On April 25, 2023, the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA’s FSIS) released a proposed determination to declare Salmonella an adulterant in breaded stuffed raw chicken products when a very low level of Salmonella contamination is exceeded. The action builds upon FSIS’ October 2022 proposed regulatory framework to reduce Salmonella infections linked to poultry products.

The U.S. Centers for Disease Control and Prevention (CDC) estimates that Salmonella cause approximately 1.35 million human infections and 26,500 hospitalizations in the U.S. every year. Of those infections, over 23 percent are attributed to poultry consumption. Additionally, data from USDA’s Economic Research Service (ERS) estimates the total annual cost of foodborne Salmonella infections in the U.S. to be $4.1 billion.

Under the proposed determination, FSIS would consider an adulterated product to be any breaded stuffed raw chicken product including a chicken component that tests positive for Salmonella at 1 colony forming unit (CFU) per gram prior to stuffing and breading. FSIS is also proposing to carry out verification procedures, including sampling and testing of chicken components of breaded stuffed raw chicken products prior to stuffing and breading, to ensure adequate Salmonella control.

If the chicken component in covered products does not meet the FSIS standard, the product lot represented by the sampled component would not be permitted for use in the final breaded stuffed raw chicken products. The chicken component represented by the sampled lot would need to be diverted to a use other than breaded stuffed raw chicken products.

Breaded stuffed raw chicken products are pre-browned and may appear cooked, but the chicken is raw. These products are stuffed with ingredients, such as a raw vegetable, butter, cheese or meat such as ham. The products are typically cooked by consumers from a frozen state, which increases the risk of the product not reaching the internal temperature needed to destroy Salmonella. In addition, it may be difficult for a consumer to determine an accurate internal temperature of these products because they contain multiple ingredients that may cook at different rates.

In proposing to declare Salmonella an adulterant in breaded stuffed raw chicken products, FSIS based its decision on several factors, including that, since 1998, FSIS and its public health partners have investigated 14 Salmonella outbreaks and approximately 200 illnesses associated with these products. The most recent outbreak was in 2021 and resulted in illnesses across 11 states.

The labeling of these products has undergone significant changes over time to better inform consumers that they are raw and to provide instructions on how to prepare them safely. Despite these efforts to improve labeling, these products continue to be associated with salmonellosis outbreaks. Additionally, data from outbreaks and FSIS’ consumer research show that some people may not realize these products contain raw chicken because the outside may appear browned and cooked, which leads them to believe that the product is safe to eat as is or not cook the product to a safe internal temperature.

FSIS is seeking public comments on the proposed determination and the proposed verification sampling program. Comments on the proposed determination and verification procedures must be received within 60 days after publication in the Federal Register.

Comments may be submitted online via the federal eRulemaking portal; by mail sent to: Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Mailstop 3758, Washington, DC 20250-3700; or by hand or courier delivery to 1400 Independence Avenue SW, Jamie L. Whitten Building, Room 350-E, Washington, DC 20250-3700. All items submitted by mail or electronic mail must include the agency name and docket number FSIS-2022-0013.