Notice2025-21737
Delayed Verification Sampling of Not Ready-to-Eat Breaded Stuffed Chicken Products
Primary source
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Published
December 2, 2025
Issuing agencies
Agriculture DepartmentFood Safety and Inspection Service
Abstract
FSIS is delaying the implementation of its verification activities related to Salmonella in not ready-to-eat (NRTE) breaded stuffed chicken product because of current testing method limitations. The current available test methods have accuracy limitations and have resulted in findings of false positives, especially at low levels of contamination.
Full Text
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<title>Federal Register, Volume 90 Issue 229 (Tuesday, December 2, 2025)</title>
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[Federal Register Volume 90, Number 229 (Tuesday, December 2, 2025)]
[Notices]
[Pages 55299-55300]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-21737]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS-2025-0180]
Delayed Verification Sampling of Not Ready-to-Eat Breaded Stuffed
Chicken Products
AGENCY: Food Safety and Inspection Service (FSIS), U.S. Department of
Agriculture (USDA).
ACTION: Notice.
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SUMMARY: FSIS is delaying the implementation of its verification
activities related to Salmonella in not ready-to-eat (NRTE) breaded
stuffed chicken product because of current testing method limitations.
The current available test methods have accuracy limitations and have
resulted in findings of false positives, especially at low levels of
contamination.
DATES: FSIS will not begin sampling and testing NRTE breaded stuffed
chicken or other verification activities related to that product on
November 3, 2025.
FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Assistant
Administrator, Office of Policy and Program Development by telephone at
(202) 205-0495.
SUPPLEMENTARY INFORMATION: FSIS is the public health agency within the
USDA responsible for ensuring that meat, poultry, and egg products are
safe, wholesome, and properly labeled. In support of this mission, FSIS
published a final determination in the Federal Register on May 1, 2024,
declaring that NRTE breaded stuffed chicken products containing
Salmonella at levels of 1 colony forming unit per gram (1 CFU/g) or
higher are adulterated under the Poultry Products Inspection Act
(PPIA)(21 U.S.C. 453 (g)(1) and (3))(89 FR 35033).
The final determination also announced FSIS' intention to implement
sampling and testing of raw incoming chicken components used to produce
NRTE breaded stuffed chicken products (88 FR 35033, 35050-35051). The
testing program was initially set to begin on May 1, 2025. On April 11,
2025, FSIS extended the start date until November 3, 2025, to give the
Agency additional time to finalize relevant guidance and instructions
and to prepare laboratories for sampling and testing (90 FR 15433).
FSIS is now announcing a further delay in the implementation of
verification sampling and testing and other verification activities for
NRTE breaded stuffed chicken products. The available methods, including
the reference method Most Probable Number (MPN) have accuracy
limitations and have resulted in findings of false positives for
Salmonella at 1 CFU/g; that is, there have been instances in which some
product that in fact contains less than 1 CFU/g has tested positive.
Specifically, an evaluation study conducted by the Agricultural
Research Service (ARS),\1\ tested source material for NRTE breaded
stuffed chicken, consistent with the sampling approach FSIS planned to
use and found false positives. According to the study, under the
specific method \2\ FSIS planned to use, if a sample contains
Salmonella at a concentration of 0.9 CFU/g, there is a 75% chance the
method will report >= 1 CFU/g. If a sample is 0.5 CFU/g, there would
still be a 40% chance the method would report >= 1 CFU/g. As a result,
moving forward with the current testing method could lead to
enforcement actions against products that are positive for Salmonella
at less than 1 CFU/g and are, therefore, not adulterated based on the
final determination published May 1, 2024 (89 FR 35033).
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\1\ Schmidt, J.W., Wu, W., Harhay, D.M. & Wheeler, T. L., (2025)
Identification of Chicken Component Samples Containing Salmonella
Concentrations Greater Than or Equal to 1 CFU/g, Meat and Muscle
Biology 9(1): 18993, 1-8. doi: <a href="https://doi.org/10.22175/mmb.18993">https://doi.org/10.22175/mmb.18993</a>.
\2\ More information about the ``Confidently Above Threshold''
(CAT) method and the CAT method protocol (CAT-80) is available in
the article in Meat and Muscle Biology at: <a href="https://doi.org/10.22175/mmb.18993">https://doi.org/10.22175/mmb.18993</a>.
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Applying a quantitative threshold (i.e., 1 CFU/g) for Salmonella in
raw poultry is a regulatory approach the Agency has not taken before.
FSIS has historically relied on presence or absence testing to verify
whether product is adulterated based on pathogen testing (e.g., when
testing ready-to-eat product for Listeria monocytogenes or Salmonella
or applicable raw beef product for Shiga toxin-producing Escherichia
coli).
Given the implications of enforcement based on a specific numerical
threshold, FSIS needs additional time to reevaluate the testing program
and determine its viability moving forward.
This delay reflects FSIS' commitment to ensuring that enforcement
decisions are based on data that are not only scientifically valid, but
also operationally reliable, reproducible, and fair. This delay also
gives industry more time to implement controls to reduce Salmonella in
source components used to produce NRTE breaded stuffed chicken.
At this time, FSIS is not establishing a new implementation date.
The duration of the delay will depend largely on whether the Agency is
able to refine the current method or develop and validate an
alternative method that can be reliably applied in a regulatory
context. FSIS will provide advance notice in the Federal Register
before beginning verification sampling and testing activities.
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, FSIS will announce this Federal
Register publication on-line through the FSIS web page located at:
<a href="https://www.fsis.usda.gov/federal-register">https://www.fsis.usda.gov/federal-register</a>.
FSIS will also announce and provide a link to this Federal Register
publication through the FSIS Constituent Update, which is used to
provide information regarding FSIS policies, procedures, regulations,
Federal Register notices, FSIS public meetings, and other types of
information that could affect or would be of interest to our
constituents and stakeholders. The Constituent Update is available on
the FSIS web page. Through the web page, FSIS can provide information
to a much broader, more diverse audience. In addition, FSIS offers an
email subscription service that provides automatic and customized
access to selected food safety news and information. This service is
available at:
[[Page 55300]]
<a href="https://www.fsis.usda.gov/subscribe">https://www.fsis.usda.gov/subscribe</a>. The available information ranges
from recalls to export information, regulations, directives, and
notices. Customers can add or delete subscriptions themselves and have
the option to password protect their accounts.
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In accordance with Federal civil rights law and USDA civil rights
regulations and policies, the USDA, its Agencies, offices, and
employees, and institutions participating in or administering USDA
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rights activity, in any program or activity conducted or funded by USDA
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Persons with disabilities who require alternative means of
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Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or
contact USDA through the Federal Relay Service at (800) 877-8339.
Additionally, program information may be made available in languages
other than English.
To file a program discrimination complaint, complete the USDA
Program Discrimination Complaint Form, AD-3027, found online at How to
File a Program Discrimination Complaint and at any USDA office or write
a letter addressed to USDA and provide in the letter all of the
information requested in the form. To request a copy of the complaint
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by: (1) mail: U.S. Department of Agriculture, Office of the Assistant
Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC
20250-9410; (2) fax: (202) 690-7442; or (3) email:
<a href="/cdn-cgi/l/email-protection#2454564b435645490a4d4a50454f4164515740450a434b52"><span class="__cf_email__" data-cfemail="5f2f2d30382d3e327136312b3e343a1f2a2c3b3e71383029">[email protected]</span></a>.
USDA is an equal opportunity provider, employer, and lender.
Denise Eblen,
Deputy Administrator.
[FR Doc. 2025-21737 Filed 12-1-25; 8:45 am]
BILLING CODE 3410-DM-P
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