[Federal Register Volume 89, Number 152 (Wednesday, August 7, 2024)]
[Proposed Rules]
[Pages 64678-64748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16963]



[[Page 64677]]

Vol. 89

Wednesday,

No. 152

August 7, 2024

Part IV





 Department of Agriculture





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Food Safety and Inspection Service





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9 CFR Part 381





Salmonella Framework for Raw Poultry Products; Proposed Rule

  Federal Register / Vol. 89, No. 152 / Wednesday, August 7, 2024 / 
Proposed Rules  

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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 381

[Docket No. FSIS-2023-0028]
RIN 0583-AD96


Salmonella Framework for Raw Poultry Products

AGENCY: Food Safety and Inspection Service (FSIS), U.S. Department of 
Agriculture (USDA).

ACTION: Proposed rule and Proposed Determination.

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SUMMARY: FSIS is announcing its proposed determination that raw chicken 
carcasses, chicken parts, comminuted chicken, and comminuted turkey 
products contaminated with certain Salmonella levels and serotypes are 
adulterated within the meaning of the Poultry Products Inspection Act 
(PPIA). The proposed determination would establish final product 
standards based on these Salmonella levels and serotypes and would 
prevent raw chicken carcasses, chicken parts, comminuted chicken, and 
comminuted turkey products that contain Salmonella at the levels and 
serotypes that would render them adulterated from entering commerce. 
FSIS is also proposing to revise the regulations that require that all 
poultry slaughter establishments develop, implement, and maintain 
written procedures to prevent contamination by enteric pathogens 
throughout the entire slaughter and dressing operation to clarify that 
these procedures must include a microbial monitoring program (MMP) that 
incorporates statistical process control (SPC) monitoring methods, to 
require sampling at rehang instead of pre-chill, and to require that 
all establishments conduct paired sampling at rehang and post-chill.

DATES: Comments on this proposal must be received on or before October 
7, 2024.

ADDRESSES: FSIS invites interested persons to submit comments on this 
document. Comments may be submitted by one of the following methods:
     Federal eRulemaking Portal: This website provides the 
ability to type short comments directly into the comment field on this 
web page or attach a file for lengthier comments. Go to: https://www.regulations.gov. Follow the on-line instructions at that site for 
submitting comments.
     Mail: Send to Docket Clerk, U.S. Department of 
Agriculture, Food Safety and Inspection Service, 1400 Independence 
Avenue SW, Mailstop 3758, Washington, DC 20250-3700.
     Hand- or courier-delivered submittals: Deliver to 1400 
Independence Avenue SW, Jamie L. Whitten Building, Room 350-E, 
Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2023-0028. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to https://www.regulations.gov.
    Docket: Go to the Federal eRulemaking Portal at https://www.regulations.gov for access to the rulemaking docket, including any 
background documents and the plain-language summary of the proposed 
rule of not more than 100 words in length required by the Providing 
Accountability Through Transparency Act of 2023. For in-person access 
to background documents or comments received, call (202) 720-5046 to 
schedule a time to visit the FSIS Docket Room at 1400 Independence 
Avenue SW, Washington, DC 20250-3700.

FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Assistant 
Administrator, Office of Policy and Program Development, FSIS, USDA; 
Telephone: (202) 205-0495.

SUPPLEMENTARY INFORMATION:

Executive Summary

    FSIS is responsible for verifying that the nation's commercial 
supply of meat, poultry, and egg products is safe, wholesome, and 
properly labeled. In support of this mission, FSIS established a 
Salmonella verification testing program in 1996 as part of the 
``Pathogen Reduction; Hazard Analysis and Critical Control Point 
Systems'' (PR/HACCP) final rule (61 FR 38805). Among other things, the 
PR/HACCP final rule established Salmonella pathogen reduction 
performance standards for raw product to allow FSIS to verify whether 
establishments have effective process controls to address Salmonella. 
The current performance standards for young chicken and turkey 
carcasses, raw chicken parts, and comminuted chicken and turkey 
products are represented as a fraction of the maximum number of 
allowable Salmonella-positive results over a targeted number of samples 
collected and analyzed in a 52-week moving window. FSIS categorizes 
establishments based on the Salmonella verification sampling results 
and posts the performance categorization of all establishments subject 
to the performance standards on the FSIS website. FSIS uses Salmonella 
performance standard categorization as a basis to prioritize in-depth 
evaluations of failing establishments' food safety systems, including 
their HACCP plan and sanitation Standard Operating Procedures (SOPs).
    While the results of FSIS' Salmonella verification sampling show 
that the current prevalence-based performance standards approach has 
been effective in reducing the proportion of poultry products 
contaminated with Salmonella, these measures have yet to have an 
observable impact on human illness rates. The estimated rate of human 
Salmonella infections from all sources has remained consistent over the 
last two decades, with over 1.3 million illnesses estimated in the 
United States each year. Additionally, while current Salmonella 
performance standards are designed to achieve the Department of Health 
and Human Services' Healthy People Initiative \1\ targets for foodborne 
illness reduction, the 2010 and 2020 Healthy People targets for a 
reduction in Salmonella infections from all sources were not met. The 
Healthy People 2030 target is to reduce Salmonella infections from all 
sources to a national case rate of no more than 11.5 per 100,000 
consumers per year. To reach this 2030 target, Salmonella illnesses 
must be reduced by 25 percent.
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    \1\ Launched by the U.S. Department of Health and Human Services 
(HHS) in 1980, the Healthy People Initiative sets out to create 
widely accessible plans to help organizations, communities and 
individuals improve public health. Each decade, HHS releases new 
goals after evaluating the successes and areas of growth from the 
previous ten years. They monitor the progress toward Healthy 
People's objectives using high-quality data and feedback., the HHS 
benchmark continues to focus on reducing poultry-based Salmonella 
infections by 25 percent, a goal that has not been reached over the 
last decade. The Healthy People 2030 objectives were released on 
August 18, 2020.
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    Poultry is among the leading sources of Salmonella foodborne 
illness acquired domestically in the United States.\2\ Therefore, on 
October 19, 2021, FSIS announced that it was mobilizing a stronger, and 
more comprehensive effort to reduce Salmonella illnesses associated 
with poultry products. In the

[[Page 64679]]

announcement, FSIS stated that it had initiated several activities 
designed to gather data and information to inform and support future 
actions related to this new effort. FSIS charged the National Committee 
on Microbiological Criteria for Food (NACMCF) to provide guidance on 
the types of microbiological criteria the Agency might use to better 
prevent Salmonella infections associated with poultry products. The 
Agency also conducted a risk profile for pathogenic Salmonella subtypes 
in poultry and developed two quantitative risk assessments --one for 
Salmonella in chicken and one for Salmonella in turkey. Additionally, 
FSIS conducted an exploratory sampling program for young chicken 
carcasses to generate microbial data to help inform future policies and 
added quantification to its Salmonella testing program.
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    \2\ Interagency Food Safety Analytics Collaboration (FSAC). 
Foodborne illness source attribution estimates for 2020 for 
Salmonella, Escherichia coli O157, and Listeria monocytogenes using 
multi-year outbreak surveillance data, United States. GA and DC: 
U.S. Department of Health and Human Services, Centers for Disease 
Control and Prevention, Food and Drug Administration, U.S. 
Department of Agriculture's Food Safety and Inspection Service. 
2022. Available at: https://www.cdc.gov/ifsac/php/annual-reports/?CDC_AAref_Val=https://www.cdc.gov/foodsafety/ifsac/annual-reports.html.
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    In addition to initiating these activities, on October 17, 2022, 
FSIS shared with stakeholders a draft regulatory framework that the 
Agency was considering for a new strategy to control Salmonella in 
poultry products and announced that FSIS would be hosting a virtual 
public meeting on November 3, 2022, to discuss the framework. The three 
components under consideration in the draft framework included:
    Component One. Requiring that establishments characterize 
Salmonella as a hazard reasonably likely to occur at receiving and 
requiring that incoming flocks be tested for Salmonella before entering 
an establishment.
    Component Two. Enhancing establishment process control monitoring 
and FSIS verification.
    Component Three. Implementing an enforceable final product standard 
that would define whether certain raw poultry products contaminated 
with certain levels and/or serotypes of Salmonella are adulterated.
    The draft framework under consideration also addressed cross-
cutting issues associated with testing for Salmonella, considerations 
for small and very small establishments, and data sharing. At the 
November 2022 public meeting, stakeholders presented oral comments on 
the three separate components of the draft framework and the cross-
cutting issues. Stakeholders also had an opportunity to submit written 
comments to FSIS by December 16, 2022.
    After carefully evaluating the written comments and other 
stakeholder input provided on the October 2022 draft framework, along 
with new studies and information that have become available since the 
Agency made the October 2022 draft framework available to the public, 
FSIS is proposing a new regulatory framework targeted at reducing 
Salmonella illnesses associated with poultry products. The proposed 
regulatory framework reflects the draft framework with some 
modifications.
    First, consistent with Component Three of the October 2022 draft 
framework, FSIS is proposing final product standards that would define 
whether certain raw poultry products contaminated with certain 
Salmonella levels and serotypes are adulterated as defined in the 
Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.). 
Specifically, FSIS has tentatively determined that raw chicken 
carcasses, chicken parts, comminuted chicken, and comminuted turkey are 
adulterated if they contain any type of Salmonella at or above 10 
colony forming units/per milliliter or gram (10 cfu/mL(g)) in 
analytical portion (i.e., mL of rinsate or gram of product) and contain 
any detectable level of at least one of the Salmonella serotypes of 
public health significance identified for that commodity. The proposed 
Salmonella serotypes of public health significance identified for raw 
chicken carcasses, chicken parts, and comminuted chicken are 
Enteritidis, Typhimurium, and I 4,[5],12:i:-, and for raw comminuted 
turkey are Hadar, Typhimurium, and Muenchen. These are the most highly 
virulent Salmonella serotypes associated with these products identified 
in the FSIS chicken and turkey risk assessments.
    The Salmonella serotypes of public health significance will likely 
change over time as the serotypes commonly associated with human 
illnesses change. FSIS would continue to track annual targets for 
reducing the proportion of poultry samples that contain Salmonella 
serotypes of public health significance as well as data on rates for 
additional serotypes commonly associated with human illness to inform 
future revisions to the Salmonella serotypes of public health 
significance. Should FSIS finalize the proposed final product 
standards, the Agency intends to further evaluate and, if necessary, 
refine these standards as advances in science and technology related to 
pathogen levels, serotypes, and virulence genes become available. If 
FSIS finalizes the proposed final product standards, the Agency intends 
to re-evaluate the serotypes of public health concern every 3-5 years 
at a minimum and whenever new information on Salmonella serotypes 
associated with human illness become available. When evaluating the 
serotypes, FSIS would consider, among other things, outbreak illness 
data, foodborne illness surveillance data, product testing data, and 
animal testing data. FSIS would publicly announce any modifications to 
the final products standards in the Federal Register. FSIS requests 
comments on this proposed timeline for re-evaluating serotypes of 
public health concern.
    Should FSIS finalize these proposed standards, the Agency intends 
to conduct a routine sampling and verification testing program for 
Salmonella in chicken carcasses, chicken parts, comminuted chicken, and 
comminuted turkey in which the Agency would collect samples of raw 
final products and analyze them for Salmonella levels and serotypes to 
determine whether the final product is adulterated. Under the proposed 
Salmonella verification testing program, FSIS intends to only collect 
and analyze samples of the final raw poultry products produced by an 
establishment, i.e., chicken carcasses to be shipped in commerce as 
whole chickens, chicken parts to be shipped in commerce as chicken 
parts, comminuted chicken to be shipped in commerce as comminuted 
chicken products, and comminuted turkey to be shipped in commerce as 
comminuted turkey products. Under this proposed determination, chicken 
parts subject to the final product standards would include legs, 
thighs, breasts, wings, quarters, and halves.
    When FSIS tests a product sample for adulterants, establishments 
must maintain control of products tested for adulterants to ensure that 
the products do not enter commerce while waiting for receipt of the 
test results. Thus, if FSIS finalizes its proposed routine Salmonella 
verification testing program for chicken carcasses, chicken parts, 
comminuted chicken, and comminuted turkey, establishments that produce 
these raw products would need to control and maintain the integrity of 
the sampled lot pending the availability of test results. If test 
results detect Salmonella at a level of 10 cfu/mL(g) or higher and at 
least one Salmonella serotype of public health significance, FSIS would 
consider products represented by the sampled lots to be adulterated and 
would issue a non-compliance record (NR). Therefore, all products in 
the lot represented by the sample would be prohibited from entering 
commerce. If any product from the lot represented by the product 
samples has entered and remains available in commerce, FSIS would 
request that the producing establishment recall the implicated 
products. Depending on the circumstances, in addition to issuing an NR, 
FSIS could take other appropriate

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enforcement action as authorized in 9 CFR part 500 because the 
establishment would have produced and shipped adulterated product. Such 
actions may include immediately suspending inspection or issuing a 
Notice of Intended Enforcement (NOIE).
    As FSIS implements the final product standards verification 
sampling program, the Agency has tentatively decided to phase out all 
current Salmonella performance standards for poultry. Thus, when the 
proposed final product verification sampling program is fully 
implemented, FSIS has tentatively decided that it would no longer use 
Salmonella sampling results to categorize establishments that produce 
poultry products and would no longer publish these establishments' 
performance standards categories on the FSIS website. The Agency is 
requesting comments on this issue.
    Consistent with Component Two of the initial proposed framework, 
FSIS is proposing to revise the regulations in 9 CFR 381.65(g) and (h) 
that require that all poultry slaughter establishments develop, 
implement, and maintain written procedures to prevent contamination by 
enteric pathogens throughout the entire slaughter and dressing 
operation and maintain records documenting those procedures. FSIS is 
proposing to amend these regulations to establish new requirements 
pertaining to how establishments monitor and document whether their 
processes for preventing microbial contamination are in control. The 
proposed revisions are intended to clarify existing regulatory 
requirements related to process control monitoring in 9 CFR 381.65(g) 
and (h).
    Under this proposal, establishments would be required to 
incorporate statistical process control (SPC) monitoring principles 
into their microbial monitoring programs (MMPs). The proposed revisions 
would require that establishments use only validated and fit for 
purpose microbial sampling and analysis procedures, generate and record 
statistically meaningful microbial monitoring data, set benchmarks by 
which to evaluate microbial monitoring data, and otherwise define the 
statistical methods the establishment will use to evaluate the recorded 
data against the predefined limits. To offset the costs associated with 
this proposal, eligible very small (VS) and very low volume (VLV) 
establishments would have access to laboratory services provided by 
FSIS at no charge to analyze the establishments' microbial monitoring 
samples for them.
    FSIS is further proposing to revise the regulations to ensure that 
establishments comply with the corrective action provisions required 
under HACCP as they apply to the establishment's MMP. FSIS is proposing 
to specifically require establishments to, at a minimum, implement 
written corrective actions, including a root cause assessment, when 
microbial monitoring results deviate from the predefined criteria in 
the MMP, the other process control monitoring results, or the process 
control determination made for the entire HACCP system.
    FSIS has developed new guidance to help establishments meet the 
proposed updated sampling and analysis requirements under 9 CFR 
381.65(g). The new guidance includes a SPC sampling plan based on 
paired sampling for Aerobic Count (AC) at the rehang and post-chill 
locations, with a one-sided process control statistical model that 
charts and calculates against minimum monitoring criteria at the 
minimum required frequency. Establishments that incorporate the 
guidance into their MMPs would not be required to provide FSIS with 
additional scientific or technical information to support their chosen 
statistical methods. FSIS also is proposing to make available to all 
poultry slaughter establishments an electronic spreadsheet file that is 
pre-programmed to calculate the monitoring measures for the guidance 
sampling plan as results are entered.
    In addition, FSIS is proposing to amend the recordkeeping 
requirements under 9 CFR 381.65(h) to require that establishments 
submit their microbial monitoring sampling results to FSIS 
electronically. FSIS is developing a web portal that will allow 
external partners to securely upload sampling information and submit it 
to FSIS electronically in a machine-readable format.\3\ Should FSIS 
finalize this proposal, the Agency would provide a template that 
establishments could use to record and submit their monthly results. 
Establishments that use the template to record the microbial monitoring 
results may upload their completed template into the portal or they may 
enter the information manually into the portal. Establishments that do 
not use the template provided by FSIS to record their results would 
need to manually enter microbial sampling data into the portal to 
submit the monthly data.
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    \3\ In a format that provides a digital representation of data 
or information that can be imported and read into a computer system 
for further processing.
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    Under Component One of the October 2022 draft framework, FSIS 
considered whether it should require poultry slaughter establishments 
to characterize Salmonella as a hazard reasonably likely to occur at 
receiving and require that incoming flocks be tested for Salmonella 
before entering an establishment. This approach would require the flock 
to meet a predetermined target level for Salmonella at receiving.
    FSIS considered the available scientific research as well as input 
from the NACMCF and concluded that, at this time, the research does not 
support the use of a threshold for test results at the receiving step 
to reduce or eliminate Salmonella from raw poultry products. In 
addition, FSIS received several comments from small poultry processors 
and producers and trade associations representing the meat and poultry 
industries that expressed concerns that the measures under 
consideration in Component One would impose an overwhelming burden on 
small producers and processors. The comments also stated that requiring 
that establishments determine that Salmonella is a hazard reasonably 
likely to occur at receiving is inconsistent with HACCP principles. 
While FSIS has decided at this time not to establish a regulatory 
requirement that establishments characterize Salmonella as a hazard 
reasonably likely to occur at receiving or that incoming flocks be 
tested for Salmonella before entering an establishment, the Agency is 
focusing on a non-regulatory approach for reducing the Salmonella load 
on incoming birds. The Agency intends to provide updated guidance on 
pre-harvest interventions and practices for preventing or reducing 
Salmonella colonization of live birds. The Agency also will continue to 
explore and develop strategies for industry to address Salmonella 
contamination risk at receiving.

Costs and Benefits of the Proposed Rule and Proposed Determination

    FSIS estimates this proposal would have a net benefit of $4.1 
million per year, ranging from $1.1 million to $6.7 million, assuming 
the proposed implementation schedule and annualizing over 10 years at a 
7 percent discount rate, as discussed below (Table 1). This proposal is 
estimated to cost industry $16.4 million per year, ranging from $3.3 to 
$32.3 million. The main cost component in this proposal is the 
requirement that establishments subject to FSIS verification sampling 
for adulterants maintain control of sampled product pending test 
results. This cost is likely an overestimate as discussed below. 
Industry may also incur costs associated with HACCP plan

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reassessments and changes to process control requirements.
    FSIS estimates this proposal would result in benefits to society of 
$20.5 million per year, ranging from $4.4 million to $39.0 million. The 
majority of the benefits are derived from prevented illnesses of $12.9 
million per year, ranging from $0.3 to $28.7 million. FSIS also 
estimated avoided costs from a reduction in the risk of outbreak-
related recalls for industry. Additional industry actions in response 
to this proposal may lead to additional benefits.

                                     Table 1--Summary of Costs and Benefits
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                                                                                 Total (million $)
                           Description                           -----------------------------------------------
                                                                        Low           Medium           High
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Costs:
Costs associated with the proposed rule:
    Statistical Process Control.................................            0.04            0.04            0.04
    Electronic data submission..................................            0.18            0.18            0.18
    HACCP plan reassessment.....................................            0.09            0.18            0.26
Costs associated with the proposed determination:
    Maintaining control of sampled product......................            2.11           14.47           29.26
    Lost value to the industry..................................            0.87            1.52            2.43
    Microbiological sampling plan reassessment..................            0.02            0.04            0.08
                                                                 -----------------------------------------------
        Total costs.............................................            3.31           16.43           32.25
Benefits and Avoided Costs:
    Prevented illnesses from consumption of chicken products....            0.09            4.35           15.11
    Prevented illnesses from consumption of comminuted turkey...            0.19            8.58           13.55
    Prevented outbreak-related recalls..........................            4.16            7.56           10.34
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        Total benefits..........................................            4.45           20.49           39.00
            Net benefits........................................            1.14            4.06            6.75
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Note: All costs and benefits are annualized over 10 years at a 7 percent discount rate. Numbers in table may not
  sum to totals due to rounding.

Table of Contents

I. Background
    A. Salmonella in Poultry and Human Illnesses
    1. Salmonella Illnesses Attributed to Poultry
    2. Salmonella Performance Standards for Poultry
    3. Salmonella Performance Standards and Illnesses
    B. Consideration of Need for a New Framework To Control 
Salmonella in Poultry
    1. Petitions and Initial Stakeholder Input
    2. FSIS Announces New Salmonella Effort
    3. Activities Initiated To Support a New Salmonella Framework
    4. Initial Measures Implemented To Address Salmonella Illnesses 
Associated With Consumption of Poultry Products
    C. Public Meeting on Salmonella Framework Under Consideration 
and Public Comments
    1. Public Meeting and Proposed Framework
    2. Public Comments on the Proposed Framework
    3. Additional Stakeholder Input
    4. Overview of Modifications to the Proposed Salmonella 
Framework
    5. Severability
II. Component Three: Proposed Final Product Standards
    A. Current Salmonella Performance Standards and Consideration of 
an Alternative Approach
    B. Pathogens as Adulterants in Raw and Not-Ready-To Eat Meat and 
Poultry Products
    C. The Adulteration Standard for Raw Poultry Products
    1. Pathogen Serogroups or Types Associated With Human Illness
    2. Dose Considerations
    3. Severity of Illnesses
    4. Consumer Cooking Practices
    E. Risk per Serving, Salmonella Levels, and Proposed 
Determination
    1. Final Product Standards Salmonella Levels and Risk per 
Serving
    2. Proposed Determination
    F. Proposed Policy Implementation
    1. HACCP Reassessment
    2. Proposed Implementation and Status of Laboratory Methods
III. Component Two: Enhanced Establishment Process Control 
Monitoring
    A. Background and Current Regulatory Requirements
    B. Need To Enhance Establishment Process Control Monitoring
    1. NACMCF Charge and Recommendations
    2. PHIS Inspection Data
    3. Exploratory Sampling Program Data
    4. FSIS Risk Assessments
    C. Proposals To Enhance Establishment Process Control Monitoring
    1. SPC Monitoring
    2. Microbial Monitoring Organism
    3. Sampling Location
    4. Sample Collection Monitoring Frequency
    5. Corrective Actions
    6. Recordkeeping Requirements
IV. Component One: Pre-Harvest Measures
    A. Scientific Support and Public Comments
    B. Possible Approaches To Control Salmonella at Pre-Harvest
    1. National Poultry Improvement Program
    2. Vaccination
    3. Supply Chain Control Programs
    4. Updated Pre-Harvest Guidance
V. State Programs and Foreign Government Programs
VI. Executive Orders 12866, as Amended by 14094, and 13563
VII. Regulatory Flexibility Act Assessment
VIII. Paperwork Reduction Act
IX. E-Government Act
X. Executive Order 12988, Civil Justice Reform
XI. E.O. 13175
XII. USDA Non-Discrimination Statement
XIII. Environmental Impact
XIV. Additional Public Notification

I. Background

A. Salmonella in Poultry and Human Illnesses

1. Salmonella Illnesses Attributed to Poultry
    Salmonella in poultry is a significant food safety and public 
health concern. The Centers for Disease Control and Prevention (CDC) 
estimates that non-typhoidal Salmonella from all sources is responsible 
for over 1.3 million illnesses, 26,500 hospitalized, and 420 deaths 
each year in the United States.\4\ From this overall number, FSIS 
estimates that there are 125,115 chicken-associated and 42,669 turkey-
associated foodborne Salmonella illnesses per year. These values are

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calculated as the product of the total number of CDC FoodNet cases per 
year (7,600),\5\ the share of these cases that are foodborne (66 
percent) \6\ and of domestic origin (89 percent),\7\ and the under-
diagnosis multiplier for Salmonella (24.3),\8\ then dividing by the 
FoodNet catchment area (15 percent).\9\ Finally, this number is 
multiplied by the portion the Interagency Food Safety Analytics 
Collaboration (IFSAC) estimates is attributable to chicken (17.3 
percent) or turkey (5.9 percent).\10\ Uncertainty remains in the FSIS 
estimation of chicken- and turkey-associated foodborne Salmonella 
illnesses per year. These illness estimates are subject to the same 
limitations encountered with other illness estimates.\11\ Nevertheless, 
FSIS believes these are the best available estimates.
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    \4\ Collier SA, Deng L, Adam EA, et al. Estimate of Burden and 
Direct Healthcare Cost of Infectious Waterborne Disease in the 
United States. Emerging Infectious Diseases. 2021;27(1):140-149. 
https://doi.org/10.3201%2Feid2701.190676.
    \5\ Collins JP, Shah HJ, Weller DL, et al. Preliminary Incidence 
and Trends of Infections Caused by Pathogens Transmitted Commonly 
Through Food--Foodborne Diseases Active Surveillance Network, 10 
U.S. Sites, 2016-2021. MMWR Morb Mortal Wkly Rep 2022;71:1260-1264. 
DOI: https://doi.org/10.15585/mmwr.mm7140a2. Note: the most recent 
annual FoodNet report was used for the total estimated FoodNet cases 
annually.
    \6\ Beshearse E, Bruce BB, Nane GF, Cooke RM, Aspinall W, Hald 
T, et al. Attribution of Illnesses Transmitted by Food and Water to 
Comprehensive Transmission Pathways Using Structured Expert 
Judgment, United, States. Emerg Infect Dis. 2021;27(1):182-195. 
https://doi.org/10.3201/eid2701.200316. Note: This article 
represented a recent appraisal of the foodborne share of all 
Salmonella illnesses.
    \7\ Scallan E, Hoekstra RM, Angulo FJ, Tauxe RV, Widdowson MA, 
Roy SL, Jones JL, Griffin PM. Foodborne illness acquired in the 
United States--major pathogens. Emerg Infect Dis. 2011 Jan;17(1):7-
15. doi: 10.3201/eid1701.p11101. PMID: 21192848; PMCID: PMC3375761. 
Note: This article outlines the general approach to estimating the 
burden of domestic foodborne illnesses. It provides an estimate for 
share of foodborne illnesses associated with foreign travel (11%) 
that was supported in the more recent Collins et al. (2022) article 
referenced above.
    \8\ Ebel, E.D., Williams, M.S., & Schlosser, W.D. (2012). 
Parametric distributions of underdiagnosis parameters used to 
estimate annual burden of illness for five foodborne pathogens. J 
Food Prot, 75, 775-778. https://doi.org/10.4315/0362-028X.JFP-11-345. Note: This article estimated parametric distributions for 
uncertainty about the under-diagnosis multiplier based on the 
Scallan et al. (2011) model assumptions.
    \9\ Scallan et al. (2011).
    \10\ Interagency Food Safety Analytics Collaboration. Foodborne 
illness source attribution estimates for 2020 for Salmonella, 
Escherichia coli O157, and Listeria monocytogenes using multi-year 
outbreak surveillance data, United States. GA and DC: U.S. 
Department of Health and Human Services, Centers for Disease Control 
and Prevention, Food and Drug Administration, U.S. Department of 
Agriculture's Food Safety and Inspection Service. 2022. Annually, 
IFSAC releases a report that estimates foodborne illness source 
attribution for major commodity groups, including Salmonella in 
poultry products. At the time this proposal was developed, the 2019 
IFSAC attribution estimates were the most recent data available. 
IFSAC released a new annual report in November 2023, which includes 
attribution estimates for 2020. In the 2023 report, IFSAC estimated 
that 18.6 percent of Salmonella illnesses are attributed to chicken 
products and 5.5 percent to turkey products, for a total 24.1 
percent attributed to poultry products. FSIS intends to incorporate 
the 2023 report attribution estimates if this rule becomes final.
    \11\ Illness estimates from any risk assessment model are 
limited by uncertainty, simply because they are models. As explained 
by Food and Agriculture Organization of the World Health 
Organization (FAO/WHO), ``uncertainty is a property of the 
methodology and data used. Assessments with different methodologies 
and data will have different levels of uncertainty regarding their 
outputs. An understanding of uncertainty is important because it 
provides insight into how the lack of knowledge can affect 
decisions.'' See FAO/WHO Microbiological Risk Assessment Guidance 
for Food (MRA 36) at 206. FAO/WHO goes on to say, ``It is the risk 
managers' role to decide if the uncertainty of a risk assessment 
output allows for a decision to be made or not.'' Id. FSIS fully 
explored uncertainty in its risk assessment models to allow risk 
managers to make a fully informed decision. Full details are on 
pages 116-128 of the chicken risk assessment and pages 94-99 of the 
turkey risk assessment. The code for these analyses has also been 
provided.
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    Salmonella illnesses associated with poultry also represent a 
considerable economic burden, particularly when accounting for not just 
the direct medical costs, but also productivity losses, lost life 
expectancy, chronic illness, and other associated pain and suffering. A 
recent study estimates that the economic costs of Salmonella illnesses 
in the United States associated with chicken is $2.8 billion 
annually.\12\
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    \12\ Scharff R.L. Food Attribution and Economic Cost Estimates 
for Meat and Poultry-Related Illnesses. Journal of Food Protection. 
2020; 83(6): 959-967.
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2. Salmonella Performance Standards for Poultry
    FSIS is responsible for verifying that the nation's commercial 
supply of meat, poultry, and egg products is safe, wholesome, and 
properly labeled. In support of this mission, FSIS began its Salmonella 
verification testing program with the PR/HACCP final rule, published on 
July 25, 1996 (61 FR 38806). Among other things, the PR/HACCP final 
rule established Salmonella pathogen reduction performance standards 
for establishments that slaughter selected classes of food animals and/
or that produce selected classes of raw ground products.\13\ The 
purpose of the Salmonella performance standards for raw product is to 
allow FSIS to verify whether establishments have effective process 
controls to address Salmonella. Since publishing the PR/HACCP final 
rule, FSIS has updated the performance standards for poultry products 
through a series of Federal Register notices.\14\
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    \13\ When FSIS initially implemented the Salmonella performance 
standards, the regulations authorized FSIS to suspend inspection if 
an establishment failed to take the corrective actions necessary to 
comply with the performance standards, or if an establishment failed 
to meet the standards on the third consecutive series of FSIS-
conducted tests for that product. However, the Agency's ability to 
directly enforce the pathogen reduction performance standards has 
been limited since 2001, after a ruling by the U.S. Court of Appeals 
for the Fifth Circuit in Supreme Beef Processors, Inc. v. USDA, 275 
F.3d 432 (5th Cir. 2001). In that case, the court enjoined FSIS from 
suspending inspection services against a meat grinding operation for 
failure to meet the Salmonella performance standards. Since that 
time, FSIS has used Salmonella failures as a basis to conduct an in-
depth evaluation of the establishment's food safety systems, 
including its HACCP plan and sanitation SOPs.
    \14\ See Salmonella Verification Sample Result Reporting: Agency 
Policy and Use in Public Health Protection (71 FR 9772, Feb 27, 
2006); New Performance Standards for Salmonella and Campylobacter in 
Young Chicken and Turkey Slaughter Establishments: Response to 
Comments and Announcement of Implementation Schedule (76 FR 15282, 
Mar 21, 2011); New Performance Standards for Salmonella and 
Campylobacter in Not-Ready-to-Eat Comminuted Chicken and Turkey 
Products and Raw Chicken Parts and Changes to Related Agency 
Verification Procedures: Response to Comments and Announcement of 
Implementation Schedule (81 FR 7285, Feb 11, 2016); Changes to the 
Salmonella and Campylobacter Verification Testing Program: Revised 
Categorization and Follow-Up Sampling Procedures (83 FR 56046, Nov 
9, 2018).
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    FSIS has established Salmonella performance standards for young 
chicken and turkey carcasses, raw chicken parts, and comminuted chicken 
and turkey products. The current performance standards are expressed as 
a fraction of the maximum number of allowable Salmonella-positive 
results over a targeted number of samples collected and analyzed in a 
52-week moving window (see Table 2). FSIS categorizes establishments 
based on the Salmonella verification sampling results and posts the 
categorization of all establishments subject to the performance 
standards on the FSIS website.15 16 In addition, FSIS 
schedules follow-up verification sampling, a Public Health Risk 
Evaluation (PHRE),\17\

[[Page 64683]]

and possibly a Food Safety Assessment (FSA) \18\ for establishments 
that do not meet the pathogen reduction performance standards. If, 
after 90 days, an establishment has not been able to regain process 
control, as determined from FSIS' follow-up sampling and from the 
results of the PHRE or FSA, and the establishment has not taken 
corrective actions, FSIS may take enforcement actions, such as by 
issuing a NOIE or by suspending inspection, under the conditions and 
according to the procedures described in 9 CFR part 500 (81 FR 7285, 
7289). FSIS does not issue an NOIE or suspend inspection based solely 
on the fact that an establishment did not meet a performance standard.
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    \15\ Salmonella Categorization of Individual Establishments for 
Poultry Products at: https://www.fsis.usda.gov/science-data/data-sets-visualizations/microbiology/salmonella-verification-testing-program-monthly.
    \16\ The category definitions under verification sampling are as 
follows:
     Category 1: Establishments that have achieved 50 
percent or less of the maximum allowable percent positive during the 
most recently completed 52- week moving window;
     Category2: Establishments that meet the maximum 
allowable percent positive but have results greater than 50 percent 
of the maximum allowable percent positive during the most recently 
completed 52-week moving window; and
     Category 3: Establishments that have exceeded the 
maximum allowable percent positive during the most recently 
completed 52-week moving window.
    \17\ The PHRE is an analysis of establishment performance based 
on ``For-cause'' and ``Routine risk-based'' criteria, FSIS Directive 
5100.4 Revision 2--Public Health Risk Evaluation Methodology 
(usda.gov).
    \18\ The purpose of an FSA is to conduct a risk-based, targeted 
review of establishment food safety systems to verify that the 
establishment is able to produce safe and wholesome meat or poultry 
products in accordance with FSIS statutory and regulatory 
requirements. FSIS Directive 5100.1--Food Safety Assessment 
Methodology (usda.gov).

                         Table 2--Salmonella Performance Standards for Poultry Products
----------------------------------------------------------------------------------------------------------------
                                                                                               Minimum number of
                                                            Performance          Maximum           samples to
                        Product                              standard *         acceptable       assess process
                                                                            percent  positive       control
----------------------------------------------------------------------------------------------------------------
Broiler Carcasses......................................            5 of 51                9.8                 11
Turkey Carcasses.......................................            4 of 56                7.1                 14
Comminuted Chicken.....................................           13 of 52               25.0                 10
Comminuted Turkey......................................            7 of 52               13.5                 10
Chicken Parts..........................................            8 of 52               15.4                 10
----------------------------------------------------------------------------------------------------------------
* The performance standard is represented as a fraction of the maximum allowable positives over the target
  number of samples collected and analyzed in a 52-week window.

3. Salmonella Performance Standards and Illnesses
    The current Salmonella performance standards are based on risk 
assessments \19\ and are designed to achieve the Healthy People targets 
for foodborne illness reduction. When FSIS implemented the performance 
standards, the Agency expected that there would be an observed 
reduction in Salmonella illnesses rates because a smaller proportion of 
certain raw poultry products would likely be contaminated with 
Salmonella than had been the case without standards (81 FR 7285). The 
results of FSIS' Salmonella verification sampling show that the current 
prevalence-based performance standards approach has been effective in 
reducing Salmonella contamination in poultry.20 21 22 
However, these measures have yet to have an observable impact on 
Salmonella illnesses. With respect to foodborne illness reduction 
goals, the Healthy People 2020 objectives had aimed to reduce the 
annual number of foodborne illnesses caused by Salmonella from 15.0 per 
100,000 population in 2006-2008 \23\. However, the CDC estimated that 
in 2019, Americans experienced 17.1 per 100,000 population Salmonella 
illnesses.\24\ This represents an increase of 14 percent from the 2006-
2008 baseline. As discussed below, there are likely several reasons why 
the reduction in Salmonella contamination in poultry products has not 
resulted in an observable impact on Salmonella illnesses.
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    \19\ Ebel, E.D., Williams, M.S., Golden, N.J., Marks, H.M., 
2012. Simplified framework for predicting changes in public health 
from performance standards applied in slaughter establishments. Food 
Control 28, 250-257; Williams, M.S., Ebel, E.D., Vose, D., 2011. 
Framework for microbial food-safety risk assessments amenable to 
Bayesian modeling. Risk Analysis 31, 548-565.
    \20\ Ebel E.D., Williams M.S., and Schlosser W.D. (2017). 
Estimating the Type II error of detecting changes in foodborne 
illness via public health surveillance. Microbial Risk Analysis 7: 
1-7. https://doi.org/10.1016/j.mran.2017.10.001.
    \21\ Ebel, ED and Williams MS (2020). Assessing the 
effectiveness of revised performance standards for Salmonella 
contamination of comminuted poultry. Microbial Risk Analysis 
14:100076. https://doi.org/10.1016/j.mran.2019.05.002.
    \22\ Williams MS, Ebel ED, Golden NJ, Saini G, Nyirabahiizi E, 
and Clinch N (2022). Assessing the effectiveness of performance 
standards for Salmonella contamination of chicken parts. 
International Journal of Food Microbiology 378: 109801. https://doi.org/10.1016/j.ijfoodmicro.2022.109801.
    \23\ HHS Office of Disease Prevention and Health Promotion 
archive. Healthy People 2020 at: https://wayback.archive-it.org/5774/20220414163116/https://www.healthypeople.gov/2020/topics-objectives/topic/food-safety/objectives.
    \24\ Tack DM, Ray L, Griffin PM, et al. Preliminary Incidence 
and Trends of Infections with Pathogens Transmitted Commonly Through 
Food--Foodborne Disease Active Surveillance Network, 10 U.S. Sites, 
2016-2019, MMWR Morb Mortal Wkly Rep 202;69:509-514. Available at: 
https://www.cdc.gov/mmwr/volumes/69/wr/mm6917a1.htm#T1_down.
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    With respect to Salmonella illnesses associated with chicken and 
turkey, one study found that the proportion of outbreaks associated 
with these commodities was essentially unchanged from 1998-2017 and 
that both the proportion of outbreaks and number of outbreaks 
associated with chicken remained essentially constant.\25\ During that 
period, the per capita annual consumption for pork, beef, and turkey 
all declined between 9 percent and 22 percent, while annual consumption 
of chicken increased by 15 percent.
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    \25\ Williams, M.S., & Ebel, E.D. (2022). Temporal changes in 
the proportion of Salmonella outbreaks associated with 12 food 
commodity groups in the United States. Epidemiology and infection, 
150, e126. https://doi.org/10.1017/S0950268822001042.
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    The overall findings of another study indicated declining trends in 
illness due to Salmonella serotypes associated with poultry and 
increasing trends in illness due to Salmonella serotypes not associated 
with poultry.\26\ However, illness attribution was not an objective of 
the analysis. Thus, the observed illness declines may have been caused 
by reduced risk in non-poultry sources that have poultry-like serotype 
profiles.
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    \26\ Powell M.R. (2023). Trends in reported illnesses due to 
poultry-and nonpoultry associated Salmonella serotypes; United 
States 1996-2019. Risk Analysis. https://doi.org/10.1111/risa.14181.
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    The Healthy People 2030 target is to reduce the Salmonella illness 
national case rate of 15.3 per 100,000 population in 2016-2018 by 25 
percent, or to no more than 11.5 per 100,000 population per year.\27\ 
Thus, to reach the 2030 target, illnesses must be reduced by 25 
percent. Although this target is for Salmonella illnesses from all 
sources, FSIS has adopted the same target for foodborne illnesses 
linked to FSIS-regulated products and aims to reduce these Salmonella 
illnesses by 25 percent. To move closer to achieving this target, FSIS 
has determined that it will need to adopt a new approach to more 
effectively reduce foodborne illness associated with FSIS-regulated 
products, starting with poultry as one of the leading food sources.
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    \27\ HHS Office of Disease Prevention and Health Promotion 
archive. Healthy People 2030 at: https://health.gov/healthypeople/objectives-and-data/browse-objectives/foodborne-illness/reduce-infections-caused-Salmonella-fs-04/data?group=None&state=United+States&from=2016&to=2018&populations=&tab=data-table#data-table.

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[[Page 64684]]

B. Consideration of Need for a New Framework To Control Salmonella in 
Poultry

1. Petitions and Initial Stakeholder Input
    Consumer advocacy organizations and other stakeholders have noted 
that the Healthy People Salmonella reduction targets have not been met 
and have submitted petitions and letters to FSIS requesting that the 
Agency revise its current approach for reducing Salmonella illnesses 
associated with poultry. For example, in January 2020, Marler Clark LLP 
submitted a petition on behalf of several individuals and consumer 
advocacy organizations requesting FSIS to issue an interpretive rule to 
declare 31 Salmonella serotypes that have been associated with 
foodborne illness outbreaks to be adulterants of all meat and poultry 
products.\28\ According to the petition, such action is needed to 
protect the health and welfare of consumers by encouraging the meat and 
poultry industry to engage in more effective oversight measures and 
create and implement effective preventative measures.
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    \28\ Marler Clark LLP petition # 20-01 ``Petition for an 
Interpretive Rule Declaring `Outbreak' Serotypes of Salmonella 
enteritica subspecies to be Adulterants'' dated January 19, 2020. 
Available at: https://www.fsis.usda.gov/policy/petitions/petition-interpretive-rule-related-certain-Salmonella-serotypes.
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    In May 2022, FSIS denied the petition without prejudice, citing a 
lack of sufficient data available to support the sweeping actions 
requested in the petition. In the response, FSIS agreed that an updated 
Salmonella strategy is necessary to reduce Salmonella illnesses 
associated with poultry and described how FSIS was working towards 
gathering data and information necessary to support a revised 
strategy.\29\
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    \29\ FSIS Final Response to Petition #20-01, May 31, 2022. 
Available at: https://www.fsis.usda.gov/policy/petitions/petition-interpretive-rule-related-certain-Salmonella-serotypes.
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    On January 25, 2021, the Center for Science in the Public Interest 
(CSPI) and other consumer advocacy organizations petitioned FSIS to 
establish enforceable standards targeting Salmonella types of greatest 
public health concern and all Campylobacter \30\ in poultry.\31\ 
Referencing the Healthy People reduction goals, the petition asserted 
that FSIS' current performance standards have not been effective in 
reducing Salmonella illnesses because they aim to reduce the prevalence 
of all Salmonella rather than prioritizing control efforts for the 
Salmonella serotypes most likely to make people sick. The petition laid 
out several suggestions for standards that FSIS could use to address 
Salmonella in poultry. The petition recommended that FSIS work with 
stakeholders and other public health agencies to establish enforceable 
final product standards to target Salmonella serotypes of greatest 
public health concern with an aim to eliminate these strains from 
poultry products over time. The petition also suggested that FSIS 
consider revising the current prevalence-based Salmonella performance 
standard to provide for quantitative testing and add Salmonella levels 
to the performance standards criteria to better ensure that when 
Salmonella is present on a product, it is present at low levels less 
likely to cause human illness. The petition asserted that FSIS is 
authorized to deem poultry products that contain virulent Salmonella 
strains and that contain pathogen levels above a set threshold to be 
adulterated under the PPIA because more virulent serotypes and certain 
levels of Salmonella are more likely to render poultry products 
injurious to health as defined in 21 U.S.C. 453(g)(1).
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    \30\ While the CSPI requested that FSIS take actions related to 
both Salmonella and Campylobacter, FSIS is currently focusing on re-
evaluating its approach to prevent Salmonella illnesses associated 
with poultry.
    \31\ CSPI petition #21-01, ``Petition to Establish Enforceable 
Standards Targeting Salmonella Types of Greatest Public Health 
Concern while Reducing all Salmonella and Campylobacter in Poultry, 
and to Require Supply Chain Controls'' (January 25, 2021) at: 
https://www.fsis.usda.gov/policy/petitions/petition-submitted-center-science-public-interest.
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    The 2021 CSPI petition also requested that FSIS initiate rulemaking 
to require that poultry establishments identify and control foodborne 
hazards within their supply chains, including Salmonella. The petition 
stated that supply chain interventions may include targeted vaccines 
developed for specific Salmonella serotypes and purchasing chicks from 
suppliers certified to be free of priority serotypes. The petition 
asserted that FSIS is authorized to require supply chain controls 
through the current HACCP regulations, which direct establishments to 
address, as appropriate, hazards both introduced in the establishment 
and introduced outside the establishment, including food safety hazards 
that occur before entry into the establishment (9 CFR 417.2). The 
petition also asserted that FSIS has authority to verify the 
effectiveness of supply chain controls under the PPIA's antemortem 
inspection authority, which requires FSIS to conduct an antemortem 
inspection in each official establishment processing poultry or poultry 
products for commerce or otherwise subject to inspection under the PPIA 
``where and to the extent considered . . . necessary,'' ``[f]or the 
purpose of preventing the entry into or flow or movement in commerce of 
. . . any poultry product which is capable of use as human food and is 
adulterated'' (21 U.S.C. 455(a)). FSIS has not yet responded to the 
2021 CSPI petition but has considered the issues raised in developing 
this proposal.
    In September 2021, FSIS received a letter from the Food Safety 
Coalition (FSC), a coalition of several food safety leaders, public 
health and consumer advocates, scientists, and members of the food 
industry. Like the CSPI petition, the FSC letter noted that although 
FSIS' current prevalence-based pathogen reduction performance standards 
have led to reduced occurrence of Salmonella contamination in poultry 
products, the Healthy People 2020 goals set by the Department of Health 
and Human Services in 2010 for lowering Salmonella and Campylobacter 
illness rates were not being met. The FSC letter stated that the likely 
reason is that FSIS' current Salmonella performance standards do not 
effectively target the particular types of Salmonella and products 
containing Salmonella levels that pose the greatest risks of illness. 
The letter stated that a new approach is needed to achieve the new 
Healthy People 2030 Salmonella illness rate target and presented 
several suggested changes to help reduce the rates of foodborne 
illness. The proposed changes recommended by the FSC included 
establishing modernized enforceable pathogen standards that ``invite 
innovation,'' as well as modernizing the HACCP framework to address 
risk reduction across the full production process, including defining 
the responsibility of poultry processors to consider pre-harvest 
practices and interventions in their HACCP plans.\32\
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    \32\ Food Safety Coalition Letter, September 2, 2021. Available 
at: https://www.fsis.usda.gov/inspection/inspection-programs/inspection-poultry-products/reducing-salmonella-poultry.
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2. FSIS Announces New Salmonella Effort
    After considering the available data on Salmonella illnesses 
associated with poultry as well as the initial stakeholder input 
discussed above, on October 19, 2021, FSIS announced that it was 
mobilizing a stronger, and more comprehensive effort to reduce 
Salmonella illnesses associated with poultry products.\33\ In the

[[Page 64685]]

announcement, FSIS explained that the Agency would be initiating 
several key activities to gather the data and information necessary to 
support future action and move closer to the national target of a 25 
percent reduction in Salmonella illnesses. The announcement also stated 
that FSIS intended to seek stakeholder feedback on specific Salmonella 
control and measurement strategies as well as using data to determine 
if there are other approaches to reduce Salmonella. The announcement 
noted that the effort would leverage USDA's strong research 
capabilities and highlighted that FSIS would ask the National Advisory 
Committee for Microbiological Criteria in Foods (NACMCF) to advise the 
Agency on how it can build on the latest science to improve its 
approach to Salmonella control. The announcement emphasized that FSIS 
would work closely with stakeholders on informing and implementing key 
activities of this framework.
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    \33\ USDA Press Release, ``USDA Launches New Effort to Reduce 
Salmonella Illnesses Linked to Poultry'' (October 19, 2021) at: 
https://www.usda.gov/media/press-releases/2021/10/19/usda-launches-new-effort-reduce-salmonella-illnesses-linked-poultry.
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    Following this announcement, the Coalition for Poultry Safety 
Reform, a multistakeholder coalition that includes individuals and 
organizations representing consumers, victims of foodborne illness, 
food safety scientists, food safety officials, and members of the 
poultry industry, submitted a letter to the USDA Deputy Under Secretary 
for Food Safety in 2022 expressing support for a new effort to address 
Salmonella. The letter requested that FSIS focus its efforts on 
developing new regulatory standards related to Salmonella covering both 
products and supply chains and that these standards be informed by a 
risk assessment based on existing data.\34\ The letter recommended that 
FSIS adopt enforceable product standards aimed at reducing risk of 
illness and develop and conduct a risk assessment to understand illness 
reduction benefits of various product standards.
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    \34\ Coalition for Poultry Safety Reform Letter, February 2, 
2022. Available at: https://www.fsis.usda.gov/inspection/inspection-programs/inspection-poultry-products/reducing-salmonella-poultry.
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3. Activities Initiated To Support a New Salmonella Framework
    After FSIS announced its new initiative to reduce Salmonella 
illnesses associated with poultry products, the Agency initiated 
several activities designed to gather data and information to inform 
and support future actions related to this new effort.
    National Advisory Committee Charge. On October 20, 2021, FSIS 
announced a public meeting of NACMCF from November 17, 2021, to 
November 19, 2021, to discuss, among other things, a new charge focused 
on enhancing Salmonella control in poultry products.\35\ Specifically, 
FSIS charged the NACMF Subcommittee on Enhancing Salmonella Control in 
Poultry Products to provide guidance on the overarching risk management 
question: What types of microbiological criteria (e.g., Salmonella 
performance standards) might FSIS use to encourage reductions in 
Salmonella in poultry products so that they are more effective in 
preventing human Salmonella infections associated with these products? 
\36\ FSIS also requested that the Subcommittee provide guidance on nine 
additional specific risk management questions. On April 25, 2022, 
NACMCF held a Subcommittee meeting for the workgroups addressing each 
of the questions in FSIS' charge to provide an update to the entire 
Subcommittee on their progress and to look at the overall timeline for 
completing the work of the Subcommittee.\37\ On November 15, 2022, 
NACMCF held a virtual public meeting to discuss and vote on the 
Subcommittee's report on Enhancing Salmonella Control in Poultry 
Products, which had been posted to the FSIS website on November 1, 
2022.\38\ NACMCF adopted the final report pending finalization with 
consideration given to oral comments provided at the virtual public 
meeting and written comments submitted as directed in a Federal 
Register notice announcing the public meeting.\39\ The comment period 
for the NACMCF report was scheduled to close on November 15, 2022, but 
was extended to December 30, 2022, to provide 60 days for public 
review.\40\ After considering the public comments, NACMCF finalized its 
report on March 13, 2023. The final report ``Response to Questions 
Posed by the Food Safety and Inspection Service: Enhancing Salmonella 
Control in Poultry Products'' (referred to as the 2023 NACMCF report in 
this document) is available to the public on the FSIS website at: 
https://www.fsis.usda.gov/policy/advisory-committees/national-advisory-committee-microbiological-criteria-foods-nacmcf/2021.
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    \35\ National Advisory Committee Meeting on Microbiological 
Criteria for Foods (NACMF) Public Meeting --November 2021. Available 
at: https://www.fsis.usda.gov/news-events/events-meetings/national-advisory-committee-microbiological-criteria-foods-nacmcf-2.
    \36\ 2021-2023 National Advisory Committee Meeting on 
Microbiological Criteria for Foods (NACMF); FSIS Charge: Enhancing 
Salmonella Control in Poultry Products Available at: https://www.fsis.usda.gov/policy/advisory-committees/national-advisory-committee-microbiological-criteria-foods-nacmcf/2021.
    \37\ NACMCF FSIS Charge: Enhancing Salmonella Control in 
Poultry, April 25, 2022. Available at: https://www.fsis.usda.gov/news-events/events-meetings/national-advisory-committee-microbiological-criteria-foods-nacmcf-fsis.
    \38\ Public Meeting; National Advisory Committee on 
Microbiological Criteria for Food, Nov 15, 2022. Available at: 
https://www.fsis.usda.gov/news-events/events-meetings/public-meeting-national-advisory-committee-microbiological-criteria.
    \39\ Public Meeting National Advisory Committee on 
Microbiological Criteria for Food (87 FR 64001). Available at: 
https://www.fsis.usda.gov/policy/federal-register-rulemaking/federal-register-notices/public-meeting-national-advisory.
    \40\ FSIS Constituent Update--Nov 10, 2022: Deadline Extended to 
Comment on NACMCF Document. Available at: https://www.fsis.usda.gov/news-events/news-press-releases/constituent-update-november-10-2022.
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    Pilot Projects. In December 2021, FSIS announced in its Constituent 
Update that the Agency was inviting poultry slaughter and processing 
establishments to submit proposals for pilot projects that will test 
different control strategies for Salmonella contamination in poultry 
products.\41\ The announcement explained that pilot projects would last 
for a defined period, during which establishments would experiment with 
new or existing pathogen control and measurement strategies and share 
data collected during the pilots with FSIS. The announcement included 
instructions on how interested establishments could submit proposals 
for pilots to FSIS. FSIS intended to analyze the data generated under 
the pilots to determine whether it supports changes to FSIS' existing 
Salmonella control strategies.
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    \41\ FSIS Constituent Update--Dec 3, 2021: FSIS Seeking 
Proposals for Pilot Projects to Control Salmonella in Poultry 
Slaughter and Processing Establishments. Available at: https://www.fsis.usda.gov/news-events/news-press-releases/constituent-update-december-3-2021.
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    Since March 2023, FSIS has granted pilot projects to 9 
establishments to examine the merits and logistics of excluding 
Salmonella poultry vaccine strains from the FSIS Salmonella performance 
categorization calculations. After evaluating the data collected under 
these pilots, on March 1, 2024, FSIS announced that beginning April 1, 
2024, it intends to exclude current commercial vaccine subtypes 
confirmed in FSIS raw poultry samples from the calculation used to 
categorize establishments under the raw poultry Salmonella performance 
standards.\42\ This action is intended to remove barriers to the use of 
vaccination as an important pre-harvest intervention to

[[Page 64686]]

control Salmonella in poultry. A summary report of the data from these 
pilots is posted on the Pilot Projects: Salmonella Control Strategies 
page of the FSIS website at: https://www.fsis.usda.gov/inspection/inspection-programs/inspection-poultry-products/reducing-salmonella-poultry/pilot.
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    \42\ FSIS Constituent Update--March 1, 2024: FSIS Intends to 
Exclude Vaccine Strains from the FSIS Salmonella Performance 
Categorization at: https://www.fsis.usda.gov/news-events/news-press-releases/constituent-update-march-1-2024.
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    On September 23, 2023, FSIS granted a pilot to 2 establishments to 
examine the merits of using preharvest results to optimize 
establishment interventions.\43\ The data generated under the pilot 
will be shared with and analyzed by FSIS to determine whether it 
supports changes to FSIS' Salmonella control strategies.
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    \43\ Pilot Projects: Salmonella control strategies. Current 
Salmonella Pilot Participants available at: https://www.fsis.usda.gov/inspection/inspection-programs/inspection-poultry-products/reducing-salmonella-poultry/pilot.
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    Research and Science Roundtable. On February 15, 2022, FSIS held a 
research and science roundtable on Salmonella in poultry.\44\ The 
intent of the roundtable was to convene research scientists to discuss 
the scientific support for various potential components of a revised 
strategy for Salmonella control in poultry. Among the topics discussed 
at the roundtable were: research on surveillance and risk assessments 
to evaluate the public health impact of the presence of Salmonella 
serotypes of concern and levels of contamination at production; 
research on Salmonella serotype dynamics in poultry production; 
research to identify pre-harvest food safety challenges and solutions; 
research modeling and correlation analysis work on pre-harvest in 
poultry; research on interventions to control Salmonella in preharvest 
and postharvest poultry production; and research in the area of 
microbial biomapping of indicators and pathogenic loads throughout the 
processing chain and using pre-harvest and post-harvest quantification 
data to develop SPC programs. The presentations on these topics and 
other materials associated with the research roundtable are available 
to the public on the FSIS website at: https://www.fsis.usda.gov/news-events/events-meetings/Salmonella-poultry-research-and-science-roundtable.
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    \44\ Salmonella in Poultry: Research and Science Roundtable. 
Available at: https://www.fsis.usda.gov/news-events/events-meetings/Salmonella-poultry-research-and-science-roundtable.
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    Exploratory Sampling Program and New Salmonella Quantification 
System. In April 2022, FSIS initiated an exploratory program that 
expanded young chicken carcass sampling at establishments subject to 
the young chicken carcass performance standard.\45\ The purpose of the 
exploratory sampling program was to generate microbial data to inform 
the Agency's effort to reduce Salmonella illnesses attributable to 
poultry. Under the program, in addition to the FSIS Salmonella 
verification sample already collected at post-chill, FSIS inspection 
program personnel (IPP) began collecting a second carcass sample at 
rehang from the same flock. In addition, FSIS IPP were instructed to 
collect the regularly scheduled National Antibiotic Resistance 
Monitoring System (NARMS) cecal samples from the same flock as the 
rehang and post-chill samples. The samples collected under the 
exploratory sampling program were initially analyzed for the presence 
of Salmonella and AC. FSIS IPP also completed a questionnaire at the 
time they collected exploratory samples to collect data on pre-harvest 
and slaughter interventions applied to the same flocks. A report on the 
exploratory sampling results is available at: https://www.regulations.gov/docket/FSIS-2023-0028.
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    \45\ FSIS Constituent Update--April 22, 2022: FSIS Expands 
Salmonella Sampling for Young Chicken Carcasses. Available at: 
https://www.fsis.usda.gov/news-events/news-press-releases/constituent-update-april-22-2022.
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    In August 2022, FSIS announced that FSIS laboratories would begin 
using new technology to quantify Salmonella in raw poultry rinses and 
updated the exploratory sampling program for young chickens to quantify 
confirmed Salmonella positive rehang and post-chill carcass results 
using the new quantification system.\46\ These analyses were in 
addition to the whole genome sequencing (WGS) that FSIS had already 
been performing on confirmed Salmonella-positive post-chill carcass 
samples.
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    \46\ FSIS Constituent Update--Aug 5, 2022: FSIS to include 
Salmonella Quantification in all Poultry Rinse Samples. Available 
at: https://www.fsis.usda.gov/news-events/news-press-releases/constituent-update-august-5-2022-0. FSIS Notice 44-22, Revised Young 
Chicken Exploratory Sampling Program, Aug 11, 2022.
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    On January 30, 2023, FSIS added Salmonella quantification testing 
and AC indicator analyses to chicken part rinsates.\47\ FSIS added 
these two analyses to comminuted chicken testing on February 27, 2023, 
and to comminuted turkey on April 3, 2023. Salmonella quantification is 
a significant step in updating the diagnostic capabilities of FSIS' 
food testing laboratories. The data generated from the new 
quantification system along with the data collected from the young 
chicken carcass exploratory sampling program were used to help inform 
the policies discussed in this document, including the quantitative 
microbial risk assessments to evaluate Salmonella in raw poultry 
discussed below. The data generated from the quantification system have 
also been added to FSIS' quarterly dataset release and are available 
at: https://www.fsis.usda.gov/science-data/data-sets-visualizations/laboratory-sampling-data.
---------------------------------------------------------------------------

    \47\ FSIS Constituent Update--Feb 3, 2023: FSIS to Expand 
Salmonella Enumeration and Aerobic Count Indicator Testing to Other 
Poultry Products. Available at: https://www.fsis.usda.gov/news-events/news-press-releases/constituent-update-february-3-2023. 
Notice 83-23, New Sampling Instructions and Testing for Chicken 
Parts and NRTE Comminuted Poultry, Feb 3, 2023. Available at: 
https://www.fsis.usda.gov/policy/fsis-notice/08-23.
---------------------------------------------------------------------------

    Risk Profile. In May 2022, FSIS initiated a risk profile for 
Salmonella subtypes in poultry linked to foodborne illness. FSIS 
developed the risk profile to provide information on whether certain 
serotypes or subtypes of Salmonella should be considered as adulterants 
in specific poultry products within the meaning of the PPIA (21 U.S.C. 
453(g)). The risk profile involved a comprehensive systematic review of 
literature and supporting data designed to provide responses to the 
following six risk management questions:
    1. What Salmonella serotypes or subtypes are linked to foodborne 
illness or outbreaks from consuming specific raw or not-ready-to-eat 
chicken or turkey products?
    2. Are these Salmonella serotypes or subtypes of concern present in 
live chickens, live turkeys, and poultry products?
    3. Can exposure to a small number of these Salmonella serotypes or 
subtypes of concern result in foodborne illness?
    4. Can exposure to these Salmonella serotypes or subtypes of 
concern cause severe, debilitating health outcomes?
    5. How can these Salmonella serotypes or subtypes of concern be 
differentiated from other Salmonella subtypes?
    6. Would ordinary consumer handling or preparation practices affect 
exposure to Salmonella serotypes or subtypes of concern?
    The risk profile was submitted for independent peer-review \48\ and 
updated in response to peer review comments. The results of the risk 
profile and how they were used to inform specific measures proposed in 
this document are discussed below. The final Risk Profile for 
Pathogenic Salmonella in Poultry (referred to as the 2023 risk profile 
in

[[Page 64687]]

this document) is available at: https://www.regulations.gov/docket/FSIS-2023-0028.
---------------------------------------------------------------------------

    \48\ Peer Review Plan: Risk Profile for Salmonella Subtypes in 
Poultry Products Linked to Foodborne Illness (usda.gov).
---------------------------------------------------------------------------

    Risk Assessments FSIS Developed to Inform Rulemaking. FSIS 
conducted two new quantitative microbial risk assessments, one for 
Salmonella in chicken and one for Salmonella in turkey, to inform the 
Agency's new framework for reducing Salmonella attributed to poultry 
consumed in the United States. FSIS expanded on this work through a 
Cooperative Agreement (FSIS-02152022) with the University of Maryland's 
Joint Institute for Food Safety and Applied Nutrition (UMD-JIFSAN), in 
partnership with EpiX Analytics, to differentiate Salmonella serotypes 
by virulence using advanced bioinformatics (i.e., machine learning) to 
evaluate genomic data.\49\ The risk assessments address the following 
risk management questions:
---------------------------------------------------------------------------

    \49\ FSIS Constituent Update--July 1, 2022: FSIS Announces 
Cooperative Agreement on Salmonella Risk Assessments. Available at: 
https://www.fsis.usda.gov/news-events/news-press-releases/constituent-update-july-1-2022. Salmonella Risk Assessments and Risk 
Management Questions at: https://www.fsis.usda.gov/inspection/inspection-programs/inspection-poultry-products/reducing-Salmonella-poultry/Salmonella-1.
---------------------------------------------------------------------------

    1. What is the public health impact (change in illnesses, 
hospitalizations, and deaths) achieved by eliminating at receiving a 
proportion of chicken (or turkey) contaminated with specific levels of 
Salmonella and/or specific Salmonella subtypes?
    2. What is the public health impact (change in illnesses, 
hospitalizations, and deaths) achieved by eliminating final product 
contaminated with specific levels of Salmonella and/or specific 
Salmonella subtypes?
    3. What is the public health impact of monitoring/enforcing process 
control from rehang to post-chill? Monitoring could include analytes 
such as Enterobacteriaceae Count (EB), AC, or other indicator 
organisms, analysis could include presence/absence or levels and the 
monitoring could also include variability of actual result versus 
expected result, log reduction, absolute sample result, or other 
individual establishment specific criteria.
    4. What is the public health impact of implementing combinations of 
the risk management options listed above?
    The risk assessments were submitted for independent peer-review 
\50\ and updated in response to peer review comments. The risk 
assessments, and the manner in which the results were used to inform 
specific measures proposed in this document, are discussed below. The 
final Quantitative Risk Assessment for Salmonella in Raw Chicken and 
Raw Chicken Products and Quantitative Risk Assessment for Salmonella in 
Raw Turkey and Raw Turkey Products (referred to as the 2023 risk 
assessments in this document) are available at: https://www.regulations.gov/docket/FSIS-2023-0028.
---------------------------------------------------------------------------

    \50\ Peer Review Plan: Quantitative Microbial Risk Assessment of 
Salmonella in Chicken Products available at: https://www.fsis.usda.gov/sites/default/files/media_file/documents/FSIS_Salmonella_Peer_Review_Plan_Chicken.pdf.Peer Review Plan: 
Quantitative Microbial Risk Assessment of Salmonella in Turkey 
Products available at: https://www.fsis.usda.gov/sites/default/files/media_file/documents/FSIS_Salmonella_Peer_Review_Plan_Turkey.pdf.
---------------------------------------------------------------------------

4. Initial Measures Implemented To Address Salmonella Illnesses 
Associated With Consumption of Poultry Products
    After FSIS announced its new Salmonella initiative in October 2021, 
in addition to initiating the activities to gather data to inform and 
support a new Salmonella Framework discussed above, the Agency 
implemented some initial measures to support this effort.
    Salmonella Key Performance Indicator. As part of USDA's strategic 
and performance planning process for fiscal years (FY) 2022-2026, FSIS 
established a new ``key performance indicator'' (KPI) targeted to 
reduce the proportion of poultry samples with Salmonella serotypes 
commonly associated with human illnesses.\51\ This KPI is a measure 
that is used to evaluate FSIS' progress towards reaching its objectives 
and goals identified in both Agency and USDA strategic plans and will 
serve as a metric for success for the USDA FY 2022-2026 Strategic Plan. 
FSIS analyzed historical Agency sampling data, in addition to FoodNet 
Fast data from the CDC, to determine the top three Salmonella serotypes 
commonly associated with human illness for this measure. The analysis 
found that these serotypes are Infantis, Enteritidis, and Typhimurium. 
FSIS will use annual targets to track progress toward reducing the 
proportion of poultry samples with the KPI serotypes and is seeking a 2 
percent reduction each year, with the goal of achieving a 10 percent 
reduction by FY 2026. KPI serotypes are useful for strategic and 
performance planning purposes, and these may differ from the serotypes 
of public health significance (which will likely change over time as 
the serotypes commonly associated with human illnesses change).
---------------------------------------------------------------------------

    \51\ FY2022-2024 Food Safety Key Performance Indicator. 
Available at: https://www.fsis.usda.gov/inspection/inspection-
programs/inspection-poultry-products/reducing-Salmonella-poultry/
Salmonella-0#:~:text=FY2022-
2026FoodSafetyKeyPerformanceIndicatorA,theUSDAFiscalYear28FY292022-
2026StrategicPlan.
---------------------------------------------------------------------------

    Final Determination. On August 1, 2022, FSIS announced that it 
would be declaring Salmonella as an adulterant in breaded and stuffed 
not-ready-to-eat (NRTE) chicken products (also referred to as ``NRTE 
breaded stuffed chicken products'').\52\ These products contain raw, 
comminuted chicken breast meat, trim, or whole chicken breast meat, but 
the finished product is heat-treated only to set the batter or breading 
on the exterior of the product, which may impart an RTE appearance.\53\ 
Although the labeling of NRTE breaded stuffed chicken products has 
undergone significant changes over time to better inform consumers that 
the products are raw and to provide instructions on how to prepare them 
safely, these products continue to be associated with Salmonella 
illness outbreaks. Based on information from Salmonella illness 
outbreaks associated with NRTE breaded stuffed chicken products and 
information from research on consumer handling practices with respect 
to these products, FSIS concluded that labeling that informs consumers 
that these products are raw and how to prepare them safely fails to 
sufficiently protect consumers from illness.
---------------------------------------------------------------------------

    \52\ Salmonella as an Adulterant in Breaded Stuffed Raw Chicken 
Products (Aug 1, 2022). Available at: https://www.usda.gov/media/press-releases/2022/08/01/usda-announces-action-declare-Salmonella-adulterant-breaded-stuffed.
    \53\ FSIS Directive 5300.1, Revision 1. Managing the 
Establishment Profile in the Public Health Information System. 
(usda.gov). See attachment 2 ``NRTE Stuffed Chicken Products that 
appear RTE.''
---------------------------------------------------------------------------

    On April 28, 2023, FSIS published a proposed determination to 
declare that NRTE breaded stuffed chicken products that contain 
Salmonella at levels of 1 cfu per gram or higher are adulterated within 
the meaning of the PPIA (88 FR 26249). FSIS also proposed to carry out 
verification procedures, including sampling and testing of the chicken 
component of NRTE breaded stuffed chicken products prior to stuffing 
and breading, to ensure producing establishments control Salmonella in 
these products. The comment period for the proposed determination was 
scheduled to close on June 27, 2023, but was extended to August 11, 
2023, in response to requests from members of the regulated 
industry.\54\
---------------------------------------------------------------------------

    \54\ FSIS Constituent Update--July 21, 2023: FSIS Extends 
Comment Period on Proposed Determination: Salmonella in Not-Ready-
To-Eat Breaded Stuffed Chicken Products. Available at: https://
www.fsis.usda.gov/news-events/news-press-releases/constituent-
update-july-21-
2023#:~:text=FSISisextendingthecommentperiodonthe,FSISextendedthedead
lineuntilJuly272023.

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[[Page 64688]]

    FSIS received 3,386 comments on the proposed determination. After 
careful consideration of the comments, on May 1, 2024, FSIS finalized 
the determination as proposed, with one change (89 FR 35033). Instead 
of collecting samples after the establishment has completed all 
processes needed to prepare the chicken component to be stuffed and 
breaded to produce a final NRTE breaded stuffed chicken product, as was 
proposed, FSIS will collect verification samples on the raw incoming 
chicken components. This change was intended to provide greater 
flexibility and reduce costs to industry.
    As noted above, NRTE breaded stuffed chicken products are 
adulterated if they contain Salmonella at 1 cfu/g or higher, regardless 
of the Salmonella serotype. FSIS adopted this approach for NRTE breaded 
stuffed chicken products because these products present a unique public 
health risk. Unlike raw chicken carcasses, chicken parts, comminuted 
chicken, and comminuted turkey, NRTE breaded stuffed chicken products 
may have a cooked appearance, are thicker in diameter than many other 
poultry products, contain multiple ingredients, and are typically 
cooked from a frozen state. In addition, outbreak data cited in the 
NRTE breaded stuffed chicken proposal indicate that these products have 
been consistently and disproportionately associated with Salmonella 
illness outbreaks over the years. As FSIS acknowledged in the NRTE 
breaded stuffed chicken proposed and final determination, although not 
all Salmonella serotypes are equally likely to cause illness, all 
serotypes have the ability to invade, replicate, and survive in human 
host cells, resulting in potentially serious disease. Thus, because of 
the unique public health risk associated with NRTE breaded stuffed 
chicken products, FSIS determined that these products are adulterated 
if they contain any Salmonella stereotypes at or above 1 cfu/g.

C. Public Meeting on Salmonella Framework Under Consideration and 
Public Comments

1. Public Meeting and Proposed Framework
    On October 17, 2022, FSIS published a Federal Register notice 
announcing that it was hosting a virtual public meeting on November 3, 
2022, to discuss a regulatory framework that the Agency was considering 
for a new strategy to control Salmonella in poultry products and more 
effectively reduce foodborne Salmonella infections linked to these 
products (87 FR 62784). In the notice, FSIS shared the key elements of 
the framework under consideration and stated that the Agency was 
soliciting comments from stakeholders on all elements of the draft 
framework, both at the public meeting and in written comments submitted 
in response to the Federal Register notice, before moving forward with 
any proposed changes to regulations or other actions. The Agency also 
made a document outlining the regulatory framework under consideration 
available to the public before the public meeting by publishing it on 
the FSIS website.\55\
---------------------------------------------------------------------------

    \55\ Proposed Regulatory Framework to Salmonella Illnesses 
Attributable to Poultry. Available at: https://www.fsis.usda.gov/inspection/inspection-programs/inspection-poultry-products/reducing-Salmonella-poultry/proposed.
---------------------------------------------------------------------------

    The three components under consideration in the draft framework 
included:
    1. Requiring that incoming flocks be tested for Salmonella before 
entering an establishment;
    2. Enhancing establishment process control monitoring and FSIS 
verification; and
    3. Implementing an enforceable final product standard.
    The framework under consideration also addressed cross-cutting 
issues associated with testing for Salmonella, considerations for small 
and VS establishments, and data sharing. FSIS specifically requested 
comments on factors the Agency should consider relative to the 
approaches outlined in each of the components, how each component can 
be strengthened, and where are there gaps in the framework. FSIS also 
requested comments on relevant scientific evidence or examples of how 
the components may be implemented or the impacts they may have on human 
Salmonella illnesses.
    At the November 3, 2022, public meeting, stakeholders presented 
oral comments to FSIS panels comprised of FSIS leadership and experts 
on the three separate components of the framework and the cross-cutting 
issues. The primary purpose of the panels was to listen to stakeholder 
input and ask clarifying questions as needed.\56\ In addition to the 
oral comments presented at the public meeting, FSIS also provided an 
opportunity for the public to submit written comments on the framework. 
The comment period for submitted written comments was scheduled to 
close on November 16, 2022, but was extended to December 16, 2022, to 
allow stakeholders sufficient time to take into consideration the 
discussion at the November 3, 2022, public meeting.\57\ A summary of 
the general issues raised by the public comments is discussed below.
---------------------------------------------------------------------------

    \56\ A transcript of the public meeting and other related 
materials are available to the public on the FSIS website at: 
https://www.fsis.usda.gov/news-events/events-meetings/public-meeting-reducing-Salmonella-poultry.
    \57\ FSIS Constituent Update--Oct 28, 20222: FSIS Extends Public 
Meeting and Comment Period on Proposed Salmonella Framework. 
Available at: https://www.fsis.usda.gov/news-events/news-press-releases/constituent-update-october-28-2022-1.
---------------------------------------------------------------------------

2. Public Comments on the Proposed Framework
    During the comment period for the proposed framework, FSIS received 
1,034 comments. Seven hundred seventy-three comments were identical or 
similar comment letters from individuals in support of the proposed 
framework, and 75 were identical or similar comment letters from 
individuals opposed to the proposed framework. One consumer advocacy 
organization submitted a comment letter with a spreadsheet containing 
4,916 names in support of the framework. Another consumer advocacy 
organization submitted a comment letter with a spreadsheet containing 
3,487 names in support of the framework. FSIS also received 149 unique 
comments from individuals, most in opposition to the proposed 
framework. In addition to the individual comments and form letters, 
FSIS received approximately 35 separate comment letters from trade 
associations representing the meat and poultry industries, consumer 
advocacy organizations, animal welfare advocacy organizations, small 
poultry growers and processors, organizations that support independent 
family farmers, a large meat producer, a trade association representing 
the veterinary profession, a State Department of Agriculture, an 
organic/sustainable agriculture organization, a biotech company 
representative, a meat scientist, and academics. The general issues 
raised on each of the components under consideration in the framework 
and on the cross-cutting issues are described below.
    Comments on Component One. Component One of the draft framework 
considered whether FSIS should require slaughter establishments to 
characterize Salmonella as a hazard reasonably likely to occur at 
receiving and require that incoming flocks be tested for Salmonella 
before entering an establishment. Under this approach, the flock would 
be required to meet a predetermined target for Salmonella at

[[Page 64689]]

receiving, which may be industry-wide or establishment-specific. The 
establishment would be required to demonstrate that its subsequent 
process will be effective in reducing Salmonella so that the product 
meets the final product standard under consideration in Component 
Three.
    Comments from individuals, consumer advocacy organizations, and 
animal welfare advocacy organizations expressed general support for the 
measures under consideration in Component One. A consumer advocacy 
organization commented that requiring incoming flocks be tested for 
Salmonella would provide incentives for producers to adopt effective 
pre-harvest measures and for establishments to take action to further 
reduce food safety risks from flocks failing the incoming Salmonella 
target, such as slaughtering more contaminated flocks at the end of the 
day.
    Comments from small poultry processors and producers, organizations 
representing small poultry producers and independent family farmers, 
and trade associations representing the meat and poultry industries 
expressed concerns that the measures under consideration in Component 
One would impose an overwhelming burden on small producers. An 
organization representing small poultry producers and several 
individual comments stated that requiring that flocks be tested for 
Salmonella before they enter an establishment would add delays and 
costs that small operators cannot afford.
    Several comments, including comments from trade associations 
representing the meat and poultry industries and organizations that 
support independent family farmers, asserted that FSIS lacks legal 
authority to require the measures under consideration in Component One, 
particularly the requirements that incoming flocks be tested for 
Salmonella. The commenters stated that FSIS' authority under the PPIA 
begins at the official establishment and does not extend to the farm. 
The commenters also asserted that Component One conflicts with HACCP 
principles in that under HACCP, establishments, not FSIS, are 
responsible for making decisions on how to execute their food safety 
system.
    Comments from trade associations representing the meat and poultry 
industries asserted that FSIS had presented no data to demonstrate that 
an incoming Salmonella threshold or limit is necessary for an 
establishment to maintain process control and sufficiently reduce 
Salmonella during processing. They also stated that FSIS did not 
explain how on-farm sampling several weeks before a flock is processed 
correlates to actual incoming Salmonella loads or provide data to show 
that reducing incoming loads would have any public health impact. The 
commenters noted that many producers and processors currently employ 
interventions aimed at reducing Salmonella on farms and suggested that 
FSIS consider other measures to incentivize pre-harvest controls 
without requiring testing, such as encouraging establishments to 
consider Salmonella a hazard reasonably likely to occur and providing 
guidance for addressing Salmonella pre-harvest. Some of the commenters 
that opposed Component One suggested removing this component entirely.
    Comments on Component Two. The measures under consideration in 
Component Two of the proposed framework would build on HACCP 
regulations, which provide a prevention-based approach to food safety. 
To ensure pathogen control throughout slaughter and processing 
operations, Component Two would modify the existing requirements for 
microbial organism testing for process control in 9 CFR 381.65(g) and 
establish additional parameters to better define the required analysis 
of the data. Establishments would be required to test for indicator 
organisms (e.g., AC or EB) at rehang and post-chill and would be 
required to use a standardized statistical approach to process control. 
FSIS would consider production volume when determining the frequency 
that establishments must collect samples.
    FSIS received several comments in support of the measures under 
consideration in Component Two from consumer advocacy organizations and 
academia. These commenters generally agreed with the proposal but 
recommended that FSIS consider additional measures, such as requiring 
establishments to test more broadly for indicator organisms and/or 
requiring testing at more sampling points. These commenters also 
recommended that FSIS work with stakeholders to develop the SPC 
approach after conducting research to determine the best points 
predictive of end product Salmonella levels and tailor the SPC for 
differences in processors' equipment and plant layouts.
    Trade associations representing the meat and poultry industries, a 
State Department of Agriculture, and an organic/sustainable agriculture 
organization expressed concerns about some of the measures under 
consideration in Component Two. The commenters asserted that there is a 
lack of necessary data to support creating a rigid SPC framework for 
all establishments. An organic/sustainable agriculture organization 
requested that small producers be exempt from this component. A trade 
association representing the meat and poultry industry suggested that 
FSIS consider conducting verification sampling at specific locations 
and allow establishments to develop their own sampling plans. An 
association representing small and VS poultry establishments stated 
that the Component Two measures under consideration will be costly and 
will not reduce Salmonella.
    Comments on Component Three. Component Three of the draft framework 
under consideration would implement an enforceable final product 
standard to prevent raw poultry products with certain levels and/or 
types of Salmonella contamination from entering the stream of commerce. 
FSIS would establish the standard by classifying certain Salmonella 
levels and/or serotypes as adulterants in raw poultry and take action 
against poultry products that exceed the final product standard.
    Consumer advocacy organizations, coalitions promoting food safety, 
and individuals with expertise in food and meat science generally 
supported Component Three and recommended that FSIS prioritize 
developing and implementing Component Three. According to these 
commenters, it is the most critical part of the framework. These 
commenters recommended an enforceable approach to combatting 
Salmonella. The commenters stated that such an approach would provide 
much greater safety to consumers by preventing highly contaminated 
product from reaching store shelves and would motivate industry to 
adequately control Salmonella because of the direct financial cost of 
losing product that does not meet the final standard.
    Some of the comments in support of Component Three requested that 
FSIS provide increased transparency and data regarding how the product 
standards under consideration would look. One consumer advocacy 
organization emphasized that FSIS should use scientifically sound risk 
assessments in determining final product standards. A consumer advocacy 
organization recommended establishing separate standards for different 
poultry products and stated that, for chicken, the standard could be 
based on FSIS' KPI serotypes Enteritidis, Infantis, and Typhimurium, 
and that for turkey, the standard could be based on serotypes Reading, 
Infantis, and Typhimurium. A

[[Page 64690]]

consumer advocacy organization stated that FSIS should set stricter 
standards for certain products if the risk assessment identifies higher 
risk poultry products and that the risk assessments would determine 
whether the final product standards should be based on Salmonella 
enumeration, serotypes, or a combination of both.
    Comments from trade associations representing the meat and poultry 
industries, trade associations representing small poultry processors 
and family farmers, a state government entity, and both large and small 
businesses associated with poultry production did not support the 
establishment of enforceable final product standards. These comments 
opposed considering Salmonella to be an adulterant in raw poultry. Many 
of the commenters stated that FSIS has historically not considered 
Salmonella as an adulterant in raw poultry because: (1) Salmonella is 
not an ``added substance'' and (2) Salmonella is not present in levels 
that render chicken or turkey injurious to health because customary 
poultry cooking practices destroy Salmonella. The commenters stated 
that FSIS has not provided any new information to support a change in 
this interpretation. Comments from these trade associations and a state 
government entity also stated that FSIS' comparison of Salmonella in 
raw poultry to Escherichia coli (E. coli) in non-intact beef is not 
relevant, given that the two are very different in how they occur in 
products and how they are destroyed through cooking.
    On the other hand, comments from consumer advocacy organizations 
stated that Salmonella may be considered as an ``added substance'' 
because it is not found in the muscle tissue of healthy animals but 
rather is deposited through cross-contamination during slaughter and 
processing. The commenters asserted that regardless of whether FSIS 
considers certain Salmonella levels or serotypes most associated with 
human illness to be an ``added substance,'' they are adulterants 
because they ``ordinarily render'' contaminated poultry products 
injurious to health.
    Commenters that opposed Component Three expressed concern about the 
delay that would result from a national verification testing program. A 
trade association representing the chicken industry argued that the 
extra time required for poultry producers to hold their product pending 
FSIS' Salmonella testing results will significantly decrease the number 
of poultry products that can safely reach store shelves. An 
organization representing small poultry producers and processors stated 
that waiting for acceptable test results would particularly affect 
small producers who may not have the capability to hold poultry for a 
long period of time.
    Some commenters recommended alternatives to Component Three that 
the commenters believed would more effectively reduce Salmonella 
infection rates from poultry. For example, a large company that 
processes poultry recommended that, instead of developing new final 
product standards based on product adulteration, FSIS update the 
current performance standards to include a new metric based on a 
quantification target that measures beyond the prevalence of 
Salmonella, which the commenter said would work well within a current 
or an updated HACCP system.
    Many comments opposed to Component Three asserted that the proposed 
measures under consideration lacked information on the data and methods 
that would be used to establish the final product standards. A trade 
association representing the chicken industry questioned whether FSIS 
had sufficient laboratory space needed to sample different product lots 
for Salmonella levels or serotypes. An organization representing 
independent family farmers recommended that, instead of establishing 
final product standards, FSIS should identify the Salmonella strains 
that cause most illnesses and target those strains specifically rather 
than providing more general product standards. The 75 similar comment 
letters that opposed the framework stated that FSIS should remove 
Component Three from the framework until the Agency provides a clear 
statement of the levels and/or strains of Salmonella that would define 
the final product standards.
    Comments on other issues raised. In addition to comments about the 
above Components, there were comments raised about the framework in 
general. Among these comments were write-in campaigns that expressed 
general support for the proposed framework. A trade association 
representing the chicken industry argued that the proposed framework 
under consideration is not necessary because FSIS' existing framework 
for addressing Salmonella control has been working. A trade association 
representing the poultry industry commented that there is a need for 
consumer research and education regarding safe handling of poultry. 
Some comments expressed concern that adopting the framework would lead 
to an increase in food waste.
    Comments on data sharing. FSIS received five comments regarding the 
need to share data. An academic suggested FSIS work with stakeholders 
to facilitate sharing of industry data that would provide additional 
insights into the sampling points that would be most predictive of 
process control. Trade associations representing the poultry industry 
urged FSIS to create a pathway for companies to share confidential 
proprietary data with the Agency and indicated it would be necessary to 
ensure that data is shared only with FSIS. A sustainable agriculture 
organization emphasized the need for an enhanced ability to share 
information among agencies, the academic community, and industry.
3. Additional Stakeholder Input
    In addition to the November 2022 public meeting, FSIS also 
participated in technical meetings with representatives from the 
poultry industry, consumer advocacy organizations, academia, and other 
stakeholders to further discuss aspects of the proposed Salmonella 
ramework. These technical meetings were organized and hosted by the 
regulated industry. The first technical meeting was held on March 21, 
2023. Among the topics discussed were differences in production 
practices and Salmonella control strategies between chicken and 
turkeys, review of ongoing risk assessments, pre-harvest control risk 
management measures, creating, implementing, and reacting to 
statistical process control measures, and Salmonella quantification 
methods. A second technical meeting was held on April 12, 2023. Among 
the topics discussed at that meeting were incentivizing use of pre-
harvest interventions, how statistical process control is used in the 
poultry industry and educational needs, and addressing lot size and 
microbiological independence, and a review of the key differences 
between beef and poultry. FSIS officials also held a virtual meeting 
with small and VS establishment owners in February 2023 to seek input 
on the Salmonella Framework under consideration.\58\
---------------------------------------------------------------------------

    \58\ Officials' Calendar of Meetings (Feb 2023) at: https://www.fsis.usda.gov/news-events/events-meetings/officials-calendar-meetings.
---------------------------------------------------------------------------

4. Overview of Modifications to the Proposed Salmonella Framework
    FSIS has carefully evaluated the written comments and other 
stakeholder input provided on the proposed Salmonella Framework, along 
with new studies and information that have become available since the 
Agency made the information about the framework under consideration

[[Page 64691]]

available to the public in November 2022. Based on this evaluation, 
FSIS has decided to modify some of the measures it had been considering 
as part of the Salmonella Framework and is proposing these modified 
measures in this document. FSIS requests comments on all measures 
proposed in this document. If, after the close of the comment period, 
the Agency determines that some portions of the modified Salmonella 
Framework can be finalized sooner than others, FSIS will finalize those 
portions separately from the others so as not to delay regulatory 
action on this important public health initiative.
    The proposed modified framework components are discussed in more 
detail under separate headings in this document. The headings for the 
proposed modified framework correspond to the component headings used 
for the draft framework that FSIS presented to the public, i.e., 
Component One, Component Two, Component Three. The components are 
discussed in this proposal in an order that emphasizes the most 
significant proposed changes first. Therefore, the discussion begins 
with Component Three: Final Product Standards, followed by Component 
Two: Enhanced Establishment Process Control Monitoring, and finally 
Component One: Pre-Harvest Measures.
    Following is a general summary of the modifications.
    Component Three Modifications. Consistent with Component Three of 
the draft framework that was under consideration, FSIS is proposing 
enforceable final product standards to prevent raw poultry products 
with certain levels and Salmonella serotypes from entering commerce. 
Under this proposal, FSIS has tentatively determined that certain raw 
poultry products that contain Salmonella in an amount that exceeds a 
specified level and that contain any detectable level of certain 
Salmonella serotypes are adulterated as defined in the PPIA. The 
proposed final product standards are as follows:
     Chicken carcasses and chicken parts: Salmonella at or 
above 10 cfu per milliliter of rinsate collected in any sample and any 
detectable level of at least one of the Salmonella serotypes of public 
health significance (i.e., Enteritidis, Typhimurium, and I 4,[5],12:i:-
);
     Comminuted chicken: Salmonella at or above 10 cfu per gram 
of product collected in any sample and any detectable level of at least 
one of the Salmonella serotypes of public health significance (i.e., 
Enteritidis, Typhimurium, and I 4,[5],12:i:-);
     Comminuted turkey: Salmonella at or above 10 cfu per gram 
of product collected in any sample and any detectable level of at least 
one of the Salmonella serotypes of public health significance (i.e., 
Hadar, Typhimurium, and Muenchen).
    FSIS is also proposing that the Agency would routinely collect 
samples of raw final products subject to the proposed standards and 
analyze them for Salmonella levels and serotypes to determine whether 
the product is adulterated.
    Component Two Modifications. To ensure that poultry slaughter 
establishments are effectively controlling Salmonella throughout their 
operations, FSIS is proposing to revise the current regulations in 9 
CFR 381.65(g) that require that all poultry slaughter establishments 
develop, implement, and maintain written procedures to prevent 
contamination by enteric pathogens throughout the entire slaughter and 
dressing operation. FSIS is proposing to revise these regulations to 
clarify that these procedures must include an MMP that incorporates SPC 
monitoring methods. These proposed amendments would also specify that 
the pre-chill sampling location is at rehang and specify the use of 
appropriate microbial organisms for monitoring process control. In 
addition, VS and VLV establishments operating under Traditional 
Inspection \59\ would have to test at both rehang and post-chill, 
instead of at post-chill only, although some of these establishments 
would have the option to use laboratory services provided by FSIS to 
analyze their monitoring samples. FSIS has developed proposed guidance 
to help establishments meet the proposed sampling and analysis 
requirements. Under this proposal, the guidance would be considered as 
a ``safe harbor'' in that establishments that follow the guidance will 
have met the proposed MMP requirements in 9 CFR 381.65(g). FSIS is also 
proposing to amend the recordkeeping requirements in 9 CFR 381.65(h) to 
require that establishments submit their microbial monitoring results 
to the Agency electronically.
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    \59\ Traditional Inspection is typically employed at smaller 
lower production volume establishments that eviscerate carcasses by 
hand (77 FR 4410).
---------------------------------------------------------------------------

    Component One Modifications. Based on the need for additional 
research and due to implementation challenges, FSIS has decided, at 
this time, not to establish a regulatory requirement that 
establishments characterize Salmonella as a hazard reasonably likely to 
occur at receiving or that incoming flocks be tested for Salmonella 
before entering an establishment. FSIS, however, will focus on 
achieving the goal of Component One--reduce the amount and type of 
Salmonella contamination that enters the establishment--through non-
regulatory strategies. These include actively encouraging the wider use 
of modified-live vaccines, which have been demonstrated to have a very 
effective role in mitigating the hazard associated with specific 
Salmonella serotypes, while reducing the entire load of similar 
serogroup Salmonella through cross-protection. FSIS is also working 
with the Animal and Plant Health Inspection Service (APHIS) to explore 
ways to expand the National Poultry Improvement Program (NPIP), which 
has been effective in reducing the prevalence of particular Salmonella 
serotypes.
    The Agency will continue to explore and develop strategies for 
addressing Salmonella contamination risk at receiving. FSIS also 
intends to revise its existing compliance guideline on Controlling 
Salmonella in Raw Poultry \60\ to provide effective guidance on pre-
harvest interventions and practices for preventing or reducing 
Salmonella colonization of live birds.
---------------------------------------------------------------------------

    \60\ FSIS Guideline for Controlling Salmonella in Raw Poultry 
(July 2021). Available at: https://www.fsis.usda.gov/guidelines/2021-0005.
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5. Severability
    While the three components in this proposal support a comprehensive 
approach to controlling Salmonella in poultry, they are each separate 
actions that could operate independently of each other to address 
Salmonella illnesses associated with poultry products. Therefore, the 
following portions of this proposal are mutually severable from each 
other: The proposed determination that would establish final product 
standards for certain raw poultry products proposed under Component 
Three; the proposed amendments to 9 CFR 381.65 (g) and (h) that would 
enhance process control monitoring in all poultry slaughter 
establishments under Component Two; and the proposed non-regulatory 
approach to address pre-harvest measures in Component One. Should FSIS 
finalize this proposal, if any of the above portions were to be set 
aside by a reviewing court, FSIS would intend for the remainder of this 
action to remain in effect.
    These proposals are discussed in more detail below.

[[Page 64692]]

II. Component Three: Proposed Final Product Standards

A. Current Salmonella Performance Standards and Consideration of an 
Alternative Approach

    As discussed above, although FSIS sampling data show that the 
occurrence of Salmonella in raw poultry products has decreased since 
FSIS implemented its prevalence-based Salmonella performance standards, 
there has not been a corresponding observed reduction in Salmonella 
illnesses in the United States. There are likely multiple reasons for 
the disconnect between the reduced Salmonella contamination in poultry 
products and continued illnesses. Individuals who become ill may be 
exposed to more virulent Salmonella strains or higher concentrations of 
Salmonella,\61\ and, as noted above, consumption of poultry has 
increased.\62\ Additionally, as discussed below, several consumer 
behavior research studies suggest that ordinary consumer cooking and 
preparation practices for many raw chicken and turkey products do not 
provide adequate assurance that these products will not be contaminated 
with Salmonella when consumed. Therefore, FSIS has decided to 
reconsider its current approach to Salmonella performance standards for 
poultry and has tentatively concluded that the Agency should adopt an 
alternative approach to more effectively reduce Salmonella illnesses 
associated with poultry products. This proposal addresses the 
disconnect between Salmonella contamination on poultry and human 
illnesses because it targets specific Salmonella serotypes more 
frequently associated with illness and limits the concentration of 
Salmonella permitted in certain raw poultry products.
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    \61\ FSIS Risk Profile for Pathogenic Salmonella in Poultry 
(2023); FAO/WHO (Food and Agriculture Organization/World Health 
Organization) ``Microbiological Risk Assessment Series 3: Hazard 
Characterization for Pathogens in Food and Water''. Geneva, Rome: 
World Health Organization, Food and Agricultural Organization of the 
United Nations; 2003; Cheng, RA, Eade CR, and Wiedmann M (2019). 
Embracing Diversity: Differences in Virulence Mechanisms, Disease 
Severity, and Host Adaptations Contribute to the Success of 
Nontyphoidal Salmonella as a Foodborne Pathogen. Frontiers in 
Microbiology, Volume 10 at: https://doi.org/10.3389/fmicb.2019.01368; Teunis, Peter FM (2022).Dose response for 
Salmonella Typhimurium and Enteritidis and other nontyphoid enteric 
salmonellae. Epidemics 41: 100653. https://doi.org/10.1016/j.epidem.2022.100653.
    \62\ Williams, M.S., & Ebel, E.D. (2022). Temporal changes in 
the proportion of Salmonella outbreaks associated with 12 food 
commodity groups in the United States. Epidemiology and infection, 
150, e126. https://doi.org/10.1017/S0950268822001042.
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    FSIS' current Salmonella performance standards focus on reducing 
the prevalence of all Salmonella without considering differences in 
virulence among individual Salmonella serotypes, strains, and 
genotypes. Thus, the current standards do not focus on the types of 
Salmonella most likely to cause human illnesses. In addition, the 
current Salmonella performance standards consider only the presence or 
absence of Salmonella in the product, while the quantity of the 
pathogen may also have an impact on illness. Thus, the current 
performance standards do not distinguish between poultry products that 
are heavily contaminated and that contain the most virulent type of 
Salmonella from those that contain trace amounts of a Salmonella with 
types not typically associated with foodborne illnesses in the United 
States.
    Additionally, and independently, the Agency's ability to directly 
enforce the pathogen reduction performance standards has been limited 
since 2001, after a ruling by the U.S. Court of Appeals for the Fifth 
Circuit in Supreme Beef Processors, Inc. v. USDA, 275 F.3d 432 (5th 
Cir. 2001). In that case, the court enjoined FSIS from suspending 
inspection services against a meat grinding operation for failure to 
meet the Salmonella performance standards. Since that time, FSIS has 
used Salmonella performance standard failures as a basis to conduct an 
in-depth evaluation of the establishment's food safety systems, 
including its HACCP plan and sanitation SOPs. However, because 
Salmonella is not currently considered an adulterant in raw poultry, 
the Agency cannot withhold the mark of inspection or otherwise prevent 
products produced in an establishment that has failed the performance 
standards from entering commerce based solely on the establishment's 
performance standard results (75 FR 27288, 27293-4). This proposal, on 
the other hand, would set an enforceable final product standard that 
prevents raw poultry products with certain levels and types of 
Salmonella contamination, which would be classified as adulterants, 
from entering the stream of commerce.
    When FSIS initially established the pathogen reduction Salmonella 
performance standards in 1996, the Agency noted that, except for E. 
coli O157:H7, FSIS had not taken the position that some amount of a 
pathogen necessarily renders a raw meat or poultry product unsafe and 
legally adulterated (61 FR 38806, 38835). At the time, the Agency 
believed that it was constrained by the lack of a scientific basis for 
determining the levels at which specific pathogens do or do not present 
a safety hazard, and it also relied in part on the fact that proper 
cooking kills pathogens on raw product (60 FR 6774, 6799). Therefore, 
the initial pathogen reduction performance standards were based on a 
statistical evaluation of the prevalence of bacteria in each 
establishment's products, measured against the nationwide prevalence of 
the bacteria in the same products (61 FR 38806, 38836). The Salmonella 
performance standards were and still are not used to determine whether 
specific product lots are legally adulterated. However, when FSIS 
established the initial performance standards, the Agency made clear 
that ``as more research is done and more data become available, and as 
more sophisticated techniques are developed for quantitative risk 
assessment for microbiological agents, it may be possible and 
appropriate to develop performance standards that use a different 
approach'' (61 FR 38806, 38836).
    Since FSIS implemented the Salmonella performance standards, the 
Agency has evaluated whether certain types of Salmonella should be 
considered as adulterants in raw meat and poultry in response to 
petitions submitted to the Agency in 2011, 2014, and 2022. For example, 
in response to two petitions submitted by CSPI in 2011 and 2014, FSIS 
evaluated whether certain antibiotic-resistant (ABR) Salmonella 
serotypes could be considered as adulterants in raw meat and raw 
poultry products under the Federal Meat Inspection Act (FMIA) and PPIA. 
The 2011 petition asked FSIS to declare four strains of ABR Salmonella 
as adulterants when found in ground meats and poultry.\63\ FSIS denied 
the 2011 petition without prejudice on July 31, 2014. In its response, 
FSIS explained that the data available at that time ``did not support 
giving the four strains of ABR Salmonella identified in the petition a 
different status as an adulterant in raw ground beef and raw ground 
poultry than Salmonella strains that are susceptible to antibiotics.'' 
\64\ The response stated that additional data on the characteristics of 
ABR Salmonella are needed to determine whether certain strains could 
qualify as adulterants under the FMIA and PPIA.

[[Page 64693]]

The response also noted that because the Agency's denial was without 
prejudice, the petitioner was not precluded from submitting a revised 
petition that includes additional information to support the requested 
action.
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    \63\ CSPI petition #11-06 (May 25, 2011), ``Petition for an 
Interpretive Rule Declaring Specific Strains of Antibiotic Resistant 
Salmonella to be Adulterants Withing the Meaning or 21 U.S.C. 
601(m)(1) and (2)(a) and 21 U.S.C. 453(g)(1) and (2)(a).'' FSIS 
final response (July 31, 2014) at: https://www.fsis.usda.gov/policy/petitions/petition-submitted-center-science-public-interest-0.
    \64\ FSIS final response to petition #11-06, p. 1.
---------------------------------------------------------------------------

    The CSPI 2014 petition was a refiling of the 2011 petition and 
asked that FSIS declare certain strains of ABR Salmonella as 
adulterants in all meat and poultry products based on evidence attained 
since 2011 that, according to the petition, demonstrates both ground 
and intact poultry products are associated with outbreaks from ABR 
Salmonella.\65\ Based on the data available at the time, FSIS denied 
the 2014 petition without prejudice on February 7, 2018. In its 
response to the petition, the Agency concluded that, with respect to 
its status as an adulterant, ``Salmonella does not appear to present 
the same issues as [E. coli O157:H7], regardless of whether it is 
resistant or susceptible to antibiotics.'' \66\ Therefore, the Agency 
stated that it ``had no basis to conclude that either ABR-Salmonella or 
non-ABR Salmonella would render injurious to health what consumers 
consider to be properly cooked meat or poultry.'' \67\
---------------------------------------------------------------------------

    \65\ CSPI petition #14-01 (October 1, 2014), ``Request for an 
Interpretive Rule Declaring Certain Antibiotic-Resistant Strains of 
Salmonella to be Adulterants'' and FSIS final response (February 7, 
2018) at: https://www.fsis.usda.gov/federal-register/petitions/request-interpretive-rule-declaring-certain-antibiotic-resistant-strains.
    \66\ FSIS final response to petition #14-06, p. 6.
    \67\ FSIS final response to petition #14-06, p. 7.
---------------------------------------------------------------------------

    As discussed above, FSIS also considered whether certain Salmonella 
serotypes should be considered as adulterants in all meat and poultry 
products in response to the January 2020 petition submitted by Marler 
Clark LLP requesting FSIS to declare 31 Salmonella serotypes that have 
been associated with foodborne illness outbreaks to be adulterants of 
all meat and poultry products.\68\ As noted above, FSIS denied the 
petition without prejudice. However, in its response, the Agency 
explained that it believes that an updated Salmonella strategy is 
necessary to reduce Salmonella illnesses associated with poultry 
products and that FSIS had initiated several activities designed to 
gather data and information to inform and support future actions 
related to Salmonella in poultry. These activities were discussed in 
the Background section of this document.
---------------------------------------------------------------------------

    \68\ Marler Clark LLP petition # 20-01 ``Petition for an 
Interpretive Rule Declaring `Outbreak' Serotypes of Salmonella 
enteritica subspecies to be Adulterants'' dated January 19, 2020. 
Available at: https://www.fsis.usda.gov/policy/petitions/petition-interpretive-rule-related-certain-Salmonella-serotypes.
---------------------------------------------------------------------------

    Since FSIS denied the 2020 Marler petition, many of the activities 
that were initiated to inform an updated Salmonella strategy have 
generated new studies and information that FSIS has determined support 
a revised approach on the use of standards to address Salmonella in 
final raw poultry products. For example, after FSIS issued the 2020 
Marler petition denial, the Agency completed its chicken carcass 
exploratory sampling program, NACMCF issued its final 2023 report, FSIS 
completed the peer-reviewed 2023 risk profile as well as the peer-
reviewed 2023 risk assessments for chicken and turkey. The Agency also 
held the November 3, 2022, public meeting and received written and oral 
stakeholder input on the proposed Salmonella Framework that the Agency 
was considering.
    As part of Component Three of the draft Salmonella Framework, FSIS 
stated that it was assessing whether certain levels and/or types of 
Salmonella on raw poultry present an elevated risk of causing human 
illness such that they should be considered adulterants. To evaluate 
the status of Salmonella in raw poultry under the PPIA, FSIS has 
considered stakeholder input received in response to the draft 
Salmonella Framework together with the available scientific information 
on Salmonella in poultry, including recommendations in the 2023 NACMCF 
report, the findings of the 2023 risk profile, and the results of the 
2023 quantitative risk assessments for Salmonella in chicken and 
turkey. Additionally, because FSIS has relied in part on ordinary 
consumer cooking practices to determine the status of pathogens as 
adulterants in raw products, the Agency also considered the available 
consumer behavior research to evaluate whether ordinary consumer 
cooking and handling practices are able to consistently mitigate the 
risk associated with certain raw poultry products contaminated with 
certain levels and/or types of Salmonella. Based on its evaluation of 
scientific evidence, the Agency has tentatively concluded that there 
are certain raw poultry products and Salmonella levels and serotype 
pairs that have characteristics that distinguish them from other raw 
products contaminated with Salmonella. FSIS has also tentatively 
determined that, based on its evaluation of available scientific 
evidence, Salmonella, when present in these specific products at the 
specified levels and serotypes, should be considered as an adulterant.
    Accordingly, FSIS is proposing final product standards that would 
define whether certain raw poultry products contaminated with certain 
Salmonella levels and serotypes are adulterants as defined in the PPIA. 
Specifically, FSIS had tentatively determined that chicken carcasses, 
chicken parts, comminuted chicken, and comminuted turkey are 
adulterated if they contain Salmonella at or above 10 cfu/per 
milliliter or gram (10 cfu/mL(g)) in analytical portion (i.e., mL of 
rinsate or gram of product) and contain any detectable level of at 
least one of the Salmonella serotypes of public health significance 
identified for that product. The Salmonella serotypes of public health 
significance identified for chicken carcasses, chicken parts, and 
comminuted chicken are Enteritidis, Typhimurium, and I 4,[5],12:i:- and 
for comminuted turkey are Hadar, Typhimurium, and Muenchen. As 
discussed below, these serotypes were the three most highly virulent 
serotypes associated with a commodity identified in the 2023 risk 
assessments. The Salmonella serotypes of public health significance 
will likely change over time as the serotypes commonly associated with 
human illnesses change. FSIS will continue to track annual targets for 
reducing the proportion of poultry samples that contain Salmonella 
serotypes of public health significance, as well as data on rates for 
serotypes commonly associated with human illness to inform future 
revisions to the Salmonella serotypes of public health significance. 
FSIS would publicly announce and request comments on any changes to the 
serotypes of public health significance in the Federal Register. 
Additionally, should FSIS finalize the proposed final product 
standards, the Agency intends to further evaluate and, if necessary, 
refine these standards as advances in science and technology related to 
pathogen levels, serotypes, and virulence genes become available. As 
discussed above, if FSIS finalizes the proposed final product 
standards, the Agency intends to re-evaluate the serotypes of public 
health concern every 3-5 years at a minimum and whenever new 
information on Salmonella serotypes associated with human illness 
become available.
    Under this proposed determination, chicken parts subject to the 
final product standards would include legs, breasts, wings, thighs, 
quarters, and halves. FSIS is not proposing final product standards for 
turkey carcasses or parts because historically there have been very few 
Salmonella-positive detections in turkey carcasses. Additionally, the 
Agency does not

[[Page 64694]]

quantify Salmonella on turkey carcass sponge samples and has never had 
a Salmonella verification sampling program for turkey parts. Thus, it 
was not possible for the 2023 turkey risk assessment to assess the risk 
management questions for turkey parts or provide a robust assessment on 
final product standards for turkey carcasses that FSIS could use to 
inform the development of final product standards for these products.
    The basis for the proposed final product standards and FSIS' 
proposed determination that products that contain the Salmonella levels 
and serotypes identified in the proposed final product standards are 
adulterated is discussed below.

B. Pathogens as Adulterants in Raw and Not-Ready-To Eat Meat and 
Poultry Products

    Under the FMIA (21 U.S.C. 601 et seq.) and the PPIA (21 U.S.C 451 
et seq.), a meat or poultry product is adulterated if, among other 
circumstances, ``it bears or contains any poisonous or deleterious 
substance which may render it injurious to health; but in case the 
substance is not an added substance, such article shall not be 
considered adulterated . . . if the quantity of such substance in or on 
such article does not ordinarily render it injurious to health'' (21 
U.S.C. 601(m)(1); 21 U.S.C. 453(g)(1)). Meat and poultry products are 
also adulterated if they are ``unsound, unhealthful, unwholesome, or 
otherwise unfit for human food'' (21 U.S.C. 601(m)(3)); 21 U.S.C. 
453(g)(3)).
    Historically, most foodborne pathogens, including Salmonella, have 
not been considered as adulterants of raw and other NRTE meat and 
poultry products based on the assumption that ordinary cooking is 
generally sufficient to destroy the pathogens.\69\ \70\ One exception 
to date is E. coli O157:H:7 and certain non-O157 Shiga toxin-producing 
Escherichia coli (STEC) in raw, non-intact beef products and intact 
cuts that are to be further processed into non-intact products before 
being distributed for consumption. These pathogens are considered 
adulterants in these specific raw products because they render 
``injurious to health'' what many consumers believe to be properly 
cooked non-intact beef products.\71\ FSIS had also determined that when 
contaminated with these pathogens, raw, non-intact beef products are 
``unhealthful, unwholesome, and otherwise unfit for human food.'' \72\
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    \69\ See proposed rule ``Pathogen Reduction; Hazard Analysis and 
Critical Control Point (HACCP) Systems,'' February 4, 1993 (60 FR 
6774 at 6798-6799) and final rule ``Pathogen Reduction; Hazard 
Analysis and Critical Control Point (HACCP) Systems,'' July 25, 1996 
(61 FR 38806 at 38835.) See also Amer. Public Health Ass'n v. Butz, 
511 F.2d 331 (U.S. App. DC, 1974).
    \70\ When raw meat or poultry products are associated with an 
illness outbreak and contain pathogens that are not considered 
adulterants in those products, FSIS considers the product linked to 
the illness outbreak to be adulterated under 21 U.S.C. 601(m)(3) or 
453(g)(3) because the product is ``. . . unsound, unhealthful, 
unwholesome, or otherwise unfit for human food'' (77 FR 72681, 72689 
(Dec. 6, 2012). Products that contain an adulterant are considered 
adulterated under 21 U.S.C. 601(m)(1) or 453(g)(1) even if they are 
not linked to an illness outbreak.
    \71\ See Texas Food Industry Association v. Espy, 870 F. Supp. 
143 (1994).
    \72\ Shiga-Toxin Producing Escherichia coli in Certain Raw Beef 
Products (76 FR 58157, 58159).
---------------------------------------------------------------------------

    When FSIS determined that certain STEC are adulterants in non-
intact raw beef products, the Agency identified characteristics 
associated with both the pathogen and the product that distinguish them 
from other raw products contaminated with other pathogens. Specially, 
FSIS considered that these STEC had been associated with illnesses and 
outbreaks, have a relatively low infectious dose, cause serious human 
illness, and can survive what many consumers consider to be ordinary 
preparation and cooking practices of non-intact beef products.
    As discussed above, on May 1, 2024, FSIS published a final 
determination to declare that NRTE breaded stuffed chicken products 
that contain Salmonella at levels of 1 cfu/g or higher are adulterated 
within the meaning of the PPIA.\73\ In that determination, FSIS stated 
that while certain STEC have been the only pathogens to date that are 
considered adulterants in a raw product, certain other pathogens may 
also exhibit characteristics that would meet the standard to be 
considered as adulterants in a specific raw product. In the proposed 
determination, FSIS also stated that if the Agency became aware of 
evidence to show that a specific pathogen and product pair presents a 
significant public health risk, it would consider the factors it 
identified to distinguish certain STEC from other pathogens as 
adulterants in certain raw beef products to determine the pathogen's 
status as an adulterant, i.e., pathogen serogroups or types associated 
with human illnesses; pathogen infectious dose; pathogen and serious 
human illnesses; and traditional or ordinary cooking practices. After 
applying these factors to Salmonella in NRTE breaded stuffed chicken 
products, FSIS decided to declare that NRTE breaded stuffed chicken 
products that contain Salmonella at levels of 1 cfu/g or higher are 
adulterated within the meaning of the PPIA.
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    \73\ Salmonella in Not-Ready-To-Eat Breaded Stuffed Chicken 
Products; May 1, 2024 (89 FR 35033) at: https://www.fsis.usda.gov/sites/default/files/media_file/documents/FSIS-2022-0013F.pdf.
---------------------------------------------------------------------------

    Specifically, FSIS determined that NRTE breaded stuffed chicken 
products that contain Salmonella at 1 cfu/g or higher are adulterated 
under 21 U.S.C. 453 (g)(1) because, in these particular products, 
Salmonella is an added substance that may render them injurious to 
health (89 FR 35034-35035). FSIS also determined that Salmonella at 1 
cfu/g in NRTE breaded stuffed chicken meets the more stringent 
``ordinarily injurious to health'' standard for substances that are not 
added as provided in 21 U.S.C. 453(g)(1)) (89 FR 35035). Finally, FSIS 
determined that NRTE breaded stuffed chicken products contaminated with 
Salmonella at levels of 1 cfu/g or higher present a serious risk of 
causing Salmonella illnesses and that this elevated risk of illness 
makes them ``unhealthful, unwholesome, or otherwise unfit for human 
food'' as defined in 21 U.S.C. 453(g)(3) (89 FR 35037).

C. The Adulteration Standard for Raw Poultry Products

    Consistent with its approach used to determine the status of 
certain STEC in certain raw beef products and to determine the status 
of Salmonella at certain levels in NRTE breaded stuffed chicken 
products, FSIS has evaluated the available information on Salmonella 
serotypes associated with human illnesses, the Salmonella infectious 
dose, the severity of human illnesses caused by Salmonella, and 
ordinary consumer preparation practices associated with these raw 
poultry products to assess the status of Salmonella in chicken 
carcasses, chicken parts, comminuted chicken, and comminuted turkey. 
Based on this evaluation, FSIS is proposing final product standards for 
levels and serotypes of Salmonella in chicken carcasses, chicken parts, 
comminuted chicken, and comminuted turkey. FSIS has also tentatively 
determined that chicken carcasses, chicken parts, comminuted chicken, 
and comminuted turkey that contain the Salmonella levels and serotypes 
identified in the final product standard are adulterated as defined in 
the PPIA because they contain a poisonous or deleterious substance that 
renders them ``injurious to health'' as defined in 21 U.S.C. 453(g)(1). 
Additionally, FSIS has tentatively determined that chicken carcasses, 
chicken parts, comminuted chicken, and comminuted turkey that contain 
the Salmonella levels and

[[Page 64695]]

serotypes identified in the final product standards are adulterated as 
defined in 21 U.S.C. 453(g)(3) because their elevated risk of illness 
makes them ``unhealthful, unwholesome, or otherwise unfit for human 
food.'' \74\ The basis for this tentative determination is discussed 
below.
---------------------------------------------------------------------------

    \74\ Under 21 U.S.C. 601(m)(3) of the FMIA and 21 U.S.C. 
453(g)(3) of the PPIA, a meat or poultry product is adulterated ``if 
it consists in whole or in part of any filthy, putrid, or decomposed 
substance or is for any other reason unsound, unhealthful, 
unwholesome, or otherwise unfit for human food.'' Historically, FSIS 
has interpreted the phrase ``is for any other reason unsound, 
unhealthful, or otherwise unfit for human food'' as providing a 
separate basis for adulteration than consists of ``any filthy, 
putrid, or decomposed substance.'' Thus, meat or poultry products 
that FSIS has determined are ``otherwise unfit for human food'' 
within the meaning of 21 U.S.C. 601(m)(3) and 21 U.S.C. 453(g)(3) do 
not also need to consist ``in whole or in part of any filthy, 
putrid, or decomposed substance.'' For example, when raw meat or 
poultry products are associated with an illness outbreak but contain 
pathogens that are not considered adulterants in raw products, FSIS 
has found products linked to the illness outbreak to be adulterated 
under 21 U.S.C. 601(m)(3) or 21 U.S.C. 453(g)(3) because they are 
``unsound, unhealthful, unwholesome or otherwise unfit for human 
food'' (77 FR 72689). FSIS has also determined that certain 
materials from cattle as well as the carcasses of non-ambulatory 
disabled cattle are adulterated because they present a sufficient 
risk of exposing humans to the bovine spongiform encephalopathy 
agent such as to render them ``unfit for human food'' under 21 
U.S.C. 601(m)(3) (69 FR 1862).
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1. Pathogen Serogroups or Types Associated With Human Illness
    Approximately 2,500 Salmonella serotypes have been identified,\75\ 
though not all serotypes have been isolated from poultry. Most human 
infections have been epidemiologically linked to fewer than 100 
serotypes. Almost all strains of Salmonella are pathogenic as they can 
invade, replicate and survive in human host cells, resulting in 
potentially fatal disease,\76\ though not all are equally likely to 
cause illness. To evaluate which Salmonella serotypes are most likely 
to be associated with human illness, FSIS considered information from 
the 2023 NACMCF report, the 2023 risk profile, and the 2023 risk 
assessments.
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    \75\ Brenner FW, Villar RG, Angulo FJ, Tauxe R, Swaminathan B. 
Salmonella nomenclature. J Clin Microbiol. 2000 Jul;38(7):2465-7. 
doi: 10.1128/JCM.38.7.2465-2467.2000. PMID: 10878026; PMCID: 
PMC86943.
    \76\ Shu-Kee Eng, Priyia Pusparajah, Nurul-Syakima Ab Mutalib, 
Hooi-Leng Ser, Kok-Gan Chan & Learn-Han Lee (2015) Salmonella: A 
review on pathogenesis, epidemiology and antibiotic resistance, 
Frontiers in Life Science, 8:3, 284-293, DOI: 10.1080/
21553769.2015.1051243.
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    NACMCF report. In the 2023 NACMCF report, the committee considered 
how foodborne illness surveillance data on human Salmonella illnesses, 
data from foodborne outbreaks associated with Salmonella in poultry, 
and data on Salmonella serotypes in poultry products can be used to 
identify the Salmonella serotypes of greatest public health concern 
associated with specific poultry products. The report stated that the 
relevant serotypes of greatest public health concern are those that are 
common causes of reported human illness, are present in poultry, and 
are transmitted through foods. The report noted that CDC surveillance 
provides data on the frequency of diagnosed illness caused by each 
serotype and that FSIS data from slaughterhouses and retail surveys can 
confirm the presence and frequency of serotypes in raw poultry. The 
report also concluded that outbreak investigations of foodborne 
salmonellosis can provide direct evidence that foodborne transmission 
of a particular serotype occurs.
    The NACMCF report noted that several approaches have been used to 
attribute human salmonellosis to specific foods and sources. These 
include case-control studies, analysis of reported foodborne outbreaks, 
and most recently, source attribution based on WGS genotyping. The 
report concluded that attribution based on outbreak data and on 
genotype both give the greatest weight to data from the most recent 
years. NACMCF found that poultry is the leading source of human 
salmonellosis, based on both reported outbreaks and genotype-based 
attribution methods. The committee also stated that these data show 
that a small number of serotypes account for most poultry-associated 
salmonellosis led by Enteritidis, Typhimurium, I:4,5,12:i:-, Infantis, 
and Heidelberg, and even fewer serogroups: groups O:4 (formerly group 
B), O:7 (group C1), and O:9 (group D1).
    Risk profile. In the 2023 risk profile, FSIS conducted a review of 
all information on Salmonella outbreaks reported in the CDC National 
Outbreak Reporting System (NORS), PubMed, and the web pages FSIS uses 
for maintaining records on outbreak investigations to determine which 
Salmonella serotypes or subtypes are linked to foodborne illnesses or 
outbreaks from consuming specific raw and NRTE chicken or turkey 
products. From these data sources, the risk profile identified 210 
foodborne Salmonella outbreaks linked to poultry products between 1998 
and 2020. Of these 210 foodborne Salmonella outbreaks, 84.8 percent 
(178/210) were linked to chicken products and 15.2 percent (32/210) to 
turkey products. Serotype information was available for 93.3 percent 
(196/210) of these outbreaks, including 2.4 percent (5/210) associated 
with multiple serotypes.
    For the purposes of the risk profile, Salmonella subtypes 
associated with human illness outbreaks attributed to consuming chicken 
or turkey are referred to as ``subtypes of concern.'' The 196 outbreaks 
in which serotype information was available involved 32 subtypes of 
concern. Seventeen serotypes of concern were only linked to chicken 
products. One serotype of concern, Reading, was linked to a turkey 
product but not to chicken. There were 10 serotypes linked to both 
chicken and turkey products.
    According to the data compiled for the risk profile, the 210 
outbreaks include 7,018 illnesses, 1,202 hospitalizations, and 10 
deaths attributed to poultry products. When considering outbreaks 
associated with either chicken or turkey products, nine serotypes 
accounted for 85 percent (5,794/7,018) of illnesses. Each of these 
subtypes caused 200 or more outbreak associated illnesses in chicken 
and/or turkey from 1998-2020. The top seven subtypes associated with 
chicken were Enteritidis, Heidelberg, Typhimurium, I 4,[5],12:i:-, 
Montevideo, Thompson, and Infantis. The top four subtypes associated 
with turkey were Enteritidis, Reading, Muenchen, and Heidelberg. The 
most common subtypes of concern associated with poultry products 
overall were Enteritidis, Heidelberg, Typhimurium, and I 4,[5],12:i:-.
    Risk assessments. The chicken and turkey risk assessments leveraged 
FSIS' 2023 risk profile to identify Salmonella serotypes in chicken and 
turkey linked to foodborne illness and adopted the guidance on risk 
assessment recommendations from the 2023 NACMCF report. FSIS developed 
a probabilistic risk assessment model describing current Salmonella 
contamination in raw poultry products and the potential human exposure 
through consumption of servings derived from these raw products. Data 
from FSIS microbiological baseline studies, routine PR/HACCP sampling, 
and exploratory sampling programs were used to describe Salmonella in 
chicken carcasses, fabricated chicken parts, and comminuted chicken and 
turkey products. FSIS partnered with EpiX Analytics through a 
Cooperative Agreement with the University of Maryland to incorporate 
genomics into the risk assessment models developed by FSIS. FSIS 
selected the grouping of serotypes into two ``clusters'' (i.e., 
``higher virulence'' and ``lower virulence'') based on the virulence 
profiles, exposure in food, and foodborne epidemiological data and EpiX 
Analytics then derived two virulence-adjusted Salmonella dose-

[[Page 64696]]

response models.\77\ FSIS used these dose-response models in its 
quantitative risk assessment models for Salmonella in chicken and 
turkey. FSIS assessed public health benefits, in terms of annual 
illnesses prevented, by modeling the impact of removal of lots with 
Salmonella at or above a certain level or with certain serotypes and 
simulated the probability of illness per serving.
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    \77\ Full details of the EpiX Analytics methodology are provided 
in Appendix A of the chicken Risk Assessment in the report entitled 
``Using genomics to identify nontyphoidal Salmonella serovars of 
concern and estimating dose-response models amenable to risk 
assessments in poultry.''
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    The analysis in the chicken risk assessment found the probability 
of illness from chicken contaminated with ``higher virulence'' 
serotypes exposures is 5.66 times larger than the probability of 
illness from chicken contaminated with ``lower virulence'' serotypes. 
In FSIS sampling, the average annual percentage of ``higher virulence'' 
serotypes is approximately 26 percent for chicken carcasses, 32 percent 
for comminuted chicken product, and 35 percent for chicken parts. The 
chicken risk assessment identified Enteritidis, Typhimurium, I 4,[5], 
12:i:-, Hadar, and Litchfield as the five most frequent ``higher 
virulence'' serotypes in chicken. The chicken risk assessment 
identified Kentucky, Infantis, Schwarzengrund, Heidelberg, and Thompson 
as the five most frequent ``lower virulence'' serotypes in chicken.
    The analysis in the turkey risk assessment found there are 49 
different serotypes in comminuted turkey products, as compared to only 
19 serotypes isolated on turkey carcasses in the Agency's pathogen 
reduction Salmonella sampling program. Reading and Hadar ranked as the 
top two in both carcasses and comminuted, comprising more than 30 
percent of the serotype samples for each commodity. Hadar was also 
observed most often in the FSIS microbiological baseline studies for 
Salmonella in turkey \78\ and appeared in the top ten CDC FoodNet 
annual summary from 2020.\79\
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    \78\ National Microbiological Baseline Data Collection Program: 
Young Turkey Survey available at: https://www.fsis.usda.gov/node/1972
    \79\ CDC FoodNet Reports available at: https://www.cdc.gov/foodnet/reports/index.html.
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    The turkey risk assessment identified Hadar, I 4,[5], 12:i: -, 
Muenchen Typhimurium, and Saintpaul as the five most frequent ``higher 
virulence'' serotypes in turkey. The turkey risk assessment identified 
Reading, Infantis, Schwarzengrund, Uganda, and Agona as the five most 
frequent ``lower virulence'' serotypes in turkey.
    The list of serotypes of public health significance is highly 
important for this framework, as it determines whether products are 
adulterated as defined in the PPIA. FSIS recognizes that science 
constantly evolves and therefore our understanding of virulence and 
other factors will evolve over time.
    The FSIS risk assessments utilized bioinformatic tools and methods 
for clustering Salmonella serotypes, and an optimized new dose-response 
model developed by EpiX Analytics. This model was genomically 
validated, and results corresponded with other standard bioinformatic 
techniques differentiating serotypes based on lineage features. Genomic 
virulence factors were used for the initial grouping of serotypes and 
the higher virulence serotypes of public health significance were 
validated by CDC illness outcome data and FSIS sampling data. FSIS did 
not rely solely on the genomic component of the risk assessment model 
to determine the list of serotypes of public health significance. FSIS 
developed a cohesive risk model that incorporates virulence factors, 
epidemiological outcomes, and frequency of exposure and conducted 
sensitivity and uncertainty analyses of the full model and the 
virulence component. FSIS requests comments on the full risk model and 
the uncertainty and sensitivity analyses, whether they are fit for the 
purpose of determining the serotypes of public health significance, and 
what model adjustments or other approaches FSIS should consider in the 
determination to adapt to evolving data, technology, and analytical 
methods.
    FSIS recognizes that science consistently evolves, and therefore 
the Agency's understanding of virulence and other factors will evolve 
over time. Because the scientific understanding of virulence and other 
relevant factors evolves, FSIS is requesting comments on whether the 
EpiX Analytics serotype clustering and dose-response adjustment (i.e., 
risk multiplier) used the best available data and genetic factors 
relevant to Salmonella risk and contamination in the United States 
poultry population. Additionally, FSIS is requesting comment on 
potential improvements to the serotype clustering robustness analysis 
and the risk multiplier sensitivity analysis.
    Final product standards serotypes of public health significance. As 
noted above, as part of USDA's strategic and performance planning 
process for FY2022-2026, FSIS established a new KPI targeted to reduce 
the proportion of FSIS poultry samples with Salmonella serotypes 
commonly associated with human illnesses.\80\ The KPI serotype list was 
determined using summary statistics, namely comparison of historical 
Agency sampling data for poultry products and CDC FoodNet data to 
determine the Salmonella serotypes commonly associated with human 
illness. It is important to note that the KPI is used as an internal 
performance measure for FSIS, which is not intended to assess industry 
performance, and, as such, was not externally peer reviewed. FSIS' 
analysis found that these serotypes are Infantis, Enteritidis, and 
Typhimurium. Thus, FSIS selected these serotypes as a KPI target for 
all raw poultry.
---------------------------------------------------------------------------

    \80\ FY2022-2024 Food Safety Key Performance Indicator. 
Available at: https://www.fsis.usda.gov/inspection/inspection-
programs/inspection-poultry-products/reducing-salmonella-poultry/
salmonella-0#:~:text=FY%202022-
2026%20Food%20Safety%20Key%20Performance%20Indicator%20A,the%20USDA%2
0Fiscal%20Year%20%28FY%29%202022-2026%20Strategic%20Plan.
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    When developing the proposed final product standards, FSIS 
considered incorporating the KPI serotypes as the ``serotypes of public 
health significance'' as suggested by some of the comments on the 
initial draft Salmonella Framework. However, after evaluating the 
information on serotypes discussed above, FSIS concluded that, while 
the KPI serotypes are useful for strategic and performance planning 
purposes, the KPI was not a robust scientific tool by which to identify 
serotypes of public health concern as adulterants. Further, the KPI 
identified serotypes of public health concern for poultry as a whole, 
and not by individual product (chicken v. turkey). The KPI does not 
reflect the serotypes most commonly associated with illnesses from 
turkey, and the chicken risk assessment determined that Infantis is not 
a highly virulent serotype.
    Therefore, instead of proposing serotypes of public health 
significance based solely on the KPI criteria, FSIS has decided that 
the proposed serotypes of public health significance should be based on 
a thorough review of multiple FSIS scientific analyses in this area, 
including the 2023 NACMCF report, the externally peer-reviewed 2023 
risk profile, and the two externally peer-reviewed risk assessments. 
Based on consideration of these scientific efforts, these serotypes are 
Enteritidis, Typhimurium, and I 4,[5],12:i:- for chicken carcasses, 
chicken parts, and comminuted chicken, and Hadar, Typhimurium, and 
Muenchen for comminuted turkey. FSIS has determined that these 
serotypes more accurately reflect serotypes most likely

[[Page 64697]]

to cause illnesses because they are based on the same epidemiological 
evidence used in the risk profile and the 2023 NACMCF report, but 
pivotally also include analyses conducted in the risk assessments, 
which includes an additional analysis of virulence factors, 
epidemiological outcomes, and frequency of exposure.
    The 2023 NACMCF report, the 2023 risk profile, and the Agency's KPI 
all identify Infantis as among the serotypes commonly associated with 
poultry-related illnesses, the scientific evidence does not support 
that the rising trend in Infantis illnesses is associated with chicken 
consumption. The emergence of Infantis in FSIS chicken sampling in 2016 
did not correspond to a proportional increase in human Infantis 
illnesses, which have been on the rise in the United States since 
2010.\81\ Put another way, given the volume of chicken consumed by the 
American public--much of which is contaminated with Infantis--if it 
were a high-risk poultry serotype, we would predict more Infantis 
illnesses. Furthermore, the 2023 chicken risk assessment, which used 
published genomic methods,\82\ also determined that Infantis is less 
virulent than many other serotypes with the exception of Kentucky. 
Additionally, the risk profile found that Infantis accounted for 2 
percent of outbreaks identified in the CDC NORS, while I 4,[5],12:i:- 
accounted for 4.1 percent of those outbreaks.
---------------------------------------------------------------------------

    \81\ NACMCF final report ``Response to Questions Posed by the 
Food Safety and Inspection Service: Enhancing Salmonella Control in 
Poultry Products'' (March 2023).
    \82\ Fenske GJ, Pouzou JG, Pouillot R, Taylor DD, Costard S, 
Zagmutt FJ. The genomic and epidemiological virulence patterns of 
Salmonella enterica serovars in the United States. PLoS One. 2023 
Dec 5;18(12):e0294624. doi: 10.1371/journal.pone.0294624. PMID: 
38051743; PMCID: PMC10697515.
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    However, FSIS is aware Salmonella Infantis remains of considerable 
concern in terms of potential severity of illness \83\ and 
antimicrobial resistance, as can be observed in its routine inclusion 
in national lists of top serotypes by outbreak numbers and sporadic 
case counts.\84\ CDC estimates that the serotypes of public health 
significance represent 66 percent of outbreaks and 68 percent of 
outbreak-associated illnesses in the past five years of outbreak data; 
including Infantis as a fourth serotype increases these figures to 75 
percent and 79 percent, respectively.\85\ Given the notable concern of 
the Salmonella Infantis REPJFX01 strain raised by the CDC and other 
public health experts, FSIS is requesting comment on the possible 
inclusion of Infantis as a serotype of public health significance. As 
discussed above, FSIS was not able to validate that chicken consumption 
is the major direct driver of the increased Infantis rates and is 
additionally asking for comment on scientific studies and data sources 
on this topic that are in line with regulatory evidence guidelines.
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    \83\ FSIS is aware only of results on Infantis severity of 
illness that reinforce it is not a high risk serotype: Brown AC, 
Chen JC, Watkins LK, et al. CTX-M-65 Extended-Spectrum [beta]-
Lactamase-Producing Salmonella enterica Serotype Infantis, United 
States. Emerging Infectious Diseases. 2018;24(12):2284-2291. 
doi:10.3201/eid2412.180500.
    \84\ Centers for Disease Control and Prevention (CDC). BEAM 
(Bacteria, Enterics, Amoeba, and Mycotics) Dashboard. Atlanta, 
Georgia: U.S. Department of Health and Human Services. www.cdc.gov/ncezid/dfwed/BEAM-dashboard.html. Accessed 06/07/2024.; Centers for 
Disease Control and Prevention (CDC). National Outbreak Reporting 
System Dashboard. Atlanta, Georgia: U.S. Department of Health and 
Human Services, CDC. Last accessed 06/07/2024. Available from URL: 
wwwn.cdc.gov/norsdashboard.; Centers for Disease Control and 
Prevention (CDC). FoodNet Fast Dashboard. Atlanta, Georgia: U.S. 
Department of Health and Human Services, CDC. Last accessed 06/07/
2024. Available from URL: https://www.cdc.gov/foodnet/foodnet-fast.html.
    \85\ These estimates are based a CDC pilot analysis of data (CDC 
unpublished data) presented in 2023 to the National Advisory 
Committee on Microbiological Criteria for Foods. See: NACMCF final 
report ``Response to Questions Posed by the Food Safety and 
Inspection Service: Enhancing Salmonella Control in Poultry 
Products'' (March 13, 2023), available at: https://www.fsis.usda.gov/policy/advisory-committees/national-advisory-committee-microbiological-criteria-foods-nacmcf/2021.
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    As research into Salmonella virulence factors and their gene 
functions continues to develop, clustering should be revisited to 
ensure reliability and consistency. FSIS took care to align the 
virulence modeling in the risk assessments with epidemiological and 
clinical patterns in surveillance data: however, current bioinformatics 
methods are based on the serotypes that have been the consistently 
highest illness causes (Enteriditis and Typhimurium) across time rather 
than the full genetic landscape of Salmonella. Furthermore, lower 
virulence serotypes can still outcompete higher virulence serotypes and 
pose public health risks. As noted above, the list of serotypes of 
public health significance is essential to this framework, as it 
determines whether products are adulterated as defined in the PPIA. 
FSIS requests comments on the initial proposed serotypes of public 
health significance and what scientific evidence and genetic Salmonella 
data sources beyond the most often studied serotypes should be 
considered, in addition to that already considered, in the 
identification of the most highly virulent serotypes identified in the 
risk assessments, which includes a thorough review of multiple FSIS 
efforts in this area, including the 2023 NACMCF report and the 
externally peer reviewed 2023 risk profile.
2. Dose Considerations
    As summarized in the 2023 risk profile, although Salmonella data 
are limited, international and domestic outbreak investigations 
associated with a variety of food products have been used to estimate 
the relationship between the number of organisms consumed and the 
probability of illness. These estimates, and more broadly the emergence 
of dose-response modeling and quantitative risk assessment over the 
past 25 years, are all based on the concept that a single bacterium is 
all that is necessary to cause infection and/or illness, that is to say 
the single-hit model.\86\ FSIS' evaluation and summarization of dose-
response models, as well as analysis of outbreak data where estimates 
for the number of organisms consumed were available, demonstrate that 
the scientific consensus is that exposure to a small number of 
Salmonella organisms can result in foodborne illness.
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    \86\ Teunis, P.F., & Havelaar, A.H. (2000). The Beta Poisson 
dose-response model is not a single-hit model. Risk analysis: an 
official publication of the Society for Risk Analysis, 20(4), 513-
520. https://doi.org/10.1111/0272-4332.204048.
---------------------------------------------------------------------------

    In a study published in 2010 (the Teunis 2010 study), and included 
in the 2023 risk profile, using a dose-response model approach 
utilizing outbreak data, and accounting for variation among outbreaks 
represented by the data, the Salmonella median illness dose was 36 cfus 
(with 95 percent prediction interval of 0.69-1.26x10\7\ cfu).\87\ The 
median illness dose refers to the dose at which 50 percent of 
individuals in an exposed population will experience symptomatic 
illness. The median illness dose and its prediction interval reflect 
variability among outbreak strains and exposed populations and 
uncertainty about the dose-response relationship. Thus, it serves as a 
useful metric for comparing the pathogenicity of different serotypes. 
Additionally, the World Health Organization Food and Agriculture 
Organization of the United Nations developed a dose-response approach 
for risk assessments for Salmonella.\88\ Also

[[Page 64698]]

using outbreaks, the model estimated a 13 percent chance of becoming 
ill if ingesting an average dose of 100 organisms. Even at the level of 
1 organism ingested, there was still a non-zero chance of illness (0.25 
percent).
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    \87\ Teunis P.F., et al., Dose-response modeling of Salmonella 
using outbreak data. Int J Food Microbiol, 2010. 144(2): p. 243-9; 
https://doi.org/10.1016/j.ijfoodmicro.2010.09.026.
    \88\ World Health Organization, Risk assessment of Salmonella in 
eggs and broiler chickens, March 25, 2002. Available at: https://www.who.int/publications/i/item/9291562293.
---------------------------------------------------------------------------

    A study published after the 2023 FSIS risk profile was peer-
reviewed revisited the 2010 Teunis study discussed above.\89\ Using 
outbreak serotype data, and accounting for variation among outbreaks 
within a particular serotype, the median Salmonella dose predicted to 
result in 50 percent of exposed individuals becoming ill 
(IllD50) was 3,360 cfu (95 percent range: 18-3.2x10\9\), 
1,500 cfu (38-8.8x10\7\), and 1 cfu (0.69-1.0x10\6\) for Enteritidis, 
Typhimurium and Infantis, respectively. For the same study, the median 
Salmonella dose predicted to result in 1 percent of exposed individuals 
becoming ill (IllD01) was 0.6 cfu (95 percent range: 0.24-
1.9), 9.9 cfu (0.32-57), and 0.07 cfu (0.01-2.0x10\4\) for Enteritidis, 
Typhimurium and Infantis, respectively. These results describe that 
individuals exposed to small doses of Salmonella can experience 
symptomatic illness. Other Salmonella serotypes were also found to 
cause illness at small doses including Heidelberg 
(IllD50=323 cfu and IllD01=1 cfu) and 
Schwarzengrund (IllD50=0.8 cfu and IllD01=0.04 
cfu).
---------------------------------------------------------------------------

    \89\ Teunis P.F.M. Dose response for Salmonella Typhimurium and 
Enteritidis and other nontyphoid enteric salmonellae. Epidemics 41 
(2022) 100653; https://doi.org/10.1016/j.epidem.2022.100653.
---------------------------------------------------------------------------

    Furthermore, the 2023 FSIS risk assessments developed two 
virulence-adjusted dose-response models (one for low virulence 
Salmonella serotypes, and another for high virulence Salmonella 
serotypes), which utilize the work described in the 2023 FSIS risk 
profile to poultry specific serotypes. The high virulence dose-response 
model (which includes the serotypes of public health significance) was 
estimated using outbreak data and employed a beta-Poisson model of 
infection for a given dose as outlined in the 2023 risk profile. Risk 
multipliers, derived from epidemiological outbreak data attributed to 
poultry sources, with consideration of prevalence in animal sources 
from FSIS poultry sampling programs, were then used to scale the 
relative risk of illness from exposures to each cluster. The 
probability of illness from consuming chicken containing high virulence 
Salmonella serotypes exposures is 5.66 times greater than the 
probability of illness from exposure to chicken products containing low 
virulence Salmonella serotypes. The dose-response findings of the 2023 
risk assessment rely on the single-hit model, and the virulence 
adjusted dose-response models estimate of a 1 in 100 probability of 
illness at 1 cfu of high virulence Salmonella per serving and a 0.2 in 
100 probability of illnesses at 1 cfu of low virulence Salmonella per 
serving. While the median illness is not attained by the low virulence 
Salmonella dose response model, the median illness dose described by 
the dose-response model for serotypes of public health significance is 
approximately 2000 cfu.
    As summarized in the 2023 risk profile, five Salmonella foodborne 
outbreaks have shown that Salmonella can cause illness from exposure of 
10 or fewer organisms per person.\90\Additionally, several outbreaks 
from a range of Salmonella serotypes in various food products have 
shown that exposure from 11 to 420 organisms per person can result in 
illness.\91\ Thus, in these published studies, illnesses resulted from 
doses ranging from 1 to 420 Salmonella organisms per person.
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    \90\ Killalea, D., et al., International Epidemiological and 
Microbiological Study of Outbreak of Salmonella Agona Infection from 
a Ready to Eat Savoury Snack--I: England and Wales and the United 
States. 1996, British Medical Journal Publishing Group.; Shohat, T., 
et al., International Epidemiological and Microbiological Study of 
Outbreak of Salmonella Agona Infection from a Ready to Eat Savoury 
Snack--Ii: Israel. BMJ, 1996. 313(7065): p. 1107-1109.; D'aoust, 
J.Y. and J.Y.D. Aoust, Infective Dose of Salmonella Typhimurium in 
Cheddar Cheese. American Journal of Epidemiology, 1985. 122(4): p. 
717-720.; D'aoust, J.Y., D.W. Warburton, and A.M. Sewell, Salmonella 
Typhimurium Phage-Type 10 from Cheddar Cheese Implicated in a Major 
Canadian Foodborne Outbreak. Journal of Food Protection, 1985. 
48(12): p. 1062-1066.; Kapperud, G., et al., Outbreak of Salmonella 
Typhimurium Infection Traced to Contaminated Chocolate and Caused by 
a Strain Lacking the 60-Megadalton Virulence Plasmid. J Clin 
Microbiol, 1990. 28(12): p. 2597-601.; Hockin, J.C. et al., An 
International Outbreak of Salmonella Nima from Imported Chocolate. J 
Food Prot. 1989. 52(1): p. 51-54.; Lehmacher, A., Bockemuhl, J., and 
Aleksic. S. Nationwide outbreak of human salmonellosis in Germany 
due to contaminated paprika and paprika-powdered potato chips. 1995. 
Epidemiol Infect. 115: p. 501-11.
    \91\ Kasuga F.et al., Archiving of food samples from restaurants 
and caterers--Quantitative profiling of outbreaks of foodborne 
Salmonella in Japan. Journal of Food Protection, 2004. 67: p. 2024-
2032; Blaser, M.J., and Newman, L.S. A review of human 
salmonellosis: I. Infective dose. Rev Infect Dis., 1982.4: p.1096-
106; Abe, K., N. et al., Prolonged incubation period of 
Salmonellosis associated with low bacterial doses. Journal of food 
protection, 2004. 67: p. 2735-2740; Hara-Kudo, Y. and K. Takatori, 
Contamination level and ingestion dose of foodborne pathogens 
associated with infections. Epidemiology and Infection, 2011. 139: 
p. 1505-1510; Hennessy T.W., et al., A national outbreak of 
Salmonella enteritidis infections from ice cream. N Engl J Med, 
1996. 334(20): p. 1281-6; Hedberg C.W., et al., A multistate 
outbreak of Salmonella javiana and Salmonella oranienburg infections 
due to consumption of contaminated cheese. JAMA, 1992. 268(22): p. 
3203-7; Todd, E.C., et al., Outbreaks where food workers have been 
implicated in the spread of foodborne disease. Part 4. Infective 
doses and pathogen carriage. J Food Prot, 2004. 71: p. 2339-73; 
Scheil W., et al., A South Australian Mdbandaka outbreak 
investigation using a database to select controls. Aust NZ J Public 
Health, 1998. 22(5): p. 536-9; Tamber, S., E. Swist, and D. Oudit, 
Physicochemical and bacteriological characteristics of organic 
sprouted chia and flax seed powders implicated in a foodborne 
Salmonellosis outbreak. Journal of Food Protection, 2016. 79(5): p. 
703-709.
---------------------------------------------------------------------------

    The 2023 risk profile identified 32 Salmonella serotypes of concern 
linked to foodborne Salmonella outbreaks from chicken and turkey 
products. These identified serotypes of concern informed all subsequent 
risk management questions, including whether exposure to a small number 
of these serotypes result in foodborne illness. Because the Salmonella 
serotypes of public health significance identified in the final product 
standards are among the 32 Salmonella serotypes of concern identified 
in the risk profile and risk assessments, it is reasonable to conclude 
that the serotypes of public health significance in the final product 
standards all cause illness at a relatively low dose.
3. Severity of Illnesses
    The 2023 risk profile found that exposure to the profile's 
Salmonella subtypes of concern, which include the final product 
standards serotypes of public health significance, can cause severe or 
debilitating human health outcomes. Although the symptoms of Salmonella 
infections are typically not reported to be as severe as some of those 
associated with STEC, Salmonella can cause bloody diarrhea, fever, 
abdominal cramps, nausea, and vomiting. In some instances, Salmonella 
enters the blood stream and makes its way to other areas of the body 
including, but not limited to, the heart, lung, bone, joints and the 
central nervous system.\92\ This can result in severe illness requiring 
hospitalizations and even death, especially in vulnerable populations, 
such as very young, elderly, and immunocompromised individuals. Even 
when Salmonella is no longer detectable in the body, prior Salmonella 
illness has also been associated with an increased risk in colon 
cancer.\93\ Also, the illness can cause debilitating, long-lasting 
conditions including inflammatory bowel disease, irritable bowel 
syndrome and reactive arthritis.
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    \92\ Batz, M.B., et al., Long-Term consequences of foodborne 
illness. Infect Dis Clin North Am, Sept 2013. 28(3) p. 599-661; 
Hohmann, E.L., Nontyphoidal Salmonellosis, Clin Infect Dis, Sept 
2001. 32 p. 263-269; Heymann, D. Salmonellosis. Control of 
Communicable Disease Manual, 2021.
    \93\ Mughini-Gras, L. et al. Increased colon cancer risk after 
severe Salmonella infection. PLoS ONE, 2018. 13(1): p. 1-19, https://doi.org/10.1371/journal.pone.0189721.

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[[Page 64699]]

    Furthermore, a study that allows for a comparison of case-fatality 
proportions of both Salmonella and STEC O157 demonstrates a higher 
frequency of deaths among Salmonella cases than among STEC O157 
cases.\94\ The estimated annual domestic foodborne illnesses reported 
in the study were 1,027,561 and 63,153 for Salmonella and STEC O157, 
respectively. Annual deaths from domestic foodborne illnesses are 378 
and 20 for Salmonella and STEC O157, respectively. Therefore, 
Salmonella deaths occur at a frequency of 4 per 10,000 illnesses, while 
STEC O157 deaths occur at a frequency of 3 per 10,000 illnesses.
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    \94\ Scallan, et al., 2011.
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4. Consumer Cooking Practices
    As noted above, until recently, with the publication of the 
proposed determination on Salmonella in NRTE breaded stuffed chicken 
products, FSIS historically has not taken the position that certain 
Salmonella levels or serotypes render raw poultry products adulterated 
as defined in the PPIA. This position was based in part on the fact 
that proper cooking kills pathogens on raw product. However, as 
discussed below, several consumer behavior research studies suggest 
that ordinary consumer cooking and preparation practices for chicken 
carcasses, chicken parts, comminuted chicken, and comminuted turkey do 
not provide adequate assurance that these products will not be 
contaminated when consumed.
    Consumer behavior research. FSIS recommends cooking poultry 
products until the center of the thickest part of the meat reaches a 
minimum internal temperature of 165 [deg]F measured by using a 
thermometer to eliminate the presence of Salmonella and other foodborne 
pathogens.\95\ However, although using a thermometer is the only 
reliable way to ensure that poultry is properly cooked, studies show 
that many consumers do not ordinarily use a thermometer to determine 
whether whole chicken, chicken parts, comminuted chicken, and 
comminuted turkey have reached an internal temperature sufficient to 
destroy Salmonella. Studies also show that many consumers that do use a 
thermometer do not always do so correctly.
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    \95\ FSIS Safe Minimum Internal Temperature Chart. 2020; 
Available at: https://www.fsis.usda.gov/food-safety/safe-food-handling-and-preparation/food-safety-basics/safe-temperature-chart.
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    In a study published in 2017, a web-enabled panel survey of U.S. 
adult grocery shoppers (n = 1,504) was conducted to describe consumers' 
handling and preparation practices for raw poultry.\96\ The purpose of 
the study was to characterize consumer food thermometer use and 
barriers to use. The study found that of the 62 percent of the survey 
respondents who reported owning a food thermometer, thermometer usage 
was highest among those cooking whole turkeys (73.2 percent). Fewer 
respondents reported using a thermometer when cooking whole chickens 
(56.7 percent), chicken breasts or other parts (26.3%), and meatloaf or 
a similar dish containing ground chicken or turkey (22.8 percent). 
Reported thermometer use was lowest among respondents cooking patties 
made with ground chicken or turkey (11.7 percent).
---------------------------------------------------------------------------

    \96\ KM Kosa, et al. (2017). Barriers to Using a Food 
Thermometer When Cooking Poultry at Home: Results from a National 
Survey. Food Protection Trends, 37/2, 116-125, available at: https://www.foodprotection.org/files/food-protection-trends/mar-apr-17-kosa.pdf.
---------------------------------------------------------------------------

    Participants who reported owning a food thermometer identified 
various reasons for not using a thermometer the last time they cooked 
poultry at home. For all cuts of poultry, the most common reason 
reported for not using a thermometer was use of another method to 
determine that the product was properly cooked (49.8 to 61.5 percent of 
respondents). The next most common reason selected was that the 
respondent never thought to use a thermometer (27 to 37.6 percent of 
respondents), which the researcher concluded suggests that these 
respondents do not consider it very important to use a food 
thermometer.
    Of the respondents that reported using another method instead of a 
food thermometer, most reported that they determined that poultry is 
properly cooked by using visual cues, i.e., color, juice clarity, and 
cleanliness of probing utensil. Of the 61.5 percent of the respondents 
that reported using another method to determine that a whole turkey or 
chicken is properly cooked, 42.2 percent cut the food to check that it 
was no longer pink, 42.2 percent relied on cooking time, and 41 percent 
checked that the juices ran clear. Of the 56.1 percent of the 
respondents that reported using another method to determine that 
chicken and turkey parts were properly cooked, 67.6 percent cut the 
food to check that it was no longer pink, 46.2 percent relied on 
cooking time and 40 percent checked that the juices ran clear. And of 
the 49 percent of the respondents that reported using another method to 
determine whether ground chicken or turkey was properly cooked, 61.5 
percent inserted a knife, toothpick, or other utensil to see if it came 
out clean, 55.4 percent relied on cooking time, and 21.0 percent cut 
the food to check that it was no longer pink.
    In an observational study published in 2016, 101 participants were 
observed as they prepared poultry and egg items to determine whether 
they followed food safety guidelines.\97\ The poultry items prepared 
for the study were a baked whole chicken breast and a pan-fried ground 
turkey patty. The study found that thermometer use for all products was 
low. Only 37 percent of participants used a thermometer to determine 
that a chicken breast was properly cooked, and only 22 percent used a 
thermometer to determine that a turkey patty was properly cooked. For 
the chicken breast, the most common method used to determine doneness 
was cutting into the chicken (50 percent), followed by color (33 
percent) and thermometer use (33 percent). For the turkey patty, the 
most common indicator used was color (39 percent), followed by cutting 
into it (30 percent), using a thermometer (22 percent), and looking at 
the juices (18 percent). The study also found that the participants who 
used a food thermometer often would use other methods, such as cutting 
into them or observing the juices, to determine if the poultry items 
were properly cooked.
---------------------------------------------------------------------------

    \97\ Maughan, et al. (2016). Food Handling Behaviors Observed in 
Consumers When Cooking Poultry and Eggs. Journal of Food Protection, 
79:6, 970-977, available at: https://www.sciencedirect.com/science/article/pii/S0362028X22080814?via%3Dihub.
---------------------------------------------------------------------------

    The study also highlighted the importance of correctly using a 
thermometer to determine that poultry is properly cooked. Of the study 
participants who used a thermometer, 36 percent did not use it 
correctly in the chicken breast, the turkey patty, or both. The study 
also found that there was no statistical difference between a 
participant who did and did not use a thermometer in achieving an end 
point temperature of at least 165 [deg]F in both the chicken breast and 
the turkey patty. Seventy-eight percent of participants that used a 
thermometer to cook the chicken breast reached a final internal 
temperature above 165 [deg]F, compared to 75 percent for those who did 
not use a thermometer. Seventy-seven percent of participants who used a 
thermometer to cook a turkey patty reached a final internal temperature 
of at least 165 [deg]F, compared to 66 percent of participants who did 
not use a thermometer.

[[Page 64700]]

    In another observational study published in 2014,\98\ 120 
volunteers were observed as they prepared chicken and salad in their 
homes. The study participants chose the manner of chicken preparation. 
Three volunteers prepared whole chicken, and all others prepared 
chicken parts. The study found that the most common method of 
determining whether the chicken was properly cooked was appearance. In 
response to a questionnaire administered after meal preparation, the 
study participants stated that to determine whether chicken was 
properly cooked, they looked for white colored meat, absence of blood 
or pink spots, and firm meat. The study found that 40 percent of the 
chicken that the participants considered to be properly cooked 
registered a temperature below 165 [deg]F.
---------------------------------------------------------------------------

    \98\ Bruhn, C.M. (2014). Chicken preparation in the home: An 
observational study. Food Protection Trends, 34(5):318-330. 
Available at: https://www.proquest.com/trade-journals/chicken-preparation-home-observational-study/docview/1640787777/se-2.
---------------------------------------------------------------------------

    In this study, fewer than 5 percent of the participants voluntarily 
used a thermometer to record chicken temperature during meal 
preparation. When asked by the researcher if they wanted to check the 
cooked chicken's temperature, 34 percent of the participants checked 
the internal temperature using either their own thermometer or the 
thermometer provided by the researcher. When chicken temperature was 
taken, the internal temperature of 60 percent of the cooked chicken 
registered 165 [deg]F or above. However, 39 percent of households 
stopped cooking even though the internal temperature of the poultry 
registered below 165 [deg]F.
    A 2020 study used a randomized experimental design and direct 
observation of meal preparation to test the effectiveness of a USDA 
food safety video intervention for consumer thermometer use.\99\ The 
study was conducted in test kitchen facilities in which cameras 
recorded participants' meal preparation from beginning to end. A total 
of 383 people participated in the study, 201 in the control group (the 
group that did not watch the food safety video) and 182 in the 
treatment group. Before preparing the meal, the treatment group watched 
a 3-minute USDA food safety video on the importance of using a food 
thermometer. Participants in the control and treatment groups were 
observed while cooking turkey burgers and preparing a salad to 
determine whether the participants used a thermometer to determine 
whether the turkey patties were properly cooked. Following meal 
preparation, all participants responded to a post observation interview 
about food handling behaviors.
---------------------------------------------------------------------------

    \99\ Duong M, Shumaker ET, Cates SC, Shelley L, Goodson L, 
Bernstein C, Lavallee A, Kirchner M, Goulter R, Jaykus LA, Chapman B 
(2020). An Observational Study of Thermometer Use by Consumers When 
Preparing Ground Turkey Patties. J Food Prot. 83(7):1167-1174. 
Available at: https://www.sciencedirect.com/science/article/pii/S0362028X2210339X.
---------------------------------------------------------------------------

    Sixty-one percent of the control group participants and 63 percent 
of the treatment group participants reported owning a food thermometer, 
which is consistent with the percentage of the respondents that 
reported owning a food thermometer in the 2017 study discussed above 
(62 percent). During the meal preparation session, the control group 
used a thermometer to determine whether the turkey patties were 
properly cooked 34 percent of the time, while the treatment group used 
a thermometer 75 percent of the time. The control participants were 
also less likely to insert the thermometer into the side of the patty 
(23 percent), the recommended practice, than the treatment participants 
(52 percent). Of the participants that used a thermometer and for whom 
temperature data were available, the turkey patties were observed to 
reach an internal temperature of 165 [deg]F 54 percent of the time for 
the control group and 73 percent of the time for the treatment group. 
Thus, while both the control and treatment groups were likely to own a 
food thermometer, the control group was much less likely to use a food 
thermometer, correctly place a thermometer, and cook patties to a safe 
internal temperature than the treatment group.
    The study also addressed whether the participants used methods 
other than a thermometer to determine whether the turkey patty was 
properly cooked. The study found that 45 percent of all participants 
used a method other than a thermometer to determine that the turkey 
patty was done cooking. Among participants who did not use the 
thermometer and for whom usable data were available, 46 percent of 
control group participants and 29 percent of the treatment group 
participants relied on the firmness or texture of the patty to 
determine that it was properly cooked, and 4 percent in the control 
group and 16 percent in the treatment group relied on patty color. 
Twenty-five percent of control group and 42 percent of treatment group 
were observed using both firmness and color of the patty.
    Thus, consumer research shows that, rather than using a thermometer 
to check the internal temperature of whole chicken, chicken parts, 
comminuted chicken products, and comminuted turkey products, many 
consumers ordinarily rely on visual and textural cues to determine that 
these products are properly cooked. However, because these subjective 
cues have not been correlated with safe internal cooking temperature, 
they are unreliable for gauging whether poultry products have reached 
an internal temperature sufficient to destroy Salmonella that may be 
present.\100\ As noted above, a 2014 observational study found that 40 
percent of the chicken that participants considered to be properly 
cooked based on subjective cues registered a temperature below 165 
[deg]F. The 2017 survey study discussed above also cited a published 
summary of food safety literature that concluded that 70 percent of 
chicken pieces visually judged by consumers as ``done'' had not reached 
a safe internal temperature.\101\ A European study that assessed the 
effect of household cooking methods on the presence and numbers of 
Salmonella Typhimurium in different types of raw poultry products found 
that improper cooking produced inadequate heat treatments that did not 
fully eliminate Salmonella from the products even when the initial 
contamination levels were as low as 10 cfu/g.\102\ Thus, based on its 
review of the available consumer research, FSIS has concluded that many 
consumers do not cook chicken carcasses, chicken parts, comminuted 
chicken, and comminuted turkey thoroughly and therefore, ordinary 
consumer cooking practices associated with these products fail to 
provide adequate assurance that the products will not be contaminated 
when consumed.
---------------------------------------------------------------------------

    \100\ M. Duong et. al (2020).
    \101\ Kosa, et al. (2017) citing CJ Byrd-Bredbenner et al. 
(2013.) Food safety in home kitchens: a synthesis of the literature. 
Int. J. Environ Res Publ Hlth 10:4060-4085.
    \102\ Roccato A, Uyttendaele M, Cibin V, Barrucci F, Cappa V, 
Zavagnin P, Longo A, Ricci A (2015). Survival of Salmonella 
Typhimurium in poultry-based meat preparations during grilling, 
frying and baking. Int J Food Microbiol 197:1-8. Available at: 
https://www.sciencedirect.com/science/article/pii/S0168160514006011?via%3Dihub.
---------------------------------------------------------------------------

    Cross-Contamination. In addition to consumer behavior research that 
found that many consumers ordinarily rely on visual and textural cues 
to determine that raw chicken and turkey products are properly cooked, 
recent studies also found that there are other ordinary consumer 
practices that create conditions for Salmonella exposure from raw 
poultry regardless of whether the products are properly cooked. 
Consumer hand washing practices are

[[Page 64701]]

one example of this cross-contamination concern.
    A 2015 observational study of consumers handling raw poultry as 
part of an at-home meal preparation event found that hands were washed 
12 percent of the time after handling raw poultry.\103\ Of note, 100 
percent of the same study group responded on a pre-observation 
questionnaire that they washed their hands before and after handling 
raw poultry. Further, a 2016 observational study found that, during the 
preparation and cooking process, 40 percent of participants correctly 
washed their hands after handling raw whole chicken carcasses, and 46 
percent correctly washed their hands after handling the raw ground 
turkey product.\104\
---------------------------------------------------------------------------

    \103\ E Mazengia, et al. (2015). Direct Observational Study of 
the Risk of Cross-Contamination during Raw Poultry Handling: 
Practices in Private Homes. Food Protection Trends, 35/1, 8-23. 
Available at: https://www.foodprotection.org/files/food-protection-trends/JAN-FEB-15-mazengia.pdf.
    \104\ Maughan, et al. (2016). Food Handling Behaviors Observed 
in Consumers When Cooking Poultry and Eggs. Journal of Food 
Protection, 79/6, 970-977. Available at: https://www.sciencedirect.com/science/article/pii/S0362028X22080814?via%3Dihub. For the purposes of the study, proper 
hand washing was defined as washing hands with soap for a minimum of 
20 seconds immediately after touching the raw product and without 
touching anything else.
---------------------------------------------------------------------------

    Research shows that washing poultry can spread bacteria to kitchen 
surfaces and other foods.\105\ Studies also show that washing or 
rinsing raw poultry is a pervasive consumer preparation practice that 
raises cross-contamination concerns. For example, a 2019 survey of food 
handling practices indicated that a lack of adherence to the 
recommended practice to not wash or rinse raw poultry may have 
widespread impact on two age groups more susceptible to contracting 
foodborne illness--young children and older adults.\106\ The Web-based 
survey found that only 39 percent of parents of young children (aged 5 
years or younger) and only 31 percent of older adults (aged 60 years or 
older) reported not rinsing or washing raw poultry. Further, in a 2014 
study on observed consumer handling behavior, 120 participants were 
asked to prepare in their home kitchen a chicken product and a salad. 
Before the observation, the participants were asked to select and 
purchase the ingredients, including a raw chicken carcass or part. The 
study found that 45 percent of the participants washed the raw chicken 
at the start of preparation.\107\
---------------------------------------------------------------------------

    \105\ Food Safety Consumer Research Project: Meal Preparation 
Experiment Related to Poultry Washing Final Report (August 20, 
2019). Available at: https://www.fsis.usda.gov/sites/default/files/media_file/2021-02/FSCRP_Year%2B2_Final_Aug2019.pdf.
    \106\ Kosa, KM, et al. (2019). Older Adults and Parents of Young 
Children Have Different Handling Practices for Raw Poultry. Journal 
of Food Protection, 82(2), 200-206, available at: https://pubmed.ncbi.nlm.nih.gov/30673351/.
    \107\ Bruhn, C.M. (2014). Chicken Preparation in the Home: An 
Observational Study. Food Protection Trends, 34/5, 318-330, 
available at: https://www.proquest.com/trade-journals/chicken-preparation-home-observational-study/docview/1640787777/se-2.
---------------------------------------------------------------------------

    Additional research indicates that food handling education on the 
recommendation to not wash or rinse raw poultry may have limited impact 
on consumer behavior. In 2016, a four-week intervention survey study 
exposed participants to an educational pilot program developed to raise 
awareness and influence consumers to not wash raw poultry.\108\ The 
results indicated that, while the program improved both knowledge and 
behavior of participants toward not washing raw poultry, the majority 
of consumers that viewed and understood the material still reported 
washing or rinsing raw poultry after the intervention program 
concluded.\109\ These studies indicate that cross-contamination events 
are common during poultry handling in home kitchens, and that 
consumers' knowledge of proper food handling is often not correlated to 
safe handling behaviors.
---------------------------------------------------------------------------

    \108\ Henley, S., et al. (2016). Don't Wash Your Chicken!: A 
Food Safety Education Campaign to Address a Common Food Mishandling 
Practice. Food Protection Trends, 36/1, 43-53, available at: https://www.foodprotection.org/files/food-protection-trends/jan-feb-16-henley.pdf.
    \109\ Twenty-five percent of consumers in the intervention group 
reported not washing whole raw poultry, compared to 20.1 percent of 
consumers in the control group. Sixteen-point-three percent of 
consumers in the intervention group reported not washing small cuts 
of raw poultry, compared to 9.8 percent of consumers in the control 
group.
---------------------------------------------------------------------------

E. Risk per Serving, Salmonella Levels, and Proposed Determination

1. Final Product Standards Salmonella Level and Risk per Serving
    Salmonella contamination and levels. The 2023 risk assessments 
include analyses of FSIS testing of chicken and turkey products that 
show that the proportion of raw chicken carcasses, chicken parts, 
comminuted chicken and comminuted turkey products contaminated with 
Salmonella is very low and that the levels are very low for 
contaminated products (Table 3).

                   Table 3--Estimated Amount of Test Positive Samples per Salmonella Threshold
----------------------------------------------------------------------------------------------------------------
                                                      Chicken      Chicken parts    Comminuted      Comminuted
                                                   carcasses (%)        (%)         chicken (%)     turkey (%)
----------------------------------------------------------------------------------------------------------------
Tests Salmonella Negative.......................           96.92           93.31           72.90           84.26
Tests Salmonella Positive.......................            3.08            6.69           27.10           15.74
    >=1 cfu/mL or /g............................               9               2              11              12
    >=10 cfu/mL or /g...........................               1            0.07               3               4
    >=100 cfu/mL or /g..........................            0.10           <0.01               1               1
----------------------------------------------------------------------------------------------------------------

    Approximately 97 percent of chicken carcasses and 93 percent of 
chicken parts test negative for Salmonella (i.e., results are below the 
0.03 cfu/mL limit of detection (LOD)). Approximately 73 percent of 
comminuted chicken and 84 percent of comminuted turkey test results are 
below the 0.003 cfu/g LOD. Of the 3 percent of chicken carcasses that 
test positive for Salmonella at the end of production, only 1 percent 
have Salmonella levels at or above 10 cfu/mL, and 0.10 percent have 
Salmonella levels at or above 100 cfu/mL. Of the chicken parts that 
test positive for Salmonella, only 0.07 percent have levels at or above 
10 cfu/mL, and less than 0.01 percent were found to have levels at or 
above 100 cfu/mL. Of the 27 percent of comminuted chicken products that 
test positive for Salmonella, only 3 percent have levels at or above 10 
cfu/g, and 1 percent have levels at or above 100 cfu/g. Finally, of the 
16 percent of comminuted turkey products that test positive for 
Salmonella, only 4 percent have levels at or above 10 cfu/g, and 1 
percent have levels at or above 100 cfu/g. Thus, given that the 
majority of chicken carcasses, chicken parts, comminuted chicken, and 
comminuted turkey have Salmonella at levels below 0.03 cfu/

[[Page 64702]]

mL(g), FSIS testing data shows that Salmonella levels at or above 10 
cfu/mL(g) represent comparatively higher levels of contamination that 
are infrequently identified in these raw poultry products.
    Risk per Serving. The risk assessments also quantify and compare 
the probability of illness associated with chicken carcasses, chicken 
parts, comminuted chicken, and comminuted turkey contaminated with 
Salmonella levels at or above 10 cfu/mL(g) with the average level of 
contamination for these raw products. The risk assessments used two 
dose-response models to provide a description of risk of illness per 
serving for Salmonella from chicken carcasses, chicken parts, 
comminuted chicken, and comminuted turkey products, when combined with 
an attenuation distribution. This attenuation distribution describes 
the variety of activities that occur between FSIS sampling a final 
product lot and a consumer ingesting a serving from that lot. These 
activities include product mixing, transportation, and cooking--all of 
which can result in both Salmonella growth and die off.
    A summary of probability of illness per serving for the main 
scenarios that were considered in the risk assessments is provided in 
Table 4. The average Salmonella level for product lots that test at or 
above each threshold level are provided, along with the average dose 
consumed, i.e., the level after attenuation, and likelihood that 
consumers are exposed to such servings.
    The model-derived baseline probability of illness for chicken 
carcasses is 0.2 illnesses per 100,000 servings, for chicken parts is 
0.3 illnesses per 100,000 servings, and 2.5 illnesses per 100,000 
servings for comminuted chicken, and 2.5 illnesses per 100,000 servings 
for comminuted turkey. Comparison of the threshold probability of 
illness to the baseline quantifies how much higher than average the 
risk per serving is for each scenario.
    Table 4--Average characteristics (level, dose, and probability of 
illness by serocluster) of failing lots for Salmonella threshold level 
scenarios in FSIS-sampled products under consideration and the overall 
likelihood of consumer exposure. The serotypes of public health 
significance (Enteritidis, Typhimurium, and I 4,[5],12:i:- for chicken 
products and Hadar, Typhimurium and Muenchen for Comminuted turkey) are 
among the higher virulence Serotype Cluster

                            Salmonella Threshold Level Scenarios Under Consideration
                                                  [cfu/mL or g]
----------------------------------------------------------------------------------------------------------------
         Measurement             Product type       0.003        0.033          1            10          100
----------------------------------------------------------------------------------------------------------------
Average level for failing      Chicken                  0.48         1.65           16           97          682
 lots (cfu/mL(g)).              Carcasses.
                               Chicken Parts...         0.08         0.30            4           33          281
                               Comminuted                 17           37          163          582        2,572
                                Chicken.
                               Comminuted                163          348        1,373        4,249       15,479
                                Turkey.
Average dose consumed for      Chicken                  0.08         0.26            3           15          108
 average failing lot (cfu/      Carcasses.
 serving).
                               Chicken Parts...         0.01         0.05         0.67            5           45
                               Comminuted                  3            6           26           92          408
                                Chicken.
                               Comminuted                 26           55          218          673        2,453
                                Turkey.
Probability of illness per     Chicken                    23           54          224          612        1,598
 100,000 servings *, high       Carcasses.
 virulence.
                               Chicken Parts...            6           16          100          340        1,050
                               Comminuted                235          363          800        1,486        2,849
                                Chicken.
                               Comminuted                801        1,166        2,184        3,490        5,660
                                Turkey.
OR
Probability of illness per     Chicken                     4            9           42          119          329
 100,000 servings *, low        Carcasses.
 virulence.
                               Chicken Parts...            1            3           18           64          211
                               Comminuted                 44           69          158          305          611
                                Chicken.
                               Comminuted                158          235          460          761        1,287
                                Turkey.
Likelihood of consumer         Chicken                   11%           3%        0.27%        0.03%       <0.01%
 exposure to raw product at     Carcasses.
 or above initial level.
                               Chicken Parts...          31%           7%        0.17%       <0.01%       <0.01%
                               Comminuted                27%          13%           3%        0.79%        0.17%
                                Chicken.
                               Comminuted                16%           7%           2%        0.60%        0.16%
                                Turkey.
----------------------------------------------------------------------------------------------------------------
* Given average initial level multiplied by attenuation distribution.

    As illustrated in Table 4, the risk assessments found that the 
probability of illness for servings of raw chicken carcasses that are 
contaminated with Salmonella levels at or above 10 cfu/mL and contain a 
serotype of public health significance is 612 illnesses per 100,000 
servings of raw chicken carcasses, while the average probability of 
illness is 0.3 illnesses per 100,000 servings; the great majority of 
which have levels far below 10 cfu/mL. Therefore, servings from 
production lots of raw chicken carcasses that test positive for 
Salmonella at levels of 10 cfu/mL or greater with a serotype of public 
health significance are 2,000-fold (i.e., ~ 612/0.3) more likely to 
cause illness than the average across all chicken carcass servings. 
Thus, while there is a relatively low probability that individuals will 
be exposed to carcasses that contain Salmonella at 10 cfu/mL, if 
exposed, there is a much higher probability of illness, i.e., 2,000-
fold, when compared to exposure to the majority of servings from 
chicken carcasses.
    For raw chicken parts, the risk assessment found that chicken parts 
servings that are contaminated with Salmonella levels at or above 10 
cfu/mL at the end of production and contain a serotype of public health 
significance have a probability of illness of 340 illnesses per 100,000 
servings, while the average probability of illness is 0.3 per 100,000 
servings for all servings; the great majority of which have levels

[[Page 64703]]

much below 10 cfu/mL. Therefore, servings from production lots of raw 
chicken parts that test positive for Salmonella at levels at or above 
10 cfu/mL with a serotype of public health significance are 1,100-fold 
(i.e., ~340/0.3) more likely to cause illness than the average across 
all chicken parts servings. Thus, while there is a relatively low 
probability that consumers will be exposed to chicken parts that 
contain Salmonella at 10 cfu/mL, if exposed, there is a much higher 
probability of illness, i.e., 1,100-fold, when compared to exposure to 
the majority of servings from raw chicken parts.
    For raw comminuted chicken servings, the risk assessments found 
that products that are contaminated with at least 10 cfu/g of 
Salmonella at the end of production and contain a serotype of public 
health significance have a 1,500 per 100,000 servings probability of 
illness, while average probability of illness is 2.5 per 100,000 
servings for all servings; the majority of which have levels below 10 
cfu/g. Therefore, servings from production lots of comminuted chicken 
that test positive for Salmonella at or above 10 cfu/g with a serotype 
of public health significance are 590-fold (i.e., ~1,500/2.5) more 
likely to cause illness than the average across all comminuted chicken 
servings. Thus, while there is a relatively low probably that consumers 
will be exposed to comminuted chicken that contains Salmonella at 10 
cfu/g, if exposed, there is a much higher probability of illness, i.e., 
590-fold, when compared to the majority of servings of comminuted 
chicken.
    For raw comminuted turkey servings, the risk assessments found that 
products that are contaminated with at least 10 cfu/g of Salmonella at 
the end of production and contain a serotype of public health 
significance have a 3,500 per 100,000 servings probability of illness, 
while the average probability of illness is 2.5 per 100,000 servings 
across all servings; the majority of which have levels below 10 cfu/g. 
Therefore, servings from production lots of comminuted turkey that test 
positive for Salmonella at or above 10 cfu/g with a serotype of public 
health significance are 1,400-fold (i.e., ~3,500/2.5) more likely to 
cause illness than the average across all comminuted turkey servings. 
Thus, while there is a relatively low probability that consumers will 
be exposed to comminuted turkey that contains Salmonella at 10 cfu/g, 
if exposed, there is a much higher probability of illness, i.e., 1,400-
fold, when compared to the majority of servings of comminuted turkey.
    Illnesses prevented. The risk assessments also predicted the total 
number of illnesses prevented annually for chicken carcasses, parts, 
and comminuted chicken and turkey for different Salmonella threshold 
levels--0.03 cfu/ml(g), 1 cfu/mL(g), 10 cfu/mL(g), and 100 cfu/mL(g) 
(Table 5). Uncertainty analyses were also run for the main scenarios 
under consideration. A threshold set at the Salmonella detection level 
for comminuted chicken and turkey (0.003 cfu/g) was not as effective as 
the higher threshold levels in Table 5 below. Therefore, an analysis 
evaluating the uncertainty around the predicted public health impact 
for a threshold of 0.003 cfu/g Salmonella in comminuted poultry was not 
evaluated in the risk assessments.
    The resulting overlapping 95 percent credible intervals around the 
estimated number of illnesses prevented suggest that there is little 
meaningful difference in effectiveness between the threshold standards 
with respect to annual illnesses prevented. However, as discussed 
above, when compared with the majority of servings, chicken carcasses, 
chicken parts, comminuted chicken, and comminuted turkey that contain 
Salmonella at 10 cfu/mL(g) or higher present a much higher probability 
of illness. Thus, based on the elevated probability of illness 
associated with raw chicken carcasses, chicken parts, comminuted 
chicken, and comminuted turkey associated with Salmonella levels at or 
above 10 cfu/mL(g), FSIS is proposing 10 cfu/mL(g) as the Salmonella 
level for the proposed final product standards.

                                Table 5--Annual Illnesses Prevented, Most Likely
                                             [95% Credible Interval]
----------------------------------------------------------------------------------------------------------------
                                        Chicken                                 Comminuted         Comminuted
         Threshold level               carcasses          Chicken parts          chicken             turkey
----------------------------------------------------------------------------------------------------------------
0.03 cfu/mL(g)...................  4600 (2000, 7100)    7900 (3300, 12700)   1500 (800, 2200)   2500 (700, 4900)
1 cfu/mL(g)......................   2400 (700, 5000)      1400 (400, 3600)   1400 (600, 2100)   2300 (600, 4800)
10 cfu/mL(g).....................   1000 (200, 3100)         200 (40, 700)   1000 (400, 1900)   2000 (500, 4300)
100 cfu/mL(g)....................      200 (0, 1500)           20 (0, 100)    600 (200, 1500)   1400 (200, 3500)
----------------------------------------------------------------------------------------------------------------

2. Proposed Determination
    After careful consideration of the information presented above, 
FSIS has concluded that raw chicken carcasses, chicken parts, 
comminuted chicken, and comminuted turkey contaminated with Salmonella 
at or above 10 cfu/mL(g) and a serotype of public health significance 
present an unacceptable risk of illness based on their risk per 
serving. As discussed above, the 2023 risk assessments for chicken 
found that production lots of raw chicken carcasses and raw chicken 
parts contaminated with these Salmonella levels and serotypes are at 
least 1,000 times more likely than average to cause illness across all 
chicken parts and carcass servings, and that servings from production 
lots of comminuted chicken and turkey contaminated with Salmonella at 
these levels and serotypes are at least 590 times more likely than 
average to cause illness across all comminuted chicken and turkey 
servings.
    Additionally, Salmonella has been associated with severe and 
debilitating human illness and available data suggest that the 
Salmonella infectious dose for the serotypes of public health concern 
is relatively low. Information from consumer behavior research shows 
that, rather than using a food thermometer to check the internal 
temperature of whole chicken, chicken parts, comminuted chicken 
products, and comminuted turkey products, many consumers ordinarily 
rely on visual and textural cues to determine that these products are 
properly cooked. Consumer research also shows that chicken that 
consumers considered to be properly cooked based on these subjective 
cues often had not reached an internal temperature sufficient to 
destroy Salmonella that may be present, and one study found that for 
certain poultry products, that application of inadequate heat 
treatments from improper cooking was unable to assure complete 
elimination of Salmonella even with a low initial contamination level 
of 10 cfu/g. Information from consumer behavior research also shows

[[Page 64704]]

that ordinary consumer handling associated with chicken carcasses, 
chicken parts, comminuted chicken, and comminuted turkey creates 
conditions for Salmonella exposure from raw poultry through cross 
contamination.
    Thus, because Salmonella can survive what many consumers consider 
to be ordinary cooking and handling practices for chicken carcasses, 
chicken parts, comminuted chicken, and comminuted turkey, and because 
the 2023 risk assessments found that servings of these products that 
test positive for Salmonella at levels at or above 10 cfu/mL(g) and a 
serotype of public health significance are much more likely to cause 
illness when compared to the majority of chicken carcasses, chicken 
parts, comminuted chicken, and comminuted turkey servings, FSIS has 
tentatively determined that, when contaminated with Salmonella at these 
levels and serotypes, these products are adulterated as defined in the 
PPIA. Specifically, FSIS has tentatively concluded that these products 
are adulterated as defined in 21 U.S.C. 453(g)(1) because their 
elevated risk of illness renders them ``injurious to health.'' FSIS has 
also tentatively concluded that they are adulterated as defined in 21 
U.S.C. 453(g)(3) because their elevated risk of illness makes them 
``unsound, unhealthful, unwholesome, or otherwise unfit for human 
food.''
    The adulteration definition in 21 U.S.C. 453(g)(1) includes two 
separate standards for determining whether a product is adulterated. 
Under 21 U.S.C. 453(g)(1), if a substance is an ``added substance'' the 
product is adulterated if the substance ``may render'' the product 
injurious to health. If the substance is not added, the product is 
adulterated ``if the quantity of such substance in or on'' the product 
``ordinarily'' renders it injurious to health.
    As noted above, in response to the draft October 2022 Salmonella 
Framework, FSIS received comments on whether Salmonella should be 
considered as an ``added substance'' in raw poultry. Comments from 
consumer advocacy organizations asserted that Salmonella should be 
considered as an ``added substance'' because it is not normally present 
in the muscle tissue of healthy birds. The comments stated that while 
Salmonella is present in the gastrointestinal tract of live birds, it 
is an ``added substance'' in poultry products because it only makes its 
way onto to poultry muscle tissue through contamination that occurs 
during slaughter and processing, specifically during defeathering and 
evisceration. To support this position, the commenters referenced case 
law that provides that where some portion of toxic substance present in 
a food has been introduced by human intervention, the entirety of that 
substance present in the food will be treated as an ``added 
substance''.\110\
---------------------------------------------------------------------------

    \110\ See United States v. Anderson Seafoods, Inc., 622 F.2d 157 
(5th Cir. 1980); Continental Seafoods, Inc. v. Schweiker, 674 F.2d 
38 (D.C. Cir. 1982).
---------------------------------------------------------------------------

    Comments from trade associations representing the meat and poultry 
industries asserted that Salmonella is not an ``added substance'' 
because it exists naturally in and on the live birds. The comments 
stated that Salmonella can exist in a chicken's skin, muscle tissue, 
and gut. A trade association representing the chicken industry cited 
references that, according to the comment, show that researchers have 
identified Salmonella in chicken neck skin, on the outer layer of skin, 
on feather follicles, connective tissue, and in drumstick muscle. The 
commenter also stated that literature shows correlations between 
Salmonella loads on the farm and in birds and at various processing 
steps, reinforcing that Salmonella enters the process via the chickens 
themselves. A comment from a trade association representing the meat 
and poultry industry stated that Salmonella can exist on the exterior 
of the animal, harbor in feather follicles, and travel from the 
gastrointestinal tract of poultry to the bloodstream, theoretically 
providing a pathway for Salmonella to be distributed throughout the 
bird.
    In addition, the comments stated that the case law provides that to 
be ``added,'' a substance must not otherwise be present in the food and 
must be artificially introduced by a person.\111\ According to the 
chicken industry trade association, the fact that Salmonella may be 
present in greater expected concentrations in some parts of a chicken 
than others does not make it an ``added substance'' in poultry muscle 
because, as with any microbe, naturally-occurring Salmonella can be 
spread through cross-contact during processing.
---------------------------------------------------------------------------

    \111\ These commenters cite United States v. Coca Cola, 241 U.S. 
265 (1915) and United States v. Anderson Seafoods, Inc. 622 F.2d 
157, 160 (5th Cir. 1980).
---------------------------------------------------------------------------

    FSIS had traditionally viewed Salmonella as ``naturally occurring'' 
in food animals.\112\ FSIS has previously rejected broad requests for 
it to declare that Salmonella is considered an ``added substance'' in 
all products,\113\ however, FSIS has not previously determined whether 
certain circumstances, considering what current scientific data 
indicates about Salmonella's spread to or within products, may render 
Salmonella an ``added substance'' in the raw products covered by this 
proposed framework. Before taking a position on whether there are any 
circumstances in which Salmonella can be considered an ``added 
substance'' in raw chicken carcasses, chicken parts, comminuted 
chicken, and comminuted turkey, FSIS has decided to request additional 
comments on both the legal and factual aspects of this issue.
---------------------------------------------------------------------------

    \112\ See FSIS Final Response to Marler Clark LLP petition # 20-
01 ``Petition for an Interpretive Rule Declaring `Outbreak' 
Serotypes of Salmonella enteritica subspecies to be Adulterants'' 
Available at: https://www.fsis.usda.gov/policy/petitions/petition-interpretive-rule-related-certain-Salmonella-serotypes.
    \113\ See FSIS Final Response to Marler Clark petition.
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    As noted above, under 21 U.S.C. 453(g)(1), there are two 
definitions for adulteration, depending on whether a substance in a 
poultry product is ``added'' or ``not added.'' However, the PPIA does 
not define the circumstances in which a substance in a poultry product 
is ``added'' within the meaning of the statute. Prior court decisions 
that address whether Salmonella is an adulterant in raw meat or poultry 
products have never directly considered whether and under what 
circumstances Salmonella may be considered an ``added substance'' under 
the PPIA.\114\
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    \114\ See American Public Health Association (APHA) v. Butz, 511 
F. 2d 331 (D.C. Cir. 1974); Continental Seafoods, Inc. v. Schweiker, 
674 F.2d 38 (D.C. Cir. 1982); Supreme Beef Processors, Inc. v. USDA, 
275 F.3d 432 (5th Cir. 2001).
---------------------------------------------------------------------------

    As noted above, some of the comments on the October 2022 draft 
Salmonella Framework asserted that Salmonella should be considered as 
an ``added substance'' in raw poultry based on the holding in U.S. v. 
Anderson Seafoods. The Anderson Seafoods case involved toxic levels of 
mercury in swordfish. The issue before the court was whether all 
mercury found in the swordfish should be considered as an ``added 
substance'' under the adulteration provisions of the FFDCA \115\ when 
some mercury in swordfish occurs naturally and some is the result of 
man-made pollution. The court held that ``where some portion of a toxin 
present in a food has been introduced by man, the entirety of that 
substance present in the food will be

[[Page 64705]]

treated as an added substance'' as defined in the statute.\116\ Based 
on this holding, some comments asserted that Salmonella should be 
considered as an ``added substance'' in raw poultry because poultry 
muscle does not normally contain Salmonella, and Salmonella only makes 
its way onto to poultry muscle tissue through contamination that occurs 
during slaughter and processing.
---------------------------------------------------------------------------

    \115\ The adulteration definition in the FFDCA at issue in 
Anderson Seafoods is, in relevant parts, identical to the definition 
in the PPIA and provides that ``A food shall be deemed to be 
adulterated (a)(1) if it bears or contains any poisonous or 
deleterious substance which may render it injurious to health; but 
in case the substance is not an added substance such food shall not 
be considered adulterated under this clause if the quantity of such 
substance in such food does not ordinarily render it injurious to 
health''(21 U.S.C. s 342(a)(1)).
    \116\ Anderson Seafoods, 622 F.2d at 161.
---------------------------------------------------------------------------

    As noted by the comments, Salmonella is present in the 
gastrointestinal tract of live birds, and there is evidence that 
extraintestinal Salmonella exist in poultry skin, livers, bones, and 
bone marrow before processing.\117\ Most Salmonella contamination on 
carcasses is believed to result from leakage of ingesta during crop 
removal and from feces during evisceration, as well as aerosolization 
during picking.\118\ \119\ After poultry carcasses are scalded, the 
carcasses travel through a series of defeathering machines where their 
feathers are removed using mechanical pickers with rubber ``fingers.'' 
During the picking process, these rubber fingers not only can massage 
Salmonella-contaminated water remaining from the scalder into the 
carcass but can also inadvertently press on the abdomen of the carcass, 
pushing out fecal matter and ingesta, resulting in transfer of 
Salmonella to the carcass skin or to the machinery.\120\ The 2023 risk 
profile identified studies that show that Salmonella can persist on 
processing equipment after cleaning and sanitation,\121\ which 
increases the potential for cross-contamination.
---------------------------------------------------------------------------

    \117\ Rimet, C.S., et al. (2019). Salmonella Harborage Sites in 
Infected Poultry That May Contribute to Contamination of Ground 
Meat. Frontiers in Sustainable Food Systems 3(2). see also Jones-
Ibarra, A.M., et al. (2019). Salmonella recovery from chicken bone 
marrow and cecal counts differ by pathogen challenge method. Poult 
Sci 98(9): 4104-4112. see also Cox, N.A., et al. (2007). Recovery of 
Campylobacter and Salmonella Serovars from the Spleen, Liver and 
Gallbladder, and Ceca of Six-and Eight-Week-Old Commercial Broilers. 
Journal of Applied Poultry Research 16(4): 477-480.
    \118\ National Advisory Committee on Microbiological Criteria 
for Foods. (2019). Response to Questions Posed by the Food Safety 
and Inspection Service Regarding Salmonella Control Strategies in 
Poultry. J Food Prot. 82(4):645-668.
    \119\ Singh M and Thippareddi H (2020). Managing Microbiological 
Food Safety Risks in Poultry Processing. White Paper for 3M Food 
Safety at: https://berstlerllc.com/wp-content/uploads/2023/03/3M-Food-Safety-Poultry-Segment-Whitepaper.pdf.
    \120\ Singh 2020.
    \121\ Obe, T., et al., Prevalence of Salmonella Enterica on 
Poultry Processing Equipment after Completion of Sanitization 
Procedures. Poultry Science, 2020. 99(9): p. 4539-4548. Veluz, G.A., 
S. Pitchiah, and C.Z. Alvarado, Attachment of Salmonella Serovars 
and Listeria Monocytogenes to Stainless Steel and Plastic Conveyor 
Belts. Poultry Science, 2012. 91(8): p. 2004-2010. Rothrock, M.J., 
Jr., et al., The Characterization of Salmonella Enterica Serotypes 
Isolated from the Scalder Tank Water of a Commercial Poultry 
Processing Plant: Recovery of a Multidrug-Resistant Heidelberg 
Strain. Poultry Science, 2015. 94(3): p. 467-472. Bailey, J.S., et 
al., Sources and Movement of Salmonella through Integrated Poultry 
Operations: A Multistate Epidemiological Investigation. Journal of 
Food Protection, 2001. 64(11): p. 1690-7.
---------------------------------------------------------------------------

    Another step in the process in which Salmonella may be spread to or 
increased in poultry carcasses is evisceration. During evisceration, 
Salmonella that is present in the gastrointestinal tract may be 
transferred to the skin and other carcass surfaces due to rupture of 
the viscera when the carcass is opened.\122\ Additionally, the 2023 
risk profile found that although used as a control step, immersion 
chilling may be an opportunity for cross-contamination of broiler 
carcasses. For example, in one study, a lower incidence of Salmonella 
in air-chilled broilers compared to immersion-chilled broilers (18.7 
percent to 24.7 percent positive carcasses) suggests that cross-
contamination may be more prevalent for immersion-chilled 
broilers.\123\
---------------------------------------------------------------------------

    \122\ Singh (2020); National Advisory Committee on 
Microbiological Criteria for Foods. (2019). Response to Questions 
Posed by the Food Safety and Inspection Service Regarding Salmonella 
Control Strategies in Poultry. J Food Prot. 82(4):645-668.
    \123\ Smith, D.P., J.A. Cason, and M.E. Berrang, Effect of Fecal 
Contamination and Cross Contamination on Numbers of Coliform, 
Escherichia coli, Campylobacter, and Salmonella on Immersion-Chilled 
Broiler Carcasses. Journal of Food Protection, 2005. 68(7): p. 1340-
1345.
---------------------------------------------------------------------------

    In addition to processes that can contribute to Salmonella 
contamination on poultry carcasses during slaughter and processing, 
further processing of carcasses into other commodities may also add 
Salmonella to or increase Salmonella in finished poultry parts, such as 
wings, breasts, and thighs. FSIS sampling data show that further 
processed chicken parts have a higher incidence of Salmonella compared 
to carcasses.\124\ This difference is likely because of cross 
contamination between positive and negative parts and carcasses during 
further processing.\125\ \126\ Further processing presents various 
opportunities in which Salmonella that is present in certain parts of 
the bird may be added to interior edible muscle where Salmonella is not 
ordinarily found. For example, Salmonella can be found in feather 
follicles in the skin.\127\ \128\ When the skin is cut, Salmonella can 
be exposed and spread during processing to previously uncontaminated 
product and/or increased in product with low levels of 
contamination.\129\ In addition, Salmonella-negative raw poultry parts 
and comminuted poultry may become cross-contaminated by contact with 
Salmonella-contaminated equipment or when they are commingled with 
Salmonella-positive products, such as when they are collected in combo 
bins for further processing.\130\ \131\
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    \124\ Sampling Results for FSIS-Regulated Products. Available 
at: https://www.fsis.usda.gov/science-data/sampling-program/sampling-results-fsis-regulated-products.
    \125\ FSIS Guidance for Controlling Salmonella in Poultry (June 
2021) p. 59. Available at: https://www.fsis.usda.gov/sites/default/files/media_file/2021-07/FSIS-GD-2021-0005.pdf.
    \126\ Codex Guideline for the Control of Campylobacter and 
Salmonella in Chicken Meat at: https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXG%2B78-2011%252FCXG_078e.pdf.
    \127\ Kim J-W and Slavik MF. 1996. Cetylpyridinium Chloride 
(CPC) treatment on poultry skin to reduce attached Salmonella. J. 
Food Prot. 59: 322-326.
    \128\ Wu D, Alali WQ, Harrison MA, and Hofacre CL. 2014. 
Prevalence of Salmonella in neck skin and bone of chickens. J Food 
Prot. 77(7): 1193-1197.
    \129\ FSIS Guidance for Controlling Salmonella in Poultry (June 
2021) pp. 59-60.
    \130\ FSIS Guidance for Controlling Salmonella in Poultry (June 
2021) pp. 59.
    \131\ Codex Guideline for the Control of Campylobacter and 
Salmonella in Chicken Meat.
---------------------------------------------------------------------------

    Comminuted products are those that are ground, mechanically 
separated, or hand- or mechanically deboned and further chopped, 
flaked, minced, or otherwise processed to reduce particle size. Because 
of the nature of comminuted processes, Salmonella contamination in 
chicken skin and bone can spread throughout an entire batch or lot 
through cross-contamination. FSIS sampling data show that ground and 
other raw comminuted chicken products that were produced using either 
bone-in or skin-on source materials were more likely to be contaminated 
with Salmonella than those fabricated from deboned, skinless source 
materials.\132\ Salmonella-contaminated equipment used to produce 
comminuted poultry may also contribute to Salmonella contamination in 
these products.
---------------------------------------------------------------------------

    \132\ FSIS Guidance for Controlling Salmonella in Poultry (June 
2021) pp. 65-66, Table 4 FSIS exploratory sampling test results, raw 
comminuted chicken by source material composition (6/1/13-6/30/15, 
2,688 samples.
---------------------------------------------------------------------------

    FSIS requests comments on whether the available science supports 
that some Salmonella in a raw poultry product is ``naturally 
occurring'' and some is ``added.'' FSIS also requests comments on 
whether, under the reasoning of Anderson Seafoods or another rationale, 
the Agency has authority to regulate Salmonella as an ``added 
substance'' if it can demonstrate that some Salmonella can be 
artificially

[[Page 64706]]

introduced into raw poultry products through processing procedures and 
other actions attributable to man.
    As discussed above, consumer behavior research shows that 
Salmonella can survive what many consumers consider to be ordinary 
cooking and handling practices for chicken carcasses, chicken parts, 
comminuted chicken, and comminuted turkey. In addition, the 2023 risk 
assessments, which modeled a broad distribution of consumer cooking 
behavior, found that servings of these products that test positive for 
Salmonella at levels at or above 10 cfu/mL(g) and a serotype of public 
health significance are much more likely to cause illness when compared 
to the majority of chicken carcasses, chicken parts, comminuted 
chicken, and comminuted turkey servings. Thus, regardless of whether 
Salmonella is considered as an ``added substance,'' FSIS tentatively 
determines through this proposal that raw chicken carcasses, chicken 
parts, comminuted chicken, and comminuted turkey that contain 
Salmonella levels at or above 10 cfu/mL(g) and a serotype of public 
health significance are adulterated under 21 U.S.C. 453(g)(1) because 
when contaminated with these levels and serotypes of Salmonella, the 
high likelihood that raw chicken carcasses, chicken parts, comminuted 
chicken, and comminuted turkey will result in illnesses when compared 
to the average serving of these products ``ordinarily'' renders them 
injurious to health. Additionally, through this proposal, FSIS 
tentatively determines that raw chicken carcasses, chicken parts, 
comminuted chicken, and comminuted turkey contaminated with Salmonella 
levels and serotypes in the proposed final product standards are 
adulterated as defined in 21 U.S.C. 453(g)(3) because their elevated 
risk of illness makes them ``unsound, unhealthful, unwholesome, or 
otherwise unfit for human food.'' This tentative determination does not 
depend on the status of Salmonella as an ``added substance.''
    FSIS requests comments on its proposed determination that, when 
contaminated with Salmonella at the levels and serotypes provided in 
the final products standards, chicken carcasses, chicken parts, 
comminuted chicken, and comminuted turkey are adulterated as defined in 
21 U.S.C. 453(g)(1) and (3) and whether there are alternative bases for 
determining adulteration for these poultry products.

F. Proposed Policy Implementation

1. HACCP Reassessment
    The HACCP system regulations require that every establishment 
reassess the adequacy of its HACCP plan at least annually and whenever 
any changes occur that could affect the underlying hazard analysis or 
alter the HACCP plan (9 CFR 417.4(a)(3)). If finalized, FSIS' proposed 
determination that chicken carcasses, chicken parts, comminuted chicken 
and comminuted turkey that contain Salmonella levels of 10 cfu/mL(g) or 
higher and any detectable levels of a serotype of public health 
significance are adulterated would be such a change. Thus, if FSIS 
finalizes this proposed determination, all establishments that produce 
chicken carcasses, chicken parts, comminuted chicken, and comminuted 
turkey as final products that will enter commerce would need to 
reassess their HACCP plans. Establishments that make changes to their 
production process because of their reassessment would also need to re-
validate their HACCP plans. FSIS would issue instructions to IPP in 
establishments that produce these final products to verify that these 
establishments have completed their reassessment before the effective 
date of any final determination resulting from this proposal.
2. Proposed Implementation and Status of Laboratory Methods
    Products subject to verification sampling. Should FSIS finalize 
these proposed standards, the Agency intends to conduct a routine 
sampling and verification testing program for Salmonella in chicken 
carcasses, chicken parts, comminuted chicken, and comminuted turkey in 
which the Agency would collect samples of raw final products and 
analyze them for Salmonella levels and serotypes to determine whether 
the final product is adulterated. FSIS would collect the verification 
samples after the establishment has completed all validated 
antimicrobial interventions. Under the proposed Salmonella verification 
testing program, FSIS intends to only collect and analyze samples of 
the final poultry products produced by an establishment, i.e., chicken 
carcasses to be shipped in commerce as whole chickens, chicken parts to 
be shipped in commerce as chicken parts, comminuted chicken to be 
shipped in commerce as comminuted chicken products, and comminuted 
turkey to be shipped in commerce as comminuted turkey products. Thus, 
under this proposal, if a chicken slaughter establishment uses 
carcasses processed in the establishment to produce other final 
products, such as chicken parts or comminuted chicken, FSIS would not 
collect whole carcass samples as part of the proposed verification 
sampling program. Likewise, chicken parts produced by an establishment 
that are intended for use in another final product produced by the 
establishment, such as comminuted chicken, would not be subject to FSIS 
verification sampling. FSIS also does not intend to collect samples of 
mechanically separated chicken or mechanically separated turkey under 
the proposed verification sampling program. However, final comminuted 
chicken and turkey products that contain mechanically separated chicken 
or turkey would be eligible for verification sampling.
    The final product samples collected under the proposed verification 
sampling plan would be determined on an establishment basis. Thus, all 
raw final products produced by an establishment that are not intended 
to be further processed into a RTE product would be subject to 
verification sampling regardless of where the product is shipped. For 
example, FSIS would consider whole carcasses or parts to be final 
products subject to verification sampling if the establishment that 
produced the carcasses or parts ships them to another establishment for 
further processing into a raw parts or comminuted product. FSIS would 
not, however, collect verification samples from raw whole carcasses, 
parts, or comminuted products that are shipped to another establishment 
for cooking or to be further processed into a ready-to-eat product. If 
off-site interventions, such as high-pressure processing or 
irradiation, are applied to prevent or control Salmonella, FSIS would 
sample the product after the off-site intervention is applied.
    Additionally, should FSIS finalize these proposed final product 
standards, the Agency intends to conduct testing for Salmonella of 
imported raw chicken carcasses, chicken parts, comminuted chicken, and 
comminuted turkey products in accordance with FSIS' import reinspection 
procedures.\133\ Poultry imports represent a small fraction of the U.S. 
domestic poultry supply, accounting for less than 0.5

[[Page 64707]]

percent in 2021. Currently, FSIS samples and tests imported chicken 
carcasses, chicken parts, comminuted chicken, and comminuted turkey for 
the presence of Salmonella. According to data from PHIS, in 2021, FSIS 
collected and analyzed about 850 samples of imported chicken and turkey 
products, which represented about 15.8 million pounds of product. These 
samples were mainly from chicken parts and carcasses, as imports of 
comminuted chicken and turkey are relatively low. While data on the 
volume of imported product with results at or above 10 cfu/mL(g) are 
not available, FSIS estimates this would be a relatively low volume of 
product.
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    \133\ FSIS Directive 9900.2, Import Reinspection of Meat, 
Poultry and Egg Products (Rev. 2)(Oct 12 2021). Available at: 
https://www.fsis.usda.gov/policy/fsis-directives/9900.2.
    FSIS Directive 9900.6, Laboratory Sampling Program for Imported 
Meat, Poultry, and Egg Products (Nov 3, 2015). Available at: https://www.fsis.usda.gov/policy/fsis-directives/9900.6.
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    Sample analysis. The detection and isolation methodology for 
Salmonella is described in MLG chapter 4.14, of the FSIS Microbiology 
Laboratory Guidebook.\134\ Based on current FSIS methodologies, when 
sampling the chicken carcasses and parts under this proposed 
determination, FSIS would collect a rinsate sample from the 
establishment to analyze 30 mL per test for Salmonella. When sampling 
comminuted chicken or comminuted turkey, the Agency would collect 1 
pound of the product from the establishment to analyze 325 g per test 
for Salmonella. Samples would be initially screened, post-enrichment, 
for the presence or absence of Salmonella. Samples that screen negative 
would be reported as ``negative.'' For samples that screen positive, 
FSIS would use selective and differential culture-based media and 
proteomics testing to confirm. In parallel, all screen positives will 
be analyzed for levels and targeted rapid serotype screening. A sample 
is considered confirmed positive for Salmonella after completion of 
confirmatory tests. Any chicken carcass, chicken parts, comminuted 
chicken, or comminuted turkey final product sample ``confirmed 
positive'' with Salmonella levels of 10 cfu/mL(g) or higher and 
screened positive for a serotype of public health significance would 
not be allowed to enter commerce. Any chicken carcass, chicken parts, 
comminuted chicken, or comminuted turkey final product sample that 
contains Salmonella levels of 10 cfu/mL(g) or higher and a serotype of 
public health significance would be considered adulterated.
---------------------------------------------------------------------------

    \134\ FSIS Microbiology Laboratory Guidebook available at: 
https://www.fsis.usda.gov/news-events/publications/microbiology-laboratory-guidebook.
---------------------------------------------------------------------------

    Based on current testing methodologies, FSIS estimates that 
Salmonella screening results and quantification results would routinely 
be available 2 days after a sample is taken. For samples above the 
quantification threshold, an additional 3 days may be necessary for a 
confirmed positive or negative result. Currently, the routine procedure 
is to use WGS to determine Salmonella isolate sequence, serotypes, and 
antimicrobial resistance (AMR) profile, which require at least 14 days 
for result reporting. FSIS could use a non-routine molecular serotyping 
methodology to determine the serotype in a more time sensitive manner 
such that results would be available by Salmonella confirmation, 5 days 
after sample collection, if not sooner.
    FSIS is proposing the combined quantification and serotype final 
product standards recognizing current efforts underway by ARS and 
private sector laboratories to develop rapid, reliable, Salmonella 
quantification and serotyping technologies. FSIS is actively working to 
explore technologies that may have the capability of WGS in determining 
serotype and reduce the current timeframe. All timeframes and methods 
are likely to change as FSIS continuously incorporates new laboratory 
technologies into its sampling verification program. Any final 
verification sampling plan resulting from this proposal would use 
testing methods that are validated and fit for purpose.
    FSIS requests comments on available technologies and methods for of 
quantification and serotyping. If FSIS finalizes this proposed sampling 
plan, data gathered from the sampling plan would enable the Agency to 
gauge more precisely the hazard posed by certain Salmonella levels and 
serotypes in chicken carcasses, chicken parts, comminuted chicken, and 
comminuted turkey. FSIS intends to further evaluate and, if necessary, 
refine the proposed status of Salmonella as an adulterant in these raw 
poultry products as advances in science and technology related to 
pathogen levels, serotypes, and virulence genes become available.
    Sampled Lot. When FSIS tests a product sample for adulterants, the 
Agency withholds its determination as to whether product is not 
adulterated, and thus eligible to enter commerce, until all test 
results that bear on the determination have been received (77 FR 
73401). Under this policy, establishments and importers of record at 
official import inspection establishments must maintain control of 
products tested for adulterants to ensure that the products do not 
enter commerce while waiting for receipt of the test results. Thus, if 
FSIS finalizes its proposed routine Salmonella verification testing 
program for chicken carcasses, chicken parts, comminuted chicken, and 
comminuted turkey, establishments that produce these raw products and 
official import inspection establishments where these raw products are 
reinspected would need to control and maintain the integrity of the 
sampled lot pending the availability of test results.
    Under any final verification sampling plan, FSIS IPP would give 
establishments and official import inspection establishments advance 
notice before IPP collect a product sample for Salmonella to give these 
entities enough time to control the sampled lot without altering the 
process that the sample represents. The sampled lot is the product 
represented by the sample collected and analyzed by FSIS. 
Establishments are responsible for providing a supportable basis for 
defining the sample lot. For sampling purposes, product lots should be 
defined such that they are microbiologically independent. 
Microbiological independence is documented by separation, e.g., 
physical, temporal, or by sanitation intervention, that clearly 
delineates the end of one production lot and the beginning of the next. 
The microbiological results from one test are independent of prior or 
later lots. In other words, if a product sample tests positive for 
Salmonella at a level of 10 cfu/mL(g) or higher and contains a 
detectable level of at least one serotype of public health 
significance, products from other production lots should not be 
implicated, provided the establishment can support that the lots remain 
microbiologically independent.
    Generally, FSIS recommends that establishments develop and 
implement in-plant sampling plans that define production lots or sub-
lots that are microbiologically independent of other production lots or 
sub-lots. Production lots that are so identified may bear distinctive 
markings on the shipping cartons. FSIS has issued guidance to help 
establishments and official import inspection establishments comply 
with the Agency's policy that does not allow product that FSIS has 
tested for adulterants to enter commerce until test results become 
available.\135\ In addition to providing guidance on adequate control 
measures that establishments and official import inspection 
establishments can implement for products tested for adulterants, the 
document also includes guidance on

[[Page 64708]]

how to define a product lot in order to determine the amount of product 
that must be controlled pending test results. If FSIS finalizes the 
proposed new standards for chicken carcasses, chicken parts, comminuted 
chicken, and comminuted turkey, FSIS would consider updating the 
guidance to cover Salmonella sampling of these raw poultry products.
---------------------------------------------------------------------------

    \135\ FSIS Compliance Guideline: Controlling Meat and Poultry 
Product Pending FSIS Test Results (2013) at: https://www.fsis.usda.gov/guidelines/2013-0003.
---------------------------------------------------------------------------

    As discussed above, establishments would be required to control the 
raw poultry products sampled by FSIS pending the test results. If test 
results detect Salmonella at a level of 10 cfu/mL(g) or higher and at 
least one Salmonella serotype of public health significance, FSIS would 
consider products represented by the sampled lots to be adulterated and 
would issue an NR. Additionally, all products in the lot represented by 
the sample would be prohibited from entering commerce. If any product 
from the lot represented by the product samples has entered commerce, 
FSIS would request that the producing establishment recall the 
implicated products. Depending on the circumstances, in addition to 
issuing an NR, FSIS could take other appropriate enforcement action as 
authorized in 9 CFR part 500 because the establishment would have 
produced and shipped adulterated product. Such actions may include 
immediately suspending inspection or issuing an NOIE.
    For imported products tested at port of entry, if the product tests 
positive for Salmonella at 10 cfu/mL(g) or higher and any detectable 
level of a Salmonella serotype of public health significance and has 
not been held at the official import inspection establishment or at an 
off-site premises under adequate controls, FSIS would request that the 
importer of record recall the product. If the product has been held, 
the product will be refused entry. Product lots subsequently presented 
for import inspection from the same foreign country and establishment 
would be held at the official import inspection establishment pending 
results in accordance with FSIS' import reinspection procedures.\136\ 
The FSIS Office of International Coordination would notify the program 
officials of the affected exporting country when a positive result is 
reported, so that they can determine whether the producing 
establishment has exported any other product from the same production 
lot to the United States. If the foreign establishment has properly 
defined the product lot on the basis of specific control factors, and 
accurately tracked the containerization of product produced under those 
controls, the establishment can reduce the likelihood that adulterated 
product will enter commerce and can more easily recover product if a 
sample is positive for Salmonella levels and serotypes that would 
render the product adulterated.
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    \136\ FSIS Directive 9900.8, Meat, Poultry, and Egg Products 
Refused Entry into the United States (Dec. 1 2020). Available at: 
https://www.fsis.usda.gov/policy/fsis-directives/9900.8.
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    Proposed implementation. To mitigate the impact of regulatory 
changes on small and VS establishments, FSIS has typically used a 
phased approach for implementation to provide additional time for small 
and VS establishments to adjust their operations to comply with any new 
regulatory requirements. FSIS defines large, small, and VS 
establishments based on the number of establishment employees and, for 
VS establishments, annual sales.\137\
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    \137\ Large establishments are establishments with 500 or more 
employees, small establishments are establishments with 10 or more 
employees but fewer than 500, and very small establishments are 
establishments with fewer than 10 employees or annual sales of less 
than $2.5 million.
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    Should FSIS finalize the proposed final product standards, the 
Agency intends to use a phased approach to initiate verification 
sampling in establishments that produce raw chicken carcasses, chicken 
parts, comminuted chicken, and comminuted turkey. However, instead of 
implementing the Agency's verification sampling program based on the 
current large, small, and VS establishment size definitions, FSIS has 
tentatively decided to establish implementation dates based on annual 
number of birds slaughtered or, for establishments that do not conduct 
slaughter operations, production volume. The current small 
establishment size definition was established in the HACCP final rule 
and corresponded to the Small Business Administration's size standards 
for business entities at that time (61 FR 38819). However, because FSIS 
has applied these standards to individual establishments rather than 
business entities, establishments classified as ``small'' may have up 
to 500 employees. Thus, FSIS believes that a phased implementation 
based on production volume would be a more effective approach to 
mitigate the impact of this proposed determination on low and VLV 
establishments than the current establishment size definitions.
    As FSIS implements the final product standards verification 
sampling program, the Agency has tentatively decided to phase out all 
current Salmonella performance standards for poultry. Thus, when the 
proposed final product verification sampling program is fully 
implemented, FSIS would no long use Salmonella sampling results to 
categorize poultry establishments and would no longer publish these 
establishments' performance standards categories on the FSIS website. 
FSIS evaluates and revises its sampling and testing programs each year. 
Any final verification sampling program resulting from this proposal 
would be sufficient to verify that establishments are meeting the final 
product standards.
    The proposed production volume categories and proposed verification 
sampling implementation schedule are as follows.

                 Table 6--Proposed Implementation Dates
------------------------------------------------------------------------
       Establishment volume category             Implementation date
------------------------------------------------------------------------
High......................................  1 year after publication.
Medium....................................  2 years after publication.
Low.......................................  3 years after publication.
Very Low..................................  3 years after publication.
------------------------------------------------------------------------


            Table 7--Proposed Volume Categories Chicken Parts
------------------------------------------------------------------------
                                                 Definition (annual
              Volume category                    production pounds)
------------------------------------------------------------------------
High......................................  Over 70,000,000.
Medium....................................  Between 1,000,000 and
                                             70,000,000.
Low.......................................  Less than 1,000,000.
------------------------------------------------------------------------


          Table 8--Proposed Volume Categories Chicken Carcasses
------------------------------------------------------------------------
                                                  Definition (birds
       Establishment volume category            slaughtered per year)
------------------------------------------------------------------------
High......................................  Over 10 million.
Medium....................................  Between 1.1 and 10 million.
Low.......................................  Between 440,001 and < 1.1
                                             million.
Very Low..................................  No more than 440,000.
------------------------------------------------------------------------


    Table 9--Proposed Volume Categories Comminuted Chicken and Turkey
------------------------------------------------------------------------
                                            Definition (daily production
              Volume category                          pounds)
------------------------------------------------------------------------
High......................................  Over 250,000.
Medium....................................  Between 6,001 and 250,000.
Low.......................................  No more than 6,000.
------------------------------------------------------------------------

    FSIS requests comments on this proposed implementation approach and 
on the proposed establishment production volume categories. FSIS also 
requests comments on whether the Agency should phase out the current 
performance standards as the Agency implements the final product 
standards or if the Agency should retain the current performance 
standards and later determine if these standards are still

[[Page 64709]]

needed when evaluating the effectiveness of the proposed final product 
standards.
    FSIS also requests comments on whether the Agency should consider 
an alternative implementation approach that would focus its final 
product verification sampling on establishments that have a 
demonstrated lack of process control. Under such an approach, FSIS 
would establish a microbial process control standard based on a 
threshold or some other parameter and require that establishments 
conduct sampling at a frequency sufficient to demonstrate that they are 
meeting the process control standard. Establishments whose results 
exceed the process control standard would be required to conduct 
intensified sampling, including environmental sampling and sampling at 
multiple points in the process, to determine if the initial results 
were an outlier or if there are problems with the establishment's 
production process. If an establishment's intensified sampling results 
show that it is meeting the process control standard, the establishment 
would return to the standard sampling protocol. If the establishment 
continues to exceed the process control standard, it would be required 
to take corrective actions and continue to conduct intensified 
sampling. If the establishment exceeds the process control standard 
again, FSIS would collect and analyze final product samples for 
Salmonella levels and serotypes because, at this point, the 
establishment would have a record that demonstrates that there are 
problems with its production process. The establishment would be 
required to control product represented by the sampled lot pending 
FSIS' test results. Product that tests positive for Salmonella at or 
above 10 cfu/mL(g) and a Salmonella serotype of public health 
significance would be considered unfit for human food and would be 
prohibited from entering commerce. If the establishment released the 
product into commerce, the product would be subject to recall.

III. Component Two: Enhanced Establishment Process Control Monitoring

A. Background and Current Regulatory Requirements

    Process control monitoring, in the context of poultry slaughter, 
consists of the programs and procedures an establishment implements to 
ensure its processes are operating as intended in preventing 
contamination (including contamination with enteric pathogens and fecal 
material) of poultry carcasses and parts throughout the slaughter and 
dressing process and to ensure that the resulting products meet 
applicable regulatory standards or definitions (79 FR 49565, 49602). 
Establishments must demonstrate that their process is in control by 
implementing verification procedures, collecting data, and developing 
and maintaining accurate records to demonstrate that their processes 
and procedures are performing as intended and as required (9 CFR 
381.65(g) and (h) and 9 CFR part 417). An effective process control 
system entails an establishment responding effectively to re-establish 
control when its ongoing verification activities show that its 
processes are not producing the expected results. Effective process 
control monitoring procedures should lead to lower rates of pathogen 
contamination because establishments will discover deficiencies in 
processing sooner and more reliably than would be the case without 
effective process control monitoring procedures.
    Contamination of poultry carcasses and parts by enteric pathogens 
and fecal material (e.g., Salmonella and Campylobacter) are hazards 
reasonably likely to occur in poultry slaughter establishments unless 
addressed in a sanitation SOP or other prerequisite program (79 FR 
49565, 49613). To ensure that establishments that slaughter poultry 
implement appropriate measures to prevent carcasses from becoming 
contaminated with pathogens, and that both FSIS and establishments have 
the documentation to verify the effectiveness of these measures on an 
on-going basis, current regulations require, among other things, that 
all establishments that slaughter poultry other than ratites develop, 
implement, and maintain written procedures to prevent contamination of 
poultry carcasses and parts by enteric pathogens and fecal material 
throughout the entire slaughter and dressing operation (9 CFR 
381.65(g)). Establishments are required to incorporate their process 
control procedures into their HACCP plan, sanitation SOPs, or other 
prerequisite programs (collectively, ``the HACCP system'') and maintain 
daily records sufficient to document the implementation and monitoring 
of these procedures (9 CFR 381.65(g) and (h)).
    Microbiological test results that represent levels of 
microbiological contamination at key steps in the slaughter process are 
necessary for establishments to provide comprehensive, objective 
evidence that they are effectively maintaining process control to 
prevent carcasses from becoming contaminated before and after they 
enter the chiller (79 FR 49565, 49602). At present, establishments 
conduct pre-chill testing to monitor how well an establishment is 
minimizing contamination on live birds coming to slaughter and on 
carcasses throughout the slaughter and dressing process, and post-chill 
testing to monitor how well an establishment is minimizing 
contamination during chilling and the overall effectiveness of any 
antimicrobial interventions that were applied (79 FR 49565, 49566). 
FSIS also collects a verification sample at the post-chill location and 
tests for Salmonella and Campylobacter. In 2012, FSIS considered 
requiring a third establishment sampling location at rehang (i.e., 
after picking and prior to evisceration) to monitor the incoming load 
of pathogens but concluded that it was unnecessary to impose the 
additional costs on industry (77 FR 4407, 4428).
    Regulations at 9 CFR 381.65 (h) and 9 CFR 417.5 (a)(1) require 
establishments to document their procedures and results in records 
subject to Agency verification. At a minimum, these procedures must 
include sampling and analysis for microbial organisms at the pre- and 
post-chill location to monitor for process control, with an exception 
for VS and VLV establishments operating under the Traditional 
Inspection System (9 CFR 381.65 (g)(1)).\138\ In 2014, FSIS stated that 
because these establishments are typically less automated and run 
slower line speeds than larger establishments operating under other 
inspection systems, they may require less complicated measures for 
maintaining and monitoring process control on an ongoing basis (79 FR 
49565, 49603). Therefore, at present, they are required to collect and 
analyze samples for microbial organisms only at the post-chill 
location.
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    \138\ Very small establishments are establishments with fewer 
than 10 employees or annual sales of less than $2.5 million dollars 
(9 CFR 381.65(g)(1)(i)). Very low volume establishments annually 
slaughter no more than 440,000 chickens, 60,000 turkeys, 60,000 
ducks, 60,000 geese, 60,000 guineas, or 60,000 squab (9 CFR 
381.65(g)(1)(ii)). Traditional Inspection must be used for turkeys 
when neither the New Turkey Inspection System (NTI) nor the New 
Poultry Inspection System (NPIS) is used. For other classes of 
poultry, Traditional Inspection must be used when SIS, NELS, and the 
NPIS are not used (9 CFR 381.76(b)(1)(v)).
---------------------------------------------------------------------------

    In addition to prescribing the sampling locations for monitoring 
process control, the regulations specify a minimum sampling frequency 
to ensure establishments can detect changes in processing or 
inconsistencies

[[Page 64710]]

that may occur (79 FR 49565, 49604). At a minimum, for chickens, 
establishments are required to collect a pair of pre-and post-chill 
samples once per 22,000 processed carcasses, but at a minimum of once 
each week of operation, and for turkeys, ducks, geese, guineas, and 
squab, establishments are required to collect a pair of samples once 
per 3,000 processed carcasses but a minimum of once each week of 
operation (9 CFR 381.65(g)(2)(i)). To minimize the sampling costs to 
the lower volume establishments, VLV establishments must minimally 
collect and analyze samples at least once during each week of operation 
starting June 1 of every year. If, after consecutively collecting 13 
weekly samples, an establishment can demonstrate that it is effectively 
maintaining process control, it may modify its sampling plan (9 CFR 
381.65(g)(2)(ii)). All establishments are required to conduct testing 
at a frequency sufficient to detect a loss of process control soon 
after it occurs so that they can take the necessary corrective actions 
to prevent further product contamination (79 FR 49565, 49605). 
Therefore, regardless of the prescribed minimum sampling frequency, the 
establishment must sample at a frequency that is adequate to monitor 
their ability to maintain process control for enteric pathogens and 
fecal contamination (9 CFR 381.65(g)(2)(iii)).
    When FSIS updated its poultry inspection regulations in 2014 (79 FR 
49565), it referenced data from FSIS' 2007-2008 Young Chicken Baseline 
survey (hereinafter, the ``baseline survey''), which found levels of 
detectable generic E. coli (GEC) on post-chill carcasses well below the 
performance criteria in the existing regulations.\139\ The baseline 
survey found that over 60 percent of samples had non-detectable levels 
of GEC. Among 12 establishments from which 10 or more samples were 
analyzed, none had detectable levels of GEC. On the other hand, FSIS 
analyzed 22 samples from each of 2 of these establishments and found 
that all 44 samples had detectable AC measurements. FSIS also concluded 
that AC levels at rehang were more highly correlated with Salmonella 
than GEC levels which suggested that AC measurements might provide a 
better measure of process control.\140\
---------------------------------------------------------------------------

    \139\ FSIS (2007). Young Chicken Survey (baseline) June 2007-
June 2008. https://www.fsis.usda.gov/sites/default/files/media_file/2020-07/Baseline_Data_Young_Chicken_2007-2008.pdf.
    \140\ Williams, M.S., et al. (2015). ``Industry-level changes in 
microbial contamination on market hog and broiler chicken carcasses 
between two locations in the slaughter process.'' Food Control 51: 
361-370.
---------------------------------------------------------------------------

    Despite the baseline survey findings, FSIS did not require that 
establishments use a specific microbial organism to monitor process 
control when it updated its regulations in 2014. Thus, at present, 
establishments decide which microbiological organisms will best help 
them to monitor the effectiveness of their process control procedures 
and may develop sampling plans to test carcasses for enteric pathogens, 
such as Salmonella, or another appropriate indicator organism. Because 
establishments must incorporate their microbiological sampling plan 
into their HACCP system, they are required to provide scientific or 
technical documentation to support the judgements made in designing 
their sampling plans, as required by 9 CFR 381.65 (h) and HACCP 
regulation 9 CFR 417.4(a).

B. Need To Enhance Establishment Process Control Monitoring

    Based on NACMCF recommendations, an analysis of PHIS inspection 
results, sampling data, and the findings of the 2023 risk assessments, 
FSIS has determined that there is a need to enhance establishment 
process control monitoring. These recommendations and findings are 
discussed below and collectively support FSIS' conclusion that 
regulatory revision will improve establishments' ability to monitor 
microbiological process control; demonstrate the effectiveness of their 
measures to prevent carcasses from becoming contaminated; and ensure 
that both FSIS and establishments have the documentation necessary to 
verify the effectiveness of these measures on an on-going basis. These 
recommendations and findings have also prompted FSIS to evaluate the 
need for additional resources, services, and guidance to help 
establishments develop microbiological process control monitoring 
programs and comply with FSIS requirements.
1. NACMCF Charge and Recommendations
    According to NACMCF, process control can be defined as maintaining 
the output of a process within a desired range based on stability and 
capability to meet specifications.\141\ Process control is accomplished 
through six steps: (1) The output must be monitored and quantified with 
appropriate sampling and testing; (2) There must be predefined limits 
and targets traceable to acceptable specifications and the history of 
the process; (3) The monitoring results must be compared to the 
relevant process control limits; (4) There must be a predetermined plan 
of action (such as a corrective action plan) based on the size and 
frequency of deviation from relevant limits; (5) The proper action must 
be decided upon based on the observed deviation; and (6) the proper 
action must be promptly taken to adjust the process.\142\
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    \141\ Note that a process can be stable and not capable of 
meeting specifications, or an unstable process may produce product 
that meets specifications. NACMCF (2015). '' Regarding 
Microbiological Criteria as Indicators of Process Control or 
Insanitary Conditions, available at https://www.fsis.usda.gov/sites/default/files/media_file/2020-07/NACMCF-Report-Process-Control-061015.pdf.
    \142\ NACMCF (2018). ``Response to Questions Posed by the 
Department of Defense Regarding Microbiological Criteria as 
Indicators of Process Control or Insanitary Conditions.'' J Food 
Prot 83(1): 115-141.
---------------------------------------------------------------------------

    In 2015, NACMCF provided microbiological limits for food categories 
that reflect process control and sanitary manufacturing conditions. 
These limits can help FSIS-regulated establishments develop systems for 
measuring SPC. SPC is an approach that uses statistical methods to 
monitor and control a process. A process is under statistical control 
when the output varies as expected within a statistical range. Process 
variability is caused by chance or assignable causes. Assignable causes 
can be linked to improperly adjusted or controlled machines, operator 
errors, or defective raw material. A process that is operating with 
assignable causes is out-of-control.\143\ Process capability is defined 
as the degree by which SPC limits fall within specifications. If the 
process exceeds an upper or a lower specification limit, the product 
does not meet the specification even if it is operating without 
assignable causes and is in control. Process capability is 
traditionally measured using a process capability index (Cp). For 
example, USDA's Agricultural Marketing Service uses Cp to monitor 
process control of fat content meeting allowable upper and 
specification lower limits and a one-side calculated process capability 
to monitor process control of microbial detection levels meeting upper 
allowable limits in raw beef finished products as part of the National 
School Lunch Program.\144\
---------------------------------------------------------------------------

    \143\ Montgomery, D.C. (2013). Introduction to Statistical 
Quality Control 7th edition, chapter 5.
    \144\ AMS National School Lunch Program, information available 
at: https://www.fns.usda.gov/nslp.
---------------------------------------------------------------------------

    Using microbiological testing to monitor SPC presents some 
challenges. Some testing may result in a discrete (presence/absence or 
binary) result or a continuous measure such as a plate

[[Page 64711]]

count. Binary results and plate counts are typically modeled using a 
binomial or Poisson probability distributions, and their log-
transformed values usually follow a lognormal distribution from which 
the statistical mean and variance may be calculated and used for SPC 
analyses that assume a normal probability distribution. Count data may 
include zero results, either due to the absence of the organism, or 
presence at levels below or above the test's limits of quantitation 
(LOQ). The later result is referred to as a censored value. Data with 
censored results exceeding the number of zeros expected by the Poisson 
distribution may consist of a heterogeneous mixture in which the 
organism is completely absent from some portion of the product and 
present in another portion. Such results may follow a zero-inflated 
Poisson distribution. A variety of methods have been proposed to fit 
censored data to a probability distribution. The choice of method 
depends on the number of samples and the proportion with enumerated 
samples. A distribution function cannot be reliably fitted to a dataset 
where fewer than 20 percent of samples are enumerated,\145\ which is an 
important consideration for using count data. Other considerations for 
SPC include sampling frequency and lot definition. With respect to 
frequency, counts are more robust than binary results, and indicators 
of process control are best obtained with higher frequency sampling. 
NACMCF recommended sampling frequency be capable of detecting the 
presence of expected assignable causes within the first 10 percent of 
their persistence time since disruptions occur for a finite period and 
not much is learned if the disruption is not detected or detected too 
late for corrective action. Product lot definition has implications 
both for determining the acceptability of a lot and for monitoring SPC. 
In general, the defined product lot should be produced under reasonably 
constant conditions so that a lot is a homogeneous volume of 
contemporaneous production for calculating the mean level and 
variability. For poultry slaughter and dressing, a homogeneous volume 
of contemporaneous production means that each lot should represent a 
cohort (flock) of birds raised, transported, slaughtered and processed 
over the same period and locations. Production lots with equivalent 
means may have different variabilities and therefore, SPC methods 
should evaluate variance both within and between production lots.
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    \145\ Williams, M.S., et al. (2013). ``Sample size guidelines 
for fitting a lognormal probability distribution to censored most 
probable number data with a Markov chain Monte Carlo method.'' 
International Journal of Food Microbiology 165(2): 89-96.
---------------------------------------------------------------------------

    When a microbiological sampling program is properly designed and 
implemented, it can provide valuable information about an 
establishment's process control. A well-designed microbiological 
sampling program should clearly define the intended use of the testing 
program, organisms of concern that will be the target of testing, 
sampling units (flocks, houses at preharvest, carcasses or parts at 
post-harvest), sampling scheme, microbiologically independent lotting 
practices, sampling locations, procedures for sample collection and for 
maintaining sample integrity, testing method, method for evaluating 
test results, and actions taken based on test results.\146\ Results 
charting is typically used to identify trends and for identifying 
exceptions to process control that could be due to assignable causes. 
For low frequency binary results, NACMCF recommended a g-chart based on 
mean time between events. For higher frequency binary results, a p-
chart based on proportions is recommended, and for counts, mean and 
range charts can be used.
---------------------------------------------------------------------------

    \146\ NACMCF (2019). ``Response to Questions Posed by the Food 
Safety and Inspection Service Regarding Salmonella Control 
Strategies in Poultry.'' Journal of Food Protection 82(4): 645-668.
---------------------------------------------------------------------------

    In 2019, NACMCF concluded that most carcass contamination results 
from leakage of ingesta during crop removal, from feces during 
evisceration, as well as aerosolization during picking.\147\ The 
committee also advised, to best assess controls, each establishment 
should look at the whole food safety system from breeder farm through 
processing, so it is not overwhelmed by the incoming load. Evaluating 
the prevalence and concentration of Salmonella on carcasses and parts 
throughout the production process unique to each facility can help to 
identify pathogen reduction at each step in the process.
---------------------------------------------------------------------------

    \147\ NACMCF (2019). ``Response to Questions Posed by the Food 
Safety and Inspection Service Regarding Salmonella Control 
Strategies in Poultry.'' Journal of Food Protection 82(4): 645-668.
---------------------------------------------------------------------------

    In its October 2021 charge to the NACMCF Subcommittee on Enhancing 
Salmonella Control in Poultry Products, FSIS noted there is a 
documented correlation between a reduction in the quantity of AC 
between carcasses and finished products and the occurrence of 
Salmonella in finished products for beef, pork, and poultry. The Agency 
specifically requested that the Subcommittee provide guidance on how 
this information might be used to set microbiological criteria to 
assess process (pathogen) control in poultry.\148\
---------------------------------------------------------------------------

    \148\ 2021-2023 NACMCF report: Question 5.
---------------------------------------------------------------------------

    In response to FSIS' request for guidance on setting 
microbiological criteria to assess process control in poultry, the 2023 
NACMCF report discussed process control as a method of determining 
trends over time and how it is useful to determine the sources of 
variation within a process. It noted that ``indicator organisms such as 
Enterobacteriaceae (EB) or [AC] have been used by the industry as 
gauges of process control and to measure the microbial reduction from 
carcasses at slaughter to post-chill.'' The report stated that 
``studies show conflicting and apparent weak correlation between 
indicators and either the presence or level of Salmonella post carcass 
wash.'' The report also stated that, in addition to published studies, 
``unpublished data provided by the poultry industry and university 
researchers suggests that indicator bacteria have very limited 
predictive value for the prevalence of Salmonella.''
    Although the report found that the available data show that in many 
cases there may not be a strong statistical correlation between the 
presence or amount of an indicator and the presence or amount of 
Salmonella at specific points during processing or in finished poultry 
products, the report concluded that, ``. . . a change in [AC] from an 
early sampling point on the slaughter line to a final sampling point on 
the processing line, as well as absolute levels at the final point, may 
provide useful information about the effectiveness of the process in 
maintaining hygienic conditions.'' Therefore, the report concluded, 
``[AC] may be useful to indicate process control even though it is not 
a true indication of the presence, level, or virulence of Salmonella.''
2. PHIS Inspection Data
    The purpose of 9 CFR 381.65(g) and (h) is to ensure that 
establishments implement appropriate measures to prevent carcasses from 
becoming contaminated throughout the slaughter and dressing operation. 
Establishments must design and implement a program that uses 
microbiological sampling and analysis to monitor their ability to 
maintain process control and produces the documentation needed for FSIS 
and the establishment to continuously verify the effectiveness of these 
measures on an on-going basis, i.e., an MMP. Establishments must 
provide scientific and technical support to justify the design of their 
MMPs.

[[Page 64712]]

    As discussed, SPC monitoring evaluates microbial data against 
predefined quantitative and qualitative specifications. SPC monitoring 
results that do not fall within the predefined specifications with 
assignable causes indicate a process is not capable or in control. An 
effective MMP must, therefore, define and support the quantitative and 
qualitative microbial monitoring criteria an establishment will use to 
gauge whether its process is in control and the corrective actions it 
will take when its microbial monitoring results are not within its 
predefined parameters. Specifically, the establishment MMP must 
incorporate three criteria--target change, quantitative consistency, 
and qualitative consistency standards. ``Target change'' refers to the 
expected change in quantified levels of microbial contamination 
detected between two monitoring points that supports the procedures' 
ability to control contamination as required in 9 CFR 381.65(g) and as 
expected by the establishment. ``Quantitative consistency'' is measured 
by how close individual sampling results are to defined target change 
parameters and how much variation is expected amongst the results over 
time. ``Qualitative consistency'' is measured by assessing whether MMP 
process control findings are consistent with other process control 
monitoring results representing the same procedures (e.g., fecal zero 
tolerance monitoring). Consistency can also be qualitatively assessed 
as whether the MMP process control determination is consistent with the 
process control determination for the HACCP system overall, i.e., if 
all HACCP monitoring intended to assess process control draws the same 
conclusion. An effective MMP also defines how an establishment will 
respond when performance is not as expected, such as the corrective 
actions it will take.
    A recent analysis of PHIS inspection data identified issues with 
the design and implementation of establishment MMPs, including how 
establishments respond to MMP results.\149\ FSIS analyses of the PHIS 
inspection verification data from February 17, 2015, through December 
31, 2022, found that MMP noncompliance with 9 CFR 381.65(g) was most 
often associated with sampling frequency and the monitoring of results 
to ensure frequency compliance (49 percent). Specifically, NRs showed 
establishments did not plan or adjust their sampling plan minimum 
frequencies in accordance with the actual slaughter volume; failed to 
collect samples at the frequency planned, at the minimum frequency 
required, or to collect additional samples when collected samples could 
not be analyzed. These noncompliance issues indicate that 
establishments are not assessing or adjusting the sampling frequency 
procedures in their MMPs as necessary due to their failure to identify 
and document the absence of expected monitoring results. These 
noncompliance issues also show that establishments often fail to 
provide adequate justification for not evaluating and updating the 
sampling frequency procedures in their MMPs in response to monitoring 
results, IPP observations, or other relevant information indicating 
that their current sampling frequency is not adequate to monitor 
process control.
---------------------------------------------------------------------------

    \149\ 7096 noncompliance records (NRs) citing 381.65(g) were 
issued between 2/17/2015 and 12/31/2022; 8 had incomplete 
descriptions and were not further analyzed. Each of the 7088 NRs 
were read by OFO analysts to determine if the microbial monitoring 
program was reviewed as part of the verification and if the 
establishment microbial monitoring program was documented to be the 
cause of observed noncompliance.
---------------------------------------------------------------------------

    NRs also indicated establishments failed to identify monitoring 
criteria, monitoring deviations, or documented trends or--when 
identified--failed to perform any root cause assessment for the 
deviation or perform corrective actions (31 percent). Further, NRs show 
that establishments failed to implement their sample collection or 
laboratory analysis methods as written (12 percent). These findings 
indicate establishments are not adequately considering or utilizing the 
MMP monitoring of process control in their overall consideration of 
whether the procedures incorporated into the HACCP system are 
performing as expected and the HACCP system is overall controlling the 
hazard to the acceptable level as intended.
3. Exploratory Sampling Program Data
    As noted above, from April to November 2022, FSIS implemented an 
exploratory sampling program \150\ to generate microbial data to inform 
the Agency's effort to reduce Salmonella illnesses attributable to 
poultry. Under the program, rehang and post-chill rinsate samples were 
tested for Salmonella, AC, and EC, and beginning August 11, 2022, for 
Salmonella levels using a quantitative method adopted by FSIS 
laboratories.
---------------------------------------------------------------------------

    \150\ FSIS Notice 44-22Revised Young Chicken Carcass Exploratory 
Sampling Program.
---------------------------------------------------------------------------

    Overall, FSIS analyzed 4,654 paired samples collected from 204 of 
the 272 establishments that slaughtered young chicken in Calendar Year 
2022. Testing results indicated that 2,910 rehang and 232 post-chill 
samples were positive for Salmonella. Of these, 1,460 rehang and 121 
post-chill samples were analyzed with the Salmonella quantitative 
method, and the results indicated that approximately 90 percent of 
rehang and 86 percent of post-chill samples were below the lower 
LOQ.\151\ Further, out of the 4,654 paired samples, tests detected AC 
in 4,592 and EB in 4,580 of both the rehang and post-chill location 
samples. Of the pairs that detected the AC or EB at both locations, 
69.2 percent of the pairs yielded a quantified value at both rehang and 
post-chill for AC; whereas only 15.9 percent yielded a quantified value 
for EB.\152\
---------------------------------------------------------------------------

    \151\ The lower LoQ for the Salmonella, AC, and EC tests 
utilized by FSIS laboratories was 10 cfu/mL.
    \152\ Comparatively, FSIS's 2007-2008 baseline survey did not 
assess results as true pairs or when both rehang and post-chill 
yielded quantifiable results. This prior survey reported the 3,275 
analyzed pairs had levels significantly lower at post-chill and 
quantifiable AC and EC was detected in 97.1 percent and 57.4 percent 
of post-chill samples, respectively. The average rehang and post-
chill AC values reported 4.51 log AC and 2.43 Log AC and EC as 3.28 
Log EC and 1.57 Log EC, respectively (average change 2.08 Log AC and 
1.71 Log EC). https://www.fsis.usda.gov/node/1973.
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    Of the 3,177 paired samples with quantified levels of AC, 98.7 
percent demonstrated a reduction in AC from rehang to post-chill; while 
only 1.29 percent of paired samples demonstrated an increase in 
AC.\153\ Among the 180 establishments with 12 or more analyzed paired 
samples,\154\ all 180 establishments had greater than 20 percent of 
samples with AC detectable above the lower LOQ at post-chill, and 25 
percent had greater than 20 percent of samples with EB above the lower 
LOQ. Salmonella percent positive was reduced from rehang to post-chill 
by an average of 56.6 percent and AC quantified level was reduced an 
average of 2.93 log10 cfu/mL (74 percent reduction).
---------------------------------------------------------------------------

    \153\ Because a distribution function cannot be reliably fitted 
to a dataset where fewer than 20 percent of the samples are above 
the LOQ, FSIS has only summarized results for quantitative AC, not 
Salmonella or EC. See Helsel, D. R. (2005). ``Nondetects and Data 
Analysis: Statistics for Censored Environmental Data.''
    \154\ FSIS had estimated at least 12 pairs would be necessary 
over the study period to evaluate an individual establishment's 
indicator organism performance and 180 of the 204-establishment 
sampled had at least 12 pairs analyzed.
---------------------------------------------------------------------------

    Based on these findings, FSIS concluded that microbial monitoring 
of EB or Salmonella is unlikely to yield the reliable quantified 
results necessary for an individual establishment to support SPC 
monitoring. There has been an observable decline in post-chill levels 
of organisms detected since the 2007-2008

[[Page 64713]]

Young Chicken Baseline Survey. The current data shows that AC is more 
likely to yield reliably detectable quantified microbial results 
compared to either EB or Salmonella for most establishments. 
Additionally, given all establishments sampled consistently 
demonstrated a qualitative decrease in levels of organisms detected 
between rehang and post-chill, FSIS has determined that assessing the 
quantified level of decrease achieved is more informative of individual 
establishment process control changes and trends than the qualitative 
criteria of whether a decrease occurred.
    4. FSIS Risk Assessments
    The 2023 risk assessments for Salmonella in chicken and turkey 
evaluated, among other things, the public health impact of monitoring 
and enforcing process control from rehang to post-chill.\155\ For all 
young chicken establishments sampled during the 2022 exploratory 
sampling program, FSIS measured an average of 4.40 and 1.39 log AC per 
mL at rehang and post-chill locations, respectively, i.e., an average 
reduction of 3.01 log AC per mL. Comparatively, the 2007-2008 baseline 
survey measured an average of 4.50 and 2.46 log AC per mL at rehang and 
post-chill locations, respectively, i.e., an average log reduction of 
2.04 log AC per mL. These data show that between 2008 and 2022, there 
were no decreases in incoming AC loads on chicken carcasses; however, 
during that time, establishments achieved an additional 1 log reduction 
in AC levels after slaughter and processing. Based on this current 
study it is reasonable to expect reductions of 3 logs in Salmonella 
between rehang and post-chill. The risk assessment found weak 
correlations between post-chill Salmonella prevalence and AC, either 
based on the AC reduction between rehang and post-chill, or the 
fraction of post-chill samples where AC is not observed. Ultimately, 
FSIS' recent chicken risk assessment concluded that a hypothetical AC 
reduction standard could achieve a 25 percent reduction in Salmonella 
illnesses attributed to chicken only if microbiological criteria based 
on 2.5-3.0 log reduction or no AC tests exceed 10 cfu/mL at the post-
chill location. The risk assessment concluded that AC is only 
moderately correlated with the occurrence of Salmonella and thus an AC 
based standard would perform less well than a Salmonella standard.
---------------------------------------------------------------------------

    \155\ The risk assessments analyzed data from the 2022 
Exploratory Project, 2007-2008 Young Chicken Baseline Survey, and 
the 2008-2009 Turkey Baseline Survey.
---------------------------------------------------------------------------

    In addition to identifying a decrease in the average level of log 
AC detected at post-chill between the 2007-2008 baseline survey and 
2022 exploratory sampling program from 2.46 to 1.39 log AC per mL, 
respectively, the 2023 chicken risk assessment identified a decrease in 
the proportion of young chicken carcass post-chill AC results above the 
limit of detection (LOD), from 97.1 percent at baseline to 70.0 percent 
currently. EB followed a similar trend with 57.4 percent during the 
prior baseline to just 16.1 percent above the LOD currently.
    The 2023 turkey risk assessment reported that the correlation 
between AC or EB and Salmonella prevalence is weak, and it was not 
possible to fully assess the public health impact of monitoring and 
enforcing process control from rehang to post-chill.

C. Proposals To Enhance Establishment Process Control Monitoring

    FSIS is proposing to amend 9 CFR 381.65(g) and (h) to establish new 
requirements pertaining to how establishments monitor and document 
whether their processes for preventing microbial contamination 
throughout the slaughter and dressing operation are in control. The 
goal of the proposed amendments is to clarify existing regulatory 
requirements related to process control monitoring and recordkeeping in 
9 CFR 381.65(g) and (h) and to better define requirements with respect 
to the type of microbial data that should be collected, how the data 
should be analyzed, the level of acceptable process control deviations, 
and how establishments should respond to process control deviations. 
The clarifications are also intended to promote the collection of more 
standardized data by establishments to facilitate data quality. If this 
proposed rule is finalized, FSIS intends to update relevant guidance to 
help establishments comply with new requirements.
1. SPC Monitoring
    This proposed rule revises 9 CFR 381.65(g) to require 
establishments to incorporate SPC monitoring principles into their 
MMPs. As discussed, SPC monitoring uses statistical methods to compare 
quantitative results against predefined benchmarks and, thereby, 
determine whether a process is operating within expected 
parameters.\156\
---------------------------------------------------------------------------

    \156\ NACMCF (2015). '' Regarding Microbiological Criteria as 
Indicators of Process Control or Insanitary Conditions, available at 
https://www.fsis.usda.gov/sites/default/files/media_file/2020-07/NACMCF-Report-Process-Control-061015.pdf.
---------------------------------------------------------------------------

    The proposed revisions to 9 CFR 381.65(g) would therefore require 
establishments to use only validated microbial sampling and laboratory 
analysis procedures, generate and record statistically meaningful 
microbial monitoring data, set benchmarks by which to evaluate 
microbial monitoring data, and to otherwise define the statistical 
methods the establishment will use to evaluate the recorded data 
against the predefined limits. The MMP design should also be consistent 
with other process control monitoring procedures and the 
establishment's HACCP system. For example, if an establishment assesses 
process control independently by evisceration line for visible fecal 
contamination, the establishment's MMP for process control of 
procedures to prevent fecal contamination should also be separated by 
evisceration line.
    Statistical Methods. There must be scientific and technical support 
to justify the design of a MMP, including the statistical methods an 
establishment will use. Specifically, the MMP must include 
documentation and data demonstrating the initial scientific basis, 
validation, and ongoing verification of the statistical methods, 
including whether the quantified monitoring data generated by the 
establishment's process is normally or not normally distributed and 
whether the statistical method is appropriate. In instances where the 
minimum sampling frequency requirements of 9 CFR 381.85(g)(2) do not 
generate ``statistically robust'' results, an establishment must either 
increase its sampling frequency to generate robust results or provide 
support to demonstrate that the minimum frequency of collection is, 
nonetheless, adequate to demonstrate whether its particular process is 
in control.
    FSIS has developed a Lower Capability Process Index (CPL) 
Statistical Measurement Model (SMM) which fits parameters for normally 
distributed data. The CPL-SMM is available for review and comment on 
the FSIS website.\157\ Under this proposal, the CPL-SMM would be 
considered a ``safe harbor,'' in that establishments that incorporate 
the CPL-SMM into their MMPs would not be required to provide FSIS with

[[Page 64714]]

additional scientific or technical information to support their chosen 
statistical methods.\158\ Should FSIS finalize this proposal, the 
Agency would make available on its website an electronic file for 
download (i.e., a spreadsheet) programmed to calculate the change 
achieved, CPL, and chart results as the establishment inputs each 
sampling result as it is received from the laboratory. FSIS will 
provide relevant instructions for adopting the ``safe harbor'' method 
in a future guidance document. An example of the electronic file that 
FSIS intends to provide is available for viewing and public comment at: 
https://www.regulations.gov/docket/FSIS-2023-0028.
---------------------------------------------------------------------------

    \157\ Statistical Process Control Monitoring Method Assessment 
and the FSIS Proposed Lower Capability Process Index (CPL) 
Statistical Measurement Model (SMM) available at: https://www.regulations.gov/docket/FSIS-2023-0028.
    \158\ Establishments are to be aware that the proposed CPL-SMM 
reflects the minimum frequency prescribed in 9 CFR 381.65(g)(2), and 
the establishment may need to increase the frequency of collection 
to meet compliance with the requirement the frequency is adequate to 
monitor their ability maintain process control as required under 9 
CFR 381.65(g)(2)(iii).
---------------------------------------------------------------------------

    FSIS requests comments on its proposed CPL-SMM and the related 
electronic file. FSIS also requests input on any other statistical 
monitoring methods that FSIS should recognize as satisfying the 
requirements of 9 CFR 381.65(g) without further scientific support, 
including but not limited to methods for normally and non-normally 
distributed results, use with specific indicator organisms, and various 
analyzed results sample sizes. FSIS requests that commenters include 
the appropriate data necessary to support any proposed alternatives as 
these data may not have been available to FSIS at the time of this 
rulemaking.
    Target Change and Quantitative Consistency Criteria. To effectively 
incorporate SPC monitoring into an MMP, establishments must define and 
support target change and quantitative consistency microbial monitoring 
criteria. ``Target change,'' in the context of microbial process 
control monitoring, is the expected change in quantified levels of 
microbial contamination detected between two sampling locations that 
supports a procedure's ability to control contamination as minimally 
required in 9 CFR 381.65(g) and as expected by the establishment. For 
an MMP, target change parameters must be appropriate for the microbial 
monitoring organism an establishment uses to monitor process control. 
At a minimum, establishment MMPs must define the minimum target change 
expected (lower specification limit). The minimal level target change 
approach sets a benchmark from which establishments can evaluate trends 
in microbial contamination during slaughter and dressing with other 
trends in slaughter performance data such as pathogen, feces and 
ingesta, and sanitary operations monitoring findings. Establishment 
MMPs may also define a maximum target change expected (upper 
specification limit).
    AC and EB are routinely utilized to monitor poultry slaughter 
process control and are frequently reported in logarithmic format 
(log).\159\ FSIS' review of current scientific support indicates that, 
when monitoring indicator organisms reported in log, establishments 
should strive for a minimum target change value of 1 log reduction and 
that a change between 0 and 1 log is not reliably detected in normally 
distributed data, particularly at the statistical power associated with 
the single pair minimum sampling frequencies prescribed in 9 CFR 
381.65(g)(2).\160\ The 2023 risk assessment also identified a moderate 
correlation with the detection of post-chill Salmonella when at least a 
3 log AC change was observed.\161\ Moreover, FSIS' exploratory sampling 
program observed an average 2.93 log AC reduction in establishments 
with at least 12 carcass pairs analyzed.
---------------------------------------------------------------------------

    \159\ Microbial organism levels are frequently transformed to 
base 10 logarithmic format (log) for statistical assessment unless 
the conversion would result in log ``0' censored data result.
    \160\ De Villena, J.F., et al. (2022). ``Bio-Mapping Indicators 
and Pathogen Loads in a Commercial Broiler Processing Facility 
Operating with High and Low Antimicrobial Intervention Levels.'' 
Foods 11(6): 775. Cano, C., et al. (2021). ``Application of 
Peroxyacetic Acid for Decontamination of Raw Poultry Products and 
Comparison to Other Commonly Used Chemical Antimicrobial 
Interventions: A Review.'' J Food Prot 84(10): 1772-1783. Brashears, 
M.M. and B.D. Chaves (2017). ``The diversity of beef safety: A 
global reason to strengthen our current systems.'' Meat Sci 132: 59-
71.
    \161\ Quantitative Microbial Risk Assessment for Salmonella in 
Raw Chicken and Raw Chicken Products at: https://www.regulations.gov/docket/FSIS-2023-0028.
---------------------------------------------------------------------------

    Based on these findings, the Agency would consider an 
establishment's target change criteria to meet the requirements in 9 
CFR 381.65(g) when its MMP sets an expected reduction of at least 1.0 
log in detected microbial levels between sampling locations.\162\ 
Establishments may, of course, set more stringent target change 
criteria in their MMP than the minimum 1.0 log reduction without 
providing additional support to FSIS. MMPs that define an expected 
target change value of less than 1.0 log must include comprehensive 
scientific support to demonstrate that its target change criteria 
reflect a statistically reliable value for measuring process control 
and why its expected target change is less than changes identified in 
national baseline data (e.g., 2 log or 3 log as above). Establishments 
that conduct microbial sampling and testing in more than two locations 
in the slaughter process may define different quantified values to be 
achieved between the various points but, minimally, the target change 
value for monitoring between each pair of points should meet the 
minimum requirement as appropriate for the microbial monitoring 
organism being monitored. Similarly, establishments monitoring more 
than one shift, evisceration line, or species/subclass of poultry may 
elect to define different quantified target change values expected 
providing they meet the same minimum requirements. In any event, 
establishments must use scientifically validated mathematical methods 
to calculate the change in levels detected between sampling locations. 
FSIS would consider a simple subtraction method (e.g., Sampling Point-A 
log value--Sampling Point-B log value) to be scientifically valid.
---------------------------------------------------------------------------

    \162\ FSIS notes that all sample results in the exploratory CPL-
SMM modeling datasets had AC reductions greater than 1 log (97.5 
percent) and mean log AC reductions across the exploratory sampling 
period were greater than 1 for 98.7 percent of establishments.
---------------------------------------------------------------------------

    MMPs must also define quantitative consistency criteria. As 
discussed, SPC monitoring includes assessing the variation of results 
as each result is reported and over time to identify and detect when 
procedures may not be functioning as intended to prevent the enteric 
pathogen and fecal contamination from being introduced at one or more 
points in the process. In statistical applications, 99 percent of 
results fall within 6 standard deviations of the mean, or 3 standard 
deviations on either side of the mean. For an MMP monitoring whether 
the minimum target change expected is met (lower specification), the 
detected change between the two points monitored is within 3 standard 
deviations less than the average change detected for all samples in the 
monitoring period.
    The establishment MMP must define and support the acceptable 
quantitative consistency (statistical variation) expected among the 
changes detected over time. The quantitative consistency expected must 
not exceed 3 standard deviations lower than the mean and for the 
establishment to conclude microbial contamination variability was 
controlled (one-side for lower specification). That is, FSIS recognizes 
the MMP defined quantified value is minimally supported when the sample 
result is no more than 3 standard deviations below the mean. As with 
target change criteria, establishments are

[[Page 64715]]

encouraged to define quantitative consistency criteria at each point 
monitored and may also set quantitative consistency criteria specific 
to shift, line, or specific/subclass of poultry slaughtered, provided 
the consistency variation target limit meets the minimum requirements 
discussed herein. Establishment MMP monitoring criteria decisions for 
target change and quantitative consistency expected, and the actual 
values observed during monitoring, must also consider and support the 
establishment's MMP organism, location, and frequency decision 
rationale. Establishments must assess their results as ongoing 
validation data to maintain support for all MMP requirements.
    Monitoring Period. As discussed, SPC involves an assessment of 
trends measured over time. As such, an establishment's MMP must define 
the period over which trends will be assessed, i.e., the ``monitoring 
period.'' FSIS' assessment of exploratory sampling program and 
Salmonella Initiative Program \163\ data found that the sample 
collection frequency impacts the monitoring period required to generate 
a statistically robust sample size and how quickly the entire sample 
size is replaced with new results, i.e., the ``sample size turnover.'' 
Based on the assessment of these available data, FSIS has identified 
the monitoring periods necessary for establishments to adequately 
assess trends over time. Establishments that incorporate these 
monitoring periods into their MMPs would not be required to provide the 
Agency with additional scientific or technical support.
---------------------------------------------------------------------------

    \163\ FSIS Salmonella Initiative Program, details available at 
https://www.fsis.usda.gov/science-data/data-sets-visualizations/microbiology/microbiological-testing-program-rte-meat-and.
---------------------------------------------------------------------------

    As shown in Table 10 below, FSIS recommends that establishment MMPs 
define the monitoring periods as follows by the minimum monitoring 
frequency (paired carcass collection) prescribed in 9 CFR 381.65(g): 
(1) Poultry establishments collecting samples at a frequency of once 
per 22,000 (chicken) or 3,000 (other species) head slaughtered, 
respectively, or greater, are to designate a monitoring period of 140 
samples or 52 weeks, whichever is shortest; (2) any poultry 
establishments collecting at a weekly frequency are to designate a 
monitoring period of the 52 most current weeks; (3) and VLV poultry 
establishments collecting 13 samples annually are to designate their 
monitoring period as all of the samples available in the most recent 52 
weeks or all the samples in the current period of operations if 
slaughter of the predominant species is seasonal and not continuous. 
All poultry slaughter establishments are required to assess for trends 
during their designated monitoring period, as well as compare the 
monitoring periods for the current 52 weeks against the prior 52 weeks. 
Further, those establishments that collect less than weekly are to also 
compare trends going back an additional 52 weeks (i.e., compare the 
current 52 weeks against the prior 104 weeks). All poultry slaughter 
establishments must also identify the sample size turnover rate based 
on their intended frequency of collection and provide scientific 
support for how the establishment will consider the turnover in their 
assessment of process control trends over time.

           Table 10--Monitoring Period by Minimum Frequency Recognized by FSIS Without Further Support
----------------------------------------------------------------------------------------------------------------
                                       Minimum monitoring                                   Minimum trend over
          Poultry species                   frequency         Minimum monitoring period         time period
----------------------------------------------------------------------------------------------------------------
Chicken............................  >=1 per 22,000 head...  Period necessary to obtain   Prior 52 weeks.
                                                              140 samples or 52 weeks,
                                                              whichever is shorter.
Turkey, Goose, Guinea, Duck, Squab.  >=1 per 3,000 head....
Any Poultry Species................  Weekly................  52 weeks...................
Any Poultry Species................  13 per year...........  All samples in 52 weeks or   Prior 104 weeks.
                                                              the period of operations
                                                              for year if seasonal
                                                              operations.
----------------------------------------------------------------------------------------------------------------

2. Microbial Monitoring Organism
    FSIS is proposing to amend 9 CFR 381.65(g) to establish new 
criteria that an establishment must meet to demonstrate that its 
selection of microbial organism is fit for purpose. Specifically, FSIS 
is proposing that establishments analyze for microbial organisms that 
are quantifiably detectable in the establishment's slaughter process 
and that will generate microbial monitoring data that is adequate to 
monitor their ability to maintain process control for enteric 
pathogens. Under this proposal, the establishment's measured results at 
each sample location must yield statistically reliable quantified value 
results.
    The Agency recognizes that in order to successfully analyze 
quantified data, at least 20 percent or more of the sample size results 
must be quantified; otherwise, the data will be skewed, i.e., shifted 
above or below the true value.\164\ Thus, to comply with the proposed 
revisions to 9 CFR 381.65(g), establishments would have to demonstrate 
and continuously validate that their chosen microbial monitoring 
organism generates a quantified value in at least 20 percent of the 
results reported at each monitored location. Results that are reported 
``above the limit of quantification'' or ``below the limit of 
quantification'' or ``0'' when log transformed would not be considered 
as quantified results, nor would samples with results not analyzed by 
the establishment. The establishment would also have to demonstrate and 
continuously validate that for each sample monitoring location, the 
microbial organism can be quantified across the upper and lower levels 
that actually occur in the establishment's individual process.
---------------------------------------------------------------------------

    \164\ Helsel, D.R. (2005). ``Nondetects and Data Analysis: 
Statistics for Censored Environmental Data.''
---------------------------------------------------------------------------

    The Agency would consider the use of AC to monitor process control 
to meet the proposed criteria discussed above. FSIS has evaluated the 
available published studies and data at the time of rulemaking and 
concluded that AC are the microbial organisms most likely to result in 
quantified results that are reliably detectable at rehang and post-
chill. Available paired microbial data representing pathogens like 
Salmonella and indicator organisms other than AC do not meet the 20 
percent minimum quantified detection recommended. Establishments that 
choose to use other indicator organisms like EB, total coliforms, or 
GEC to assess the minimum target level of change, equal to or greater 
than 1 log10, must support the estimated change in a statistically 
appropriate manner.

[[Page 64716]]

    Regardless of the microbial monitoring organism chosen, the 
proposed revisions would require establishments to demonstrate that 
their chosen sample collection method is appropriate for the product 
sampled, the microbial organism monitored, and the laboratory method 
used to analyze the samples. Moreover, the proposed revision would 
require establishments' microbial sampling results to be generated by 
validated laboratory analyses and methods. Current HACCP regulations 
also require ongoing verification of the establishment's microbial 
monitoring procedures including the methods and equipment used (9 CFR 
417.4).
    Establishments that adhere to the Agency's carcass rinse and sponge 
sample collection method \165\ would not be required to provide 
additional support to justify their chosen method of organism 
collection. Further, establishments that document sample analyses by 
International Standards Organization (ISO) or USDA's Accredited 
Laboratory Program (ALP) accredited laboratories would not be required 
to provide the Agency with additional support to justify their use of 
laboratory analyses and methods. Nonetheless, all establishments would 
be required to demonstrate and continuously validate that their MMPs 
analysis method can detect the selected microbial monitoring organism 
at the levels intended, expected, and occurring at the monitored points 
in the process. FSIS requests comments on whether FSIS should require 
establishments to use ISO accredited or USDA ALP accredited 
laboratories to analyze their microbial monitoring samples.
---------------------------------------------------------------------------

    \165\ FSIS Directive 10,250.1, Salmonella and Campylobacter 
Verification Program for Raw Poultry Products, https://www.fsis.usda.gov/policy/fsis-directives/10250.1.
---------------------------------------------------------------------------

    In lieu of requiring the VS or VLV establishments that slaughter 
the predominate species of poultry under Traditional Inspection to 
utilize their own resources to meet compliance with the proposed 
revisions to 9 CFR 381.65(g), FSIS is proposing that such 
establishments have access to laboratory services provided by FSIS at 
no monetary cost for sample supplies, analyses, or shipment. Eligible 
establishments would be required to agree to terms of participation 
that would be publicly announced following the publication of any final 
rule resulting from this proposal. These terms would limit the use of 
laboratory microbial analyses service to eligible establishments that 
sample for AC, given more than 75 percent of the post-chill carcass 
samples analyzed as part of the recent FSIS exploratory sampling 
assessment were below the FSIS lower limit of detection for EB and 
nearly 85 percent of the enumerated post-chill Salmonella were below 
the level of quantification.\166\ The terms would also address 
laboratory service logistics such as establishment sample collection 
and shipment methods, collection and shipment dates to assure 
laboratory analysis capacity, reporting of establishment results 
through PHIS and LIMS-Direct email, and that the establishment agree to 
incorporate the FSIS CPL-SMM into its MMP exactly as described in the 
Statistical Process Control Monitoring Method Assessment and the FSIS 
Proposed Lower Capability Process Index (CPL) Statistical Measurement 
Model (SMM) at: https://www.regulations.gov/docket/FSIS-2023-0028.
---------------------------------------------------------------------------

    \166\ Quantitative Microbial Risk Assessment for Salmonella in 
Raw Chicken and Raw Chicken Products at: https://www.regulations.gov/docket/FSIS-2023-0028.
---------------------------------------------------------------------------

3. Sampling Location
    FSIS is proposing to revise the sampling location regulations at 9 
CFR 381.65(g)(1) to require that establishments, at a minimum, collect 
and analyze samples for microbial organisms at the rehang and post-
chill points in the process, as opposed to the pre-chill and post-chill 
locations. FSIS has determined that sampling at the rehang point in the 
process, i.e., after picking and prior to evisceration, is likely to be 
more effective for monitoring process control, given the introduction 
of carcass contamination tends to occur at slaughter process steps at 
or just prior to the rehang location and evisceration \167\ and pre-
chill sampling often takes place after evisceration and some 
antimicrobial interventions have already occurred.\168\ The FSIS 2023 
chicken risk assessment and FSIS assessment of exploratory sampling 
program data reported that there has been an increase in the log AC 
reduction achieved between rehang and post-chill influenced mostly 
because the levels of indicator organisms detected post-chill have 
declined since the prior 2007-2008 baseline study. FSIS has observed 
that pre-chill samples collected after evisceration and after most 
interventions, and prior to the chiller, typically have lower levels of 
organisms detected than rehang samples collected prior to evisceration 
and fewer intervention steps.
---------------------------------------------------------------------------

    \167\ NACMCF (2019). ``Response to Questions Posed by the Food 
Safety and Inspection Service Regarding Salmonella Control 
Strategies in Poultry.'' Journal of Food Protection 82(4): 645-668.
    \168\ Exploratory Project questionnaire responses indicate that 
51 percent of the establishments applied one or more interventions 
prior to rehang, whereas all but one establishment applied one or 
more interventions after rehang.
---------------------------------------------------------------------------

    Under this proposal, establishments would be required to identify 
and provide supporting rationale for the exact point where they intend 
to collect their rehang sample. Establishments would be permitted to 
collect a pre-chill sample at a location other than rehang if they 
provide supporting data to demonstrate that the alternative location is 
at least as effective as rehang sampling for monitoring their ability 
to maintain process control. However, one benefit of rehang sampling is 
that it allows establishments to assess the level of microbial 
contamination early in the slaughter process and, thereby, better 
understand the level of enteric pathogen hazard associated with flocks 
at receiving. Also, according to NACMCF, monitoring change in AC ``from 
an early sampling point on the slaughter line to the final sampling 
point on the processing line . . . may provide useful information about 
the effectiveness of the process in maintaining hygiene conditions.'' 
\169\ Moreover, continuing to monitor at pre-chill, which tends to 
occur after establishments apply antimicrobial interventions, would 
make it more difficult for establishments to justify how the microbial 
monitoring data they generate validates that their established target 
change and quantitative consistency parameters are adequate to monitor 
process control. Thus, ideally, the exact point of an establishment`s 
rehang sampling should be immediately after the early slaughter 
processing steps that are mostly likely to introduce microbial 
contamination and before the establishment's use of antimicrobial 
interventions. Establishments slaughtering poultry predominantly under 
religious exemptions that result in feet on, un-eviscerated carcasses, 
or otherwise are slaughtered at post-picking but prior to the 
evisceration rehang step are to collect samples at the point in the 
process that results in the greatest source of introduction of enteric 
pathogen and fecal contamination.
---------------------------------------------------------------------------

    \169\ 2021-2023 National Advisory Committee Meeting on 
Microbiological Criteria for Foods (NACMCF); FSIS Charge: Enhancing 
Salmonella Control in Poultry Products Available at: https://www.fsis.usda.gov/policy/advisory-committees/national-advisory-committee-microbiological-criteria-foods-nacmcf/2021.
---------------------------------------------------------------------------

    Finally, FSIS' proposed amendments to 9 CFR 381.65(g)(1) would 
require VS and VLV establishments operating under Traditional 
Inspection to--like all other establishments--collect and analyze 
microbial samples at rehang and

[[Page 64717]]

post-chill locations. These establishments are currently required to 
collect microbial samples at the post-chill point only. To offset the 
economic impact of this amendment, these establishments would be 
eligible to have access to laboratory services provided by FSIS at no 
cost as described and discussed above. The FSIS 2023 risk assessment 
and the Agency's assessment of the exploratory sampling program data 
both recognized that greater levels of detected microbial organisms 
were more likely to be observed in the smaller size and volume 
establishments than the larger establishments, although microbial 
levels detected at post-chill were overall lower than previously 
observed during the 2007-2008 baseline study. FSIS has concluded that 
post-chill samples representing only the end of the slaughter process 
does not provide the same level of MMP adequacy to monitor process 
control throughout the slaughter and dressing process as minimum two-
point sampling. Microbial monitoring at both rehang and post-chill will 
help VS and VLV establishments operating under Traditional Inspection 
to assess levels of microbial contamination at a point closer to the 
start of the slaughter process and the effect that their anti-microbial 
intervention steps have in reducing such contamination.
4. Sample Collection Monitoring Frequency
    As discussed, a recent FSIS review of PHIS inspection data found 
that MMP noncompliance issues were frequently associated with sampling 
frequency and that the noncompliant establishments were most often 
those that produced lower volumes of product. FSIS is proposing, 
therefore, to amend 9 CFR 381.65(g) to make it easier for 
establishments to understand and comply with minimum sampling frequency 
requirements. First, FSIS is proposing to update the sampling frequency 
regulations for VLV establishments, which currently require that such 
establishments collect and analyze 13 weekly samples starting on June 1 
of each year. FSIS has concluded that the current requirement would not 
generate statistically robust process control monitoring data 
regardless of if the results are collected over 13 consecutive weeks or 
at other intervals throughout the year. FSIS has also concluded that 
the June 1 requirement makes it difficult for VLV establishments to 
demonstrate that their MMP is adequate to monitor process control 
without collecting additional samples at other times of the year, such 
as during the establishment's greatest seasonal production or the 
slaughter of poultry from growers associated with greater risks of 
increased microbial carcass contamination. As such, FSIS is proposing 
to revise 9 CFR 381.65(g)(2)(ii) to remove the June 1 requirement and 
otherwise give VLV establishments the flexibility to collect their 13 
weekly samples in accordance with their slaughter operations throughout 
the year. The MMP decision making rationale for all establishments, 
regardless of annual slaughter volume, must support how the 
establishment will determine when the monitoring will be performed and 
how the specific carcass will be selected for sampling.
    Second, to help all establishments better understand their minimum 
sampling frequency requirements and develop their sampling frequency 
procedures, FSIS is proposing to tie sampling frequency requirements to 
annual slaughter volumes, as opposed to weekly slaughter volumes. As 
discussed, FSIS review of NRs found that many establishments have 
trouble planning or adjusting their sampling frequency regime to comply 
with current regulations given actual weekly slaughter volumes tends to 
fluctuate irregularly. Moreover, FSIS reviewed current sampling 
frequency requirements relative to annual slaughter volumes and 
determined that they require many lower volume establishments to 
collect samples at a greater rate than larger establishments.\170\ The 
proposed revisions, which are outlined in Table 11 and Table 12 below, 
would simplify proposed slaughter volume criteria cut points for VLV, 
low volume, and medium to high volume establishments and make it easier 
for establishments to adapt to fluctuating conditions. Specifically, 
FSIS is proposing that medium to large volume establishments 
slaughtering as their predominant species more than 1,100,000 chickens 
or 156,000 other poultry species annually be required to collect at a 
minimum frequency of one paired sample every 22,000 or 3,000 head 
slaughtered, respectively.\171\ Further, FSIS is proposing that LV 
establishments that slaughter as their predominant species between 
440,001 to 1,100,000 chickens or 60,001 to 156,000 other poultry 
species annually be required to collect a minimum of one paired sample 
a week, regardless of weekly fluctuations in their actual slaughter 
volume. Lastly, FSIS is proposing that VLV establishments be required 
to collect a minimum of 13 weekly paired samples per year. Those VLV 
establishments that plan to operate less than 13 weeks per year may 
collect their 13 annual samples on a less than weekly basis, assuming 
they can demonstrate that their sample frequency is effectively 
monitoring that they are maintaining process control throughout the 
year and during any periods of slaughter operations. Regardless of 
these minimum required frequencies, FSIS regulations would continue to 
mandate that all establishments collect samples at a frequency that is 
adequate for the establishment to monitor process control.
---------------------------------------------------------------------------

    \170\ E.g., under current regulations, non-VLV establishments 
that slaughter less than 22,000 chickens per week (i.e., between 
440,001 to 1,144,000 head annually) are required to collect at least 
1 sample weekly, resulting in a collection range of 1 sample per 
every 8,461 to 22,000 chickens (i.e., a midpoint rate of 1 sample 
per every 15,231 head). This is a greater sampling rate than those 
larger volume establishments collecting a minimum of only one sample 
every 22,000 head.
    \171\ Under current regulations, these establishments collect 1 
sample for every 22,000 chickens or 3000 other poultry species 
slaughtered. This is an annualized slaughter volume of 1,140,000 
head of chicken or 156,000 other species. To simplify proposed 
slaughter volume criteria cut points, FSIS rounded 1,144,000 to the 
1,100,000 identified in Table 11; an annual slaughter of 1,100,000 
averages 21,153 head per week.

             Table 11--Proposed Revisions to 9 CFR 381.65(g)(2) Minimum Sampling Frequency: Chicken
----------------------------------------------------------------------------------------------------------------
     Predominant poultry species         Establishment volume    Annual slaughter head     Minimum frequency of
             slaughtered                        sizes                    volume             paired collection
----------------------------------------------------------------------------------------------------------------
Chicken..............................  Very Low Volume........  1-440,000..............  13 Weekly Pairs per
                                                                                          Year.
Chicken..............................  Low Volume.............  440,001-1,100,000......  Weekly.
Chicken..............................  Medium and High Volume.  >=1,100,000............  1 per 22,000.
----------------------------------------------------------------------------------------------------------------


[[Page 64718]]


   Table 12--Proposed Revisions to 9 CFR 381.65(g)(2) Minimum Sampling Frequency: Turkey, Geese, Guinea, Duck,
                                                      Squab
----------------------------------------------------------------------------------------------------------------
     Predominant poultry species         Establishment volume    Annual slaughter head     Minimum frequency of
             slaughtered                        sizes                    volume             paired collection
----------------------------------------------------------------------------------------------------------------
Turkey, geese, guineas, Ducks, Squab.  Medium and High Volume.  >=156,000..............  1 per 3,000.
Turkey, Geese, Guinea, Ducks, Squab..  Low Volume.............  60,001-156,000.........  Weekly.
Turkey, Geese, Guinea, Ducks, Squab..  Very Low Volume........  1-60,000...............  13 Weekly Pairs per
                                                                                          Year.
----------------------------------------------------------------------------------------------------------------

5. Corrective Actions
    FSIS is proposing to amend 9 CFR 381.65(g) to further clarify that 
MMP monitoring results and documented corrective actions must be part 
of the pre-shipment review process required under 9 CFR 417.5(c). 
Current regulations at 9 CFR 381.65(g) require establishments to 
incorporate microbial monitoring procedures into their HACCP systems. 
Under 9 CFR 417, HACCP records must be maintained and continuously 
evaluated as part of the establishment's validation, ongoing 
verification, and reassessment process. Moreover, HACCP regulations at 
9 CFR 417.3 and 417.5 specifically require establishments to identify, 
in writing, the corrective actions that they will take when a HACCP 
system procedure may have failed. This failure may be observed by 
either the establishment or FSIS and may include failure to implement 
or maintain a procedure, evidence that the outcome of a procedure was 
ineffective, or when monitoring identifies the defined allowable limits 
have not been met.
    FSIS is proposing to revise the regulations to ensure that 
establishments comply with these corrective action provisions as they 
apply to the establishment's MMP. Specifically, FSIS is proposing to 
amend 9 CFR 381.65(g) to require establishments to, at a minimum, 
implement written corrective actions, including a root cause 
assessment, when microbial monitoring results deviate from predefined 
target change, quantitative consistency, or other criteria defined in 
the MMP.
    FSIS is also proposing that establishments' MMPs define the 
corrective actions the establishment intends to take when its MMP 
results do not align with other process control monitoring conclusions 
or when its MMP results do not support the conclusion that its HACCP 
system is controlling hazards as intended. FSIS recognizes a 
qualitative analysis of MMP results is necessary, given that a process 
can be stable and not capable of meeting quantitative specifications or 
unstable yet produce product that meets quantitative 
specifications.\172\ Thus, establishments will need to continually 
consider their MMP results in conjunction with all other process 
control monitoring efforts to qualitatively assess the overall ability 
of their procedures to maintain process control and function as 
intended. Establishments are to investigate and implement corrective 
actions when their MMP monitoring results do not align with the other 
process control monitoring conclusions. FSIS expects establishments to 
consider their MMP results as part of their total HACCP system 
validation and ongoing verification in the assessment of whether the 
procedures as required by 9 CFR 381.65(g) are controlling the 
biological hazard (enteric pathogens) as intended by the 
establishment's HACCP system. A slaughter establishment's HACCP system 
should clearly identify what process control procedures are monitored 
by the MMP, any other process control monitoring results reflecting the 
same procedures, a lot of products represented by this process control 
monitoring, and any other procedures intended to control the same 
hazard as the procedures required by 9 CFR 381.65(g). Establishment 
documented corrective actions to observed MMP deviations must 
demonstrate the establishment assessed the root cause of any deviation 
in target change, quantitative consistency, and qualitative consistency 
as described above.
---------------------------------------------------------------------------

    \172\ NACMCF (2015). ``Regarding Microbiological Criteria as 
Indicators of Process Control or Insanitary Conditions, available at 
https://www.fsis.usda.gov/sites/default/files/media_file/2020-07/NACMCF-Report-Process-Control-061015.pdf.
---------------------------------------------------------------------------

6. Recordkeeping Requirements
    FSIS is proposing to add a new paragraph (2) to 381.65(h) that 
would require establishments to electronically submit a copy of their 
microbial monitoring results to FSIS on a monthly basis. As part of the 
publication of any final requirements, FSIS would provide a template to 
each establishment for submitting monthly results. While FSIS 
inspectors would continue to review process control sampling data in 
establishments, the proposed change would allow FSIS headquarters 
personnel to evaluate national trends to determine the efficacy of the 
revised process control requirements in reducing final product 
contamination and to inform FSIS' decision-making concerning agency 
verification sampling.
    As part of the Salmonella Framework effort, FSIS met with internal 
FSIS, industry, and other government official stakeholders to explore 
potential improvements to FSIS receipt of third-party data. FSIS, 
academic, and industry stakeholders expressed concern around the lack 
of options for nationally represented industry microbial data. FSIS has 
determined it could update its information technology systems to 
provide for both individual result and bulk result data uploads by 
third parties. FSIS would publish guidance regarding the electronic 
submission of data alongside any final rule resulting from this 
proposal. FSIS is developing a web portal that will allow external 
partners to securely upload their sampling information and submit the 
data to FSIS electronically in a machine-readable format. The proposed 
fields that would be uploaded into the portal are: a sample 
identification number, the establishment number, date, time, slaughter 
line number, location of sample collection (e.g., rehang, post-chill), 
poultry species sampled, sample type (e.g., rinsate, sponge), analyte 
(e.g., AC, EB), analyte units (e.g., cfu/mL), quantified analyte 
result, and text analyte result (e.g., Upper LOD). FSIS is 
seeking comments on the proposed data fields requested. Establishments 
would have the option of entering the information directly into the 
system or utilizing the FSIS provided spreadsheet file discussed above 
as a template to bulk upload the information. FSIS anticipates that 
most establishments would use the FSIS provided template as the HACCP 
MMP monitoring record to avoid duplication of monitoring results.
    FSIS is also seeking comment on specific data use opportunities 
which could be pursued that would support FSIS investing additional 
resources into the technology systems necessary to

[[Page 64719]]

blind the proprietary MMP result record copies for research, industry, 
academic, or other pursuits.

IV. Component One: Pre-Harvest Measures

A. Scientific Support and Public Comments

    Under Component One of the October 2022 draft framework, FSIS 
indicated that it was considering whether it should require poultry 
slaughter establishments to characterize Salmonella as a hazard 
reasonably likely to occur at receiving and require that incoming 
flocks be tested for Salmonella before entering an establishment. This 
component is grounded in the strong scientific support for use of pre-
harvest interventions and management practices, in particular that 
removing flocks of highly Salmonella-contaminated birds from the 
slaughter process would result in less human exposure to Salmonella.
    The results of the 2023 risk assessments underscore the potential 
public health benefit of requiring pre-harvest interventions and 
management practices to reduce Salmonella contamination on poultry. 
Within the risk assessments, risk management options for controlling 
Salmonella at the receiving step focused on chicken and turkey 
slaughter establishments and sample results at the rehang location as a 
proxy for sampling live birds at or before the receiving step.\173\ The 
2023 risk assessments estimated the impact of eliminating certain 
serotypes. Two options were modeled: in the first, rehang results were 
considered as a verification of pre-harvest Salmonella control 
strategies. More effective strategies mean lower rates of certain 
serotypes at rehang. For the second option, rehang testing results 
would be used to take actions, such as diverting positive flocks with 
higher virulence serotypes to a safe end point (e.g., cook product from 
those flocks).
---------------------------------------------------------------------------

    \173\ For chicken FSIS used rehang sample data collected during 
the FSIS young chicken carcass exploratory sampling program (April 
to November 2022). For turkey, FSIS modeled Salmonella at receiving 
using rehang sampling data from the 2008-2009 FSIS Young Turkey 
Carcass baseline study due to the absence of other data for the 
turkey industry.
---------------------------------------------------------------------------

    If rehang testing is considered as a verification of pre-harvest 
strategies, between 27,000 and 55,000 annual salmonellosis cases could 
be avoided if flocks that have higher virulence serotypes were not 
being processed for food. Alternatively, if rehang testing is used to 
identify and divert contaminated carcasses, about 36,000 cases could be 
avoided. However, to achieve these outcomes, flocks with a higher 
virulence serotype would be diverted to a safe end point (e.g., for 
cooking at an official establishment), resulting in the diversion of 
46,000 flocks. Further, the rehang step takes place during processing. 
Requiring processors to react to testing--with results not available to 
at least two days--is not feasible. co Currently, FSIS analyzes about 
10,000 young chicken carcasses from rinsates collected at the post-
chill location annually. By comparison, there are approximately 9.384 
billion carcasses that are processed each year at approximately two 
hundred slaughter establishments. Therefore, currently, FSIS analyzes 
about one out of every million young chicken carcasses processed 
annually.
    Testing results at or before the receiving step may have a 
substantial public health impact. However, the requirements associated 
with the first option (verification of pre-harvest Salmonella control 
strategies) would require substantial industry resources, and there is 
no guarantee that the poultry industry would implement such Salmonella 
control strategies, since the first option would not penalize 
establishments for having highly virulent serotypes at the rehang step. 
The second option (divert flocks that test positive to a safe endpoint) 
would require the same resources as the first option. However, FSIS is 
not proposing such a diversion requirement at this time.
    FSIS does not have a routine sampling program at the rehang 
location, but the Agency evaluated such a program as part of the 2022 
young chicken exploratory sampling program discussed above. Among 180 
establishments sampled twelve or more times at the rehang location, 
Salmonella positive rates for young chicken carcasses ranged from 0 to 
100 percent, and the 95 percent confidence interval ranged from 54.9 to 
69.0 percent. Variability at the rehang location was also observed with 
AC and EB. Among 180 establishments with at least twelve analyzed 
sample pairs, the ACs average at the rehang location was 4.40 log cfu 
per mL (95 percent confidence 4.34 to 4.46 log cfu per mL) and EB 
average was 3.00 log cfu per mL (95 percent confidence 2.94 to 3.06 log 
CFU per mL).
    Two recent NACMCF reports, one published in March 2019 and the 
March 2023 NACMF Final Report, support the important role pre-harvest 
measures play in controlling Salmonella in poultry.
    2019 NACMCF Report. At a March 2017 NACMCF meeting, FSIS asked the 
committee to address the issue of how to reduce the prevalence of 
Salmonella on poultry throughout the farm-to-table continuum.\174\ In 
March 2019, the committee's final report addressing the Agency's 
questions was published in the Journal of Food Protection.\175\ 
Questions two, three, and six related to pre-harvest measures to 
control Salmonella in poultry. Question two asked where Salmonella 
resides inside and on the surface of poultry and how those populations 
of bacteria contribute to food contamination. The committee responded 
that most carcass contamination is believed to result from leakage of 
ingesta during crop removal and from feces during evisceration, as well 
as aerosolization during picking. In addition, Salmonella may be 
present in feather follicles and on the surface of broilers when they 
enter the slaughter establishment. Several preslaughter strategies to 
reduce the burden of Salmonella in flocks entering slaughter 
establishments have been shown to be effective, and data demonstrating 
a correlation between flock status of Salmonella and pre- and post-
chill contamination have been reported. Control measures for Salmonella 
in poultry can be classified as those that target (i) exposure and 
colonization within an individual animal, (ii) transmission between 
parent flocks and progeny, and (iii) transmission between birds within 
a flock. The committee also noted that Salmonella vaccination is one 
breeder-level pre-harvest intervention that contributes to an overall 
reduction and/or elimination of specific Salmonella serotypes. The 
committee stated that the most effective vaccination strategy is to 
focus on vaccination of breeder flocks and reduce vertical transmission 
of Salmonella.
---------------------------------------------------------------------------

    \174\ 2015-2017 NACMCF Charge, Salmonella Control Strategies in 
Poultry, available at: https://www.fsis.usda.gov/news-events/publications/2015-2017-national-advisory-committee-microbiological-criteria-foods.
    \175\ Response to Questions Posed by the Food Safety and 
Inspection Service Regarding Salmonella Control Strategies in 
Poultry (March 26, 2019), Journal of Food Safety, available at: 
https://www.fsis.usda.gov/news-events/publications/2015-2017-national-advisory-committee-microbiological-criteria-foods.
---------------------------------------------------------------------------

    Question three asked whether removing flocks of highly Salmonella-
contaminated birds entering the slaughter establishment can reduce 
foodborne illnesses in humans. The committee responded that it is 
logical to expect that removing flocks of highly Salmonella-
contaminated birds from the slaughter process would result in less 
human exposure to that source of Salmonella, potentially resulting in 
reduced foodborne illness in humans.

[[Page 64720]]

However, there was no consensus within the committee regarding the 
predictive ability of farm sampling and subsequent Salmonella 
contamination on neck skin at the end of processing. Given uncertainty 
about the impact of removing flocks of highly Salmonella-contaminated 
birds from slaughter, the committee recommended that process controls 
be validated to address a worst-case scenario for contamination of 
incoming birds and be continually operating at that level to address 
the potential risk from highly contaminated birds. The committee 
concluded that rather than establishing lot- or flock-specific 
thresholds, Salmonella management programs should be based on 
historical trend analyses of specific farms and transportation 
supplying birds to the slaughter process. Sampling birds immediately 
before entering the slaughter process would be ideal, but detection 
technology did not currently exist to provide the rapid detection 
needed for this scenario. Historical data might be used to build 
statistical models to predict the potential for elevated levels of 
Salmonella from a particular farm. In addition, monitoring of external 
factors, such as weather or seasonality, may help indicate the 
possibility of a higher-than-normal contamination level. Historical 
knowledge of process controls and facility capability can be used by a 
processor to determine whether process controls should be reassessed 
and validated to address predicted risks.
    Question six asked the committee to identify the top three focus 
points, control measures, or best practices that would be compatible 
with industry-wide practices and could be addressed or implemented to 
achieve the highest rate of reductions of Salmonella product 
contamination and foodborne illness. The committee's response included 
the statement that prevention or elimination of Salmonella 
colonization, should be effective for reducing Salmonella in final 
product and contributing to public health improvements.
    2023 NACMCF Report. In the 2023 NACMCF report, the committee 
addressed issues related to pre-harvest measures to control Salmonella 
in poultry.\176\ For question two of the NACMCF charges, FSIS asked the 
committee what types of microbiological criteria could be established 
to encourage control of Salmonella at pre-harvest, and what industry 
data would provide evidence of control. As part of its response, the 
committee noted that vaccination programs have been incorporated on 
U.S. farms. The committee described such vaccination programs as an 
effective management practice for controlling Salmonella at pre-harvest 
and noted that vaccines are likely the only serotype-specific 
intervention strategies.
---------------------------------------------------------------------------

    \176\ NACMCF final report ``Response to Questions Posed by the 
Food Safety and Inspection Service: Enhancing Salmonella Control in 
Poultry Products'' (March 13, 2023), available at: https://www.fsis.usda.gov/policy/advisory-committees/national-advisory-committee-microbiological-criteria-foods-nacmcf/2021.
---------------------------------------------------------------------------

    Together, the 2019 and 2023 NACMCF report responses related to pre-
harvest measures support the use of these measures to control 
Salmonella in poultry. In the 2019 report, the committee concluded that 
preslaughter strategies to reduce the burden of Salmonella in flocks 
entering slaughter establishments are effective, and that data show a 
correlation between flock status of Salmonella and pre- and post-chill 
contamination. The 2019 report also indicated that it is probable that 
removing flocks of highly Salmonella-contaminated birds from the 
slaughter process would result in less human exposure to that source of 
Salmonella, potentially resulting in reduced foodborne illness in 
humans. In the 2023 report, the committee recommended that the Agency 
target for consideration conditions in houses, transport crates, and 
holding areas that harbor and transmit Salmonella by universal 
implementation of known and validated mitigation strategies. Of note, 
both final reports indicated uncertainty regarding whether current 
testing technology and data are available to design and broadly 
implement effective threshold requirements for segregating Salmonella-
contaminated flocks at receiving.
    As discussed above, FSIS received comments on Component One of the 
October 2022 draft Salmonella Framework that raised concerns related to 
costs, testing technology, and implementation challenges. Several 
comments from small poultry processors and producers and trade 
associations representing the meat and poultry industries that 
expressed concerns that the measures under consideration in Component 
One would impose an overwhelming burden on small producers and 
processors.
    In light of these comments, FSIS has decided at this time not to 
establish a regulatory requirement that establishments characterize 
Salmonella as a hazard reasonably likely to occur at receiving or that 
incoming flocks be tested for Salmonella before entering an 
establishment. FSIS will actively seek evidence and best practices from 
the poultry industry. The Agency will revisit its strategy for using 
testing (including quantitation and deep serotyping) to minimize the 
risk of cross-contamination at processing when logistical challenges 
have been addressed and testing becomes more timely and affordable.
    FSIS has decided, instead, for the time being, to focus on non-
regulatory approaches to controlling Salmonella at preharvest and 
reducing the Salmonella load on birds at receiving. FSIS not proposing 
to enforce measures under Component One at this time. If the Agency 
decides to make any of the approaches discussed below mandatory, it 
will do so through future rulemaking.

B. Possible Approaches To Control Salmonella at Pre-Harvest

1. National Poultry Improvement Program
    FSIS will explore whether existing or new certification programs 
under the National Poultry Improvement Program (``NPIP'' or the 
``Plan'') could serve to verify and document producers' actions (such 
as use of Salmonella vaccines) to control Salmonella, including 
serotypes of public health significance.
    Administered by APHIS, NPIP is a cooperative industry, state, and 
federal program initially established to improve poultry and poultry 
products and prevent and control poultry diseases.\177\ The Plan 
identifies States, flocks, hatcheries, dealers, and slaughter plants 
that meet certain disease control standards specified in the Plan's 
various programs. NPIP regulations in 9 CFR parts 145 and 146 contain 
requirements that must be observed by participating flocks, including 
testing and biosecurity measures. These measures are updated over time 
as the science and technology evolve and improve. Affiliated flock-
owners participate in the Plan through an agreement with a 
participating hatchery. Participating hatcheries must be maintained in 
sanitary condition as outlined in the NPIP Program Standards and the 
U.S. Code of Federal Regulations and are subject to third party audit 
by an official state agency at least once every two years or a 
sufficient frequency to ensure compliance. NPIP programs are available 
for multiplier and primary breeding flocks for meat-type chicken and 
products (9 CFR part 145 subparts C and H), and turkey breeding flocks 
and products (9 CFR part 145 subpart D). These programs include 
biosecurity measures and may include testing for Salmonella or 
Salmonella serotype Enteritidis. The

[[Page 64721]]

Plan's ``U.S. Salmonella Monitored Program'' is intended for primary 
breeders of meat type chickens to reduce the incidence of Salmonella 
organisms in hatching eggs and chicks through an effective and 
practical sanitation program at the breeder farm and in the hatchery. 
The Plan's ``U.S. S. Enteritidis Clean Program'' is intended for 
primary or multiplier breeders of meat-type chickens wishing to assure 
their customers that the chicks produced are certified free of 
Salmonella Enteritidis.
---------------------------------------------------------------------------

    \177\ USDA Animal and Plant Health and Inspection Service 
(APHIS) National Poultry Improvement Plan information available at: 
https://www.poultryimprovement.org/default.cfm.
---------------------------------------------------------------------------

2. Vaccination
    FSIS will more actively encourage the development, licensure, and 
use of poultry vaccines against Salmonella serotypes of public health 
concern, particularly live attenuated vaccines, and will provide 
sampling data and technical support, as appropriate, to industry and 
regulatory bodies to advance these goals.
    Salmonella vaccination is one tool in a multifaceted approach to 
overall Salmonella reduction and/or elimination of specific Salmonella 
serotypes. Vaccines reduce the susceptibility of individual birds to 
Salmonella infection, transmission among breeding flocks, cross-
contamination during meat bird production, contamination of poultry 
house environments, and transmission to subsequent flocks. Live 
attenuated vaccines are derived from a specific strain of a target 
organism (i.e., Salmonella Typhimurium), subunit vaccines containing 
protein or nucleic acid from the target organism, and autogenous 
inactivated vaccines against a cocktail of strains found in a local 
area. Vaccines may provide cross protection across serotypes. For 
example, the availability of a commercial live attenuated vaccine 
created from Salmonella Typhimurium corresponded to a profound decline 
in the incidence of both Typhimurium and a related serotype Heidelberg 
illnesses.\178\ Attenuated strains can be designed to expose common 
antigens, therefore inducing cross-protective immunity against diverse 
Salmonella serotypes.\179\ Although vaccines can be protective and 
limit horizontal transmission of infection within broiler flocks, they 
must be given multiple times to all birds in each flock and, therefore, 
present logistical and cost challenges that must be overcome.
---------------------------------------------------------------------------

    \178\ NACMCF Report: ``Response to Questions Posed by the Food 
Safety and Inspection Service: Enhancing Salmonella Control in 
Poultry Products'' (Mar 2023). Available at: https://www.fsis.usda.gov/policy/advisory-committees/national-advisory-committee-microbiological-criteria-foods-nacmcf/2021.
    \179\ Aehle, S. and R. Curtiss (2017). Chapter 14--Current and 
Future Perspectives on Development of Salmonella Vaccine 
Technologies. Producing Safe Eggs. S. C. Ricke and R. K. Gast. San 
Diego, Academic Press: 281-299; Hassan, J. O. and R. Curtiss Iii 
(1997). ``Efficacy of a live avirulent Salmonella typhimurium 
vaccine in preventing colonization and invasion of laying hens by 
Salmonella typhimurium and Salmonella enteritidis.'' Avian Dis 
41(4): 783-791.
---------------------------------------------------------------------------

    FSIS will continue to collect data on the impact of vaccine use on 
FSIS verification testing through pilot projects. As noted above, since 
March 2023, FSIS has granted pilot projects to 9 establishments to 
examine the merits and logistics of excluding Salmonella poultry 
vaccine strains from the FSIS Salmonella performance categorization 
calculation. Modified live Salmonella vaccines are used to reduce 
Salmonella colonization in poultry. These vaccine strains are not 
foodborne pathogens, making them a valuable pre-harvest tool for 
controlling wild-type Salmonella. FSIS is able to identify vaccine 
strains isolated from raw poultry products through the use of whole 
genome sequencing.
    FSIS examined Salmonella detection and serotype data from flocks 
vaccinated with a modified live Salmonella vaccine at pre- and post-
intervention points in the participating slaughter establishments. 
These data show that vaccine strains can occasionally be found in raw 
poultry products even when the vaccine is used as directed on the 
label. After reviewing the data, FSIS concluded that its policy to 
count such strains as a positive result in performance categorization 
may discourage use of vaccination as a tool to control Salmonella. 
Therefore, on March 1, 2024, FSIS announced that beginning April 1, 
2024, it intends to exclude current commercial vaccine subtypes 
confirmed in FSIS raw poultry samples from the calculation used to 
categorize establishments under the raw poultry Salmonella performance 
standards.\180\ This action is intended to remove barriers to the use 
of vaccination as an important pre-harvest intervention to control 
Salmonella in poultry. A summary report of the data from these pilots 
is posted on the Pilot Projects: Salmonella Control Strategies page of 
the FSIS website at: https://www.fsis.usda.gov/inspection/inspection-programs/inspection-poultry-products/reducing-salmonella-poultry/pilot.
---------------------------------------------------------------------------

    \180\ FSIS Constituent Update--March 1, 2024: FSIS Intends to 
Exclude Vaccine Strains from the FSIS Salmonella Performance 
Categorization at: https://www.fsis.usda.gov/news-events/news-press-releases/constituent-update-march-1-2024.
---------------------------------------------------------------------------

3. Supply Chain Control Programs
    Establishments operating under HACCP regulations (9 CFR part 417) 
must perform a hazard analysis to identify food safety hazards that can 
occur before, during, and after entry into the establishment and to 
identify the preventive measures the establishment can apply to control 
those hazards. Establishments that identify hazards that occur before 
entry face the challenge of providing assurance that preventive 
measures are effectively applied. FSIS-inspected establishments 
operating under HACCP must document, validate, and verify the 
effectiveness of their hazard control(s). While not required to do so, 
establishments slaughtering poultry that have identified Salmonella as 
a hazard during the breeder and multiplier and production stages are 
encouraged by FSIS to use supply chain programs \181\ to verify the 
effectiveness of their supplier's interventions, and the Agency will 
ramp up its efforts to assist any establishment that wants to implement 
a supply chain program.
---------------------------------------------------------------------------

    \181\ One example of a supply chain program is a process 
verified program (PVP) administered by USDA's Agricultural Marketing 
Service (AMS). A PVP may include one or more agricultural processes 
or portions of processes where self-described process points are 
supported by a documented management system, and independently 
verified by a qualified AMS auditor. One PVP available to the 
poultry industry is the Quality System Assessment (QSA). The QSA 
provides companies that supply agricultural products and services 
the opportunity to assure customers of their ability to provide 
consistent quality products or services. It is limited to programs 
or portions of programs where specified product requirements are 
supported by a documented quality management system. USDA AMS 
Process Verified Program information available at: https://www.ams.usda.gov/services/auditing/process-verified-programs.
---------------------------------------------------------------------------

4. Updated Pre-Harvest Guidance
    FSIS intends to revise its existing guideline on Controlling 
Salmonella in Raw Poultry \182\ to provide updated guidance on pre-
harvest interventions and management practices for preventing and 
reducing Salmonella colonization in live birds. FSIS remains committed 
to identifying and developing strategies for addressing Salmonella 
contamination in the pre-harvest environment. Additionally, the Agency 
is working with the USDA's Agricultural Research Service (ARS) on a 
literature review of Salmonella presence in poultry at pre-harvest.
---------------------------------------------------------------------------

    \182\ FSIS Guideline for Controlling Salmonella in Raw Poultry 
(June 2021), available at: https://www.fsis.usda.gov/guidelines/2021-0005.
---------------------------------------------------------------------------

V. State Programs and Foreign Government Programs

    States that have their own poultry inspection programs for poultry

[[Page 64722]]

products produced and transported solely within the State are required 
to have mandatory ante-mortem and post-mortem inspection, reinspection, 
and sanitation requirements that are at least equal to those in the 
PPIA (21 U.S.C. 454(a)(1)). Therefore, if FSIS finalizes this proposed 
rule and determination, these States would need to develop sampling 
procedures and testing methods to detect Salmonella at or above 10 cfu/
mL(g) in an analytical portion and Salmonella serotypes of public 
health significance identified for raw chicken carcasses, chicken 
parts, comminuted chicken, and comminuted turkey products that are at 
least as sensitive as FSIS' procedures and testing methods for 
Salmonella. Additionally, these States would need to implement 
requirements for poultry slaughter establishments to develop, 
implement, and maintain written procedures to prevent contamination by 
enteric pathogens throughout the entire slaughter and dressing 
operation that are at least equal to FSIS' proposed revisions to the 
poultry regulations. FSIS will coordinate closely with States that 
maintain federally supported poultry inspection programs to ensure that 
this Salmonella Framework for raw poultry products is implemented in 
all intrastate establishments.
    Foreign countries that are eligible to export poultry products to 
the United States must apply inspection, sanitary, and other standards 
that are equivalent to those that FSIS applies to those products (21 
U.S.C. 466). Thus, in evaluating a foreign country's poultry inspection 
system to determine the country's eligibility to export products to the 
United States, FSIS will consider whether the sampling procedures and 
testing methods that the country implements for detection of Salmonella 
at or above 10 cfu/mL(g) in an analytical portion and Salmonella 
serotypes of public health significance identified for raw chicken 
carcasses, chicken parts, comminuted chicken, and comminuted turkey 
products are equivalent to FSIS' sampling procedures and testing 
methods. Additionally, FSIS will also evaluate whether the country's 
requirements for slaughter establishments to develop, implement, and 
maintain written procedures to prevent contamination by enteric 
pathogens throughout the entire slaughter and dressing operation are 
equivalent to FSIS' proposed revisions to the poultry regulations. FSIS 
will continue to use the existing equivalence process to ensure that 
foreign countries implement requirements, sampling procedures and 
testing methods equivalent to FSIS' proposed revisions to the poultry 
regulations and the sampling procedures and testing methods for 
Salmonella in raw chicken carcasses, chicken parts, comminuted chicken, 
and comminuted turkey products. FSIS intends to provide countries that 
export poultry products to the United States 3 years after publication 
of the final rule to submit adequate documentation to support that 
their poultry inspection system is equivalent to FSIS' inspection 
system. Thus, exporting countries would have a 3-year transition period 
in which they could continue to export poultry products to the United 
States while they implement measures to ensure that their poultry 
inspection system is equivalent to the U.S. system. FSIS would likely 
begin testing imported raw chicken carcasses, chicken parts, comminuted 
chicken, and comminuted turkey products to verify products are not 
adulterated one year after the final publication. FSIS will provide 
additional details on these issues in any final rule and determination 
resulting from this proposal.

VI. Executive Orders 12866, as Amended by 14094, and 13563

    Executive Orders (E.O.) 12866, as amended by 14094, and 13563 
direct agencies to assess all costs and benefits of available 
regulatory alternatives and, if regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety effects, distributive 
impacts, and equity). E.O. 13563 emphasizes the importance of 
quantifying both costs and benefits, of reducing costs, of harmonizing 
rules, and of promoting flexibility. This proposed rule and proposed 
determination have been designated a ``significant'' regulatory action 
by the Office of Information and Regulatory Affairs under section 3(f) 
of E.O. 12866. Accordingly, the proposed rule and proposed 
determination have been reviewed by the Office of Management and Budget 
under E.O. 12866.
Regulatory Impact Analysis
    FSIS is proposing to clarify certain process control requirements 
for poultry slaughter establishments and establish final product 
standards for chicken carcasses, chicken parts, comminuted chicken, and 
comminuted turkey. This proposal is aimed at reducing Salmonella 
illnesses in the U.S. population.
    FSIS is proposing to clarify current requirements for monitoring 
compliance with 9 CFR 381.65(g) for poultry slaughter establishments 
and to require poultry slaughter establishments to submit process 
control monitoring data electronically to FSIS. These establishments 
are currently required to monitor their processes to ensure they comply 
with FSIS regulations. FSIS is clarifying that MMPs need to be 
statistically based and is requiring that establishments collect 
samples specifically at rehang, or an alternative location if they 
submit and maintain supporting documentation. The proposed 
clarifications are estimated to have minimal economic impact on most 
establishments, while the potential effects on VLV and VS 
establishments operating under Traditional Inspection, as described in 
this analysis, would be potentially mitigated by the use of laboratory 
services provided by FSIS.
    FSIS is also proposing to implement new standards for chicken 
carcasses, chicken parts, comminuted chicken, and comminuted turkey as 
final products that would enter commerce. Product subject to these 
standards, as described in the foregoing, would be subject to FSIS 
routine sampling and verification testing for Salmonella. 
Establishments subject to FSIS verification sampling would be required 
to maintain control of sampled product pending test results. Product 
lots that do not meet the standards would be considered adulterated and 
would be diverted from commerce. Establishments could divert 
adulterated product to be fully cooked at a federal establishment and 
then sent into commerce.
    Finally, FSIS is encouraging establishments to consider including 
pre-harvest measures in their HACCP systems to address the hazard of 
Salmonella contamination prior to slaughter. The Agency is not 
requiring that establishments adopt pre-harvest measures; thus, any 
potential costs or benefits associated with those measures are 
especially challenging to analyze, and we request comment on relevant 
data and analytic methods of analysis.
Need for the Rule
    This regulatory action is necessary because while the results of 
FSIS' Salmonella verification sampling show that the current 
prevalence-based performance standards approach has been effective in 
reducing the proportion of poultry products contaminated with 
Salmonella, these measures have yet to have an observable impact on 
overall human Salmonella illness rates (see the Salmonella Performance 
Standards and Illnesses section for more details). An estimated 23 
percent of Salmonella illnesses are

[[Page 64723]]

attributed to poultry--17 percent to chicken products and 6 percent to 
turkey products--making poultry one of the leading sources of foodborne 
Salmonella illnesses in the United States.\183\ Thus, a reduction in 
Salmonella illnesses associated with poultry consumption would be 
expected to have an impact on overall Salmonella illnesses. A 2015 
analysis found that poultry consumption was more likely than any other 
animal protein to lead to Salmonella illnesses.\184\ Additionally, a 
2021 study observed that Salmonella outbreaks related to consumption of 
single ingredient poultry products were disproportionately higher than 
the estimated level of consumption of single ingredient poultry 
products.\185\
---------------------------------------------------------------------------

    \183\ The Interagency Food Safety Analytics Collaboration 
(IFSAC), ``Foodborne illness source attribution estimates for 2019 
for Salmonella, Escherichia coli O157, Listeria monocytogenes, and 
Campylobacter using multi-year outbreak surveillance data, United 
States,'' October 2021, https://www.cdc.gov/ifsac/php/annual-reports/index.html. Annually, IFSAC releases a report that estimates 
foodborne illness source attribution for major commodity groups, 
including Salmonella in poultry products. At the time this proposal 
was developed, the 2019 IFSAC attribution estimates were the most 
recent data available. IFSAC released a new annual report in 
November 2023, which includes attribution estimates for 2020. In the 
2023 report, IFSAC estimated that 18.6 percent of Salmonella 
illnesses are attributed to chicken products and 5.5 percent to 
turkey products, for a total 24.1 percent attributed to poultry 
products. FSIS intends to incorporate the 2023 report attribution 
estimates if this proposal is finalized. IFSAC, ``Foodborne illness 
source attribution estimates for Salmonella, Escherichia coli O157, 
and Listeria monocytogenes--United States 2021,'' November 2023, 
https://www.cdc.gov/ifsac/php/annual-reports/index.html.
    \184\ The analysis estimated that the risk of getting sick from 
Salmonella from one serving of poultry products was 94, 97, and 87 
percent larger than that for a serving of pork, beef, and lamb 
products, respectively. Hsi, D.J., Ebel, E.D., Williams, M.S., 
Golden, N.J. and Schlosser, W.D., 2015. Comparing foodborne illness 
risks among meat commodities in the United States, Food Control, 54, 
pp.353-359. https://doi.org/10.1016/j.foodcont.2015.02.018.
    \185\ The analysis observed that while chicken and turkey 
consumption represent roughly 0.6 and 0.2 percent of the U.S. daily 
diet, the share of outbreaks linked to these products is 
significantly higher: 2.1 and 1.5 percent, respectively. These 
estimates are for chicken and turkey consumed as single-ingredient 
foods. Richardson, L.C., Cole D., Hoekstra, R.M., Rajasingham, A., 
Johnson, S.D., Bruce, B.B., 2021. Foods Implicated in U.S. Outbreaks 
Differ from the Types Most Commonly Consumed. Journal of Food 
Protection, 84(5), pp.869-875. https://doi.org/10.4315/JFP-20-293.
---------------------------------------------------------------------------

    As part of this proposal for Salmonella in poultry, FSIS is 
proposing to clarify existing regulatory requirements related to 
process control monitoring and recordkeeping in 9 CFR 381.65(g) and (h) 
to better ensure that poultry slaughter establishments are effectively 
controlling Salmonella throughout their slaughter and dressing 
operations. FSIS is also proposing to declare that raw chicken 
carcasses, parts, and comminuted chicken and turkey that contain 
Salmonella at or above 10 cfu/mL(g) and a serotype of public health 
significance are adulterated because the 2023 risk assessments found 
that servings contaminated with these Salmonella levels and serotypes 
are much more likely to cause illness than the majority of chicken 
carcasses, chicken parts, comminuted chicken, and comminuted turkey 
servings (see the Risk per Serving, Salmonella Levels, and Proposed 
Determination section for more details). The 2023 risk assessments 
estimate that diverting products that contain these Salmonella levels 
and serotypes from commerce would prevent annual foodborne illnesses 
from Salmonella linked to poultry.\186\ Moreover, the FSIS risk profile 
indicates that for certain Salmonella serotypes often linked to poultry 
products a small amount of Salmonella bacteria can cause illness.\187\ 
It also noted that these serotypes caused hospitalization more 
frequently and led to invasive disease and death as well as 
debilitating human health outcomes.
---------------------------------------------------------------------------

    \186\ USDA, FSIS, ``Quantitative Microbiological Risk Assessment 
for Salmonella in Raw Chicken and Raw Chicken Products,'' January 
2023; USDA, FSIS, ``Quantitative Microbiological Risk Assessment for 
Salmonella in Raw Turkey and Raw Turkey Products,'' January 2023 at: 
https://www.regulations.gov/docket/FSIS-2023-0028.
    \187\ USDA, FSIS, ``Risk Profile for Pathogenic Salmonella 
Subtypes in Poultry,'' February 28, 2023 at: https://www.regulations.gov/docket/FSIS-2023-0028.
---------------------------------------------------------------------------

    FSIS is taking this regulatory action to protect public health and 
reduce the number of Salmonella illnesses linked to poultry products. 
If this proposal is finalized, it would protect consumers from 
consuming products that have a higher probability of illness and would 
incentivize producers implement food safety measures that would 
minimize the risk of Salmonella illnesses.
Baseline for Evaluation of Costs and Benefits
    Poultry consumption has grown 13 percent over the past 10 years, 
with broiler meat accounting for 83 percent of the total consumption, 
while turkey accounts for about 16 percent. Poultry--mainly chicken--is 
the main source of animal protein across demographic groups and is 
consumed both at home and away from home.\188\ Poultry products are 
available in multiple formulations, ranging from raw whole birds and 
parts to fully cooked, ready-to-eat products. In the United States, 
chicken breasts, legs, and wings are the most consumed chicken 
products.\189\ Turkey consumption, in contrast, is mainly as whole 
turkey, deli meat, ground turkey, or turkey bacon. Ground turkey 
consumption has increased substantially in the last decade, mainly as 
consumers opt for this product as a substitute for ground beef.\190\
---------------------------------------------------------------------------

    \188\ There is variability in poultry consumption among 
demographic groups. For example, poultry consumption is higher among 
the non-Hispanic Black population, followed by Hispanics and non-
Hispanic Asians. Poultry also represents a substantial source of 
protein for children, with chicken being the main source of animal 
protein among them. USDA, ERS, ``Racial and Ethnic Diversification 
Will Likely Shape U.S. Food Demand and Diet Quality,'' by Diansheng 
Dong and Hayden Stewart, April 4, 2022, https://www.ers.usda.gov/amber-waves/2022/april/racial-and-ethnic-diversification-will-likely-shape-u-s-food-demand-and-diet-quality/.
    \189\ USDA, Economic Research Service (ERS), ``Chicken leads 
U.S. per person availability of meat over last decade,'' March 1, 
2023, https://www.ers.usda.gov/data-products/chart-gallery/gallery/chart-detail/?chartId=105929.
    \190\ National Turkey Federation, ``Turkey by the Numbers,'' 
accessed June 20, 2021, https://www.eatturkey.org/turkeystats/; 
Agricultural Marketing Resource Center, ``Turkey Profile,'' January 
2022, https://www.agmrc.org/commodities-products/livestock-dairy-poultry/poultry/turkey-profile.
---------------------------------------------------------------------------

    On average, U.S. poultry establishments slaughtered 9.5 billion 
birds annually between 2017 and 2021, which is approximately 49.4 
billion pounds of poultry. Broiler and turkey meat accounted for 87 and 
12 percent of this production, respectively.\191\ The U.S. poultry 
supply is mainly comprised of domestically grown and processed poultry 
as imports represent a very small fraction of the total supply.\192\ 
Federally inspected establishments produce the vast majority of U.S. 
commercial poultry supply.\193\ Most federally inspected establishments 
that produce a high volume of product solely produce chicken or turkey 
products. Some establishments also slaughter other classes of poultry, 
such as duck and geese. While there are establishments that slaughter 
multiple species, they tend to produce a low volume of product.
---------------------------------------------------------------------------

    \191\ Other types of poultry (e.g., duck) account for the 
remaining 1 percent.
    \192\ Imports of poultry products into the United States 
represented less than 0.5 percent of total U.S. poultry consumption 
in 2021. The United States is a net exporter of poultry to the world 
and is the second largest exporter globally, with exports 
representing about 16 percent of the total domestic production in 
2021. USDA, Foreign Agricultural Service, ``Production, Supply and 
Distribution database,'' accessed May 11, 2023.
    \193\ USDA, National Agricultural Statistics Service, Surveys: 
Poultry Slaughter, October 19, 2020, https://www.nass.usda.gov/Surveys/Guide_to_NASS_Surveys/Poultry_Slaughter/index.php.

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[[Page 64724]]

Establishments Subject to the Current Salmonella Performance Standards 
and Proposed Final Product Standards
    FSIS used 2021 Public Health Information System (PHIS) data to 
identify establishments under the current Salmonella performance 
standards that produce chicken carcasses, chicken parts, comminuted 
chicken, and comminuted turkey, as well as their production 
volumes.\194\
---------------------------------------------------------------------------

    \194\ USDA, FSIS, Public Health Information System database, 
accessed January 2, 2023 and April 5, 2023. Certain establishments 
are currently excluded from Salmonella verification testing. 81 FR 
7288. FSIS adjusted the estimates for chicken parts, comminuted 
chicken, and comminuted turkey to match slaughter totals in the 
analysis period.
---------------------------------------------------------------------------

Chicken Carcasses
    In 2021, there were a total of 188 establishments under FSIS 
verification sampling for chicken carcasses that slaughtered over 8.3 
billion chickens. FSIS classified these establishments into one of four 
volume categories (Table 13). Of these, 142 establishments were high-
volume establishments, 9 were medium-volume, 4 were low-volume, and 33 
were VLV chicken slaughter establishments. The 142 high-volume 
establishments accounted for over 99.5 percent of the total head count 
slaughtered in 2021.

                  Table 13--Chicken Carcasses: Establishments Under FSIS Performance Standards
                                                     [2021]
----------------------------------------------------------------------------------------------------------------
                                                             Number of      Annual production       Share of
  Establishment volume category     Definition (birds)     establishments    (million birds)     production (%)
----------------------------------------------------------------------------------------------------------------
High.............................  10 million or more..                142              8,270              99.52
Medium...........................  More than 1.1                         9                 33               0.40
                                    million and less
                                    than 10 million.
Low..............................  More than 440,001                     4                  2               0.03
                                    and less than 1.1
                                    million.
Very Low \1\.....................  No more than 440,000                 33                  4               0.05
                                                        --------------------------------------------------------
    Total........................  ....................                188              8,309  .................
----------------------------------------------------------------------------------------------------------------
\1\ Very low-volume establishments are defined in 9 CFR 381.65g(1)(i).
Note: Numbers in table may not sum to totals due to rounding.

Chicken Parts
    In 2021, there were 490 establishments under FSIS verification 
sampling that produced chicken legs, breasts, wings, halves, and/or 
quarters (Table 14). Of these, 484 establishments were subject to FSIS 
performance standards sampling for chicken legs, breasts, and wings. 
The proposal would apply to establishments that produce chicken legs, 
breasts, wings, thighs, halves, and quarters. In 2021, most of the 
establishments producing chicken halves and quarters also produced 
legs, breasts, and wings. FSIS sampling at these establishments would 
be adjusted to incorporate chicken halves and quarters samples, while 
maintaining the current sampling frequency. In 2021, six establishments 
produced chicken halves and quarters, but did not produce legs, 
breasts, or wings. These six establishments are currently sampled as 
part of FSIS' exploratory sampling program for chicken halves and 
quarters.
    FSIS estimates that these establishments produced over 31.2 billion 
pounds of chicken parts in 2021. FSIS classified these establishments 
according to the volume categories the Agency used in the 2016 cost-
benefit analysis in support of FSIS ``Chicken Parts and Not Ready-To-
Eat Comminuted Poultry Performance Standards.'' \195\ In 2021, 154 of 
these establishments were high-volume, 209 were medium-volume, and 127 
were low-volume establishments (Table 14). The 154 high-volume 
establishments accounted for roughly 90 percent of the production 
volume of chicken parts in 2021.
---------------------------------------------------------------------------

    \195\ USDA, FSIS, ``Chicken Parts and Not Ready-To-Eat 
Comminuted Poultry Performance Standards,'' Final Cost-Benefit 
Analysis, February 11, 2016, https://www.fsis.usda.gov/sites/default/files/media_file/documents/FRN-related-CBA-Salmonella-Campy-2014-0023-022016.pdf.

                 Table 14--Chicken Parts: Establishments Under FSIS Performance Standards (2021)
----------------------------------------------------------------------------------------------------------------
                                    Definition (annual       Number of      Annual production       Share of
  Establishment volume category     production pounds)     establishments    (million pounds)    production (%)
----------------------------------------------------------------------------------------------------------------
 
High.............................  70 million or more..                154             28,113               90.1
Medium...........................  More than 1 million                 209              3,055                9.8
                                    and less than 70
                                    million.
Low..............................  1 million or less...                127                 40                0.1
                                                        --------------------------------------------------------
    Total........................  ....................                490             31,208  .................
----------------------------------------------------------------------------------------------------------------
Note: Numbers in table may not sum to totals due to rounding.

Comminuted Chicken
    In 2021, there were 74 establishments under FSIS verification 
sampling for comminuted chicken (Table 15). FSIS estimates that these 
establishments produced about 2.3 billion pounds of comminuted chicken 
in 2021. Using the categories in the 2016 cost-benefit analysis, the 
Agency classified 35 establishments as medium-volume and 39 
establishments as low-volume. The

[[Page 64725]]

35 medium-volume establishments accounted for 97.2 percent of total 
production of comminuted chicken in 2021.

              Table 15--Comminuted Chicken: Establishments Under FSIS Performance Standards (2021)
----------------------------------------------------------------------------------------------------------------
                                     Definition (daily       Number of      Annual production       Share of
  Establishment volume category     production pounds)     establishments    (million pounds)    production (%)
----------------------------------------------------------------------------------------------------------------
High.............................  250,000 or more.....                  0                  0                0.0
Medium...........................  More than 6,000 and                  35              2,193               97.2
                                    less than 250,000.
Low..............................  Less than 6,000.....                 39                 63                2.8
                                                        --------------------------------------------------------
    Total........................  ....................                 74              2,256  .................
----------------------------------------------------------------------------------------------------------------
Note: Numbers in table may not sum to totals due to rounding.

Comminuted Turkey
    In 2021, there were 48 establishments under FSIS verification 
sampling for comminuted turkey (Table 16). FSIS estimates that these 
establishments produced about 1.7 billion pounds of comminuted turkey 
in 2021. Using the categories in the 2016 cost-benefit analysis, the 
Agency classified 5 establishments as high-volume, 25 establishments as 
medium-volume, and 18 as low-volume establishments. The 5 high-volume 
establishments accounted for 54.2 percent of the total production in 
2021, while medium-volume establishments accounted for 45.3 percent, 
and low-volume establishments accounted for less than 1 percent of the 
total.

               Table 16--Comminuted Turkey: Establishments Under FSIS Performance Standards (2021)
----------------------------------------------------------------------------------------------------------------
                                     Definition (daily       Number of      Annual production       Share of
  Establishment volume category     production pounds)     establishments    (million pounds)    production (%)
----------------------------------------------------------------------------------------------------------------
High.............................  250,000 or more.....                  5                917               54.2
Medium...........................  More than 6,001 and                  25                766               45.3
                                    less than 250,000.
Low..............................  Less than 6,000.....                 18                  8                0.5
                                                        --------------------------------------------------------
    Total........................  ....................                 48              1,691  .................
----------------------------------------------------------------------------------------------------------------
Note: Numbers in table may not sum to totals due to rounding.

Salmonella on Poultry Products
    Salmonella is a foodborne pathogen commonly attributed to 
consumption of contaminated products that can lead to serious illness 
and death. In the United States, it is estimated to cause over 1.35 
million illnesses annually, including 26,500 hospitalizations and 420 
deaths.\196\ Salmonella is estimated to be the leading pathogen in 
terms of total cost of illnesses in the United States, with about 24 
percent of the total cost.\197\ A 2020 study estimated that the 
economic costs of Salmonella illnesses associated with chicken is $2.8 
billion annually.\198\ A 2021 Interagency Food Safety Analytics 
Collaboration report attributed roughly 23 percent of the total annual 
Salmonella illnesses to consumption of poultry products, mainly chicken 
(17 percent) and turkey (6 percent).\199\ Salmonella outbreaks linked 
to poultry products have continued to occur over the last two decades. 
From 1998 to 2020, FSIS identified 210 foodborne Salmonella outbreaks 
linked to chicken or turkey (Figure 1).\200\ Generally, chicken 
products were implicated in 84.8 percent (178 out of 210) of the 
outbreaks and turkey products were implicated in 15.2 percent (32 out 
of 210) of the outbreaks.\201\
---------------------------------------------------------------------------

    \196\ CDC, ``Salmonella,'' November 10, 2022. https://www.cdc.gov/salmonella/index.html; USDA, FSIS, ``Risk Profile for 
Pathogenic Salmonella Subtypes in Poultry,'' February 28, 2023 at: 
https://www.regulations.gov/docket/FSIS-2023-0028.
    \197\ USDA, ERS, ``Cost Estimates of Foodborne Illnesses,'' 
Total cost of foodborne illness estimates for 15 leading foodborne 
pathogens dataset, March 10, 2021, https://www.ers.usda.gov/data-products/cost-estimates-of-foodborne-illnesses.aspx.
    \198\ USDA, FSIS, ``USDA Releases Proposed Regulatory Framework 
to Reduce Salmonella Infections Linked to Poultry Products,'' 
October 14, 2022, https://www.fsis.usda.gov/news-events/news-press-releases/usda-releases-proposed-regulatory-framework-reduce-salmonella. A cost of illness model that replaces the productivity 
loss estimates with a pain, suffering, and functional disability 
measure based on monetized quality-adjusted life year estimates 
indicates that the estimated annual cost of Salmonella illness was 
around $11.4 billion (ranging from $2.5 to $29.1 billion) in 2010 
dollars. Scharff, R.L., 2012. Economic burden from health losses due 
to foodborne illness in the United States. Journal of food 
protection, 75(1), pp.123-131, DOI: 10.4315/0362-028X.JFP-11-058.
    \199\ The Interagency Food Safety Analytics Collaboration, 
``Foodborne illness source attribution estimates for 2019 for 
Salmonella, Escherichia coli O157, Listeria monocytogenes, and 
Campylobacter using multi-year outbreak surveillance data, United 
States,'' October 2021, https://www.cdc.gov/foodsafety/ifsac/pdf/P19-2019-report-TriAgency-508.pdf.
    \200\ Chicken was considered the source of contamination on the 
outbreak linked to stuffed chicken products.
    \201\ CDC, National Outbreak Reporting System (NORS), NORS 
Dashboard, accessed April 2023, https://wwwn.cdc.gov/norsdashboard/
;USDA, FSIS, ``Outbreak Investigations: Response May 10, 2023 
https://www.fsis.usda.gov/food-safety/foodborne-illness-and-disease/outbreaks/outbreak-investigations-response.

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[[Page 64726]]

[GRAPHIC] [TIFF OMITTED] TP07AU24.041

    In 2023, FSIS developed a risk profile that details current 
knowledge on Salmonella to inform Agency efforts. The risk profile 
identified 28 Salmonella serotypes (out of around 2,500 serotypes) and 
four serogroups which were attributed to human salmonellosis from 
consuming chicken and turkey products. The FSIS risk profile indicated 
that for at least some subtypes of concern a small amount (i.e., low 
dose of Salmonella bacteria), can cause illness. The FSIS risk profile 
noted that certain serotypes caused hospitalization more frequently and 
also led to invasive disease and death. Some subtypes have also been 
found to cause debilitating human health outcomes. Among these outcomes 
are cancer, inflammatory bowel disease, irritable bowel syndrome, and 
reactive arthritis. The overall hospitalization rate for all Salmonella 
is about 2 percent and the fatality rate is about 0.04 percent. 
However, the hospitalization rate for these serotypes is nearly 23 
percent and the fatality rate is about 0.5 percent.\202\
---------------------------------------------------------------------------

    \202\ USDA, FSIS, ``Risk Profile for Pathogenic Salmonella 
Subtypes in Poultry,'' February 28, 2023 at: https://www.regulations.gov/docket/FSIS-2023-0028.
---------------------------------------------------------------------------

    Salmonella is the main pathogen resulting in foodborne illness-
related deaths and hospitalizations, as well as loss of quality-
adjusted life years (QALYs) and disability-adjusted life years (DALYs). 
The CDC estimates that Salmonella accounts for about 11 percent of 
total cases of domestically acquired foodborne illness.\203\ However, 
it disproportionately accounts for about 44 percent of deaths 
associated with domestic bacterial foodborne illness from major 
pathogens and 28 percent of the hospitalizations. It has also been 
estimated to lead to the highest amount of QALYs lost among 14 domestic 
foodborne bacterial, viral, and parasitic pathogens. Salmonella is also 
estimated to contribute to 32,900 lost DALYs, or about 30 percent of 
lost DALYs from seven leading foodborne pathogens.\204\
---------------------------------------------------------------------------

    \203\ CDC, ``Burden of Foodborne Illness: Findings,'' November 
5, 2018, https://www.cdc.gov/foodborneburden/2011-foodborne-estimates.html.
    \204\ USDA, FSIS, ``Risk Profile for Pathogenic Salmonella 
Subtypes in Poultry,'' February 28, 2023 at: https://www.regulations.gov/docket/FSIS-2023-0028.
---------------------------------------------------------------------------

Potential Costs and Benefits of the Proposed Rule and Proposed 
Determination
    FSIS estimates that this proposal would result in a reduction in 
Salmonella illnesses among consumers. Furthermore, for producers, the 
reduction in the risk of illness, and hence outbreaks, would result in 
a lower risk of having to recall product. Producers would, as a result 
avoid the costs associated with that reduction. While producers would 
respond to this proposal in a way that makes economic sense to them, 
FSIS estimated the quantified cost associated with this proposal as 
explained in more detail below.
    This proposal would also benefit industry as FSIS would clarify 
process control requirements for poultry slaughter establishments, 
which would likely contribute to a reduction in Salmonella 
contamination. Further, the Agency would incentivize innovation and the 
adoption of safer scientific methods in poultry production.
    In the following sections, this analysis presents potential costs 
and benefits generated over a range of assumptions that could accrue as 
a result of FSIS' action, if this rule is finalized. To implement this 
proposal, FSIS would adopt an implementation schedule that would allow 
medium-, low-, and very low-volume establishments additional 
flexibility. Specifically, medium-volume establishments would have two 
years after the proposal is finalized to comply with the proposed 
requirements, while low- and very low-volume establishments would have 
three years. High-volume establishments would be required to comply 
with these proposed requirements one year after this rule is finalized. 
The Agency incorporated this implementation schedule into the 
annualization of costs and benefits estimates in this analysis, which 
are presented after the one-time and recurring cost estimates for each 
requirement. FSIS annualized costs and benefits using a 7 percent 
discount rate over a period of 10 years. FSIS applied the share of 
production for each establishment category to derive the lost value and 
prevented illness estimates that correspond with the implementation 
schedule. FSIS is seeking comment on these assumptions.

[[Page 64727]]

Potential Costs of the Proposed Rule and Proposed Determination
Costs Associated With the Proposed Rule
Statistical Process Control Costs
    FSIS currently requires poultry slaughter establishments to 
develop, implement, and maintain written procedures to prevent 
contamination by enteric pathogens and fecal contamination throughout 
the entire slaughter operation and incorporate these procedures into 
their HACCP systems (9 CFR 381.65(g)). At a minimum, these procedures 
must include sampling and analysis for microbial organisms at pre-and 
post-chill to monitor their ability to maintain process control, with 
some exceptions for VS and VLV establishments operating under 
Traditional Inspection. The proposal specifies that establishments must 
collect the pre-chill sample at rehang (post-picking and pre-
evisceration) and clarifies that its microbial organism monitoring 
practices must result in data suitable for monitoring process control. 
While many establishments already meet the proposed specifications, 
some establishments may change where they collect the pre-chill sample 
or change the microbial organism they test for. However, establishments 
may continue their current sampling location and microbial organism 
monitoring practices, or adopt an alternative location and organism, if 
they submit and maintain supporting documentation. The Agency is also 
providing guidance for establishments to develop their MMPs. FSIS 
assumes that most establishments would meet the proposed MMP 
requirements without having to make any changes that would result in 
costs, while some establishments would have to make minor changes in 
response to this proposal at de minimis costs. The Agency is seeking 
comments on these assumptions.
    FSIS regulations currently require that VLV establishments collect 
process control monitoring samples minimally once per week for a 
minimum of 13 consecutive weeks per year, beginning the first week of 
June.\205\ FSIS is proposing to eliminate the requirement that VLV 
establishments begin sample collection the first week in June, which 
would allow establishments to begin collecting samples throughout the 
year. FSIS estimates there is no cost associated with this revised 
requirement, while establishments may benefit from this flexibility.
---------------------------------------------------------------------------

    \205\ 9 CFR 381.65(g)(2)(ii).
---------------------------------------------------------------------------

    FSIS estimates that 90 VLV and 2 VS poultry slaughter 
establishments operating under Traditional Inspection would likely need 
to make changes in response to the proposed process control 
requirements.\206\ FSIS is proposing to revise 9 CFR 381.65g(1) such 
that all poultry slaughter establishments would be required to collect 
samples at the rehang and post-chill locations. Very small and VLV 
establishments operating under Traditional Inspection are currently 
required to collect samples only at post-chill. FSIS currently requires 
that VLV establishments minimally collect 13 weekly samples per year to 
monitor process control. If this rule is finalized, these 
establishments would be required to collect and analyze 13 additional 
samples per year. The number of additional samples for VS 
establishments operating under Traditional Inspection that are not VLV 
establishments depends on their production volume. FSIS assumed that 
these VS establishments currently collect 52 samples per year and, 
consequently, would collect an additional 52 samples per year. FSIS is 
seeking comment on these assumptions.
---------------------------------------------------------------------------

    \206\ Very low-volume establishments are those that slaughter 
less than 440,000 chickens or 60,000 of any other poultry class 
annually. Very small establishments are those with less than 10 
employees or under $2.5 million in annual sales. 9 CFR 381.65g(1)(i) 
and 9 CFR 381.65g(1)(ii).
---------------------------------------------------------------------------

    FSIS would reduce the burden this proposed increase in sampling 
places on VLV and VS establishments operating under Traditional 
Inspection by making laboratory services available to these 
establishments. Use of the laboratories provided by FSIS would enable 
these establishments to comply with the proposed minimum requirements 
for MMPs. Should these establishments elect not to use the laboratory 
services provided by FSIS, the Agency estimated the combined cost for 
these establishments to meet the proposed increase in sampling would be 
$48,412 annually (Table 17). Assuming the proposed implementation 
schedule and annualizing over 10 years at a 7 percent discount rate, 
the cost for these establishments to meet the proposed increase in 
sampling would be $35,950. This analysis assumed samples collected at 
these establishments are analyzed for AC, at a cost of $38 per sample.

               Table 17--Statistical Process Control Costs
------------------------------------------------------------------------
                                        Number of
        Establishments type           establishments    Testing cost ($)
                                          (2021)
------------------------------------------------------------------------
Very low-volume under Traditional                  90             44,460
 Inspection.......................
Very small under Traditional                        2              3,952
 Inspection.......................
                                   -------------------------------------
    Total.........................                 92             48,412
    Annualized \1\................  .................             35,950
------------------------------------------------------------------------
\1\ Costs annualized at a discount rate of 7% over 10 years.
* Note: Numbers in table may not sum to totals due to rounding.

Electronic Data Submission
    FSIS would require poultry slaughter establishments subject to 9 
CFR 381.65(g) and (h) to electronically submit data generated as part 
of their process control monitoring. FSIS estimates that high- and 
medium-volume establishments already compile process control data 
electronically due to the large volume of their operations and the 
frequency of their sample collection and analysis. To mitigate the 
impact on low- and VLV establishments, should this rule become final, 
the Agency would develop and publish a template these establishments 
could use to record and submit their monthly results.
    In 2021, there were 298 establishments that would have been subject 
to this change, of which 175 were high-volume, 15 medium-, 14 low-, and 
94 very low-volume.\207\

[[Page 64728]]

Establishments that elect to use laboratory services provided by FSIS 
for their process control samples would meet this requirement and not 
incur additional costs. This analysis assumed that none of the eligible 
establishments would choose to use laboratories provided by FSIS and 
the Agency estimated the costs associated with this requirement for all 
eligible establishments. Consequently, there is a tendency toward 
overstatement in the cost to regulated establishments associated with 
this proposal.
---------------------------------------------------------------------------

    \207\ The 94 VLV establishments include the 90 establishments 
operating under Traditional Inspection, as well as four 
establishments not under Traditional Inspection.
---------------------------------------------------------------------------

    FSIS assumed it would take a quality control (QC) manager 30 
minutes (0.5 hours) once a month to submit these data. FSIS estimates 
that the average wage for a QC manager is $113.24, which includes an 
average hourly wage of $56.62 multiplied by a benefits and overhead 
factor of two.\208\ Under these assumptions, the combined cost to 
industry is $202,473 (0.5 hours x 12 months x 298 establishments x 
$113.24) per year (Table 18), including $118,902 for high-volume 
establishments, $10,192 for medium-volume, $9,512 for low-volume, and 
$63,867 for VLV. Assuming the proposed implementation schedule and 
annualizing over 10 years at a 7 percent discount rate, the cost for 
electronic data submissions is $182,228.
---------------------------------------------------------------------------

    \208\ Mean hourly wage estimate of $56.62 obtained from the 
Bureau of Labor Statistics, May 2021 National Industry Specific 
Occupational Employment and Wage Estimates for 11-3051 Management 
Occupations. https://www.bls.gov/oes/2021/may/oes113051.htm.

                                   Table 18--Electronic Data Submission Costs
----------------------------------------------------------------------------------------------------------------
                                                                             Cost ($)
                                                 ---------------------------------------------------------------
          Establishment volume category                                              All other
                                                      Chicken         Turkey          classes          Total
----------------------------------------------------------------------------------------------------------------
High............................................          97,839          19,024           2,038         118,902
Medium..........................................           8,153             679           1,359          10,192
Low.............................................           7,474             679           1,359           9,512
Very Low........................................          55,714           7,474             679          63,867
                                                 ---------------------------------------------------------------
    Total.......................................         169,181          27,857           5,436         202,473
    Annualized \1\..............................  ..............  ..............  ..............         182,228
----------------------------------------------------------------------------------------------------------------
\1\ Costs annualized at a discount rate of 7% over 10 years.
Note: Numbers in table may not sum to totals due to rounding.

HACCP Plan Reassessment Costs 209
---------------------------------------------------------------------------

    \209\ Note: For simplicity, this section includes HACCP 
reassessment costs associated with the proposed rule and proposed 
determination, as some establishments subject to the proposed rule 
are also subject to the proposed determination.
---------------------------------------------------------------------------

    The Agency assumed that every poultry slaughter establishment would 
reassess their HACCP plans and incur associated costs. This likely 
overestimates costs because not every establishment would reassess 
their HACCP plans. For chicken slaughter establishments that produce 
chicken carcasses subject to these proposed final product standards and 
are also subject to the proposed process control requirements, FSIS 
assumed they would only reassess their slaughter HACCP plan once. 
However, for establishments that produce multiple products subject to 
these final product standards, FSIS assumed they would reassess their 
HACCP plans for each of the products they produce that are affected by 
the proposed changes. However, establishments that have to reassess 
HACCP plans for multiple products would likely experience some 
economies of scope. Furthermore, establishments could coordinate 
reassessing their HACCP plans in response to this proposal with 
currently required annual reassessments.
    FSIS estimates that the total cost to industry from reassessing 
HACCP plans as a result of this proposal is $1.39 million, ranging from 
$0.70 to $2.09 million (Table 19). Assuming the proposed implementation 
schedule and annualizing over 10 years at a 7 percent discount rate, 
the cost for HACCP plan reassessment is $0.18 million, ranging from 
$0.09 million to $0.26 million. High- and medium-volume establishments 
need an average of 60 hours (ranging from 30 to 90), while low and VLV 
establishments need an average of 30 hours (ranging from 15 to 45) to 
reassess a HACCP plan, according to the 2015 ``Costs of Food Safety 
Investments'' report. This report estimated costs for large and small 
establishments. FSIS assumed the large category would correspond with 
high- and medium-volume establishments, while the small category would 
correspond with low- and very low-volume establishments. FSIS used data 
from the U.S. Bureau of Labor Statistics to update the hourly wage for 
estimating these labor costs. Specifically, FSIS used the 2021 hourly 
wage for a production worker of $30.78, which includes an average 
hourly wage of $15.39 multiplied by a benefits and overhead factor of 
two.

                                     Table 19--HACCP Plan Reassessment Costs
----------------------------------------------------------------------------------------------------------------
                                                                             Cost (million $)
    Establishment volume category         Number of     --------------------------------------------------------
                                        establishments          Low                Mid                High
----------------------------------------------------------------------------------------------------------------
High................................                333               0.31               0.61               0.92
Medium..............................                279               0.26               0.52               0.77
Low.................................                193               0.09               0.18               0.27
Very Low............................                 91               0.04               0.08               0.13
                                     ---------------------------------------------------------------------------
    Total...........................  .................               0.70               1.39               2.09
    Annualized \1\..................  .................               0.09               0.18               0.26
----------------------------------------------------------------------------------------------------------------
\1\ Costs are annualized at a 7 percent discount rate over 10 years.

[[Page 64729]]

 
Note: Number of establishments is not additive as some establishments produce multiple products. Numbers in
  table may not sum to totals due to rounding.

Validation of HACCP Plans
    If an establishment makes changes to their HACCP plan, they would 
also have to validate it, incurring associated costs. However, the 
Agency assumed few establishments would make changes to their MMPs and 
only those that make changes would need to validate their HACCP plans. 
Additionally, the Agency assumed that many establishments have already 
implemented Salmonella controls in response to the 2016 FSIS 
performance standards and will not need to make changes to their HACCP 
plan. The 2015 ``Costs of Food Safety Interventions'' report indicates 
that high- and medium-volume establishments would need an average of 
320 labor hours, while low- or very low-volume establishments would 
need an average of 400 hours to validate a HACCP plan. The estimated 
cost for HACCP plan validation is $25,894 for a high or medium-volume 
establishment, on average, and for a low- or very low-volume 
establishment it is $32,368. FSIS used the 2021 hourly wage for a food 
scientist of $80.92, which includes an average hourly wage of $40.46 
multiplied by a benefits and overhead factor of two, for this 
estimate.\210\ FSIS did not include a total industry HACCP validation 
cost because FSIS does not have data on the number of establishments 
that will make changes to their plans in response to this proposal. 
FSIS is requesting comments to address this data gap.
---------------------------------------------------------------------------

    \210\ BLS, May 2021 National Industry-Specific Occupational 
Employment and Wage Estimates for 19-1012 Food Scientists and 
Technologists, accessed April 13, 2023, https://www.bls.gov/oes/2021/may/oes191012.htm.
---------------------------------------------------------------------------

Costs Associated With the Proposed Determination
Maintaining Control of Sampled Product Costs
    FSIS is proposing that chicken carcasses, chicken parts, comminuted 
chicken, and comminuted turkey with Salmonella levels at or above 10 
cfu/mL(g) and one of the Salmonella serotypes of public health 
significance intended for consumption as final products would be 
adulterated. As proposed, FSIS inspected establishments would be 
required to maintain control of product sampled as part of FSIS 
verification sampling for adulterants. Any chicken carcass, parts, 
comminuted chicken, or comminuted turkey final products testing 
positive for Salmonella levels at 10 cfu/mL(g) or higher would not be 
allowed to enter commerce until the Salmonella serotype result is 
reported and no serotypes of public health significance are detected.
    If this proposal is finalized, establishments would be required to 
prevent product sampled as part of FSIS verification sampling from 
entering commerce until a negative test result or one above the 10 cfu/
mL(g) level but not containing a serotype of public health significance 
is received. FSIS does not require establishments to hold product at 
their physical location; thus, product can be stored off-site at an 
establishment's storage facility, or another private or public storage 
facility, pending test results. Product subject to FSIS verification 
sampling can also be diverted and processed into a product that is not 
subject to these final product standards (i.e., fully cooked products) 
instead of being sent to cold storage.
    FSIS anticipates that the Agency would provide establishments with 
final adulteration results five days after the sample is 
collected.\211\ Results on a product's level of Salmonella would 
require industry to hold sampled lots for two days and results on the 
presence of a serotype of public health significance would take an 
additional three days. The Agency assumed that establishments would 
maintain control of product until final adulteration results are 
available. Establishments would be able to move product with test 
results at levels below 10 cfu/mL(g) into commerce, which would 
necessitate product to be under establishment's control for up to two 
days. The Agency assumed that establishments would decide to divert 
adulterated product after results on its adulteration status are 
available. This cost is described in the Lost value to the industry 
costs section.
---------------------------------------------------------------------------

    \211\ While the Agency currently uses whole genome sequencing to 
determine the presence of Salmonella serotypes on product sampled by 
FSIS, the Agency would adopt an alternative approach that would lead 
to results on the presence of Salmonella serotypes in one to three 
days after screening.
---------------------------------------------------------------------------

    To estimate the industry cost for holding product pending test 
results, FSIS used 2021 data from PHIS. FSIS assumed that 
establishments subject to these final product standards would maintain 
control of each sampled lot pending FSIS verification sampling results. 
Regulated establishments define their production lots according to 
their specific conditions and FSIS allows establishments to adjust 
their lot sizes if they provide scientific justification for defining 
lots.\212\ Thus, FSIS used Agency data to approximate the amount of 
product subject to verification sampling. For chicken carcasses, the 
estimated lot size is 46,000 birds for high- and medium-volume 
establishments and 1,800 birds for low- and very low-volume 
establishments.\213\ For establishments producing chicken parts, 
comminuted chicken, and comminuted turkey, the estimated lot sizes are 
(1) one hour, (2) one shift, and (3) one day of production. These 
estimated lot sizes, respectively, represent the low, medium, and high 
scenarios used for estimating the cost of maintaining control of 
product pending test results for chicken parts, comminuted chicken, and 
comminuted turkey in this analysis. FSIS is seeking comment on these 
assumptions.
---------------------------------------------------------------------------

    \212\ 77 FR 73401.
    \213\ Establishments that slaughter less than 1 million birds 
per year had flock sizes ranging from 100 to 3,500 birds. FSIS used 
the average, or 1,800 birds, to approximate the total sampled 
production at these establishments.
---------------------------------------------------------------------------

    Since FSIS is proposing to sample these products at the same rate 
as the current performance standards, the Agency used the number of 
samples collected in 2021 at establishments that would be subject to 
this proposal and the estimated lot sizes to approximate the volume of 
product that would be subject to the Agency's verification sampling 
program.\214\
---------------------------------------------------------------------------

    \214\ FSIS collects up to five continuous samples per month at 
establishments producing young chicken and turkey carcasses, and raw 
chicken parts, comminuted chicken and turkey products. USDA, FSIS, 
``Salmonella Verification Testing Program Monthly Posting,'' April 
20, 2023, https://www.fsis.usda.gov/science-data/data-sets-
visualizations/microbiology/Salmonella-verification-testing-program-
monthly.
---------------------------------------------------------------------------

    FSIS used the per pound cost of cold storage as estimated in the 
2015 ``Costs of Food Safety Investments'' report to monetize the cost 
to industry from holding product due to this proposal.\215\

[[Page 64730]]

FSIS updated this estimate to 2021 dollars by applying the growth in 
the ``Moving, storage, freight expense'' consumer price index.\216\ The 
resulting cost of cold storage estimate, on a per pound, per day basis 
is $0.0023 in 2021 dollars. Establishments may already store product in 
their facilities or in an off-site location for a certain amount of 
time. However, the Agency assumed that all costs of storing product for 
the sampled lots are due to this proposal. FSIS is seeking comments on 
cold storage costs and availability at inspected establishments or off-
site facilities.
---------------------------------------------------------------------------

    \215\ For cold storage, the report assumes that the cost of 
creating and maintaining onsite storage would be equivalent to 
third-party, offsite cold storage. The establishment needs to ensure 
that the offsite cold storage facility is certified for food-grade 
products by USDA. Incoming product will already be cooled, so the 
storage facility would only need to maintain the product 
temperature. FSIS assumed product would be refrigerated. RTI Costs 
of Food Safety Investments. September 2015. Contract No. AG-3A94-B-
13-0003 Order No. AG-3A94-K-14-0056. Revised Final Report. Prepared 
by Catherine L. Viator, Mary K. Muth, Jenna E. Brophy. RTI 
International. RTI Project Number 0214016.003.000.001. The full 
report is available here: https://www.fsis.usda.gov/sites/default/files/media_file/documents/Costs_of_Food_Safety_Investments_FSIS-2022-0013.pdf.
    \216\ Bureau of Labor Statistics (BLS), Consumer Price Index 
(CPI), ``Moving, storage, freight expense in U.S. city average, all 
urban consumers, not seasonally adjusted,'' (Series ID 
CUUR0000SEHP03), accessed February 14, 2023. This CPI grew 37.5 
percent from 2015 to 2021.
---------------------------------------------------------------------------

Chicken Carcasses
    FSIS estimated that in 2021 establishments subject to the 
performance standards produced 33.2 billion pounds of chicken 
carcasses. \217\ The Agency estimated that about 11 percent of chicken 
carcasses are consumed as whole birds and, thus, final products subject 
to the proposal.\218\ To account for uncertainty in this estimate, the 
Agency used 6, 11, and 16 percent as the low, medium, and high 
estimates of the volume of chicken carcasses subject to the proposal. 
FSIS estimated that in 2021 a total of 162.9 million pounds, ranging 
from 88.9 to 237.0 million, would have been sampled as part of these 
final product standards (Table 20).\219\ There is likely a tendency 
toward overstatement in this estimate of the volume of product subject 
to FSIS verification sampling as lot sizes vary by establishments and 
lot sizes may be smaller than the sizes FSIS assumed for this analysis.
---------------------------------------------------------------------------

    \217\ (8.3 billion birds x 4 pounds). Dressed weights for 
chickens vary. For broilers, which is the main class of poultry 
slaughtered at FSIS inspected establishments, the 2023 chicken Risk 
Assessment used an average carcass weight was 4 pounds.
    \218\ USDA, FSIS, ``Quantitative Microbiological Risk Assessment 
for Salmonella in Raw Chicken and Raw Chicken Products,'' January 
2023 at: https://www.regulations.gov/docket/FSIS-2023-0028.
    Estimates from the National Chicken Council indicate that about 
9 percent of broilers, the main chicken subclass produced in the 
United States, were marketed as whole birds in 2021. National 
Chicken Council (NCC), ``How Broilers are Marketed,'' accessed May 
11, 2023, https://www.nationalchickencouncil.org/statistic/how-broilers-are-marketed/.
    \219\ This is the sum of the estimated sampled volume for all 
establishment categories. For each category, this volume is 
calculated as: number of establishments x average number of samples 
x lot size converted to pounds x estimated share of production 
intended as final product. For example, the medium estimate for 
high-volume establishments is 142 x 55 x (46,000 x 4) x 0.10. 
Calculations might not sum to totals due to rounding.

             Table 20--Chicken Carcasses: Estimated Sampled Volume by Establishment Volume Category
                                                     [2021]
----------------------------------------------------------------------------------------------------------------
                                                                Estimated sampled volume (million pounds)
    Establishment volume category         Number of     --------------------------------------------------------
                                        establishments          Low               Medium              High
----------------------------------------------------------------------------------------------------------------
High................................                142               86.8              159.1              231.4
Medium..............................                  9                1.8                3.4                4.9
Low.................................                  4               0.04                0.1                0.1
Very Low............................                 33                0.2                0.4                0.6
                                     ---------------------------------------------------------------------------
    Total...........................                188               88.9              162.9              237.0
----------------------------------------------------------------------------------------------------------------
Note: Numbers in table may not sum to totals due to rounding.

    This analysis assumed establishments would maintain control of 
sampled product until results on the level of Salmonella are available, 
which is expected to take two days. FSIS assumes establishments would 
move into commerce product with test results below 10 cfu/mL(g) and 
would hold product at or above that level for an additional three days. 
FSIS estimated that 654,123 pounds of chicken carcasses would have test 
results at or above 10 cfu/mL, which would be held until results on the 
presence of a serotype of public health significance were available. 
FSIS estimated the total cost to industry of holding all sampled 
chicken carcasses pending test results at $0.75 million annually 
[(162.9 million x $0.0023 x 2) + (654,123 x $0.0023 x 3)], ranging from 
$0.41 to $1.09 million (Table 21). Assuming the proposed implementation 
schedule and annualizing over 10 years at a 7 percent discount rate, 
the cost for holding chicken carcasses pending test results is $0.75 
million, ranging from $0.41 million to $1.09 million.

                    Table 21--Chicken Carcasses: Maintaining Control of Sampled Product Costs
----------------------------------------------------------------------------------------------------------------
                                                                        Estimated cost (million $)
                        Category                        --------------------------------------------------------
                                                                Low               Medium              High
----------------------------------------------------------------------------------------------------------------
High...................................................               0.40               0.73               1.07
Medium.................................................               0.01               0.02               0.02
Low....................................................             0.0002             0.0003             0.0005
Very low...............................................             0.0011             0.0020             0.0029
                                                        --------------------------------------------------------
    Total..............................................               0.41               0.75               1.09
    Annualized \1\.....................................               0.41               0.75               1.09
----------------------------------------------------------------------------------------------------------------
\1\ Costs are annualized at a 7 percent discount rate over 10 years.
Note: Numbers in table may not sum to totals due to rounding.


[[Page 64731]]

Chicken Parts
    FSIS estimated that in 2021 establishments subject to the 
performance standards processed 31.2 billion pounds of chicken 
parts.\220\ Raw chicken parts processed at FSIS regulated 
establishments can be sent into commerce as final products or further 
processed into a variety of preparations, including cooked products 
(e.g., fully cooked chicken breasts). As such, FSIS assumed that 80, 
85, or 90 percent of the estimated production of chicken parts would be 
raw final product subject to this proposal. FSIS is seeking comments on 
this assumption. FSIS estimated that 2.6 billion pounds of chicken 
parts, ranging from 308 million to 5.5 billion, would have been sampled 
as part of these final product standards (Table 22).\221\ There is 
likely a tendency toward overstatement in this estimate of the volume 
of product subject to FSIS verification sampling as lot sizes vary by 
establishments and lot sizes may be smaller than the sizes FSIS assumed 
for this analysis.
---------------------------------------------------------------------------

    \220\ The 2023 chicken risk assessment estimated that, of the 
total chicken slaughtered volume, about 83 percent is consumed as 
chicken parts. In 2021, total chicken slaughter volume was an 
estimated 37 billion pounds, 31.2 billion of which are estimated to 
be processed into chicken parts.
    \221\ FSIS calculated these estimates using average daily 
production volume and total number of samples in 2021 for each of 
the establishments producing chicken parts assuming lot sizes of one 
hour, one shift, and one day of production. FSIS multiplied this 
result by the share production intended as final product to obtain 
the low, medium, and high estimates.

               Table 22--Chicken Parts: Estimated Sampled Volume by Establishment Volume Category
                                                     [2021]
----------------------------------------------------------------------------------------------------------------
                                                                Estimated sampled volume (million pounds)
              Category                    Number of     --------------------------------------------------------
                                        establishments          Low               Medium              High
----------------------------------------------------------------------------------------------------------------
High................................                154                286              2,433              5,153
Medium..............................                209                 21                181                325
Low.................................                127                  0                  3                  5
                                     ---------------------------------------------------------------------------
    Total...........................                490                308              2,617              5,483
----------------------------------------------------------------------------------------------------------------
Note: Numbers in table may not sum to totals due to rounding.

    This analysis assumed establishments would maintain control of 
sampled product until results on the level of Salmonella are available, 
which is expected to take two days. FSIS assumed establishments would 
move product with test results below 10 cfu/mL(g) into commerce and 
would hold for an additional three days product with results at or 
above that level. FSIS estimated that about 246,949 pounds of chicken 
parts would have test results at or above 10 cfu/mL(g), which would be 
held until results on the presence of a serotype of public health 
significance were available. FSIS estimated the cost to industry of 
holding all sampled chicken parts pending test results at $12.0 million 
annually [(2.6 billion x $0.0023 x 2) + (246,949 x $0.0023 x 3)], 
ranging from $1.4 to $25.1 million (Table 22). Assuming the proposed 
implementation schedule and annualizing over 10 years at a 7 percent 
discount rate, the cost for holding chicken parts pending test results 
is $11.88 million, ranging from $1.4 million to $24.9 million.

                      Table 23--Chicken Parts: Maintaining Control of Sampled Product Costs
----------------------------------------------------------------------------------------------------------------
                                                                             Cost (million $)
                        Category                        --------------------------------------------------------
                                                                Low               Medium              High
----------------------------------------------------------------------------------------------------------------
High...................................................               1.31              11.15              23.62
Medium.................................................               0.10               0.83               1.49
Low....................................................               0.00               0.02               0.02
                                                        --------------------------------------------------------
    Total..............................................               1.41              12.00              25.13
    Annualized \1\.....................................               1.40              11.88              24.93
----------------------------------------------------------------------------------------------------------------
\1\ Costs are annualized at a 7 percent discount rate over 10 years.
Note: Numbers in table may not sum to totals due to rounding.

Comminuted Chicken
    FSIS estimated that in 2021 establishments subject to the 
performance standards processed 2.3 billion pounds of comminuted 
chicken. Raw comminuted chicken processed at FSIS regulated 
establishments can be sent into commerce as final products or further 
processed into a variety of preparations, including cooked products 
(e.g., fully cooked chicken nuggets). As such, FSIS assumed that 80, 
85, or 90 percent of the estimated production of comminuted chicken 
would be raw final product subject to this proposal. FSIS is seeking 
comments on this assumption. FSIS estimated that 264.19 million pounds, 
ranging from 26.1 to 427.65 million pounds of comminuted chicken, would 
have been sampled as part of these final product standards (Table 
24).\222\ There is likely a tendency toward overstatement in this 
estimate of the volume of product subject to FSIS verification sampling 
as lot sizes vary by establishments and lot sizes may be smaller than 
the sizes FSIS assumed for this analysis.
---------------------------------------------------------------------------

    \222\ FSIS calculated these estimates using average daily 
production volume and total production days in 2021 for each of the 
establishments producing comminuted chicken and multiplying by the 
share production intended as final product.

[[Page 64732]]



             Table 24--Comminuted Chicken: Estimated Sampled Volume by Establishment Volume Category
                                                     [2021]
----------------------------------------------------------------------------------------------------------------
                                                                Estimated sampled volume (million pounds)
              Category                    Number of     --------------------------------------------------------
                                        establishments          Low               Medium              High
----------------------------------------------------------------------------------------------------------------
High................................                  0                  0                  0                  0
Medium..............................                 35              25.12             254.59             415.22
Low.................................                 39               1.02               9.59              12.43
                                     ---------------------------------------------------------------------------
    Total...........................                 74              26.14             264.19             427.65
----------------------------------------------------------------------------------------------------------------
Note: Numbers in table may not sum to totals due to rounding.

    This analysis assumed establishments would maintain control of this 
product until results on the level of Salmonella are available, which 
is expected to take two days. FSIS assumed establishments would move 
product with test results below 10 cfu/mL(g) into commerce and would 
hold for an additional three days products with results at or above 
that level. FSIS estimated that about 5.0 million pounds of comminuted 
chicken would have test results at or above 10 cfu/mL(g), which would 
be held until results on the presence of a serotype of public health 
significance were available. FSIS estimated the cost to industry of 
holding all sampled comminuted chicken pending test results at $1.3 
million annually (264.2 million x $0.0023 x 2) + (5.0 million x $0.0023 
x 3)], ranging from $0.2 to $2.0 million (Table 25). Assuming the 
proposed implementation schedule and annualizing over 10 years at a 7 
percent discount rate, the cost for holding comminuted chicken products 
pending test results is $1.1 million, ranging from $0.1 million to $1.7 
million.

                   Table 25--Comminuted Chicken: Maintaining Control of Sampled Product Costs
----------------------------------------------------------------------------------------------------------------
                                                                             Cost (million $)
                        Category                        --------------------------------------------------------
                                                                Low               Medium              High
----------------------------------------------------------------------------------------------------------------
High...................................................                  0                  0                  0
Medium.................................................               0.15               1.20               1.94
Low....................................................              0.006               0.04               0.06
                                                        --------------------------------------------------------
    Total..............................................               0.15               1.25               1.99
    Annualized \1\.....................................               0.13               1.07               1.72
----------------------------------------------------------------------------------------------------------------
\1\ Costs are annualized at a 7 percent discount rate over 10 years.
Note: Numbers in table may not sum to totals due to rounding.

Comminuted Turkey
    FSIS estimated that in 2021 establishments subject to the 
performance standards processed 1.7 billion pounds of comminuted 
turkey. Raw comminuted turkey processed at FSIS regulated 
establishments can be sent into commerce as final products or further 
processed into preparations including cooked products (e.g., fully 
cooked sausages). As such, FSIS assumed that 80, 85, or 90 percent of 
the estimated production of comminuted turkey would be raw final 
product subject to this proposal. FSIS is seeking comments on this 
assumption. FSIS estimates that 156.7 million pounds, ranging from 18.4 
to 330.4 million, would have been sampled as part of these final 
product standards (Table 26).\223\ There is likely a tendency toward 
overstatement in this estimate of the volume of product subject to FSIS 
verification sampling as lot sizes vary by establishments and lot sizes 
may be smaller than the sizes FSIS assumed for this analysis.
---------------------------------------------------------------------------

    \223\ FSIS calculated these estimates using average daily 
production volume and total production days in 2021 for each of the 
establishments producing comminuted turkey and multiplying by the 
share production intended as final product.

             Table 26--Comminuted Turkey: Estimated Sampled Volume by Establishment Volume Category
                                                     [2021]
----------------------------------------------------------------------------------------------------------------
                                                                Estimated sampled volume (million pounds)
              Category                    Number of     --------------------------------------------------------
                                        establishments          Low               Medium              High
----------------------------------------------------------------------------------------------------------------
High................................                  5              11.49              97.71             206.91
Medium..............................                 25               6.90              58.63             122.86
Low.................................                 18               0.04               0.36               0.65
                                     ---------------------------------------------------------------------------
    Total...........................                 48              18.43             156.69             330.42
----------------------------------------------------------------------------------------------------------------
Note: Numbers in table may not sum to totals due to rounding.


[[Page 64733]]

    This analysis assumed establishments would maintain control of this 
product until results on the level of Salmonella are available, which 
is expected to take two days. FSIS assumed establishments would move 
product with test results below 10 cfu/mL(g) into commerce and would 
hold for an additional three days product with results at or above that 
level. FSIS estimated that about 2.3 million pounds of comminuted 
turkey would have test results at or above 10 cfu/mL, which would be 
held until results on the presence of a serotype of public health 
significance were available. FSIS estimated the cost to industry of 
holding all sampled comminuted turkey pending test results at $0.7 
million annually [(156.7 million x $0.0023 x 2) + (2.3 million x 
$0.0023 x 3)], ranging from $0.1 to $1.5 million (Table 27). Assuming 
the proposed implementation schedule and annualizing over 10 years at a 
7 percent discount rate, the cost for holding comminuted turkey 
products pending test results is $0.70 million, ranging from $0.09 
million to $1.45 million.

                    Table 27--Comminuted Turkey: Maintaining Control of Sampled Product Costs
----------------------------------------------------------------------------------------------------------------
                                                                             Cost (million $)
                        Category                        --------------------------------------------------------
                                                                Low               Medium              High
----------------------------------------------------------------------------------------------------------------
High...................................................               0.06               0.45               0.96
Medium.................................................               0.04               0.28               0.57
Low....................................................             0.0003             0.0017             0.0031
                                                        --------------------------------------------------------
    Total..............................................               0.10               0.73               1.53
    Annualized \1\.....................................               0.09               0.70               1.45
----------------------------------------------------------------------------------------------------------------
\1\ Costs are annualized at a 7 percent discount rate over 10 years.
Note: Numbers in table may not sum to totals due to rounding.

Import Establishments Costs
    FSIS conducts sampling activities at official import inspection 
establishments to verify that a foreign country's poultry inspection 
system is equivalent to the U.S. poultry inspection system. If this 
rule is finalized, FSIS would adapt its current Salmonella sampling 
program for imported chicken carcasses, chicken parts, comminuted 
chicken, and comminuted turkey. Import establishments would be required 
to maintain control of sampled product pending test results to verify 
that these products are not adulterated. Similar to domestic producers, 
FSIS assumed that official import inspection establishments would 
maintain control of sampled imported product lots for two days until 
results on the level of Salmonella are available. Sampled product with 
results below 10 CFU/mL(g) could be moved into commerce. If test 
results show Salmonella at or above 10 CFU/mL(g), FSIS assumed 
establishments would maintain control of these product lots for an 
additional one to three days, until the presence or absence of a 
serotype of public health significance is confirmed. Adulterated 
product would be diverted from U.S. commerce.
    FSIS estimates the cost to import establishments for maintaining 
control of imported product subject to FSIS verification sampling for 
Salmonella, as described in this proposal, would be minimal. Poultry 
imports represent a small fraction of the U.S. domestic poultry supply, 
accounting for less than 0.5 percent in 2021.\224\ In that year, only 
three countries exported raw chicken and turkey products to the United 
States: Canada, Chile, and Mexico.\225\ Canada was the sole exporter of 
whole chicken carcasses, accounting for about 14 million pounds of 
chicken. Chile, in turn, was the main exporter of chicken parts (132 
million pounds).\226\
---------------------------------------------------------------------------

    \224\ USDA, Foreign Agricultural Service, ``Production, Supply 
and Distribution database,'' accessed May 11, 2023. Although U.S. 
import data does not directly correspond with the final product 
categories in this proposal, FSIS used available trade data to 
identify Harmonized Tariff Schedule (HTS) codes that would 
approximate imports of chicken carcasses, chicken parts, comminuted 
chicken, and comminuted turkey. FSIS estimates that imports of 
chicken carcasses to the United States reached 13.7 million pounds 
in 2021 (HTS 0207.11 and 0207.12, Whole young chickens and Whole 
frozen chickens, respectively), while imports of chicken parts and 
comminuted chicken were 164 million pounds (HTS 0207.13 and 0207.14, 
Meat and edible offal of chickens, fresh or chilled and frozen, 
respectively). FSIS assumed that imports under HTS 0207.26 and 
0207.27 (Meat and edible offal of turkeys, fresh or chilled and 
frozen, respectively) approximate imports of comminuted turkey, 
although this is likely an overestimate as this HTS code also 
includes turkey parts. Imports under HTS 0207.26 and 0207.27, 
combined, reached 74.3 million pounds in 2022. Imports under these 
HTS codes represent 0.5 percent of U.S. production of chicken 
carcasses, 0.04 percent of U.S. production of chicken parts and 
comminuted chicken, and 4 percent of imports of comminuted turkey. 
U.S. International Trade Commission DataWeb/U.S. Department of 
Commerce, accessed June 28, 2023.
    \225\ Three countries are eligible to export raw chicken and 
turkey products to the United States--Canada, Chile, and Poland,--
while Mexico is eligible to export only processed poultry products 
slaughtered under Federal inspection in the United States or in a 
country eligible to export slaughtered poultry to the United States. 
USDA, FSIS, ``Eligible Foreign Establishments,'' July 14, 2023, 
https://www.fsis.usda.gov/inspection/import-export/import-export-library/eligible-foreign-establishments.
    \226\ U.S. International Trade Commission DataWeb/U.S. 
Department of Commerce accessed June 28, 2023.
---------------------------------------------------------------------------

    Currently, FSIS samples and tests imported chicken carcasses, 
chicken parts, comminuted chicken, and comminuted turkey for the 
presence of Salmonella. According to data from PHIS, in 2021, FSIS 
collected and analyzed about 850 samples of imported chicken and turkey 
products, which represented about 15.8 million pounds of product. These 
samples were mainly from chicken parts and carcasses, as imports of 
comminuted chicken and turkey are relatively low.
    FSIS estimated the cost for these import establishments assuming 
that establishments would maintain control pending test results of all 
sampled product identified in 2021 data, which is likely an 
overestimate. The estimated cost for import establishments is $0.07 
million per year (15.8 million pounds x 2 days x $0.0023). While data 
on the volume imported of product with results at or above 10 cfu/mL(g) 
are not available, FSIS estimates this would be a relatively low volume 
of product. In 2021, about 17 percent of imported poultry samples were 
positive for the presence of Salmonella, representing about 2.6 million 
pounds of product. This is likely a high estimate as countries would be 
required to implement measures to maintain equivalence with the U.S. 
poultry inspection system if this rule is finalized.

[[Page 64734]]

Total Costs to Industry From Maintaining Control of Sampled Product
    FSIS estimated that the total cost to industry from complying with 
FSIS verification sampling requirements in this proposal is $14.47 
million annually, ranging from $2.11 to $29.26 million (Table 28), 
assuming the proposed implementation schedule and annualizing over 10 
years at a 7 percent discount rate. As previously described, 
establishments are required to maintain control pending test results 
for product subject to FSIS verification sampling for adulterants. FSIS 
estimated that an average of 3.2 billion pounds of product per year 
would be subject to FSIS verification sampling. FSIS allows 
establishments to move product to an alternate location pending test 
results for an adulterant as long as they maintain control of the 
sampled product. Producers can also elect to divert sampled product 
into a product that is not subject to these standards (i.e., fully 
cooked products), rather than maintaining control of it pending test 
results. Moreover, FSIS allows establishments to produce smaller 
representative product lots for FSIS verification sampling if they 
demonstrate that the lot presented is microbiologically independent 
from other production lots.\227\ Thus, the cost for holding product 
pending test results is likely an overestimate. FSIS is seeking 
comments on these assumptions.
---------------------------------------------------------------------------

    \227\ 77 FR 73402.

               Table 28--Summary of Costs to Industry From Maintaining Control of Sampled Product
----------------------------------------------------------------------------------------------------------------
                                          Number of                        Cost (million $) \2\
               Product                  establishments  --------------------------------------------------------
                                             \1\                Low               Medium              High
----------------------------------------------------------------------------------------------------------------
Chicken carcasses...................                188               0.41               0.75               1.09
Chicken parts.......................                490               1.40              11.88              24.93
Comminuted chicken..................                 74               0.13               1.07               1.72
    Subtotal for chicken products...                752               1.94              13.71              27.74
Comminuted turkey...................                 48               0.09               0.69               1.45
Import establishments...............                 12               0.07               0.07               0.07
                                     ---------------------------------------------------------------------------
    Total...........................  .................               2.11              14.47              29.26
----------------------------------------------------------------------------------------------------------------
\1\ Establishments may produce more than one of the products subject to these final product standards.
\2\ Costs are annualized at a 7 percent discount rate over 10 years.
Note: Numbers in table may not sum to totals due to rounding.

Lost Value to the Industry Costs
    FSIS estimated the cost to industry from lost value resulting from 
diverting adulterated product subject to these final product standards. 
FSIS assumed that establishments would divert product after receiving 
final results showing a level of Salmonella at or above 10 cfu/mL(g) 
and the presence of a serotype of public health significance. As 
previously mentioned, FSIS laboratories would provide results on the 
level of Salmonella to establishments within two days from sample 
collection and results on the presence of a serotype of public health 
significance three days after initial results.
    The 2023 risk assessments estimated that approximately 0.2 million 
pounds of chicken carcasses, 0.07 million pounds of chicken parts, 1.6 
million pounds of comminuted chicken, and 0.6 million pounds of 
comminuted turkey per year would have Salmonella levels at or above 10 
cfu/mL(g) and would contain a serotype of public health significance 
(Table 29). This represents less than 0.1 percent of estimated 
production for each of the product categories.

  Table 29--Total Production, Volume Over 10 cfu/mL(g) and Containing a Serotype of Public Health Significance,
                                       and Share of Production by Product
----------------------------------------------------------------------------------------------------------------
                                                                              Volume over 10
                                                                              cfu/mL(g) and
                                                                               containing a
                        Product                           Total production     serotype of          Share of
                                                          (million pounds)    public health      production (%)
                                                                               significance
                                                                             (million pounds)
----------------------------------------------------------------------------------------------------------------
Chicken carcasses......................................             33,238                0.2           0.000005
Chicken parts..........................................             31,208               0.07           0.000002
Comminuted chicken.....................................              2,256                1.6           0.000691
Comminuted turkey......................................              1,691                0.6           0.000336
----------------------------------------------------------------------------------------------------------------
Note: Numbers in table may not sum to totals due to rounding.

    To estimate the cost to industry of this lost value as a result of 
this proposal, FSIS applied the per pound retail price of select 
poultry products to the estimated volume of lost product. FSIS used 
data from 2017 to 2021 and used a range in these prices to account for 
variability and uncertainty: the lowest retail price in the five-year 
period as the minimum, the highest as the maximum, and the five-year 
average as the medium estimate. For chicken carcasses, FSIS used the 
retail price for whole fresh chicken while for chicken parts the Agency 
used the retail price for chicken breasts (Table 30). Because data for 
the five-year period for comminuted or ground chicken were not readily 
available, FSIS used the retail price for chicken legs as a proxy. For 
comminuted turkey, FSIS used data for whole frozen turkeys as data for 
the five-year period for comminuted or ground turkey were not 
available.

[[Page 64735]]



                                 Table 30--Retail Prices for Select Commodities
----------------------------------------------------------------------------------------------------------------
                                                                           Price per pound ($)
             Product                   Price source     --------------------------------------------------------
                                                                Low               Medium              High
----------------------------------------------------------------------------------------------------------------
Chicken carcasses................  Whole fresh chicken                1.36               1.51               1.75
                                    \a\.
Chicken parts....................  Chicken breasts \b\.               2.90               3.19               3.72
Comminuted chicken...............  Chicken legs \c\....               1.32               1.50               1.73
Comminuted turkey................  Whole frozen turkey                0.80               0.99               1.23
                                    \d\.
----------------------------------------------------------------------------------------------------------------
\a\ U.S. Bureau of Labor Statistics (BLS), Chicken, fresh, whole, per lb. (453.6 gm) in U.S. city average,
  average price, not seasonally adjusted [APU0000706111], , accessed July 6, 2023, https://data.bls.gov/timeseries/APU0000706111?amp%253bdata_tool=XGtable&output_view=data&include_graphs=true.
\b\ BLS, Chicken breast, boneless, per lb. (453.6 gm) [APU0000FF1101], accessed July 6, 2023; https://data.bls.gov/timeseries/APU0000FF1101?amp%253bdata_tool=XGtable&output_view=data&include_graphs=true.
\c\ BLS, Chicken legs, bone-in, per lb. (453.6 gm) in U.S. city average, average price, not seasonally adjusted
  [APU0000706212], accessed July 6, 2023, https://data.bls.gov/timeseries/APU0000706212?amp%253bdata_tool=XGtable&output_view=data&include_graphs=true.
\d\ USDA, Economic Research Service, Turkey Sector: Background & Statistics: Price Statistics, April 18, 2023,
  https://www.ers.usda.gov/newsroom/trending-topics/turkey-sector-background-statistics.

    Previous FSIS analyses assumed that diverted product would lose 66 
percent of its value.\228\ As product under these final product 
standards are raw materials that can be diverted to a variety of fully 
cooked preparations, the Agency used a range to estimate the cost of 
lost value to the industry. Specifically, FSIS used 34, 50, and 66 
percent as the low, medium, and high estimates. FSIS estimated that the 
cost to industry from diverting product is $1.7 million annually, with 
a range of $1.0 to $2.6 million (Table 31). Assuming the proposed 
implementation schedule and annualizing over 10 years at a 7 percent 
discount rate, the cost for lost value of products subject to this 
proposal is $1.5 million, ranging from $0.9 million to $2.4 million.
---------------------------------------------------------------------------

    \228\ USDA, FSIS, ``Cost-Benefit Analysis for FSIS's 
Implementation of Its Non-O157 STEC Testing on Beef Manufacturing 
Trimmings and Expansion of Its Testing to Ground Beef and Ground 
Beef Components Other Than Beef Manufacturing Trimmings,'' June 
2020, https://www.fsis.usda.gov/sites/default/files/media_file/2020-07/FSIS-Non-0157-STEC-Testing-CBA-June-2020.pdf; USDA, FSIS, 
``Salmonella in Certain Not-Ready-To-Eat Breaded Stuffed Chicken 
Products,'' Preliminary Cost-Benefit Analysis, April 2023, https://www.fsis.usda.gov/sites/default/files/media_file/documents/NRTE_Stuffed_Chicken_CBA_FSIS-2022-0013.pdf.

                              Table 31--Lost Value to the Industry Costs, Million $
----------------------------------------------------------------------------------------------------------------
                        Product                                 Low               Medium              High
----------------------------------------------------------------------------------------------------------------
Chicken carcasses......................................                0.1                0.1                0.2
Chicken parts..........................................                0.1                0.1                0.2
Comminuted chicken.....................................                0.7                1.2                1.8
Comminuted turkey......................................                0.2                0.3                0.5
                                                        --------------------------------------------------------
    Total..............................................                1.0                1.7                2.6
    Annualized \1\.....................................                0.9                1.5                2.4
----------------------------------------------------------------------------------------------------------------
\1\ Costs are annualized at a 7 percent discount rate over 10 years.
Note: Numbers in table may not sum to totals due to rounding.

Microbiological Sampling Plan Reassessment Costs
    Establishments subject to these proposed final product standards 
may incur costs associated with reassessing their sampling plans. 
Current performance standards focus on the presence or absence of 
Salmonella in certain poultry products. However, the proposed standards 
would make product adulterated if it contains Salmonella at or above 10 
cfu/mL(g) and has at least one of the serotypes of public health 
significance. To estimate a cost associated with this requirement, FSIS 
assumed a portion of establishments would reassess their 
microbiological sampling plans. Consistent with the estimates in the 
previous cost-benefit analysis for the 2016 performance standards, FSIS 
estimated the cost of reassessing a sampling plan for 30, 40, and 50 
percent of the establishments subject to this proposal.\229\ FSIS 
included all volume categories in these estimates. However, as 
previously noted in the cost-benefit analysis for the 2016 performance 
standards, FSIS does not expect low and VLV establishments to have an 
internal sampling plan.\230\ FSIS assumed that these establishments 
would opt to not incur the expense of developing a sampling plan as 
sampling does not directly contribute to pathogen reduction. The Agency 
is seeking comments on this assumption.
---------------------------------------------------------------------------

    \229\ USDA, FSIS, Chicken Parts and Not Ready-To-Eat Comminuted 
Poultry Performance Standards, Final Cost-Benefit Analysis, February 
11, 2016, https://www.fsis.usda.gov/sites/default/files/media_file/documents/FRN-related-CBA-Salmonella-Campy-2014-0023-022016.pdf.
    \230\ USDA, FSIS, Chicken Parts and Not Ready-To-Eat Comminuted 
Poultry Performance Standards, Final Cost-Benefit Analysis, February 
11, 2016, https://www.fsis.usda.gov/sites/default/files/media_file/documents/FRN-related-CBA-Salmonella-Campy-2014-0023-022016.pdf.
---------------------------------------------------------------------------

    FSIS estimated that the total cost to industry from reassessing 
their sampling plans is $0.3 million, ranging from $0.1 to $0.6 million 
(Table 32). Assuming the proposed implementation schedule and 
annualizing over 10 years at a 7 percent discount rate, the cost for 
microbiological sampling plan reassessment is $0.04 million, ranging 
from $0.02 million to $0.08 million. High- and medium-volume 
establishments need an average of 40 hours (ranging from 20 to 60), 
while low- and very low-volume establishments need an average of 20 
hours (ranging from 10 to 30) to reassess a sampling plan, according to 
the 2017 Costs of Food Safety Investments in the Meat and Poultry 
Slaughter

[[Page 64736]]

Industries.\231\ This publication estimated costs for large and small 
establishments. FSIS assumed the large category would correspond with 
high- and medium-volume establishments, while the small category would 
correspond with low- and very low-volume establishments. FSIS used data 
from the U.S. Bureau of Labor Statistics to update the hourly wage for 
estimating these labor costs. Specifically, FSIS used the 2021 hourly 
wage for a production worker of $30.78, which includes an average 
hourly wage of $15.39 multiplied by a benefits and overhead factor of 
two.
---------------------------------------------------------------------------

    \231\ Viator CL, Muth MK, Brophy JE, Noyes G. Costs of Food 
Safety Investments in the Meat and Poultry Slaughter Industries. J 
Food Sci. 2017 Feb;82(2):260-269. doi: 10.1111/1750-3841.13597. Epub 
2017 Jan 24. PMID: 28117890. FSIS derived the labor hours from the 
total costs presented on table 5 and the wage rate for production 
occupations on table 2. BLS, May 2021 National Industry-Specific 
Occupational Employment and Wage Estimates for 19-1012 Food 
Scientists and Technologists, accessed April 13, 2023, https://www.bls.gov/oes/current/oes191012.htm.

                           Table 32--Microbiological Sampling Plan Reassessment Costs
----------------------------------------------------------------------------------------------------------------
                                                                            Cost (thousand $)
    Establishment volume category         Number of     --------------------------------------------------------
                                        establishments          Low               Medium              High
----------------------------------------------------------------------------------------------------------------
High................................                302               0.06               0.15               0.28
Medium..............................                276               0.05               0.14               0.25
Low.................................                190               0.02               0.05               0.08
Very Low............................                 91              0.003              0.007              0.014
                                     ---------------------------------------------------------------------------
    Total...........................  .................               0.13               0.34               0.63
    Annualized \1\..................  .................               0.02               0.04               0.08
----------------------------------------------------------------------------------------------------------------
\1\ Costs are annualized at a 7 percent discount rate over 10 years.
Note: Numbers in table may not sum to totals due to rounding.

Validation of Microbiological Sampling Plans
    If an establishment makes changes to their microbiological sampling 
plans in response to this proposal, they would incur costs associated 
with validating these changes. The 2015 ``Costs of Food Safety 
Interventions'' report indicates that high- and medium-volume 
establishments would need an average of 960 labor hours for validation 
of a microbiological sampling plan and 1,200 labor hours for low- and 
very low-volume establishments. On a per plan basis, the cost for 
validation of a microbiological sampling plan for a high- or medium-
volume establishment is $77,683, on average, while for low- or very 
low-volume establishments, the average cost is $97,104. FSIS used the 
2021 hourly wage for a food scientist of $80.92, which includes an 
average hourly wage of $40.46 multiplied by a benefits and overhead 
factor of 2.\232\ FSIS did not include an estimate of total industry 
validation costs for microbiological sampling plans because FSIS does 
not have data on the number of establishments that would make changes 
to their plans in response to this proposal. FSIS is requesting 
comments to address this data gap.
---------------------------------------------------------------------------

    \232\ Viator CL, Muth MK, Brophy JE, Noyes G. Costs of Food 
Safety Investments in the Meat and Poultry Slaughter Industries. J 
Food Sci. 2017 Feb;82(2):260-269. doi: 10.1111/1750-3841.13597. Epub 
2017 Jan 24. PMID: 28117890. FSIS derived the labor hours from the 
total costs presented on table 5 and the wage rate for production 
occupations on table 2. BLS, May 2021 National Industry-Specific 
Occupational Employment and Wage Estimates for 19-1012 Food 
Scientists and Technologists, accessed April 13, 2023, https://www.bls.gov/oes/current/oes191012.htm.
---------------------------------------------------------------------------

Corrective Actions
    FSIS would require establishments that do not meet the final 
product standards to take corrective actions. These corrective actions 
would be aimed at removing adulterated product from market and making 
changes to prevent production of adulterated product in the future. 
Interventions available to the poultry industry include antimicrobial 
agents, new equipment, and employee practices. FSIS does not have 
information on the types or frequency of corrective actions 
establishments may take in response to not meeting the final products 
standards, and the Agency is seeking comments on the potential costs 
associated with these.
Summary of Costs to Industry From This Proposed Rule and Proposed 
Determination
    FSIS estimated the main cost to industry to comply with this 
proposal is $16.4 million annually, with a range of $3.3 to $32.3 
million (Table 33), assuming the proposed implementation schedule and 
annualizing over 10 years at a 7 percent discount rate. The principal 
component of this cost is the requirement that establishments must 
maintain control of product subject to FSIS verification sampling for 
adulterants pending test results. The cost estimate associated with 
this requirement is likely an overestimate as it is possible that 
establishments' current practices and procedures would allow them to 
maintain control of a lower volume of product. Additionally, all 
timeframes and methods for Salmonella testing are likely to change as 
FSIS continuously incorporates new laboratory technologies into its 
sampling verification program. FSIS is seeking comment on these 
estimates. FSIS estimated that the total costs to establishments from 
reassessing HACCP and microbiological sampling plans, combined, is 
$0.22 million ($0.18 + $0.04 million). The estimated cost associated 
with the proposed statistical process control requirements is $0.04 
million, which is likely an overestimate as certain establishments 
would be able to mitigate the cost by using laboratory services 
provided by FSIS, as previously described. To varying degrees, industry 
may also incur other costs associated with their individual responses 
to this proposal. The Agency estimated that this total cost represents 
less than 1 percent of the total industry's revenue in 2021. In 2021, 
the estimated total sales value for broilers and turkeys, on a live 
basis, was $37.4 billion, with a five-year average between 2017 and 
2021 of $33.5 billion.\233\ This value increased to $57.5 billion in 
2022. For the poultry processing industry, the

[[Page 64737]]

total 2021 revenue was $77 billion, according to U.S. Census data.\234\
---------------------------------------------------------------------------

    \233\ USDA, ERS, ``Poultry Sector at a Glance'' June 1, 2023, 
https://www.ers.usda.gov/topics/animal-products/poultry-eggs/sector-at-a-glance/; USDA, National Agricultural Statistics Service, 
``Poultry--Production and Value: 2022 Summary,'' April 2023, https://downloads.usda.library.cornell.edu/usda-esmis/files/m039k491c/wm119387d/5138kw352/plva0423.pdf.
    \234\ Sales, value of shipments, or revenue for the Poultry 
processing industry, as defined in the North American Industry 
Classification System code 311615. U.S. Census Bureau, Annual Survey 
of Manufacturers: Summary Statistics for Industry Groups and 
Industries in the U.S.: 2018-2021 (NAICS 311615), accessed on April 
11, 2023.

                                       Table 33--Summary of Industry Costs
----------------------------------------------------------------------------------------------------------------
                                                                                 Cost (million $)
                        Cost descriptions                        -----------------------------------------------
                                                                        Low           Medium           High
----------------------------------------------------------------------------------------------------------------
Costs associated with the proposed rule:
    Statistical process control.................................            0.04            0.04            0.04
    Electronic data submission..................................            0.18            0.18            0.18
    HACCP plan reassessment.....................................            0.09            0.18            0.26
Costs associated with the proposed determination:
    Maintaining control of sampled product......................            2.11           14.47           29.26
    Lost value to the industry..................................            0.87            1.52            2.43
    Microbiological sampling plan reassessment..................            0.02            0.04            0.08
                                                                 -----------------------------------------------
        Total \1\...............................................            3.31           16.43           32.25
----------------------------------------------------------------------------------------------------------------
\1\ Costs are annualized at a 7 percent discount rate over 10 years.
Note: Numbers in table may not sum to totals due to rounding.

    FSIS estimates industry would incur annual costs in response to 
this rule. Table 34 includes the expected undiscounted annual costs of 
this proposal assuming the implementation schedule over a 10-year 
period.

                                 Table 34--Summary of Annual Costs Over 10 Years
----------------------------------------------------------------------------------------------------------------
                          Year                                  Low               Medium              High
----------------------------------------------------------------------------------------------------------------
1......................................................          2,342,792         13,490,291         27,612,367
2......................................................          3,330,215         16,984,639         33,483,179
3......................................................          3,250,382         16,788,952         33,160,044
4......................................................          3,099,498         16,471,425         32,667,872
5......................................................          3,099,498         16,469,009         32,667,872
6......................................................          3,099,498         16,466,751         32,667,872
7......................................................          3,099,498         16,464,641         32,667,872
8......................................................          3,099,498         16,462,668         32,667,872
9......................................................          3,099,498         16,460,825         32,667,872
10.....................................................          3,099,498         16,459,102         32,667,872
----------------------------------------------------------------------------------------------------------------

Costs to FSIS
    FSIS does not anticipate the proposal, including using laboratory 
services provided by FSIS for analyzing process control samples for VS 
and VLV establishments under Traditional Inspection, as well as 
conducting verification sampling for the final product standards, will 
increase Agency costs. The Agency would adapt its current sampling for 
Salmonella on poultry products to conduct verification sampling for the 
new final product standards and would be able to shift existing 
resources as necessary to implement this proposal if finalized. FSIS 
currently enumerates samples collected as part of FSIS verification 
sampling for Salmonella. Consequently, if this proposal is finalized, 
the only additional cost to FSIS would be to incorporate serotype 
testing on Salmonella positive samples. The Agency estimates analyzing 
these tests would require 520 labor hours, or $0.03 million, per year 
to analyze results, with additional hours, including data management, 
procurement, result review and authorization, as needed.\235\
---------------------------------------------------------------------------

    \235\ FSIS used the 2024 base salary of a GS-12 step 1 full time 
employee of $35.67 per hour and included the Civilian Position Full 
Fringe Benefit Cost Factor of 36.25 percent. Executive Office of The 
President, Office of Management and Budget, Circular No. A-76 
(Revised), May 29, 2003, https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/circulars/A76/a76_incl_tech_correction.pdf.
---------------------------------------------------------------------------

    Costs related to follow-up sampling and conducting FSAs are not 
expected to increase. The Agency would conduct follow up sampling and a 
PHRE for any establishments that does not meet the final product 
standards. FSIS would use the results of the PHRE to determine the need 
for an FSA. FSIS currently conducts follow up sampling and PHREs on 
establishments that do not meet the current Salmonella performance 
standards. For instance, in 2022, FSIS conducted 30 FSAs at category 
three establishments. The Agency estimated that the average cost to 
conduct a for-cause FSA in 2016 was about $4,800, which, inflated to 
2021 dollars, is about $5,400 per FSA.\236\
---------------------------------------------------------------------------

    \236\ Based on the FSIS Office of the Chief Financial Officer 
(OCFO) preliminary analysis of the average cost per FSA under the 
new FSA methodology, FY 2016. The costs were inflated, by using the 
2021 BLS Consumer Price Index (CPI) All items in U.S. city average, 
all urban consumers, not seasonally adjusted (CUUR0000SA0, 
CUUS0000SA0 Not Seasonally Adjusted).
---------------------------------------------------------------------------

Potential Benefits and Avoided Costs From the Proposed Rule and 
Proposed Determination
Prevented Salmonella Illnesses
    FSIS is proposing to declare Salmonella at or above 10 cfu/mL(g) 
and containing a serotype of public health significance an adulterant 
on chicken carcasses, chicken parts, comminuted chicken, and comminuted 
turkey as final products that would enter commerce. The 2023 risk 
assessments provide a range of data on the public health impacts 
achieved by reducing

[[Page 64738]]

final product contaminated with Salmonella, as well as the higher risk 
per serving associated with product that would be declared adulterated 
by the proposal. FSIS used this range of data to estimate the potential 
public health benefits of this proposal. FSIS also used findings from 
the FSIS risk profile to create these estimates, including information 
regarding the higher virulence of certain Salmonella serotypes, as well 
as the potential debilitating human health outcomes from Salmonella 
infection (e.g., reactive arthritis), which are not included in the 
cost of illness estimates.
    The 2023 risk assessments estimated the number of illnesses that 
could be prevented if product lots with results at or above 10 cfu/
mL(g) of Salmonella are diverted from commerce as part of FSIS 
verification sampling programs. For chicken carcasses, the 2023 chicken 
risk assessment estimated that 1,000 illnesses could be prevented, 
while for chicken parts and comminuted chicken it estimated 200 and 
1,000 illnesses, respectively. The 2023 chicken risk assessment 
assessed the effect of a carcass final product standard on all chicken 
associated illnesses, including those from parts and comminuted product 
consumption, but could not assess the effect of carcasses and secondary 
products standards sequentially. As such, the 2023 chicken risk 
assessment estimates for chicken products are not additive.\237\ For 
comminuted turkey, the 2023 turkey risk assessment estimated that 2,100 
illnesses could be prevented.\238\ This analysis presents three 
illustrative scenarios based on these results.
---------------------------------------------------------------------------

    \237\ USDA, FSIS, ``Quantitative Microbiological Risk Assessment 
for Salmonella in Raw Chicken and Raw Chicken Products,'' January 
2023 at: https://www.regulations.gov/docket/FSIS-2023-0028.
    \238\ USDA, FSIS, ``Quantitative Microbiological Risk Assessment 
for Salmonella in Raw Turkey and Raw Turkey Products,'' January 2023 
at: https://www.regulations.gov/docket/FSIS-2023-0028.
---------------------------------------------------------------------------

    FSIS estimated that if this proposal becomes final, the number of 
illnesses prevented may range from 765 to 4,300 cases per year (Table 
34).\239\ These estimates are based on the best data currently 
available.
---------------------------------------------------------------------------

    \239\ FSIS used these estimates for calculating the monetary 
benefits associated with this proposal given the higher risk per 
serving and probability of illness associated with serotypes of 
public health significance. Thus, while the amount of product with 
results at or above 10 cfu/mL(g) that is diverted is higher, the 
number of prevented illnesses is potentially a representative 
scenario of the total benefits associated with this rule.
---------------------------------------------------------------------------

    For the low estimate, the Agency used sampling data and results 
from the 2023 risk assessments to estimate the number of prevented 
illnesses from the final products standards. FSIS sampling data show 
that the serotypes of public health significance identified in this 
proposal are present in 24 percent of the chicken carcass samples and 
25 percent of the comminuted turkey samples.\240\ The Agency applied 
the share of samples with at least one serotype of public health 
significance to the estimated number of prevented illnesses from 
diverting chicken carcasses and comminuted turkey with results at or 
above 10 cfu/mL(g). Thus, for the low estimate in this analysis, the 
Agency estimated that the final product standards would prevent a total 
of 765 Salmonella illnesses, 240 from chicken carcasses and 525 from 
comminuted turkey. Research indicates that chicken carcass samples 
often contain multiple Salmonella serotypes.\241\ For example, it is 
likely that a sample from a chicken carcass could test positive for 
Salmonella Kentucky and also contain Salmonella Enteritidis, which is a 
serotype of public health significance, but Salmonella Enteritidis was 
not captured by FSIS testing on that sample. At present there is no 
rapid way to screen for multiple Salmonella serotypes at one time. 
Moreover, the 2023 chicken risk assessment estimated that diverting 
from commerce chicken carcasses containing serotypes in the higher 
virulence cluster would result in 1,800 prevented illnesses, which is 
higher than the estimated number of illnesses prevented from diverting 
carcasses with Salmonella at or above 10 cfu/mL (1,000 illnesses).\242\ 
Additionally, FSIS data show that serotypes of public health 
significance have been detected at higher rates in chicken parts and 
comminuted chicken products.\243\ Further, the serotypes of public 
health significance have been identified in over 50 percent of the 
outbreaks associated with chicken products between 2012 and 2021. FSIS 
is seeking comments on these assumptions and estimates. While the 
estimates in the 2023 risk assessments refer to Salmonella levels and 
serotypes separately, the data indicate that the number of illnesses 
prevented by the final product standards in this proposal is higher 
than the low estimate included in this analysis.
---------------------------------------------------------------------------

    \240\ FSIS used only the prevented illness estimates for chicken 
carcasses as the 2023 chicken risk assessment could not assess the 
effect of carcasses and secondary products standards sequentially. 
USDA, FSIS, ``Quantitative Microbiological Risk Assessment for 
Salmonella in Raw Chicken and Raw Chicken Products,'' January 2023 
at: https://www.regulations.gov/docket/FSIS-2023-0028.
    \241\ USDA, FSIS, ``Quantitative Microbiological Risk Assessment 
for Salmonella in Raw Chicken and Raw Chicken Products,'' January 
2023 at: https://www.regulations.gov/docket/FSIS-2023-0028; Obe, T., 
Siceloff, A.T., Crowe, M.G., Scott, H.M., & Shariat, N.W. (2023). 
Combined Quantification and Deep Serotyping for Salmonella Risk 
Profiling in Broiler Flocks. Applied and Environmental Microbiology, 
899(4), e02035-02022. https://doi.org/10.1128/aem.02035-22; 
Thompson, C.P., Doak, A.N., Amirani, N., Schroeder, E.A., Wright, 
J., Kariyawasam, S., Lamendella, R., & Shariat, N.W. (2018). High-
Resolution Identification of Multiple Salmonella Serovars in a 
Single Sample by Using CRISPR-SeroSeq. Applied and Environmental 
Microbiology, 84(21), e01859-18.
    \242\ These estimates are not available for chicken parts, 
comminuted chicken, or comminuted turkey products.
    \243\ The serotypes of public health significance have been 
identified in FSIS sampling programs for poultry products at varying 
rates between 2016 and 2021: 24 percent of chicken carcass samples, 
33 percent of chicken parts samples, 29 percent of comminuted 
chicken samples, and 25 percent of comminuted turkey samples. USDA, 
FSIS, ``Quantitative Microbiological Risk Assessment for Salmonella 
in Raw Chicken and Raw Chicken Products,'' January 2023 at: https://www.regulations.gov/docket/FSIS-2023-0028; USDA, FSIS, 
``Quantitative Microbiological Risk Assessment for Salmonella in Raw 
Turkey and Raw Turkey Products,'' January 2023 at: https://www.regulations.gov/docket/FSIS-2023-0028.
---------------------------------------------------------------------------

    For the medium estimate, FSIS used the 2023 risk assessments 
results of illnesses prevented from diverting chicken carcasses (1,000 
illnesses) and comminuted turkey (2,100 illnesses) with Salmonella 
levels at or above 10 cfu/mL(g). This estimate accounts for some of the 
uncertainty around potential health benefits from this proposal. The 
Agency used this because as discussed above, products with Salmonella 
at or above 10 cfu/mL(g) have a higher risk per serving than other 
products and would be more likely to cause illness. Specifically, the 
2023 chicken risk assessment noted that the probability of illness for 
a serving that tests at or above 10 cfu/mL(g) and has a serotype of 
public health significance is 2,000-fold higher than the average across 
all servings for carcass lots, 1,100-fold higher than the average 
serving for chicken parts, and 590-fold higher than the average serving 
for comminuted chicken products. In contrast, the probability of 
illness per serving for lots with Salmonella at 0.03 cfu/mL(g), which 
is the current screening limit of detection for carcasses and parts is 
at least 14-fold higher than for average lots. The probability of 
illness per serving for comminuted chicken lots with Salmonella at 0.03 
cfu/mL(g), which is the current screening limit of detection, is at 
least 160-fold higher than for average lots. Research shows that it is 
likely that the share of product samples with serotypes of public 
health significance is higher than current estimates indicate, and this 
share varies between product subject to this proposal (24 percent for 
chicken

[[Page 64739]]

carcasses, 33 percent for chicken parts, 29 percent for comminuted 
chicken, and 25 percent for comminuted turkey). Furthermore, industry 
may react to this proposal in a variety of ways. For example, while the 
assumptions in the cost estimates reflect the requirement of 
maintaining control of product until adulteration results are 
available, some establishments may opt to divert chicken carcasses, 
chicken parts, comminuted chicken, and comminuted turkey products with 
test results at or above 10 cfu/mL(g) instead of waiting until results 
on the adulteration status of the product is available. For these 
reasons, FSIS estimates that the number of prevented illnesses from 
diverting chicken carcasses at or above 10 cfu/mL better approximates a 
portion of the illnesses not included in the low estimate as the Agency 
estimates that diverting these products from commerce would lead to a 
greater reduction in illnesses. Additionally, this proposal clarifies 
process control requirements, and encourages establishments to adopt 
pre-harvest measures, which may have compounding effects on reducing 
cross-contamination and may prevent a higher number of illnesses each 
year.
    For the high estimate, FSIS used the combined estimated number of 
prevented illnesses from diverting chicken carcasses (1,000 illnesses), 
chicken parts (200 illnesses), comminuted chicken (1,000 illnesses), 
and comminuted turkey (2,100 illnesses) product from the 2023 risk 
assessments. As noted above, the prevented illness estimates in the 
2023 risk assessments reflect a standard at the 10 cfu/mL(g) level for 
these products. While these estimates do not reflect the final products 
standards in this proposal, FSIS is including these as a high estimate 
for the reasons outlined above. For the low and medium estimates, FSIS 
used only the prevented illness estimates for chicken carcasses as the 
2023 chicken risk assessment could not assess the effect of carcasses 
and secondary products (parts and comminuted chicken) standards 
sequentially, as mentioned above. In contrast, for the high estimate, 
FSIS used the sum of all three estimates (chicken carcasses, chicken 
parts, and comminuted chicken) to illustrate a potential number of 
illnesses prevented from implementing this proposed policy, including 
the potential compounding benefits across product types and the upper 
limit of direct and indirect (i.e., benefits from actions industry 
voluntarily takes in response to this proposal) health benefits. The 
Agency used the same estimate for comminuted turkey for the medium and 
high estimates. FSIS is seeking comments on these estimates.

                          Table 34--Estimated Number of Illnesses Prevented by Product
----------------------------------------------------------------------------------------------------------------
                                                                           Prevented illnesses
                        Product                         --------------------------------------------------------
                                                                Low               Medium              High
----------------------------------------------------------------------------------------------------------------
Chicken products:......................................                240              1,000              2,200
    Chicken carcasses..................................                240              1,000              1,000
    Chicken parts......................................  .................  .................                200
    Comminuted chicken.................................  .................  .................              1,000
Comminuted turkey......................................                525              2,100              2,100
                                                        --------------------------------------------------------
    Total..............................................                765              3,100              4,300
----------------------------------------------------------------------------------------------------------------

    Public health benefits, including in the form of prevented 
illnesses, are difficult to monetize as a market for these does not 
exist. Typically, economic analyses use alternative methods for these 
non-market measures that approximate the value of these benefits. To 
monetize the estimated direct public health impact of this proposal, 
and consistent with other Agency regulatory impact analyses,\244\ FSIS 
applied the estimated cost of a Salmonella illness to the estimated 
number of prevented illnesses. FSIS used the ``Cost Estimates of 
Foodborne Illnesses'' developed by the U.S. Department of Agriculture, 
Economic Research Service to do so.\245\ These estimates incorporate 
associated expenditures on medical care, lost wages due to productivity 
loss, and estimates of willingness to pay (WTP) to reduce 
mortality.\246\ This WTP measure is estimated in the form of the value 
of a statistical life. The average per case cost for Salmonella in 2021 
dollars was $4,351, with a lower bound estimate of $387 and a higher 
bound estimate of $6,873. The variability in the cost estimate is 
driven by variations in the number of fatalities, which are zero at the 
low estimate and 378 at the high estimate.
---------------------------------------------------------------------------

    \244\ USDA, FSIS, ``Salmonella in Certain Not-Ready-To-Eat 
Breaded Stuffed Chicken Products,'' Preliminary Cost-Benefit 
Analysis, April 2023, https://www.fsis.usda.gov/sites/default/files/media_file/documents/NRTE_Stuffed_Chicken_CBA_FSIS-2022-0013.pdf. 
USDA, FSIS, ``Proposed Performance Standards for Salmonella in Raw 
Comminuted Pork and Intact or Non-Intact Pork Cuts,'' Preliminary 
Cost-Benefit Analysis, February 16, 2022, https://www.fsis.usda.gov/sites/default/files/media_file/2022-02/Pork-Salmonella-Performance-Standards-Cost-Benefit-Analysis.pdf; USDA, FSIS, Chicken Parts and 
Not Ready-To-Eat Comminuted Poultry Performance Standards, Final 
Cost-Benefit Analysis, February 11, 2016, https://www.fsis.usda.gov/sites/default/files/media_file/documents/FRN-related-CBA-Salmonella-Campy-2014-0023-022016.pdf.
    \245\ USDA, ERS, ``Cost Estimates of Foodborne Illnesses,'' Cost 
of foodborne illness estimates for Salmonella (non-typhoidal) 
dataset, January 29, 2021 https://www.ers.usda.gov/data-products/cost-estimates-of-foodborne-illnesses.aspx.
    \246\ This is incorporated through value of a statistical life 
estimates that are applied to mortality associated with each 
pathogen for which estimates were developed.
---------------------------------------------------------------------------

    FSIS estimated the total benefits from prevented illness for this 
proposal at $13.49 million ([1,000 prevented illnesses from chicken 
products + 2,100 prevented illnesses from comminuted turkey products] x 
$4,351), with a range from $0.3 million to $29.55 million (Table 35). 
Assuming the proposed implementation schedule and annualizing over 10 
years at a 7 percent discount rate, the benefits associated with the 
estimated prevented illnesses are $12.92 million, ranging from $0.28 
million to $28.66 million.

[[Page 64740]]



                  Table 35--Estimated Benefits From Prevented Illnesses for Each Product Group
----------------------------------------------------------------------------------------------------------------
                                                                           Benefits (million $)
                     Product group                      --------------------------------------------------------
                                                                Low               Medium              High
----------------------------------------------------------------------------------------------------------------
Chicken products.......................................               0.09               4.35              15.12
Comminuted turkey......................................               0.20               9.14              14.43
                                                        --------------------------------------------------------
    Total..............................................               0.30              13.49              29.55
    Annualized \1\.....................................               0.28              12.92              28.66
----------------------------------------------------------------------------------------------------------------
\1\ Costs are annualized at a 7 percent discount rate over 10 years.
Note: Numbers in table may not sum to totals due to rounding.

    The cost estimate of foodborne illness for Salmonella cases is 
likely an underestimate of the total economic burden of foodborne 
illness. Specifically, cost of illness estimates account for major 
costs of medical treatment, time lost to illness, and individuals' WTP 
to reduce risk of death but these do not include other components of 
individual's WTP (to reduce illness, pain and suffering or costs 
associated with potential severe, debilitating human health 
outcomes).\247\ According to the FSIS Risk Profile, Salmonella subtypes 
of concern can cause severe human health outcomes, including acute 
gastroenteritis, bacteremia (bacteria in the blood), and focal 
infections. Salmonella infections can also lead to debilitating human 
health outcomes in a subset of patients, which includes reactive 
arthritis, cancer, inflammatory bowel disease, and irritable bowel 
syndrome, which are not included in these estimates. The FSIS Risk 
Profile notes that 5.8 percent of Salmonella cases develop reactive 
arthritis, and about 66 percent had persistent symptoms five years 
after becoming infected with Salmonella. Additionally, about 3.3 
percent of cases developed irritable bowel syndrome. Salmonella 
infection can also increase the risk of colon cancer.\248\
---------------------------------------------------------------------------

    \247\ Hoffmann, Sandra, Bryan Maculloch, and Michael Batz. 
Economic Burden of Major Foodborne Illnesses Acquired in the United 
States, EIB-140, U.S. Department of Agriculture, Economic Research 
Service, May 2015, p.3-5.
    \248\ USDA, FSIS, ``Risk Profile for Pathogenic Salmonella 
Subtypes in Poultry,'' February 28, 2023 at: https://www.regulations.gov/docket/FSIS-2023-0028.
---------------------------------------------------------------------------

    Salmonella infections can result in a variety of outcomes and for 
some serotypes a small number of bacteria can cause illness.\249\ The 
2023 risk assessments estimated a higher proportion of deaths among the 
serotypes identified as higher virulence, including some identified by 
FSIS as part of this proposal. For all Salmonella, the domestic 
foodborne hospitalization rate is about 2 percent, and the fatality 
rate is about 0.04 percent. In contrast, the FSIS risk profile noted 
that, for a subset of Salmonella serotypes, the hospitalization rate 
was 22.8 percent, and the fatality rate was 0.5 percent.\250\ 
Salmonella illnesses disproportionately impact children under five 
years old and adults over 65, who experience higher rates of illnesses 
and death.\251\ The FSIS risk profile notes that children under 1 year 
of age are particularly susceptible to invasive disease and infants 
have a higher likelihood of bacteremia resulting from Salmonella 
illness compared with adults.
---------------------------------------------------------------------------

    \249\ USDA, FSIS, ``Risk Profile for Pathogenic Salmonella 
Subtypes in Poultry,'' February 28, 2023 at: https://www.regulations.gov/docket/FSIS-2023-0028.
    \250\ USDA, FSIS, ``Risk Profile for Pathogenic Salmonella 
Subtypes in Poultry,'' February 28, 2023 at: https://www.regulations.gov/docket/FSIS-2023-0028.
    \251\ CDC, FoodNet Fast, Pathogen Surveillance, October 8, 2022, 
https://wwwn.cdc.gov/foodnetfast/ foodnetfast/.
---------------------------------------------------------------------------

Costs Avoided From Prevented Outbreak-Related Recalls
    FSIS estimates that this proposal would result in prevented 
outbreak-related recalls. Specifically, by diverting adulterated 
products entering commerce, should this rule become final, official 
establishments would likely have a reduction in the risk of recalls due 
to Salmonella illness outbreaks. FSIS assumed that, if finalized, this 
proposal would prevent one to three recalls over a 10-year period, as 
described below.
    Recalls are companies' actions to remove product that may be 
adulterated or misbranded from commerce.\252\ Companies recall products 
due to a variety of reasons, including due to illness outbreaks. For 
instance, between 2012 and 2021 there were 7 recalls due to Salmonella 
outbreaks linked to various poultry products.\253\ In that same period, 
there were 100 outbreaks linked to Salmonella in poultry products.\254\ 
While not all outbreaks lead to product recalls, poultry establishments 
face the risk of recalling product that may result in human illnesses. 
As previously mentioned, product that would be adulterated under this 
proposal (i.e., with Salmonella levels at or above 10 cfu/mL(g) and 
containing a serotype of public health significance) have a higher risk 
per serving and hence a higher probability of resulting in illnesses.
---------------------------------------------------------------------------

    \252\ USDA, FSIS, ``Managing Adulterated or Misbranded Meat, 
Poultry, and Egg Products--Revision 8,'' December 19, 2023, https://www.fsis.usda.gov/policy/fsis-directives/8080.1.
    \253\ This excludes recalls associated with raw stuffed and 
breaded chicken products. USDA, FSIS, ``Recalls and Public Health 
Alerts,'' accessed July 10, 2023, https://www.fsis.usda.gov/recalls.
    \254\ USDA, FSIS, ``Risk Profile for Pathogenic Salmonella 
Subtypes in Poultry,'' February 28, 2023 at: https://www.regulations.gov/docket/FSIS-2023-0028.
---------------------------------------------------------------------------

    Poultry establishments have economic incentives to prevent recalls, 
which are costly to industry and have spillover effects beyond the 
product lot that is subject to it. Recalls have a direct cost for 
establishments in the form of lost profits, product retrieval and 
disposal costs, business interruptions, and customer reimbursement, 
among others. Additional indirect costs are also part of the economic 
impact of a food recall, including external costs to distributors, 
wholesalers, and retailers, among others, which have been estimated to 
be 51, 6, and 5 percent of the total cost of a recall for 
manufacturers, wholesalers, and retailers, respectively.\255\ These 
include lost sales as consumers purchase alternative brands or 
products, potential litigation and liability risk, and brand damage 
affecting non-recalled product of the same brand. The exact cost of a 
recall varies depending on factors such as company size, product 
volume, and geographic distribution of the recalled product, among 
others. For publicly traded companies, recalls could reduce the

[[Page 64741]]

stock market prices of the implicated companies and could lead them to 
bankruptcy and business closure. Recalls also negatively impact 
consumers by creating anxiety and time-consuming inconveniences, which 
includes looking for recall information, checking the products 
purchased, and returning or disposing of products identified by the 
recalls.
---------------------------------------------------------------------------

    \255\ U.S. Department of Health and Human Services, Food and 
Drug Administration (FDA), ``Requirement for Additional Traceability 
Records for Certain Foods Final Regulatory Impact Analysis'' 
November 21, 2022, https://www.fda.gov/media/163155/download?attachment; FDA, ``Requirements for Tobacco Product 
Manufacturing Practice (Proposed Rule) Preliminary Regulatory Impact 
Analysis,'' March 10, 2023, https://www.fda.gov/media/166055/download?attachment.
---------------------------------------------------------------------------

    Individual establishments may not currently effectively control for 
Salmonella to further reduce their risk due to the perceived low risk 
of a recall. For instance, the 7 recalls between 2014 and 2021 were 
linked to different establishments. Further, an individual 
establishment may experience pressure to underinvest in food safety 
measures given uncertainty over how much other establishments may 
invest in food safety measures and a need to maintain cost 
competitiveness. Since consumers are unable to distinguish between 
products in the marketplace that have higher probabilities of resulting 
in Salmonella illness and those with lower probabilities, both types of 
products are sold at the same price point. Under such market 
conditions, establishments are disincentivized from investing in food 
safety measures and controlling for Salmonella. This results in an 
increased risk of Salmonella illnesses, and, in consequence, an 
increased risk of outbreaks and outbreak-related recalls for 
establishments.
    If this proposal is finalized, establishments producing chicken 
carcasses, chicken parts, comminuted chicken, and comminuted turkey 
products would have the same incentives for controlling for Salmonella. 
Consequently, establishments producing these products would have a 
lower risk of recalls due to Salmonella illnesses and outbreaks. 
Establishments that invest in food safety controls would benefit from 
having a clear standard where product that would be adulterated would 
be diverted from commerce. Diverting adulterated product from commerce 
would equally reduce the probability of recalls for all FSIS regulated 
establishments, serving as insurance against this risk. While this 
would benefit establishments of all sizes, the benefit may be more 
pronounced for low and very low volume establishments, for which the 
burden of a recall may be higher. As the proposal would reduce the 
probability that all regulated establishments incur costs associated 
with product recalls, the Agency is approximating this quantitative 
benefit by estimating the avoided cost of outbreak-related recalls. 
(See discussion above, about recalls leading to external costs, 
including to wholesalers and distributors.)
    FSIS estimated that one outbreak-related recall may cost the U.S. 
poultry industry about $31.3 million in 2021 dollars.\256\ While the 
cost of a recall varies depending on multiple factors, recalls due to 
illness outbreaks (class I) are a significant event for producers and 
are likely more costly than other types of recalls.\257\ The 2023 risk 
assessments estimated that annually roughly 8 lots of chicken carcasses 
(0.7), chicken parts (0.2), comminuted chicken (5), and comminuted 
turkey (2) would be diverted as a result of this proposal.\258\ This 
equals roughly 80 lots of adulterated products diverted in 10 years. 
FSIS estimates it is likely that at least a portion of these diverted 
lots would have otherwise led to outbreaks and, consequently, recalls. 
As mentioned above, data indicate that industry has conducted recalls 
for about 7 percent of the outbreaks in the last 10 years (7 recalls in 
100 outbreaks). Considering these products have a higher probability of 
resulting in illnesses and could have led to Salmonella outbreaks, if 7 
percent of them led to recalls, this would have resulted in 5.6 recalls 
over 10 years. To illustrate the avoided cost from a reduction in the 
risk of outbreak-related recalls, FSIS assumed that this proposal would 
prevent two recalls (medium estimate), with a range of one (low 
estimate) to three (high estimate) recalls in a 10-year period. This is 
roughly 2.5 percent of the diverted lots, ranging from 1.3 percent to 
3.8 percent. The estimated benefits from preventing recalls as part of 
this proposal is $7.6 million, ranging from $4.2 million to $10.3 
million, annualized over 10 years at a 7 percent discount rate.
---------------------------------------------------------------------------

    \256\ This estimate is derived from a report by the Consumers 
Brands Association that surveyed 36 food, beverage, and consumer 
products companies that have faced a recall in the previous five 
years to derive these estimates. Based on the report, FSIS estimated 
the cost of an outbreak related recall at $25.8 million in 2011 
dollars. The Agency adjusted this estimate for inflation using the 
consumer price index. Consumers Brands Association, ``Capturing 
Recall Costs: Measuring and Recovering the Losses,'' 2011, https://globalfoodsafetyresource.com/wp-content/uploads/2014/08/www.gmaonline.org_file-manager_images_gmapublications_Capturing_Recall_Costs_GMA_Whitepaper_FINAL.pdf; BLS, Consumer Price Index, All items in U.S. city 
average, all urban consumers, not seasonally adjusted (CUUR0000SA0, 
CUUS0000SA0 Not Seasonally Adjusted).
    \257\ FSIS uses a classification system for recalls. Class I 
recalls are a health hazard situation where there is a reasonable 
probability that the use of the product will cause serious, adverse 
health consequences or death. Class II recalls are those with a 
remote probability that the product will cause adverse health 
consequences, while Class III recalls are situations where the 
product will not cause adverse health consequences. USDA, FSIS, 
``Managing Adulterated or Misbranded Meat, Poultry, and Egg 
Products--Revision 8,'' December 19, 2023, https://www.fsis.usda.gov/policy/fsis-directives/8080.1.
    \258\ USDA, FSIS, ``Quantitative Microbiological Risk Assessment 
for Salmonella in Raw Chicken and Raw Chicken Products,'' January 
2023; USDA, FSIS, ``Quantitative Microbiological Risk Assessment for 
Salmonella in Raw Turkey and Raw Turkey Products,'' January 2023 at: 
https://www.regulations.gov/docket/FSIS-2023-0028.
---------------------------------------------------------------------------

Summary of Costs and Benefits
    FSIS estimated this proposal would have a net benefit of $4.1 
million per year, ranging from $1.1 million to $6.7 million, assuming 
the proposed implementation schedule and annualizing over 10 years at a 
7 percent discount rate (Table 35).
    This proposal is estimated to cost industry $16.4 million per year, 
ranging from $3.3 to $32.3 million, assuming the proposed 
implementation schedule and annualizing over 10 years at a 7 percent 
discount rate. The majority of this cost, $14.5 million, ranging from 
$2.1 million to $29.3 million, is associated with requiring 
establishments to maintain control of sampled product pending test 
results, followed by industry cost due to lost product value of $1.5 
million, ranging from $0.9 million to $2.4 million. Industry may also 
incur costs associated with HACCP and microbiological sampling plan 
reassessments and changes to MMPs for process control. To varying 
degrees, industry may also incur other costs associated with their 
individual responses to this proposal.
    In terms of benefits, this proposal is estimated to result in 
benefits to society of $20.5 million per year, ranging from $4.4 
million to $39.0 million (Table 36), assuming the proposed 
implementation schedule and annualizing over 10 years at a 7 percent 
discount rate. The majority of the benefits are derived from prevented 
illnesses of $12.9 million per year, ranging from $0.3 to $28.7 
million. Additional benefits from this proposal include the reduction 
in the risk of outbreak-related recalls for products subject to these 
final product standards, which represent an estimated $7.6 million in 
benefits to industry, ranging from $4.2 million to $10.3 million. 
Moreover, industry might take additional actions in response to this 
proposal, which may lead to additional benefits. For example, producers 
may adopt testing programs, process control measures, or pre-harvest 
measures that may result in additional benefits from this proposal.

[[Page 64742]]



                                     Table 36--Summary of Costs and Benefits
----------------------------------------------------------------------------------------------------------------
                                                                                 Total (million $)
                           Description                           -----------------------------------------------
                                                                        Low           Medium           High
----------------------------------------------------------------------------------------------------------------
                                                      Costs
----------------------------------------------------------------------------------------------------------------
Costs associated with the proposed rule:
    Statistical Process Control.................................            0.04            0.04            0.04
    Electronic data submission..................................            0.18            0.18            0.18
    HACCP plan reassessment.....................................            0.09            0.18            0.26
Costs associated with the proposed determination:
    Maintaining control of sampled product......................            2.11           14.47           29.26
    Lost value to the industry..................................            0.87            1.52            2.43
    Microbiological sampling plan reassessment..................            0.02            0.04            0.08
                                                                 -----------------------------------------------
        Total costs.............................................            3.31           16.43           32.25
----------------------------------------------------------------------------------------------------------------
                                                    Benefits
----------------------------------------------------------------------------------------------------------------
Prevented illnesses from adulterated chicken products...........            0.09            4.35           15.11
Prevented illnesses from adulterated comminuted turkey..........            0.19            8.58           13.55
Avoided cost from prevented outbreak-related recalls............            4.16            7.56           10.34
                                                                 -----------------------------------------------
    Total benefits..............................................            4.45           20.49           39.00
        Net benefits............................................            1.14            4.06            6.75
----------------------------------------------------------------------------------------------------------------
Note: All costs and benefits are annualized over 10 years at a 7 percent discount rate. Numbers in table may not
  sum to totals due to rounding.

    This regulatory impact analysis provides potential cost and 
benefits scenarios. As discussed in the Potential benefits and avoided 
costs from the proposed rule and proposed determination section, 
establishments may elect to divert product before final adulteration 
results are available to them. To also illustrate this possibility, 
FSIS estimated the potential costs associated with establishments 
diverting product with test results at or above 10 cfu/mL(g) before a 
serotype of public health significance is detected. This would likely 
increase industry cost by $3.6 million, ranging from $2.1 million to 
$5.7 million. This range is associated with changes to the cost of 
maintaining control of sampled product, which would decrease, while the 
lost value to industry from diverting product would likely increase. 
While FSIS did not incorporate these into the main scenarios presented 
in this regulatory impact analysis, the net benefit from industry 
diverting product that tests at or above 10 cfu would be $0.5 million, 
ranging from a net cost of $0.9 million to a net benefit of $1.0 
million and keeping all other assumptions constant.\259\
---------------------------------------------------------------------------

    \259\ In this scenario, the low bound in the net benefits 
estimate reflects the adjustment in illnesses made in the Expected 
benefits section to account for the share of product that is likely 
to be at or above 10 cfu/mL(g) and contain a serotype of public 
health significance. Hence, the net cost would be lower than $0.9 
million.
---------------------------------------------------------------------------

    FSIS compared the respective low, medium, and high costs and 
benefits estimates as the Agency's primary estimates to summarize the 
potential economic outcomes of this proposal. However, each of the cost 
scenarios in this analysis could result in any of the benefit scenarios 
also previously discussed. As such, when considering a wider range for 
these scenarios, FSIS estimated this proposal would have a net benefit 
of $4.1 million per year, ranging from -$31.9 million to $35.7 million, 
assuming the proposed implementation schedule and annualizing over 10 
years at a 7 percent discount rate.
Alternative Regulatory Approaches
    FSIS considered the following five alternatives in the analysis for 
this proposal (Table 37). To evaluate potential alternatives, FSIS 
first analyzed the costs and benefits associated with taking no 
regulatory action, which is discussed under Alternative 1 and 
represents the baseline for this analysis. Alternative 2 discusses the 
proposal. For Alternative 3, which is a more stringent regulatory 
scenario, FSIS estimated the costs and benefits associated with 
declaring adulterated chicken carcasses, chicken parts, comminuted 
chicken, and comminuted turkey with levels of Salmonella at or above 1 
cfu/mL(g) and containing a serotype of public health significance. 
Alternative 4 represents a more lenient regulatory scenario by 
estimating costs and benefits associated with declaring these products 
adulterated with Salmonella levels at or above 100 cfu/mL(g) and 
containing a serotype of public health significance. Finally, 
Alternative 5 represents the most stringent scenario considered and 
estimates the benefits and costs associated with declaring chicken 
carcasses, chicken parts, comminuted chicken, and comminuted turkey 
with Salmonella at or above 1 cfu/mL(g) adulterated regardless of 
serotype. For each alternative, the Agency assumed that all other 
costs, specifically those associated with process control requirements 
(collecting an additional sample and electronic data submission), as 
well as HACCP and microbiological sampling plan reassessments, would 
remain equal. Similarly, the Agency assumed that the benefits from 
preventing outbreak-related recalls would be the same for each 
alternative.

[[Page 64743]]



                                        Table 37--Regulatory Alternatives
----------------------------------------------------------------------------------------------------------------
                                                                Benefits (medium estimate)       Net (medium
          Alternative \1\             Costs (medium estimate)               \2\                   estimate)
----------------------------------------------------------------------------------------------------------------
1: No regulatory action (Baseline)  Continued illnesses and     No new costs to industry..  n/a.
                                     deaths associated with
                                     Salmonella from these
                                     products.
2: The proposed rule and proposed   $16.43 million compared to  $20.49 million from         $4.06 million.
 determination.                      the baseline.               prevented Salmonella
                                                                 illnesses and outbreak-
                                                                 related recalls.
3: The proposed rule and proposed   $29.52 million compared to  $19.65 million from         ($9.88) million.
 determination with a lower level    the baseline.               prevented Salmonella
 for adulterated product (1 cfu/                                 illnesses and outbreak-
 mL(g) and serotypes of public                                   related recalls.
 health significance).
4: The proposed rule and proposed   $15.34 million compared to  $8.85 million in the form   ($6.59 million).
 determination with a higher level   the baseline.               of prevented Salmonella
 for adulterated product (100 cfu/                               illnesses and outbreak-
 mL(g) and serotypes of public                                   related recalls.
 health significance).
5: The proposed rule and proposed   $49.96 million compared to  $34.50 million from         ($15.45 million).
 determination with a lower          the baseline.               prevented Salmonella
 contamination level for                                         illnesses and outbreak-
 adulterated product of 1 cfu/                                   related recalls.
 mL(g) Salmonella regardless of
 serotype.
----------------------------------------------------------------------------------------------------------------
\1\ Costs and benefits are annualized at a 7 percent discount rate over 10 years.
\2\ Alternatives 2-5 have additional potential benefits from reduced risk of outbreak-related recalls and
  increased consumer trust.
Note: Numbers in table may not sum to totals due to rounding.

    Alternative 1: No regulatory action (Baseline).
    FSIS considered keeping the current performance standards for 
Salmonella in poultry products and taking no regulatory action. This 
alternative would prevent society from realizing benefits in the form 
of prevented illnesses due to Salmonella contamination. While this 
alternative would not impose costs on industry from maintaining control 
of sampled product or lost value due to diverted product, the Agency 
would fail to address the increased probability of illness resulting 
from chicken carcasses, chicken parts, comminuted chicken, and 
comminuted turkey that contain Salmonella at or above 10 cfu/mL(g) and 
a serotype of public health significance. FSIS would also fail to 
clarify process control requirements for poultry slaughter 
establishments. Therefore, the Agency rejects this alternative.
    Alternative 2: The proposed rule and proposed determination.
    Under this proposal, chicken carcasses and parts and comminuted 
chicken and turkey products which are final products that will enter 
commerce that test at or above 10 cfu/mL(g) and contain a Salmonella 
serotype of public health significance would be adulterated. FSIS would 
also clarify process control requirements for poultry slaughter 
establishments, require that VLV and VS establishments operating under 
Traditional Inspection collect and analyze an additional sample for 
process control monitoring, and require all establishments 
electronically submit process control data. Society would benefit from 
this proposal as FSIS estimated that between 765 and 4,300 Salmonella 
illnesses could be prevented each year. This represents between 0.5 and 
3 percent of the total number of Salmonella illnesses attributed to 
products subject to this proposal.\260\ Additionally, industry would 
benefit from a reduced risk of outbreak-related recalls. This is the 
Agency's preferred alternative.
---------------------------------------------------------------------------

    \260\ According to the 2023 risk assessments, there are 125,000 
and 18,000 Salmonella illnesses attributed to products subject to 
this proposed rule each year. USDA, FSIS, ``Quantitative 
Microbiological Risk Assessment for Salmonella in Raw Chicken and 
Raw Chicken Products,'' January 2023 at: https://www.regulations.gov/docket/FSIS-2023-0028; USDA, FSIS, 
``Quantitative Microbiological Risk Assessment for Salmonella in Raw 
Turkey and Raw Turkey Products,'' January 2023 at: https://www.regulations.gov/docket/FSIS-2023-0028.
---------------------------------------------------------------------------

    Alternative 3: The proposed rule and proposed determination with a 
lower contamination level for adulterated product of 1 cfu/mL(g) and 
serotypes of public health significance.
    Alternative 3 would consider product under this proposal to be 
adulterated if it contains 1 cfu/mL(g) and a Salmonella serotype of 
public health significance. This alternative results in higher costs 
for industry to comply with the proposal, resulting from the increased 
volume of lost product that is diverted ($14.48 million, ranging from 
$8.29 million to $21.08 million). Alternative 3 also presents higher 
benefits from prevented Salmonella illnesses, which range from 1,214 to 
7,750. This represents between 0.8 and 5.4 percent of the total number 
of Salmonella illnesses attributed to products subject to this 
proposal.\261\ However, the net benefits from this alternative 
(benefits minus costs) are negative for all scenarios. Therefore, the 
Agency rejects this alternative.
---------------------------------------------------------------------------

    \261\ According to the 2023 risk assessments, there are 125,000 
and 18,000 Salmonella illnesses attributed to products subject to 
this proposed rule each year. USDA, FSIS, ``Quantitative 
Microbiological Risk Assessment for Salmonella in Raw Chicken and 
Raw Chicken Products,'' January 2023 at: https://www.regulations.gov/docket/FSIS-2023-0028; USDA, FSIS, 
``Quantitative Microbiological Risk Assessment for Salmonella in Raw 
Turkey and Raw Turkey Products,'' January 2023 at: https://www.regulations.gov/docket/FSIS-2023-0028.
---------------------------------------------------------------------------

    Alternative 4: The proposed rule and proposed determination with a 
higher contamination level for adulterated product of 100 cfu/mL(g) and 
serotypes of public health significance.
    Alternative 4 would consider product under this proposal to be 
adulterated if it contains 100 cfu/mL(g) and a Salmonella serotype of 
public health significance. This alternative results in lower costs for 
industry to comply with the proposal, as a lower volume of product 
would have initial results at or above 100 cfu/mL(g) and would result 
in a lower lost value for the industry ($0.62 million, ranging from 
$0.35 million to $3.16 million). Alternative 4 also presents fewer 
prevented Salmonella illnesses, which range from 384 to 2,220. This 
represents between 0.3 and 1.5 percent of the total number of 
Salmonella illnesses attributed to products subject to this 
proposal.\262\ The

[[Page 64744]]

net benefits from this alternative (benefits minus costs) are negative 
at the medium, and high estimates. Therefore, the Agency rejects this 
alternative.
---------------------------------------------------------------------------

    \262\ According to the 2023 risk assessments, there are 125,000 
and 18,000 Salmonella illnesses attributed to products subject to 
this proposed rule each year. USDA, FSIS, ``Quantitative 
Microbiological Risk Assessment for Salmonella in Raw Chicken and 
Raw Chicken Products,'' January 2023 at: https://www.regulations.gov/docket/FSIS-2023-0028; USDA, FSIS, 
``Quantitative Microbiological Risk Assessment for Salmonella in Raw 
Turkey and Raw Turkey Products,'' January 2023 at: https://www.regulations.gov/docket/FSIS-2023-0028.
---------------------------------------------------------------------------

    Alternative 5. The proposed rule and proposed determination with a 
lower contamination level for adulterated product of 1 cfu/mL(g) 
Salmonella regardless of serotype.
    Alternative 5 would consider product under this proposal to be 
adulterated if it contains 1 cfu/mL(g) Salmonella, regardless of the 
presence of Salmonella serotype. This alternative results in higher 
costs for industry to comply with the proposal, as a higher volume of 
product would be adulterated with results at or above 1 cfu/mL(g). The 
lost value to industry would increase to $48.0 million (ranging from 
$27.4 million to $72.0 million), which is the highest in comparison to 
the other alternatives. Alternative 5 also presents higher benefits 
from prevented Salmonella illnesses, which range from 5,000 to 7,750. 
This represents between 3.5 and 5.4 percent of the total number of 
Salmonella illnesses attributed to products subject to this 
proposal.\263\ However, this alternative results in the lowest net 
benefits (benefits minus costs) and all scenarios result in net costs. 
Therefore, the Agency rejects this alternative.
---------------------------------------------------------------------------

    \263\ According to the 2023 risk assessments, there are 125,000 
and 18,000 Salmonella illnesses attributed to products subject to 
this proposed rule each year. USDA, FSIS, ``Quantitative 
Microbiological Risk Assessment for Salmonella in Raw Chicken and 
Raw Chicken Products,'' January 2023 at: https://www.regulations.gov/docket/FSIS-2023-0028; USDA, FSIS, 
``Quantitative Microbiological Risk Assessment for Salmonella in Raw 
Turkey and Raw Turkey Products,'' January 2023 at: https://www.regulations.gov/docket/FSIS-2023-0028.
---------------------------------------------------------------------------

VII. Regulatory Flexibility Act Assessment

    The FSIS Administrator has made a preliminary determination that 
this proposed rule and proposed determination, if finalized, would not 
have a significant economic impact on a substantial number of small 
entities in the U.S., as defined by the Regulatory Flexibility Act (5 
U.S.C. 601 et seq.). Establishments subject to this proposal are 
classified in the 311615 Poultry Processing sector of the North 
American Industry Classification System (NAICS). The U.S. Small 
Business Administration (SBA) size standard for small businesses in 
this section is 1,250 employees.\264\ This NAICS sector includes 
establishments ``primarily engaged in (1) slaughtering poultry and 
small game and/or (2) preparing processed poultry and small game meat 
and meat byproducts.'' As a result, the sector includes establishments 
that produce products beyond the scope of this proposal, including 
further processing of poultry products. FSIS has typically classified 
establishments in three size categories based on employment counts and 
annual sales: large establishments have over 500 employees, small 
establishments have between 10 and 499 employees, and very small 
establishments have less than 10 employees or less than $2.5 million in 
annual sales.\265\ These categories, however, do not necessarily 
capture the variability in production volumes between regulated 
establishments. For this reason, FSIS classified establishments based 
on production volumes of the products subject to this proposal.
---------------------------------------------------------------------------

    \264\ U.S. Census Bureau, ``North American Industry 
Classification System--2022 NAICS Definition: 311615 Poultry 
Processing January 3, 2024, https://www.census.gov/naics/?input=311615&year=2022&details=311615; SBA, Table of size 
standards, October 25, 2023, https://www.sba.gov/sites/default/files/2023-06/Table%20of%20Size%20Standards_Effective%20March%2017%2C%202023%20%282%29.pdf.
    \265\ 61 FR 38806.
---------------------------------------------------------------------------

    FSIS established volume categories for this proposal based on 
Agency data on establishments' production volumes and the 2016 cost-
benefit analysis in support of the FSIS ``Chicken Parts and Not Ready-
To-Eat Comminuted Poultry Performance Standards,'' as shown in tables 
38 and 39.\266\ Furthermore, FSIS uses production volumes for 
allocating samples to be collected at regulated establishments, 
therefore these volume categories more closely capture the estimated 
impact of this proposal. This proposal is estimated to impact a total 
of 284 establishments classified as low- and very low-volume 
establishments. FSIS considers these volume categories to be small 
entities.
---------------------------------------------------------------------------

    \266\ USDA, FSIS, Chicken Parts and Not Ready-To-Eat Comminuted 
Poultry Performance Standards, Final Cost-Benefit Analysis, February 
11, 2016, https://www.fsis.usda.gov/sites/default/files/media_file/documents/FRN-related-CBA-Salmonella-Campy-2014-0023-022016.pdf.
---------------------------------------------------------------------------

Final Product Standards

    The volume categories for establishments subject to the proposed 
final product standards are summarized in Table 38. Of these, 37 
establishments produced chicken carcasses, 127 produced chicken parts, 
39 produced comminuted chicken, and 18 produced comminuted turkey 
products that would be subject to the final product standards. This 
represents roughly 27.6 percent of the establishments impacted by this 
proposal.\267\ Low- and very low-volume establishments, combined, 
accounted for 0.08 percent of the total chicken carcasses produced in 
2021. In that same year, low-volume establishments represented 0.1, 
2.8, and 0.5 percent of the total production of chicken parts, 
comminuted chicken, and comminuted turkey, respectively.\268\
---------------------------------------------------------------------------

    \267\ Some establishments may produce more than one product 
subject to these final product standards. For these estimates, FSIS 
counted establishments separately for each product subject to the 
final product standards, therefore, establishments may be counted 
more than once.
    \268\ Note that there is no very low-volume category for chicken 
parts, comminuted chicken, and comminuted turkey.

             Table 38--Volume Categories for Establishments Subject to the Final Products Standards
----------------------------------------------------------------------------------------------------------------
                                   Chicken carcasses     Chicken parts    Comminuted chicken   Comminuted turkey
 Establishment volume  category   (birds slaughtered  (annual production   (daily production   (daily production
                                       annually)            pounds)             pounds)             pounds)
----------------------------------------------------------------------------------------------------------------
High............................  10 million or more  70 million or more  250,000 or more...  250,000 or more.
Medium..........................  More than 1.1       More than 1         More than 6,000     More than 6,000
                                   million and less    million and less    and less than       and less than
                                   than 10 million.    than 70 million.    250,000.            250,000.
Low.............................  More than 440,001   1 million or less.  Less than 6,000...  Less than 6,000.
                                   and less than 1.1
                                   million.
Very Low \1\....................  No more than        n/a...............  n/a...............  n/a.
                                   440,000.
----------------------------------------------------------------------------------------------------------------
\1\ Very low-volume establishments are defined in 9 CFR 381.65g(1)(i).


[[Page 64745]]

    As a result of the proposal, based on the assumptions and estimates 
described in the Regulatory Impact Analysis section, FSIS estimates 
that the medium per establishment cost for low-volume establishments 
that produce chicken carcasses is $1,260 per year. For very low-volume 
establishments in this product group, the medium per establishment cost 
would be $1,067, if the proposal is finalized. For low-volume 
establishments that produce chicken parts, comminuted chicken, and 
comminuted turkey, the estimated medium per establishment cost is 
$1,305, $3,152, and $1,296 per year, respectively.
    FSIS used the per pound retail prices described in the Lost value 
to the industry costs section to estimate the average revenue for low-
and very low-volume establishments from producing chicken carcasses, 
chicken parts, comminuted chicken, and comminuted turkey. FSIS 
estimates the cost associated with this proposal represents about 0.04 
percent of the chicken carcass revenue for low-volume establishments 
and 0.15 percent for very low-volume establishments.\269\ For low-
volume establishments producing chicken parts, the estimated cost of 
the proposal represents about 0.1 percent of the estimated 
revenue.\270\ This estimated cost represents 0.9 and 0.4 percent of the 
estimated revenue for low-volume establishments that produce comminuted 
chicken and comminuted turkey, respectively.\271\
---------------------------------------------------------------------------

    \269\ FSIS estimated the average chicken carcass revenue for 
low-volume establishments at $3.2 million, while for very low-volume 
establishments this revenue was $0.7 million in 2021.
    \270\ FSIS estimated the average chicken parts revenue for low-
volume establishments at $1.2 million.
    \271\ FSIS estimated the average comminuted chicken revenue for 
low-volume establishments at $0.35 million, while for low-volume 
establishments producing comminuted turkey, this estimate is $0.32 
million.
---------------------------------------------------------------------------

    FSIS also expects the cost burden of this proposal on low- and very 
low-volume establishments to be limited due to several factors:
    (1) FSIS estimates that the total cost for low- and very low-volume 
establishments for complying with this proposal is small. As proposed, 
final product standards account for the largest proportion of estimated 
costs, which are estimated to cost these establishments $1,569, on 
average, per establishment per year. This cost will vary depending on 
an establishment's production level.
    (2) The cost estimates presented as part of this analysis are based 
on FSIS' estimated lot size. FSIS allows establishments to produce 
smaller representative batches of product for sampling.\272\ 
Consequently, low- and very low-volume establishments can reduce costs 
by reducing their lot size when FSIS collects a sample.
---------------------------------------------------------------------------

    \272\ 77 FR 73402.
---------------------------------------------------------------------------

    (3) FSIS is also adopting an implementation schedule that allows 
low- and very low-volume establishments additional flexibility to 
adjust to the new regulations. Low- and very low-volume establishments 
would have three years to comply with this proposal after it is 
finalized.

Process Control Requirements

    The volume categories for establishments subject to the statistical 
process control requirements are summarized in Table 39. Of the 284 
small entities impacted by this proposal, 108 are poultry slaughter 
establishments subject to the statistical process control requirements, 
or about 36.2 percent of all poultry slaughter establishments. This 
proposal requires that very low-volume and very small establishments 
operating under Traditional Inspection collect an additional sample for 
monitoring process control, as explained in the Statistical Process 
Control costs section. This requirement is estimated to impact 92 
establishments that are considered to be small entities by FSIS. The 
rule also requires all poultry slaughter establishments to 
electronically submit to FSIS data generated as part of their process 
control monitoring. This requirement is estimated to impact 108 
establishments that are considered to be small entities by FSIS. In 
2021, there were 93 low and very low-volume chicken slaughter 
establishments, 12 turkey slaughter, 1 duck slaughter, 1 goose 
slaughter, and 1 squab slaughter establishments.\273\ In that year, low 
and very low volume establishments accounted for 0.2 percent of chicken 
slaughter, 0.1 percent of turkey slaughter, and 0.01 percent of duck 
slaughter. For goose slaughter, one establishment accounted for about 
98 percent of total slaughter in 2021, while one low volume 
establishment accounted for 16 percent of squab slaughter in that year.
---------------------------------------------------------------------------

    \273\ For establishments that slaughter multiple species, 
process control requirements apply to the most predominant species 
slaughtered annually.

      Table 39--Volume Categories for Establishments Subject to the
                Statistical Process Control Requirements
------------------------------------------------------------------------
                Chicken                     All other poultry classes
------------------------------------------------------------------------
More than 10 million...................  More than 1 million.
Between 1.1 million and 10 million.....  Between 156 thousand and 1
                                          million.
Between 440 thousand and 1.1 million...  Between 60 thousand and 156
                                          thousand.
Less than 440 thousand.................  Less than 60 thousand.
------------------------------------------------------------------------

    FSIS estimated process control requirements would cost $2,129 per 
establishment per year. As these establishments produce a wide variety 
of products, including multiple poultry classes, FSIS is unable to 
estimate the share this cost represents of establishments' total 
revenue. However, FSIS production data show that 79 establishments (73 
percent) slaughter more than one class of poultry. Additionally, 36 
establishments (about 33 percent) produce other nonpoultry FSIS 
inspected products. Nonpoultry products represent 54 percent, on 
average, of these establishments' total production by volume. However, 
to mitigate the impact and costs of this requirement, the Agency is 
proposing to make laboratory services available to analyze process 
control samples instead of the establishment using establishment 
resources or commercial laboratories. In addition, FSIS is providing a 
template for establishments to use when submitting data to the Agency. 
Consequently, these costs could be mitigated is represents potential 
cost savings for these establishments.

VIII. Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520), FSIS has reviewed the proposed rule. All establishments 
that slaughter poultry are currently required to

[[Page 64746]]

monitor their ability to maintain process control through microbial 
testing and recordkeeping under the currently approved information 
collection, 0583-0156, Modernization of Poultry Slaughter Inspection. 
FSIS is proposing to revise this collection to require that 
establishments submit their microbial sampling results to FSIS 
electronically on a monthly basis. FSIS is also proposing to require 
that all establishments, including VS and VLV establishments operating 
under Traditional Inspection to test at 2 points (rehang and post-
chill) instead of only post-chill. VS and VLV establishments operating 
under Traditional Inspection would have the option to use laboratory 
resources provided by FSIS to analyze their monitoring samples for 
them, but they would still be required to have their results recorded 
and submitted to FSIS electronically.
    Should FSIS finalize this proposal, the Agency would provide a 
template that establishments could use to record and submit their 
monthly results. FSIS is developing a web portal that will allow 
external partners to securely upload sampling information and submit it 
to FSIS in a machine- readable format. The proposed fields that would 
be uploaded into the portal are: a sample identification number, the 
establishment number, date, time, slaughter line number, location of 
sample collection (e.g., rehang, post-chill), poultry species sampled, 
sample type (e.g., rinsate, sponge), analyte (e.g., AC, EB), analyte 
units (e.g., cfu/mL), quantified analyte result, and text analyte 
result (e.g., Upper LOD). Establishments that use the 
spreadsheet template to record the microbial monitoring results may 
upload their completed spreadsheet into the web portal to submit their 
monthly microbial data to FSIS or they may enter the information 
manually into the portal. Establishments that do not use the spread 
sheet provided by FSIS as a template to record their results would need 
to manually enter their microbial sampling data into the portal to 
submit their monthly data.
    FSIS is revising this information collection to add 1,788 total 
burden hours due to the proposed new requirements. The burden estimate 
has also been updated to reflect the current number of poultry 
slaughter establishment respondents, which has increased from 289 to 
298 since the initial information collection approval. FSIS requests 
comments on the proposed data fields and on the proposed electronic 
data submission process.
    FSIS estimates that a total of 298 establishments would conduct 
microbial testing and enter 6-12 associated data points into the spread 
sheet, or directly into the portal, 12 times annually for a total of 
1,788 hours.

                                                 Microbial Testing, Recording, and Electronic Submission
                                                                [9 CFR 381.65(g) and (h)]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                          Time for
                                                                        Number of      responses per     Total annual     response in      Total annual
                                                                       respondents       respondent       responses          mins.        time in hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total..............................................................             298                1               12               30            1,788
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Copies of this information collection assessment can be obtained 
from Gina Kouba, Office of Policy and Program Development, Food Safety 
and Inspection Service, USDA, 1400 Independence Avenue SW, Mailstop 
3758, South Building, Washington, DC 20250-3700; (202) 937-4272. 
Comments are invited on: (a) whether the proposed collection of 
information is necessary for the proper performance of FSIS' functions, 
including whether the information will have practical utility; (b) the 
accuracy of FSIS' estimate of the burden of the proposed collection of 
information, including the validity of the method and assumptions used; 
(c) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (d) ways to minimize the burden of the 
collection of information, including through the use of appropriate 
automated, electronic, mechanical, or other technological collection 
techniques, or other forms of information technology. Comments may be 
sent to both FSIS, at the addresses provided above, and the Desk 
Officer for Agriculture, Office of Information and Regulatory Affairs, 
Office of Management and Budget (OMB), Washington, DC 20253

IX. E-Government Act

    FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et seq.) by, among other things, 
promoting the use of the internet and other information technologies 
and providing increased opportunities for citizen access to Government 
information and services, and for other purposes.

X. Executive Order 12988, Civil Justice Reform

    This proposed rule has been reviewed under E.O. 12988, Civil 
Justice Reform. Under this proposed rule: (1) All State and local laws 
and regulations that are inconsistent with this proposed rule will be 
preempted; (2) no retroactive effect will be given to this proposed 
rule; and (3) no administrative proceedings will be required before 
parties may file suit in court challenging this proposed rule.

XI. E.O. 13175

    E.O. 13175 requires Federal agencies to consult and coordinate with 
tribes on a government to-government basis on policies that have tribal 
implications, including regulations, legislative comments or proposed 
legislation, and other policy statements or actions that have 
substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal Government and Indian tribes or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes. FSIS has assessed the impact of this 
proposed rule on Indian tribes and determined that this proposed rule 
does not, to our knowledge, have tribal implications that require 
tribal consultation under E.O. 13175. If a tribe requests consultation, 
FSIS will work with the Office of Tribal Relations to ensure meaningful 
consultation is provided where changes, additions, and modifications 
identified herein are not expressly mandated by Congress.

XII. USDA Non-Discrimination Statement

    In accordance with Federal civil rights law and USDA civil rights 
regulations and policies, USDA, its Mission Areas, agencies, staff 
offices, employees, and institutions participating in or administering 
USDA programs are prohibited from discriminating based on race, color, 
national origin, religion, sex, gender identity (including gender 
expression), sexual orientation, disability, age, marital status, 
family/parental status,

[[Page 64747]]

income derived from a public assistance program, political beliefs, or 
reprisal or retaliation for prior civil rights activity, in any program 
or activity conducted or funded by USDA (not all bases apply to all 
programs). Remedies and complaint filing deadlines vary by program or 
incident. Program information may be made available in languages other 
than English. Persons with disabilities who require alternative means 
of communication to obtain program information (e.g., Braille, large 
print, audiotape, American Sign Language) should contact the 
responsible Mission Area, agency, or staff office; the USDA TARGET 
Center at (202) 720-2600 (voice and TTY); or the Federal Relay Service 
at (800) 877-8339. To file a program discrimination complaint, a 
complainant should complete a Form, AD-3027, USDA Program 
Discrimination Complaint Form, which can be obtained online at https://www.usda.gov/forms/electronic-forms, from any USDA office, by calling 
(866) 632-9992, or by writing a letter addressed to USDA. The letter 
must contain the complainant's name, address, telephone number, and a 
written description of the alleged discriminatory action in sufficient 
detail to inform the Assistant Secretary for Civil Rights about the 
nature and date of an alleged civil rights violation. The completed AD-
3027 form or letter must be submitted to USDA 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: (833) 256-1665 or (202) 690-7442; or (3) Email: 
usda.gov">program.intake@usda.gov.
    USDA is an equal opportunity provider, employer, and lender.

XIII. Environmental Impact

    Each USDA agency is required to comply with 7 CFR part 1b of the 
Departmental regulations, which supplements the National Environmental 
Policy Act regulations published by the Council on Environmental 
Quality. Under these regulations, actions of certain USDA agencies and 
agency units are categorically excluded from the preparation of an 
Environmental Assessment (EA) or an Environmental Impact Statement 
(EIS) unless the agency head determines that an action may have a 
significant environmental effect (7 CFR 1b.4(b)). FSIS is among the 
agencies categorically excluded from the preparation of an EA or EIS (7 
CFR 1b.4(b)(6)). This proposed rule would establish final product 
standards for certain raw poultry products. Under this proposal, raw 
chicken carcasses, chicken parts, comminuted chicken, and comminuted 
turkey that contain Salmonella levels and serotypes in the proposed 
final product standards would be adulterated. This proposed rule would 
also revise the regulations that require that all poultry slaughter 
establishments develop, implement, and maintain written procedures to 
prevent contamination by enteric pathogens throughout the entire 
slaughter and dressing operation to clarify that these procedures must 
include a MMP that incorporates SPC monitoring methods and to require 
all establishments to conduct testing at rehang and post chill. FSIS 
has determined that this proposed rule would not create any 
extraordinary circumstances that would result in this normally excluded 
action having a significant individual or cumulative effect on the 
human environment. Therefore, this action is appropriately subject to 
the categorical exclusion from the preparation of an environmental 
assessment or environmental impact statement provided under 7 CFR 
1b.4(b)(6) of the U.S. Department of Agriculture regulations.

XIV. 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: 
https://www.fsis.usda.gov/federal-register. FSIS will also announce and 
provide a link 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 is able to provide 
information to a much broader, more diverse audience. In addition, FSIS 
offers an email subscription service which provides automatic and 
customized access to selected food safety news and information. This 
service is available at: https://www.fsis.usda.gov/subscribe. Options 
range from recalls to export information, regulations, directives, and 
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the option to password protect their accounts.

List of Subjects in 9 CFR Part 381

    Meat inspection, Poultry and poultry products.

    For the reasons set forth in the preamble, FSIS proposes to amend 9 
CFR part 381 as follows:

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

0
1. The authority citation for part 381 continues to read as follows:

    Authority: 7 U.S.C. 138f, 1633; 21 U.S.C. 451-472; 7 CFR 2.7, 
2.18, 2.53.
0
2. Amend Sec.  381.65 by revising paragraphs (g) and (h) to read as 
follows:


Sec.  381.65  Operations and procedures, generally.

* * * * *
    (g) Procedures for controlling contamination throughout the 
slaughter and dressing operation. Official poultry slaughter 
establishments must develop, implement, and maintain written procedures 
to prevent contamination of carcasses and parts by enteric pathogens 
and fecal contamination throughout the entire slaughter and dressing 
operation. Establishments must incorporate these procedures into their 
HACCP plans, or sanitation SOPs, or other prerequisite programs. At a 
minimum, these procedures must establish a microbial monitoring program 
that includes sampling and analysis of microbial organisms in 
accordance with the requirements in paragraphs(g)(1)-(5) of this 
section to monitor an establishment's ability to maintain process 
control.
    (1) Sampling locations. Establishments must collect and analyze 
samples for microbial organisms at the rehang and post-chill points in 
the process.
    (i) The establishment's microbial monitoring program must identify 
and provide supporting rationale for the specific point in the process 
where rehang and post-chill samples will be collected.
    (ii) An establishment may collect samples at a location other than 
rehang if the establishment provides supporting data to demonstrate 
that the alternate location is at least as effective as rehang sampling 
for monitoring the establishment's ability to maintain process control.
    (2) Sampling frequency.
    (i) Except as provided in paragraph (g)(2)(ii) of this section, all 
official poultry establishments must collect and analyze paired 
monitoring samples at the following rates. Establishments that 
slaughter multiple species may conduct sampling on the type of poultry 
slaughtered in the greatest number.
    (A) Chickens

[[Page 64748]]



----------------------------------------------------------------------------------------------------------------
      Predominant poultry species           Establishment volume     Annual slaughter     Minimum frequency of
              slaughtered                          sizes               head volume         paired collection
----------------------------------------------------------------------------------------------------------------
Chicken................................  Very Low Volume..........          1-440,000  13 Weekly Pairs per Year.
Chicken................................  Low Volume...............  440,001-1,100,000  Weekly.
Chicken................................  Medium and High Volume...        >=1,100,000  1 per 22,000.
----------------------------------------------------------------------------------------------------------------

    (B) Turkeys, ducks, geese, guineas and squabs

----------------------------------------------------------------------------------------------------------------
      Predominant poultry species           Establishment volume     Annual slaughter     Minimum frequency of
              slaughtered                          sizes               head volume         paired collection
----------------------------------------------------------------------------------------------------------------
Turkey, Geese, Guinea, Ducks, Squab....  Very Low Volume..........           1-60,000  13 Weekly Pairs per Year.
Turkey, Geese, Guinea, Ducks, Squab....  Low Volume...............     60,001-156,000  Weekly.
Turkey, Geese, Guineas, Ducks Squab....  Medium and High Volume...          >=156,000  1 per 3,000.
----------------------------------------------------------------------------------------------------------------

    (ii) Very low volume establishments as defined in paragraphs 
(g)(2)(i)(A) and (B) of this section that plan to operate less than 13 
weeks per year may collect and analyze 13 samples less than weekly if 
the establishment can demonstrate that it is effectively maintaining 
process control throughout the year and during any periods of slaughter 
operations.
    (iii) Establishments must sample at a frequency that is adequate to 
monitor their ability to maintain process control for enteric 
pathogens.
    (iv) Establishments must maintain accurate records of all test 
results and retain these records as provided in paragraph(h) of this 
section.
    (3) Microbial Organism and Methods. Establishments must analyze 
monitoring samples for microbial organisms that are quantifiably 
detectable in their slaughter process and that will generate microbial 
monitoring data that is adequate to monitor their ability to maintain 
process control for enteric pathogens.
    (i) The establishment's measured results at each sample location 
must yield statistically reliable quantified value results
    (ii) The establishments' sample collection method must be 
appropriate for the product sampled, the microbial organism monitored, 
and the laboratory method used to analyze the samples.
    (iii) The establishment's microbial sampling results must be 
generated by validated laboratory analyses and methods.
    (4) Microbial Monitoring Criteria. The establishment must use 
appropriate statistical methods to compare microbial monitoring data 
against predefined quantitative limits adequate to gauge its ability to 
maintain process control. At a minimum, the microbial monitoring 
program must identify and support limits for:
    (i) The minimal expected change in microbial levels measured 
between sampling locations; and
    (ii) The expected consistency of the levels of change detected over 
a specified monitoring period.
    (5) Corrective Actions. The establishment must implement written 
corrective actions, including a root cause assessment, at a minimum 
when:
    (i) The microbial monitoring results deviate from predefined 
quantitative limits;
    (ii) The microbial monitoring results are not consistent with the 
other process control monitoring results for the same procedures; or
    (iii) The microbial monitoring results are not consistent with the 
process control determination made for the entire slaughter HACCP 
system.
    (h) Recordkeeping requirements. Official poultry slaughter 
establishments must maintain daily records sufficient to document the 
implementation and monitoring of the procedures required under 
paragraph (g) of this section. Records required by this section may be 
maintained on computers if the establishment implements appropriate 
controls to ensure the integrity of the electronic data. Records 
required by this section must be maintained for at least one year and 
must be accessible to FSIS.
    (1) Official poultry slaughter establishments must submit their 
microbial sampling results to FSIS electronically on a monthly basis.
    (2) [reserved]

    Done in Washington, DC.
Paul Kiecker,
Administrator.
[FR Doc. 2024-16963 Filed 8-6-24; 8:45 am]
BILLING CODE 3410-DM-P