CDC is collaborating with public health officials in many states, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS), the U.S. Food and Drug Administration (FDA), and the State of Rhode Island to investigate a multistate outbreak of Salmonella serotype Montevideo infections. Investigators are using DNA analysis of Salmonella bacteria obtained through diagnostic testing to identify cases of illness that may be part of this outbreak.

As of 9:00 pm EST on February 10, 2010, a total of 225 individuals infected with the outbreak strain of Salmonella Montevideo, which displays either of two closely related PFGE patterns, have been reported from 44 states and District of Columbia since July 1, 2009. The number of ill persons identified in each state with this strain is as follows: AK (1), AL (2), AZ (6), CA (30), CO (4), CT (5), DC (1), DE (2), FL (3), GA (3), IA (1), ID (2), IL (15), IN (3), KS (3), LA (1), MA (13), MD (1), ME (1), MI (4), MN (5), MO (2), MS (1), NC (10), ND (1), NE (1), NH (2), NJ (8), NM (2), NY (18), OH (9), OK (1), OR (9), PA (6), RI (2), SC (1), SD (3), TN (5), TX (7), UT (9), VA (1), WA (17), WI (1), WV (1), and WY (2). Because the main Salmonella Montevideo outbreak PFGE pattern is commonly occurring in the United States, public health investigators may determine that some of the illnesses are not part of this outbreak.

Salmonella Senftenberg, a different serotype of Salmonella, has been found in food samples from retail and a patient household during this outbreak investigation. PulseNet identified 5 persons who had illness caused by Salmonella Senftenberg with matching PFGE patterns between July 1, 2009 and today. Public health officials have interviewed 4 of the 5 ill persons with this strain of Salmonella Senftenberg and determined that one consumed a recalled salami product during the week before their illness began. These five cases are not included in the overall case count reported above.

Among the persons with reported dates available, illnesses began between July 4, 2009 and January 24, 2010. Infected individuals range in age from < 1 year old to 93 years old and the median age is 39 years. Fifty-three percent of patients are male. Among the 166 patients with available information, 43 (26%) were hospitalized. No deaths have been reported.

During January 16-21, 2010, CDC and public health officials in multiple states conducted an epidemiologic study by comparing foods eaten by 41 ill and 41 well persons. Preliminary analysis of this study has suggested salami as a possible source of illness. Ill persons (58%) were significantly more likely than well persons (16%) to report eating salami. Additionally, 16 ill persons have been identified who purchased the same type of sliced salami variety pack at different grocery store locations before becoming ill; Two additional ill persons have been identified who purchased a similar type of sliced salami deli tray before becoming ill. These data suggest this product is the source of some of these illnesses. This sliced salami variety pack was recently recalled by Daniele International Inc. CDC and public health officials in multiple states continue to interview ill persons to ask them about the foods they ate during the week before they became ill as well as to collect shopper card information.

On January 23, 2010, FSIS issued a news release that Daniele International Inc. is recalling approximately 1,240,000 pounds of ready-to-eat varieties of Italian sausage products (including salame/salami) in commerce and potentially available to customers in retail locations because they may be contaminated with Salmonella. On February 4, 2010, FSIS updated its January 23, 2010 news release to include two additional salame/salami products, adding approximately 23,754 pounds to the initial recall. These products can have an extended shelf life of up to one year. The manufacturer has voluntarily halted production of salami products.

This initial recall followed isolation of Salmonella in a private laboratory from a retail sample of a salami product produced by Daniele International; this product was different than the sliced salami variety pack purchased at different grocery store locations by the 16 ill persons. FSIS reviewed and affirmed these private laboratory results. The Salmonella strain initially found by the private laboratory was different from the strains causing the outbreak. However, the Washington State Department of Health subsequently tested the bacterial culture provided by the private laboratory (the salami was not provided) and identified two different Salmonella serotypes, the strain found by the private lab and Salmonella Montevideo indistinguishable from the outbreak strain and Salmonella Senftenberg. In addition, the Iowa Department of Public Health and public health officials in Plymouth County, Iowa investigated a patient with Salmonella Montevideo infection indistinguishable from the outbreak strain and discovered an open sliced salami variety pack frozen at the patient’s home. The patient had eaten this product before becoming ill. This sliced salami variety pack was the same as that purchased by 16 other ill persons. Using DNA analysis, the University of Iowa Hygienic Laboratory (Iowa’s public health laboratory) confirmed that the Salmonella isolated from this leftover salami was indistinguishable from the outbreak strain of Salmonella Montevideo.

On January 31, 2010, FSIS issued a second news release that Daniele International Inc. has expanded its recall to include more ready-to-eat (RTE) varieties of Italian sausage products. Specific products include:

* Packages of “DANIELE HOT SOPRESSATA CALABRESE,” produced on 11/7/09, 12/16/09 and 12/18/09.
* Packages of “DANIELE SOPRESSATA CALABRESE,” produced on 12/16/09 and 12/18/09.
* Packages of “BOAR’S HEAD BRAND HOT SOPRESSATA CALABRESE,” produced on 11/28/09, 12/9/09 and 12/14/09.

The recall was being expanded as a result of a confirmed finding of Salmonella in an unopened salami product reported by the Illinois Department of Public Health. The product was sampled during the course of an ongoing investigation of a multistate outbreak of Salmonella serotype Montevideo illnesses. The product tested was not included in the previous recall (FSIS Recall 006-2010) issued January 23, 2010, but is similar to products bought by customers who later became sick and were identified as part of the Montevideo investigation. The company believes that black pepper is a possible source of Salmonella contamination.

On February 4, 2010, FSIS announced that Daniele International Inc. added two more products to its list of recalled products. Specific products include:

* Approximately 6-pound packages of “DANIELE SALAME GRANDE COATED WITH PORK FAT & PEPPER.”

Further testing is ongoing at a state health partner laboratory, and might determine if the product tested in Illinois contained the Salmonella Montevideo strain associated with the multistate outbreak.
Daniele International Inc. has recalled ready-to-eat varieties of Italian sausage products, including salami, which are regulated by the USDA. Some of the products contain black pepper, which is regulated by the FDA.

Recent test results provided by the Rhode Island Department of Health revealed that an opened container of black pepper used in the manufacturing of at least some of the recalled products was positive for Salmonella Montevideo and that the DNA fingerprint matched the outbreak strain: *.

The FDA is investigating the supply chain of the black pepper used in the manufacturing of the recalled meat products. The Agency has collected and is currently analyzing black pepper samples. To date, all the samples collected and analyzed by the FDA have tested negative for Salmonella, however, sample collection and analysis continues.

CDC and its public health partners are continuing the epidemiologic investigation to verify that the outbreak is controlled. CDC, USDA-FSIS, and FDA continue to work closely to identify the specific products or ingredients that became contaminated and how the contamination occurred and to identify any other food vehicles that may be involved.