The Food and Drug Administration announced December 6th that it is assisting in the investigation of an outbreak of E. coli O157 infection in consumers associated with eating food from several Taco Bell restaurants in Northeastern states. FDA said it was actively working with state and local health officials, the U.S. Centers for Disease Control and Prevention (CDC), the firm, suppliers and distributors to determine the cause of the sicknesses and prevent additional infections.
States reporting probable cases associated with the outbreak are: New Jersey (20); New York (15); Pennsylvania (7); and Delaware (1). Additional cases are suspected in these states and in Connecticut. Thirty five individuals have been hospitalized, three with hemolytic uremic syndrome (HUS). No deaths were reported up to December 2. CDC first reported that the first reported onset of illness connected with this outbreak occurred on November 20, 2006.
On December 2 Taco Bell Corp. announced it was voluntarily removing green onions from its restaurants nationwide after preliminary tests by the firm indicated the possible presence of E. coli O157:H7 in samples of the product. To that date the confirmatory test had not been reported by Taco Bell. In view of this FDA was continuing to explore the possibility of other food commodities being the source of the E. coli.
FDA obtained samples of all non-meat items served in the restaurants that could carry the pathogen. These include cilantro, cheddar cheese, blended cheese, green onions, yellow onions, tomatoes and lettuce. The samples were tested at FDA laboratories. The states involved were testing as well. As at December 2 the agency did not have data implicating or ruling out any of these items.
FDA was also working with Taco Bell Corp. and its suppliers and distributors to obtain information on sources and distribution of products, to aid in tracing back any products identified as contaminated with the pathogen. The agency cooperated with CDC and state and local health officials to determine the specific cause of the outbreak and prevent further illnesses.
Infection with E. coli O157 causes diarrhea, often bloody. Although most healthy adults can recover completely within a week, some people can develop hemolytic uremic syndrome (HUS), a form of kidney failure. HUS is most likely to occur in young children and the elderly. The condition can lead to serious kidney damage and even death.
Consumers who are concerned that they may have contracted E. coli O157 infection should notify their local health department, contact their physician or health care provider or seek medical attention, as needed.
FDA will provide regular updates on this investigation as more information becomes available.

The Food and Drug Administration is continuing its investigation of an outbreak of E. coli O157:H7 infections linked to eating food from Taco Bell restaurants in 5 states. FDA is collaborating with state and local health officials, the U.S. Centers for Disease Control and Prevention (CDC), and the firm to identify the cause of the outbreak.
The peak of the outbreak occurred in the last week of November. The number of new cases being identified has declined substantially. For the latest details about these cases, see the CDC website at http://www.cdc.gov/ecoli/2006/december/120806.htm.
Number of Cases
CDC today reports 67 probable or confirmed cases of illness associated with the outbreak: 30 cases in New Jersey, 22 cases in New York, 12 cases in Pennsylvania, 2 cases in Delaware and 1 case in South Carolina (a person who became ill after eating at a Taco Bell in Pennsylvania). In the vast majority of the cases, individuals reported having eaten at a Taco Bell restaurant within seven days before onset of illness. Other cases of illness are under investigation by state public health officials. Among the 67 cases, 51 were hospitalized and 8 developed a type of kidney failure called hemolytic uremic syndrome (HUS). Illness onset dates range from November 20 to December 5.
Source of Outbreak
The source of the outbreak has not been determined, although it is presumed to be a contaminated food or foods. Testing by FDA of samples of food items from Taco Bell restaurants has found no E. coli O157:H7. CDC is conducting an ongoing “case control” study that involves interviewing ill and well Taco Bell restaurant patrons about what food items they consumed. By comparing foods consumed by ill and well persons, investigators can show statistical links to particular food ingredients. Of those ingredients, those consumed raw are of particular interest. The CDC study is demonstrating that onions are probably not linked to this outbreak.
On December 6, Taco Bell Corp. announced it was voluntarily removing green onions from its restaurants nationwide after preliminary tests by the firm indicated the possible presence of E. coli O157:H7 in samples of the product. However, more sophisticated and reliable confirmatory tests conducted by FDA on the same samples tested negative for the presence of E. coli O157:H7.
FDA has been working with Taco Bell Corp. and its suppliers and distributors to obtain information on sources and distribution of products, to aid in tracing back any product found to be contaminated with the bacteria or identified by the CDC case-control study as a vehicle of transmission.
E. coli O157:H7 Infection
Infection with E. coli O157:H7 causes diarrhea, often bloody. Although most healthy adults can recover completely within a week, some people can develop hemolytic uremic syndrome, a form of kidney failure. This condition is most likely to occur in young children and the elderly. The condition can lead to serious kidney damage and even death. Consumers who are concerned that they may have contracted E. coli O157:H7 infection should notify their local health department, and contact their physician or health care provider to seek medical attention as needed.
FDA will provide additional updates on this investigation as more information becomes available.
December 14, the U.S. Centers of Disease Control and Prevention (CDC) stated that the E. coli O157:H7 outbreak linked to Taco Bell restaurants in Northeastern states appears to be over. However, additional cases from the outbreak period could still be identified. Based on a number of factors, iceberg lettuce is considered overall to be the single most likely source of the outbreak at this time. The Food and Drug Administration (FDA) continues to narrow its investigation by focusing its efforts on finding the sources of shredded iceberg lettuce served at the restaurants.
The peak of the outbreak occurred from the last week of November until the beginning of December. No new cases have been reported as of December 14, 2006. A total of 71 cases in five states have been reported to the CDC: Delaware (2 cases), New Jersey (33 cases), New York (22 cases), Pennsylvania (13 cases) and South Carolina (1 case – this person ate at a Taco Bell in Pennsylvania). 53 hospitalizations and 8 cases of Hemolytic Uremic Syndrome (HUS) have been reported.
FDA investigators continue to expedite review of Taco Bell’s records in order to trace the distribution channels of the iceberg lettuce and identify the farm or farms where the lettuce was grown, as well as all firms and facilities that handled the product.
The agency is aware of the outbreaks of E. coli O157:H7 at Taco John’s restaurants in Iowa and Minnesota, and is monitoring these closely in cooperation with state health authorities. Based on genetic fingerprinting of the E.coli, these outbreaks do not appear at this time to be related to the Taco Bell outbreak. FDA continues to collaborate with CDC, and with state and local health officials, to determine how these outbreaks occurred and find the source of suspect food items.
More information about E. coli O157:H7 and the outbreak linked to Taco Bell restaurants on the East Coast is available at: http://www.fda.gov/oc/opacom/h.....rants.html.