Peanut butter provides such an environment, and although it typically undergoes heat treatment to temperatures > 158°F (>70°C), such heating might not always eliminate salmonellae (10). In addition, after heat treatment, peanut butter that is being processed might be contaminated by salmonellae that are introduced into the production environment on raw peanuts or another source (e.g., animals in the production plant, salmonellae brought into the plant on containers or humans from the outside environment, or other ingredients used to make peanut butter).
This outbreak demonstrates the potential for widespread illness from a broadly distributed contaminated product, one that has not been previously implicated in a foodborne illness outbreak in the United States. In addition, the outbreak demonstrates that processed food can become contaminated even when the production process includes a heat-treatment step, underscoring the need for effective preventive controls in food-processing plants to prevent contamination.
Certain consumers might still be eating peanut butter from contaminated lots. All remaining jars of Peter Pan and Great Value peanut butter with a product code beginning with 2111 should be discarded.

CDC. Foodborne diseases active surveillance network (FoodNet): population survey atlas of exposures, 2002. Atlanta, GA: CDC; 2004. Available at
Brenner FW, Villar RG, Angulo FJ, Tauxe RV, Swaminathan B. Salmonella nomenclature. J Clin Microbiol 2000;38:2465--7.
CDC. Salmonella surveillance summary, 2004. Atlanta, GA: US Department of Health and Human Services, CDC; 2006. Available at
CDC. Salmonella serotype Tennessee in powdered milk products and infant formula---Canada and the United States, 1993. MMWR 1993; 42:501--19.
Sivapalasingam, S, Hoekstra RM, McQuiston JR, et al. Salmonella bacteriuria: an increasing entity in elderly women in the United States. Epidemiol Infect 2004;132:897--902.
Scheil W, Cameron S, Dalton C, Murray C, Wilson D. A South Australian Salmonella Mbandaka outbreak investigation using a database to select controls. Aust N Z J Public Health 1998;22:536--9.
Killalea D, Ward LR, de Roberts D, et al. International epidemiological and microbiological study of outbreak of Salmonella agona infection from a ready-to-eat savoury snack---I: England and Wales and the United States. BMJ 1996;313:1105--7.
Shohat T, Green MS, Marom D, et al. International epidemiological and microbiological study of outbreak of Salmonella agona infection from a ready-to-eat savoury snack---II: Israel. BMJ 1996;313:1107--9.
Mattick KL, Jorgensen F, Legan JD, Lappin-Scott HM, Humphrey TJ. Habituation of Salmonella spp. at reduced water activity and its effect on heat tolerance. Appl Environ Microbiol 2001;66:4921--5.
Shachar D, Yaron S. Heat tolerance of Salmonella enterica serovars Agona, Enteritidis, and Typhimurium in peanut butter. J Food Protect 2006;69:2687--91.

* CDC PulseNet patterns JNXX01.0010, JNXX01.0011, and JNXX01.0026.

USA Today
 ConAgra Faces Tough Sell on Peter Pan

By Josh Funk, AP Business Writer

OMAHA, Neb. — When Peter Pan peanut butter returns to stores in July, some consumers' first thoughts will undoubtedly be about this year's salmonella outbreak and total recall of the brand.

"I would be hesitant" to buy Peter Pan, college student Kevin Akerson said while grocery shopping in Omaha recently.

The company that makes Peter Pan, ConAgra Foods Inc., will have to find ways to convince consumers like Akerson that its peanut butter is safe.

But consumers like Audrey M. Wright, who have missed Peter Pan since it disappeared from stores in mid-February, give the company hope.

"We had to throw out a jar of Peter Pan with regrets," said Wright, who was shopping in the same west Omaha Hy-Vee grocery store Akerson was. "I like ConAgra."

The Omaha-based food company won't discuss the details of its Peter Pan marketing plan for competitive reasons, but ConAgra is eager to win back consumers after the outbreak that sickened more than 400 people and spawned numerous lawsuits.

Marketing experts say ConAgra would do well to study the examples of companies that successfully dealt with past recalls by being forthright, like the makers of Tylenol did in the 1980s. But ultimately, ConAgra simply needs to reassure consumers and deliver a safe product.

"When people own up to it, Americans forgive," said John Lord, professor and chairman of St. Joseph's University's food marketing program. "When they don't, we get upset."

The division of Johnson & Johnson that markets Tylenol set the standard for dealing with brand crisis with the way it handled the 1982 cyanide tampering scare in Chicago.

J&J removed 264,000 bottles of the painkiller from Chicago stores and offered replacements to consumers. The company offered prompt updates and developed tamper-resistant packaging to prevent any recurrence. The recall cost J&J about $100 million, but the public regained confidence in Tylenol quickly.

The Tylenol example gets brought up often because the manufacturer handled it so well, said Joe Marconi who teaches marketing at DePaul University in Chicago. But companies should be careful about following that example too closely because Marconi said it may appear insincere and formulaic. For example, he said featuring the CEO in advertising during a crisis can backfire.

"It's been done so many times that it appears less effective," Marconi said.

But Lord said it's the companies that refuse to discuss and take responsibility for a problem that often have trouble regaining consumer trust.

ConAgra officials have revealed what they think caused the problems at their Sylvester, Ga., plant. Chief Executive Gary Rodkin has repeatedly apologized and pledged to settle claims quickly.

"We put consumer safety first with no compromise," Rodkin said during a call with investors last month.

ConAgra officials said they believe moisture in the company's peanut butter plant likely helped salmonella bacteria to grow and later infect the finished product. The moisture came from a roof leak and a faulty sprinkler head that triggered the plant's fire sprinklers twice, and the salmonella likely came from the raw peanuts. But they can't be entirely sure what caused the problems.

So ConAgra plans to do more than just eliminate the source of the moisture. The company said it would renovate the Georgia plant to make sure there is greater separation between raw peanuts and the finished product.

While those repairs are being made, ConAgra has arranged for another company to make Peter Pan, but it refuses to name the other company.

ConAgra also plans to change its testing routine for peanut butter to ensure the product is safe.

But with several major outbreaks of food contamination in the past year, Lord believes many American consumers are skittish.

"Right now we're a country that's pretty squirrelly on food safety issues," Lord said.

That's where history may be on ConAgra's side, according to Marconi, who wrote "Crisis Marketing: When Bad Things Happen to Good Companies."

"The biggest and best thing Peter Pan has going for it is it's one of the older brands. It has an established track record," Marconi said.

Marconi said the Peter Pan label needs to carry a message that lets consumers know ConAgra stands behind the product and that the peanut butter inside is new.

A simple message like "certified pure" combined with a satisfaction guarantee on the label might be enough for most consumers, Marconi said.

"You have to reassure the public that the problem you had has been corrected," Marconi said.

For consumers like Elizabeth Morrison, ConAgra's pledge to clean up and renovate its peanut butter plant might be enough. Morrison said she's not going to worry about her peanut butter much unless there is a pattern of problems.

"These things can happen anywhere," Morrison said.

But other consumers like Teresa Neff may need more convincing.

"It does make you concerned about your entire food supply," Neff said.

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