In early July, 2009, a number of individuals tested positive for a matching strain of Salmonella Montevideo. Over the next several months, a marked increase in the number of Salmonella infections with the exact same genetic fingerprint emerged—a number far greater than is typical for this particular bacteria. The Centers for Disease Control (CDC), along with a number of state and local health departments, were now in the process of investigating whether a common source was making all of these individuals ill.

By January 2010, the CDC and public health officials in multiple states conducted an epidemiologic study 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 were identified who purchased the same type of sliced salami variety pack at different grocery store locations before becoming ill; three additional ill persons were identified who purchased a similar type of sliced salami deli tray before becoming ill. These variety packs and deli trays all included salamis made with black pepper, which was added after the lethality step. These data suggest this product was the source of some of these illnesses. This sliced salami variety pack and sliced salami deli tray was manufactured and sold by Daniele International, Inc.

The smoking gun came on January 20, 2010, when the Washington State Department of Health announced that three unopened packages of Daniele product purchased at Costco were positive for the same outbreak strain of Salmonella Montevideo that had been making people ill since July of the previous year.

Following this news, on January 23, 2010, Daniele announced a voluntary recall of a variety of its pepper-coated salame/salami products. The traceback efforts by the various health officials across the country continued in an attempt to determine how Daniele’s product initially became contaminated with Salmonella.

Environmental samples were collected from Daniele’s Burrillville, Rhode Island facility, known as Plant #54. A sample collected from a floor drain cap was a positive genetic match to the outbreak strain of Salmonella. Another sample taken from the floor drain was positive for a different of Salmonella, known as Senftenberg.

Additionally, samples were taken of both opened and unopened black and red pepper product at Daniele’s plant. The samples were from pepper suppliers Wholesome Spice of Brooklyn, New York, and Mincing Overseas Spice Company of Dayton, New Jersey. A selection of the test results from these samples are summarized below:

• RED PEPPER

o Red Pepper Product (unopened) – All from Wholesome Spice – FDA Collected Samples

• Sample 556150 – Lot #111109-CR1 – Salmonella Montevideo PFGE pattern matched outbreak strain.

• Sample 556152 – Lot #011810-CR1 – Salmonella Montevideo PFGE pattern matched outbreak strain.

• Sample 515545 – Lot #092909-GR1 – Salmonella Group C1 (Montevideo is part of this group).

o Red Pepper Product (open/closed unknown) – Daniele Collected Samples

• 8 samples collected, 3 were positive for Salmonella Montevideo (2 were from Wholesome Spice lot 011810-CR1, and 1 was from Mincing lot 3357J). The serotype is Montevideo. The positive Mincing lot is a 2 enzyme match to the Montevideo lot positive.

o Red Pepper Product (open/closed unknown, but sampled from the same containers as FDA’s samples) – Rhode Island DOH Collected Samples

• 8 samples collected, 1 was Salmonella positive from the Wholesome lot 011810-CR1. Strain was Montevideo with PFGE pattern matching outbreak strain.

• BLACK PEPPER

o Ground Black Pepper Product (opened) – FDA Collected Samples

• Sample 488275 – From Mincing lot 3386G – Salmonella Montevideo PFGE pattern matched outbreak strain.

o Whole Black Pepper Product (unopened) – FDA Collected Samples

• Sample 609458 – From Wholesome lot 011810 WB-1 – Salmonella Group C1 (Montevideo is part of this group).

• Sample 609460 – From Mincing lot 3258R (whole black pepper recleaned product) – Salmonella Group C1 (Montevideo is part of this group).

o Black Pepper Product (unopened) – Daniele Collected Samples

• 3 positives from Wholesome lot 010510-GB1 – Salmonella Montevideo PFGE pattern matched outbreak strain.

• 1 positive from Mincing lot 3386G – Salmonella Montevideo PFGE pattern matched outbreak strain.

o Whole Black Pepper Product (opened) – Rhode Island DOH Collected Samples

• 1 positive from Mincing lot 3258R – Salmonella (collected on 2/22/10)

• 1 positive from Wholesome lot 4492 – Salmonella (collected on 2/22/10)

The results showed that black and red pepper distributed to Daniele by both Wholesome Spice and Mincing Overseas Spice was contaminated with the same genetic strain of Salmonella as the outbreak strain.

On February 25, 2010, Wholesome Spice announced a recall of 25-pound boxes of crushed red pepper sold between April 6, 2009 and January 20, 2010. On March 5, 2010, Mincing Overseas Spice announced a recall of two lots of black pepper shipped to Florida, Iowa, Illinois, Indiana, Massachusetts, Oklahoma, New Jersey, New York, Pennsylvania, Rhode Island, Texas, and Wiscsonsin. As a result of these two recalls, approximately 11 additional companies announced recalls for product manufactured using pepper from Wholesome Spice and Mincing Overseas Spice.

To date, the Centers for Disease Control and Prevention (CDC) has confirmed at least 272 people in 44 states have been infected with the identifical PFGE pattern associated with the outbreak. 

In addition, Salmonella Senftenberg, a different serotype of Salmonella, was found in Daniele product food samples from retail and a patient household during the outbreak investigation, as well as from an environmental sample taken from Daniele’s plant. PulseNet, a national network of public health and food regulatory agency laboratories coordinated by the CDC, identified 11 persons who had illness caused by Salmonella Senftenberg with matching PFGE patterns between July 1, 2009 and April 28, 2010.

Thus, Daniele’s recalled product was contaminated with multiple strains of Salmonella.