WASHINGTON — The US Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) has announced its decision to declare Salmonella an adulterant in raw breaded stuffed chicken products when they exceed a threshold of 1 colony forming unit (CFU) per gram or higher for Salmonella contamination. 

The final determination adds to FSIS’ overall efforts to reduce illnesses caused by Salmonella related to the raw poultry supply in the United States. FSIS plans to address Salmonella contamination in other raw poultry products later this year. The agency announced a proposed declaration of the policy 12 months ago.

“Under President Biden’s leadership, USDA is taking significant steps toward keeping American consumers safe from foodborne illness,” said Agriculture Secretary Tom Vilsack. “This final determination marks the first time that Salmonella is being declared an adulterant in a class of raw poultry products. This policy change is important because it will allow us to stop the sale of these products when we find levels of Salmonella contamination that could make people sick.”

FSIS will use sampling and testing of the raw incoming chicken component of these products prior to stuffing and breading to ensure that production establishments control Salmonella in these products as a verification procedure. The final raw breaded stuffed chicken products in the lot will not be permitted to be used if the chicken component does not meet the standard. The determination, including FSIS’ sampling and verification testing, will be effective 12 months after its publication in the Federal Register.

FSIS will consider any raw breaded stuffed chicken products that include a chicken component that tested positive for Salmonella at 1 CFU per gram or higher to be adulterated.

FSIS considered the best available science and data using similar criteria as in its 1994, 1999, and 2011 E. coli policymaking when determining that Salmonella is an adulterant in raw breaded stuffed chicken products. The determination of breaded stuffed chicken products relied on the same factors when declaring seven Shiga toxin-producing Escherichia coli (STEC) strains adulterants in select raw beef products. Those factors included the available information on serotypes linked to human illnesses, infectious dose, severity of illnesses and typical consumer preparation practices associated with a product.

Over the last 26 years, FSIS and public health officials have investigated 14 Salmonella outbreaks and about 200 illnesses linked to these products. The most recent outbreak, in 2021, resulted in illnesses in 11 states. These products account for less than 0.15% of the total domestic chicken supply, but outbreaks linked to these products represented approximately 5% of all chicken-associated outbreaks in the United States from 1998 to 2020.

Pre-browned and appearing cooked, the chicken component in raw breaded stuffed chicken products is raw. Consumers typically cook the products from a frozen state, thus increasing the risk of the product not reaching the internal temperature needed to destroy Salmonella. Despite the efforts of FSIS and the industry to improve labeling, these products continue to be associated with Salmonella illness outbreaks.

The Centers for Disease Control and Prevention (CDC) estimates more than 1 million human infections each year in the United States are caused by Salmonella bacteria. Food is the leading source of Salmonella infections and poultry products are one of the leading sources of foodborne Salmonella illnesses.

As science and technology related to pathogen levels, serotypes, laboratory methods, and infectious doses become available and advance, FSIS will evaluate and modify its policies and standards related to the oversight of raw breaded stuffed chicken products.

To view the final determination, visit the FSIS Federal Register Rules web page.