Daniele International Inc., an establishment with operations in Pascoag and Mapleville, R.I., is now recalling approximately 1,263,754 pounds of ready-to-eat (RTE) varieties of Italian sausage products, including salami/salame, in commerce and potentially available to customers in retail locations because they may be contaminated with Salmonella, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

FSIS became aware of the problem during the course of an ongoing investigation of a multi-state outbreak of Salmonella serotype Montevideo illnesses. The Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), FSIS, state health and agriculture departments, and Daniele International are cooperating in this investigation. The CDC has posted information about the multi-state outbreak on its website (http://www.cdc.gov/salmonella/ montevideo/index.html) but the investigation is ongoing, and has not yet definitively identified a food vehicle(s).

During the course of that investigation, a sample of product found in commerce was tested on behalf of a participating state department of health and found to contain Salmonella, which FSIS has a zero tolerance for in RTE products. The product tested was similar to products bought by customers who later became sick in the Montevideo investigation, but currently there is not a direct link. The Salmonella strain in the tested product does not appear to be the Montevideo strain of interest and further testing of the sample is ongoing at a state health partner laboratory. FSIS is continuing to work with the CDC, affected state public health partners, and the company on the investigation and will update the public on the progress of this investigation as information becomes available.

In addition, the company presented information to FSIS and took the additional action to voluntarily recall all products in commerce associated with black pepper, which the company believes is a possible source of contamination.

The products subject to recall include:

* 3-ounce packages of "DANIELE NATURALE SALAME COATED WITH COARSE BLACK PEPPER."

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

The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service, continues to work closely with the Rhode Island Department of Health and other states in the investigation of an outbreak of Salmonella Montevideo infections associated with certain Italian-style sausage products including salami/salame.

The CDC reports that 207 people have been infected with a matching strain of Salmonella Montevideo in at least 42 states and the District of Columbia. Recently, the 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 suggested salami/salame as a possible source of illness: http://www.cdc.gov/salmonella/montevideo/index.html.

On Jan. 23, 2010, Daniele International Inc. recalled ready-to-eat varieties of Italian style meats and expanded its recall a week later to include additional ready-to-eat meats. The recalled products, including salami and Hot Sopressata Calabrese, are regulated by the USDA: http://www.fsis.usda.gov/News_&_Events/Recall_006_2010_Expanded/index.asp.

Recent samples of black pepper collected by the Rhode Island Department of Health at Daniele International Inc. tested positive for Salmonella. One sample from an open container matched the outbreak strain. The remaining supply of pepper testing positive for Salmonella has been voluntarily placed on hold by both of Daniele’s suppliers.

The FDA is actively investigating the supply chain of the black pepper used in the manufacturing of the recalled meat products to see if it poses a risk to consumers. The agency has collected and is currently analyzing both domestic and imported 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.