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Regulatory Issues

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USDA Finalizes Policy on Declaring Salmonella in Raw Breaded Stuffed Chicken Products

The U.S. Department of Agriculture’s Food Safety and Inspection Service has made its final determination to declare Salmonella an adulterant in raw breaded stuffed chicken products when they exceed a specific threshold (1 colony forming unit per gram or higher) for Salmonella contamination.

This final determination is part of FSIS’ broader efforts to reduce Salmonella illnesses associated with the raw poultry supply in the United States. FSIS intends to address Salmonella contamination in other raw poultry products later this year.

“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.”

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

FSIS will carry out verification procedures, including sampling and testing of the raw incoming chicken component of these products prior to stuffing and breading, to ensure producing establishments control Salmonella in these products. If the chicken component in these products does not meet this standard, the product lot represented by the sampled component would not be permitted to be used to produce the final raw breaded stuffed chicken products. The determination, including FSIS’ sampling and verification testing, will be effective 12 months after its publication in the Federal Register.

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

FSIS and its public health partners have investigated 14 Salmonella outbreaks and approximately 200 illnesses associated with these products since 1998. The most recent outbreak was in 2021 and resulted in illnesses across 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 U.S. during 1998-2020.

Raw breaded stuffed chicken products are pre-browned and may appear cooked, but the chicken is raw. 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. Despite FSIS’ and industry’s efforts to improve labeling, these products continue to be associated with Salmonella illness outbreaks.

The Centers for Disease Control and Prevention estimates that Salmonella bacteria cause over 1 million human infections in the United States each year. Food is the leading source of Salmonella infections and poultry products are one of the leading sources of foodborne Salmonella illnesses.

FSIS will continue to evaluate and, if necessary, refine its policies and standards related to the oversight of raw breaded stuffed chicken products as advances in science and technology related to pathogen levels, serotypes, laboratory methods and infectious dose become available.

This final determination builds on USDA’s continued efforts under the Biden-Harris Administration to protect American consumers, whether to ensure food safety or prevent false and misleading label claims. Earlier this year, USDA published a final rule allowing the voluntary “Product of USA” claim to be applied only to those FSIS-regulated products that are derived from animals born, raised, slaughtered and processed in the United States. USDA is currently re-evaluating the FSIS guideline for animal-raising claims to better ensure that they are adequately substantiated.

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

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USDA Issues Order on Avian Influenza in Dairy Cattle

To further protect the U.S. livestock industry from the threat posed by highly pathogenic H5N1 avian influenza, USDA’s Animal and Plant Health Inspection Service announced a federal order requiring the measures effective Monday, April 29.

Mandatory Testing for Interstate Movement of Dairy Cattle

  • Prior to interstate movement, dairy cattle are required to receive a negative test for Influenza A virus at an approved National Animal Health Laboratory Network  laboratory.
  • Owners of herds in which dairy cattle test positive for interstate movement will be required to provide epidemiological information, including animal movement tracing.
  • Dairy cattle moving interstate must adhere to conditions specified by APHIS.
  • As will be described in forthcoming guidance, these steps will be immediately required for lactating dairy cattle, while these requirements for other classes of dairy cattle will be based on scientific factors concerning the virus and its evolving risk profile.

Mandatory Reporting

  • Laboratories and state veterinarians must report positive Influenza A nucleic acid detection diagnostic results (e.g. PCR or genetic sequencing) in livestock to USDA APHIS.
  • Laboratories and state veterinarians must report positive Influenza A serology diagnostic results in livestock to USDA APHIS.

USDA has identified spread between cows within the same herd, spread from cows to poultry, spread between dairies associated with cattle movements, and cows without clinical signs that have tested positive. On April 16, APHIS microbiologists identified a shift in an H5N1 sample from a cow in Kansas that could indicate that the virus has an adaptation to mammals. Centers for Disease Control and Prevention conducted further analysis of the specimen sequence, which did not change their overall risk assessment for the general public, because the substitution has been seen previously in other mammalian infections and does not impact viral transmission. Additionally, APHIS’ National Veterinary Services Laboratories found H5N1 in a lung tissue sample from an asymptomatic cull dairy cow that originated from an affected herd and did not enter the food supply.

The novel movement of H5N1 between wild birds and dairy cows requires further testing and time to develop a critical understanding to support any future courses of action. This Federal Order is critical to increasing the information available for USDA. Requiring positive test reporting will help USDA better under this disease and testing before interstate movement will limit its spread.

Thus far, USDA has not found changes to the virus that would make it more transmissible to humans and between people. While cases among humans in direct contact with infected animals are possible, the U.S. Centers for Disease Control and Prevention believes that the current risk to the public remains low.

Additionally, ASDA continues to see affected cows recover after supported care with little to no associated mortality. The agency also continues to work with partners in the states and industry to emphasize the critical importance biosecurity plays in limiting disease spread for all livestock and poultry.

View the federal order.

In an effort to maximize understanding and research on H5N1 in dairy cattle, on April 21, APHIS made publicly available 239 genetic sequences from the U.S. H5N1 clade 2.3.4.4b influenza virus recently found in samples associated with the ongoing HPAI outbreak in poultry and wild birds, and the recent H5N1 event in dairy cattle. APHIS has also offered virus samples to interested researchers to facilitate epidemiological study. Increasing the understanding of this disease and how it spreads is critical to stopping it.

This is why APHIS is urging dairy cattle producers and those who work in or with the industry to share epidemiological information from affected farms, even if they are not planning to move cattle interstate. APHIS further urges producer participation in public health assessments to continue to confirm worker safety and monitor for any potential changes in the virus that could impact transmissibility.

In addition,  the U.S. Food and Drug Administration released an update on the ongoing work to ensure continued effectiveness of the federal-state milk safety system. It is important to emphasize that, based on the information and research available to us at this time, the FDA and USDA believe that the commercial milk supply is safe because of both the pasteurization process and the required diversion or destruction of milk from sick cows.

Pasteurization has continuously proven to inactivate bacteria and viruses in milk. The FDA and USDA continue to work closely to collect and evaluate additional data and information specific to avian influenza in dairy cattle and to support state counterparts as this emerging disease in dairy cattle is managed.

As USDA continues to take steps to protect the health of livestock, the department continues to work closely with federal partners at the CDC on protecting the health of people and FDA on protecting the safety of the food supply. The U.S. government is committed to addressing this situation with urgency.

To learn more about USDA’s response to HPAI in dairy cattle, visit www.aphis.usda.gov/livestock-poultry-disease/avian/avian-influenza/hpai-detections/livestock.

For more news of interest to the livestock and dairy industries, subscribe to Gourmet News.

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