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March 1, 2013
On March 1, 2013, the FDA released its report on the environmental assessment inspection into the factors potentially contributing to the contamination of fresh whole cantaloupe linked to a multi-state outbreak of salmonellosis in the summer of 2012.
On September 20 and 21, 2012, the FDA, along with Indiana State Department of Health officials, conducted an environmental assessment inspection at Chamberlain Farms, in Owensville, Indiana. Cantaloupe from this farm had been linked to an outbreak of salmonellosis caused by Salmonella Typhimurium and Salmonella Newport that made 261 people in 24 states ill and caused 3 deaths.
The purpose of the environmental assessment inspection, which was done with the cooperation of Chamberlain Farms, was to gather more information that would help identify the factors that potentially contributed to the introduction, growth, or spread of the Salmonella strains that contaminated the cantaloupe.
According to the report, the initial contamination of the cantaloupes likely occurred in the production fields and was spread by operations and practices within the packinghouse. It is also likely that the contamination proliferated during storage and transport to market.
During the environmental assessment inspection the team collected environmental samples from the growing fields, area wells, and the packing house. Environmental samples are samples taken from surfaces that would likely harbor bacteria. In this case, the environmental samples included soil, wild animal excreta, well water, pooling water on field perimeters, drainage ditch water, and packing house surfaces. The team also collected cantaloupes from one of the fields.
The presence of Salmonella was found in 16 of the subsamples taken from the growing fields, and four of those contained a strain of Salmonella that was the same as the outbreak strain. Additionally, a subsample from a cantaloupe collected from one of the fields, a subsample from a cattle pasture next to a growing field, and one subsample collected from the packinghouse showed the presence of Salmonella.
Because the samples collected from agricultural water sources were negative for Salmonella, agricultural water used for irrigation, crop protection sprays, and in the packinghouse were not a likely route for introducing Salmonella. However, while water may not have been the primary source of Salmonella contamination in the growing, harvesting, and packing or holding environments, use of agricultural water in these operations may have acted as a vehicle to spread contamination, once introduced.
In the packing house, the assessment team found conditions that may have contributed to the Salmonella contamination of the cantaloupe.
- The design of the packinghouse allowed water to pool on the floor near equipment, and the floor was not easy to clean.
- There was evidence that birds were roosting in the building’s rafters. Bird droppings were seen on the equipment and floor below the rafters, which were directly above food contact surfaces (e.g., brush rollers, conveyor belts, grading table), or directly above the product during conveyance, grading, and sorting.
- The drip-line of the packinghouse roof extended over the conveyor belt and brush washer, so rain water and related roof debris were likely to have run-off from the roof on to food contact surfaces.
- The firm did not pre-cool the cantaloupes before storing and shipping, and cantaloupes were packed while still moist from washing on the packing line. Wet fruit, packed still warm with field heat, potentially created conditions that would allow Salmonella to live and grow.
- The firm did not adequately monitor or control wash water disinfectant levels to control, reduce or prevent the potential for cross contamination, and it also failed to empty garbage receptacles, resulting in an area where pests could live.
The FDA recommends that fresh fruit and vegetable producers employ good agricultural and management practices recommended for the growing, harvesting, washing, sorting, packing, storing, and transporting of fruits and vegetables sold to consumers in an unprocessed or minimally processed raw form.
These recommended practices are set forth in FDA and USDA’s “Guidance for Industry -- Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables” and FDA’s “Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Melons; Draft Guidance” and “Guidance for Industry: Letter to Firms that Grow, Harvest, Sort, Pack, Process, or Ship Fresh Cantaloupe."
Throughout the course of the investigation and response to this outbreak, the FDA regularly posted updates to keep the public informed. This summary was developed to document the milestones of the investigation and any outcomes as a reference for the public and the FDA’s partners in the investigation.
The U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and state and local officials investigated a multi-state outbreak of Salmonella Typhimurium and Salmonella Newport infections linked to cantaloupe from Chamberlain Farms, of Owensville, Indiana.
The CDC reported a total of 261 people infected with the outbreak strains of Salmonella Typhimurium and Salmonella Newport in 24 states : Alabama (25), Arkansas (6), Florida (1), Georgia (13), Illinois (36), Indiana (30), Iowa (9), Kentucky (66), Maryland (1), Michigan (8), Minnesota (2), Mississippi (7), Missouri (17), Montana (1), New Jersey (2), North Carolina (5), Ohio (5), Oklahoma (1), Pennsylvania (2), South Carolina (4), Tennessee (8), Texas (2), Virginia (1), and Wisconsin (9). There were 94 people hospitalized. Three deaths were reported in Kentucky.
Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps 12 to 72 hours after infection. The illness usually lasts 4 to 7 days, and most people recover without treatment. However, in some people, the diarrhea may be so severe that the patient needs to be hospitalized. In these patients, the Salmonella infection may spread from the intestines to the blood stream, and then to other body sites and can cause death unless the person is treated promptly with antibiotics.
Children are the most likely to get salmonellosis. The rate of diagnosed infections in children less than five years old is higher than the rate in all other persons. Young children, the elderly, and those with compromised immune systems are the most likely to have severe infections. It is estimated that approximately 400 persons die each year with acute salmonellosis.
In interviews collected during the outbreak, ill persons answered questions about foods consumed and other exposures during the week before becoming ill. Eighty-one (65%) of 123 ill persons interviewed reported consuming cantaloupe in the week before their illness began.
Laboratory testing conducted by the Kentucky Division of Laboratory Services isolated the outbreak strain of Salmonella Typhimurium from two cantaloupes collected from a retail location in Kentucky. Traceback investigations indicated that these cantaloupes originated from Chamberlain Farms.
From August 14-16, 2012, FDA investigators collected samples of cantaloupe at Chamberlain Farms. They also took samples in the farm’s cantaloupe packinghouse from surfaces that would likely harbor bacteria. This action was taken in cooperation with the Indiana State Department of Health.
On 16 August, 2012, Chamberlain Farms had begun removing cantaloupe from the market, and had decided to cease distributing cantaloupe for the rest of the growing season.
On August 22, 2012, after officials from the FDA and the state of Indiana briefed Chamberlain Farms on the current status of the investigation,Chamberlain Farms made the decision to recall its cantaloupe from the market to ensure the widest possible awareness of this action. A review of records indicated that the Chamberlain Farms cantaloupe was initially shipped to Indiana, Iowa, Kentucky, Missouri, Tennessee, Ohio, Illinois, and Wisconsin, although further shipment was likely.
On August 28, 2012, FDA announced that samples of cantaloupe collected at Chamberlain Farms showed the presence of Salmonella Typhimurium with a DNA fingerprint that was the same as the outbreak strain of Salmonella Typhimurium that sickened 228 of the 261 people affected by the outbreak.
On September 13, 2012, FDA announced that samples of cantaloupe collected at Chamberlain Farms also showed the presence of Salmonella Newport with a DNA fingerprint that was the same as the outbreak strain of Salmonella Newport that sickened 33 of the 261 people affected by the outbreak. The link was supported by traceback information collected by state officials in Indiana and Illinois showing that patients consumed cantaloupe bought at stores supplied by Chamberlain Farms.
Additionally, the state of Indiana had reported that sampling of watermelon from a field at Chamberlain Farms showed the presence of Salmonella Newport with a different DNA fingerprint which was also under investigation by the CDC and FDA. No evidence was found linking illnesses associated with this outbreak strain to Chamberlain Farms products. However, Chamberlain Farms asked stores to remove their watermelon from store shelves as a precaution.
On September 7, 2012, a Schnucks Markets’ press release announced the action and the response taken by the grocery chain to remove these watermelons.
On October 3, 2012, the FDA Form 483 (Inspectional Observations) for Chamberlain Farms (PDF - 140KB) was made available in the FDA Office of Regulatory Affairs FOIA Electronic Reading Room. Among the inspectional observations made were:
• Indications of poor sanitary practices in the firm’s cantaloupe packing shed which were demonstrated by environmental swabs and product samples that showed the presence of Salmonella
• Food contact surfaces constructed in a way that did not allow for adequate cleaning
• Failure to clean as frequently as necessary to protect against contamination of food
• Standing water in the packing shed
• A water processing line not constructed in a way that would prevent food contamination
• The firm was not monitoring the effective levels of the chlorine sanitizer in the water within the concrete dump tank of the cantaloupe processing line
• Failure to remove litter and waste that might attract pests
On October 5, 2012, CDC reported that the outbreak appeared to be over .
On December 14, 2012, the FDA issued a warning letter to Chamberlain Farms.
During the outbreak, FDA advised consumers who were buying or had recently bought cantaloupe to ask their retailers if the cantaloupe was grown on Chamberlain Farms of Owensville, Indiana. The FDA warned consumers not to eat this cantaloupe, and if they had purchased it, to throw it away.
The FDA further advised that if consumers believed they had cantaloupe from Chamberlain Farms, they should not try to wash the harmful bacteria off the cantaloupe as contamination may be both on the inside and outside of the cantaloupe, and cutting, slicing, and dicing may transfer harmful bacteria from the fruit’s surface to the fruit’s flesh.
The information in this release reflects the FDA’s best efforts to communicate what it has learned from the manufacturer and the state and local public health agencies involved in the investigation. The agency will update this page as more information becomes available.