1

U.S. Department of Agriculture/

Food Safety and Inspection Service

FY2024 Public Health Regulations

July 2023
2

Table of Contents

Summary......................................................................................................................................... 5

1.0 Introduction............................................................................................................................... 8

2.0 Selection of PHRs..................................................................................................................... 9

2.1 Criteria for Selection of Candidate Regulations................................................................... 9

2.2 Relationship with Pathogen Positives and Enforcement Actions....................................... 10

3.0 Candidate Regulations............................................................................................................ 11

4.0 Relationship Between Candidate Regulations and Pathogen Positives and Enforcement 

Actions................................................................................................................................... 11

4.1 Salmonella........................................................................................................................... 11

4.1.1 Salmonella in Intact Chicken....................................................................................... 14

4.1.2 Salmonella in Intact Turkey......................................................................................... 14

4.1.3 Salmonella in Ground Beef.......................................................................................... 15

4.1.4 Salmonella in Intact Beef............................................................................................. 16

4.1.5 Salmonella in Ground Chicken.................................................................................... 19

4.1.6 Salmonella in Ground Turkey...................................................................................... 20

4.1.7 Salmonella in Intact Pork............................................................................................. 21

4.1.8 Salmonella in Ground Pork.......................................................................................... 22

4.1.9 Salmonella in Chicken Parts........................................................................................ 24

4.1.10 Salmonella in Siluriformes ........................................................................................ 24

4.1.11 Salmonella in Ready-to-Eat Products........................................................................ 25

4.2 E. coli .................................................................................................................................. 25

4.2.1 E. coli O157:H7 ........................................................................................................... 25

4.2.2 Non-O157 STEC.......................................................................................................... 26

4.3 Listeria monocytogenes ...................................................................................................... 27

4.4 Campylobacter.................................................................................................................... 28

4.4.1 Campylobacter in Intact Chicken ................................................................................ 30

4.4.2 Campylobacter in Intact Turkey .................................................................................. 31

4.4.3 Campylobacter in Ground Chicken ............................................................................. 31

4.4.4 Campylobacter in Ground Turkey............................................................................... 32

4.4.5 Campylobacter in Chicken Parts ................................................................................. 33

4.5 Enforcement Actions .......................................................................................................... 34

5.0 List of FY2024 PHRs.............................................................................................................. 38

6.0 Cut Points for FY2024 PHRs.................................................................................................. 42

7.0 Conclusion .............................................................................................................................. 45

Appendix A: FY2024 PHRs Regulations..................................................................................... 46

Appendix B: FY2024 Candidate Regulations............................................................................... 48

Appendix C: Comparison of FY2023 PHRs List with FY2024 PHRs List.................................. 63

Appendix D: Methodology and Calculation of PHRs Cut Points................................................. 64
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List of Figures and Tables

Table S-1 PHRs Upper Cut Points.................................................................................................. 6

Table S-2 PHRs Lower Cut Points................................................................................................. 6

Table S-3 Number of Establishments in Levels Based Solely on the PHRs Criterion................... 7

Table 4-1 Comparison of Noncompliance Rates 90 Days before a Salmonella Positive with 

Those for Establishments with No Salmonella Positives ............................................................. 12

Table 4-2 Comparison of Noncompliance Rates 90 Days before an Intact Chicken Salmonella

Positive with Those for Establishments with No Intact Chicken Salmonella Positives.............. 14

Table 4-3 Comparison of Noncompliance Rates 90 Days before an Intact Turkey Salmonella

Positive with Those for Establishments with No Intact Turkey Salmonella Positives................. 15

Table 4-4 Comparison of Noncompliance Rates 90 Days before a Ground Beef Salmonella

Positive with Those for Establishments with No Ground Beef Salmonella Positives.................. 15

Table 4-5 Comparison of Noncompliance Rates 90 Days before an Intact Beef Salmonella

Positive with Those for Establishments with No Intact Beef Salmonella Positives..................... 17

Table 4-6 Comparison of Noncompliance Rates 90 Days before a Ground Chicken Salmonella

Positive with Those for Establishments with No Ground Chicken Salmonella Positives........... 19

Table 4-7 Comparison of Noncompliance Rates 90 Days before a Ground Turkey Salmonella

Positive with Those for Establishments with No Ground Turkey Salmonella Positives.............. 20

Table 4-8 Comparison of Noncompliance Rates 90 Days before an Intact Pork Salmonella

Positive with Those for Establishments with No Intact Pork Salmonella Positives..................... 22

Table 4-9 Comparison of Noncompliance Rates 90 Days before a Ground Pork Salmonella

Positive with those for Establishments with No Ground Pork Salmonella Positives................... 23

Table 4-10 Comparison of Noncompliance Rates 90 Days before a Chicken Parts Salmonella

Positive with Those for Establishments with No Chicken Parts Salmonella Positives................ 24

Table 4-11 Comparison of Noncompliance Rates 90 Days before a Siluriformes Salmonella

Positive with Those for Establishments with No Siluriformes Salmonella Positives .................. 25

Table 4-12 Comparison of Noncompliance Rates 90 Days before an E. coli O157:H7 Positive 

with Those for Establishments with no E. coli O157:H7 Positives.............................................. 26

Table 4-13 Comparison of Noncompliance Rates 90 Days before a non-O157 STEC Positive 

with Those for Establishments with No non-O157 STEC Positives ............................................ 27

Table 4-14 Comparison of Noncompliance Rates 90 Days before a Lm Positive with Those for 

Establishments with No Lm Positives........................................................................................... 27

Table 4-15 Comparison of Noncompliance Rates 90 Days before a Campylobacter Positive with 

Those for Establishments with No Campylobacter Positives....................................................... 29

Table 4-16 Comparison of Noncompliance Rates 90 Days before a Campylobacter Intact 

Chicken Positive with Those for Establishments with No Campylobacter Intact Chicken 

Positives........................................................................................................................................ 30

Table 4-17 Comparison of Noncompliance Rates 90 Days before a Campylobacter Intact 

Turkey Positive with Those for Establishments with No Campylobacter Intact Turkey Positives

....................................................................................................................................................... 31

Table 4-18 Comparison of Noncompliance Rates 90 Days before a Ground Chicken 

Campylobacter Positive with Those for Establishments with No Ground Chicken Campylobacter

Positives........................................................................................................................................ 32

Table 4-19 Comparison of Noncompliance Rates 90 Days before a Ground Turkey 

Campylobacter Positive with those for Establishments with No Ground Turkey Campylobacter

Positives........................................................................................................................................ 32
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Table 4-20 Comparison of Noncompliance Rates 90 Days before a Chicken Parts Campylobacter

Positive with Those for Establishments with No Chicken Parts Campylobacter Positives ......... 33

Table 4-21 Comparison of Noncompliance Rates 90 Days before an Enforcement Action with 

Those for Establishments with No Enforcement Actions............................................................. 35

Table 5-1 List of FY2024 PHRs................................................................................................... 38

Table 5-2 Events That Triggered Inclusion of a Regulation in the FY2024 PHRs List............... 41

Table 5-3 Regulations Triggered for Inclusion in the FY2024 PHRs List by Only a Single Event

....................................................................................................................................................... 42

Table 6-1 Mean and Standard Deviation of Quarterly FY2024 PHRs Rate................................. 43

Table 6-2 FY2024 PHRs Upper-Level Cut Points ....................................................................... 44

Table 6-3 FY2024 PHRs Lower-Level Cut Points....................................................................... 44

Table 6-4 Classification of Establishments Based Solely on the PHRs Criterion........................ 44

Table A-1 List of FY2024 PHRs.................................................................................................. 46

Table B-1 FY2024 List of Candidate Regulations ....................................................................... 48

Table C-1 Regulations on the FY2023 PHRs List No Longer on the FY2024 PHRs List........... 63

Table C-2 Regulations on the FY2024 PHRs List That Were Not on the FY2023 PHRs List .... 63

Figure D-1 Log Transformed Non-Zero Noncompliance Rates of PHRs with 20 or More 

Verifications 90 Days before a Pathogen Positive or Enforcement Action.................................. 64

Figure D-2 Goodness of Fit for Normal Distribution of the Log Transformation........................ 65

Table D-1 Quarterly PHRs Mean, Standard Deviation and Level Distribution ........................... 65

Table D-2 Average Mean and Standard Deviation of Log Transformed Non-Zero PHRs Rates by 

Establishment Type....................................................................................................................... 66

Table D-3 FY2024 PHRs Upper and Lower Cut Points............................................................... 66

Table D-4 March 2023 Level Distribution Based on the Previous Year’s (FY2023) PHRs Cut 

Points............................................................................................................................................. 66
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SUMMARY

The Food Safety and Inspection Service (FSIS) “public health regulations” (PHRs) are 

regulations1that have significantly higher individual noncompliance rates at establishments 

within 90-days of a pathogen-positive laboratory sample—Salmonella, Escherichia coli (E. coli)

O157:H7, non-O157 Shiga toxin-producing E. coli (STEC), Listeria monocytogenes (Lm), or 

Campylobacter—or a public health-related enforcement action, compared to establishments with 

no pathogen positives or enforcement actions.

2 Although correlation does not necessarily 

indicate a higher risk in food safety, it can be helpful for agencies in allocating resources. FSIS 

expects establishments to comply with all regulatory requirements.

This report describes the agency’s data-driven approach to select the PHRs that will prioritize 

certain inspection activities for the 2024 fiscal year (FY) spanning October 1, 2023, to 

September 30, 2024. FSIS uses decision criteria, including PHRs, to prioritize establishments for

“public health risk evaluations”

3

(PHREs) through which FSIS determines the need for a “food 

safety assessment” (FSA) or enforcement action. In addition to exceeding an upper threshold for 

PHRs noncompliance rate, other decision criteria for PHREs include pathogen testing results, 

recalls, outbreaks, regulatory findings, and inspection results. The list of PHRs, as well as the 

upper and lower thresholds that inform PHREs and alert FSIS inspection program personnel of 

elevated PHRs noncompliance, are updated annually (around July 1) with targeted 

implementation in October.

The FY2024 PHRs list is based on calendar year (CY) 2022 FSIS verification data from January 

1, 2022, to December 31, 2022. For inclusion in the FY2024 PHRs list, FSIS evaluated a curated 

list of candidate regulations from Title 9 of the Code of Federal Regulations (CFR) to determine 

whether noncompliance with each regulation occurred more frequently in establishments within 

90 days of having pathogen-positive samples or enforcement actions compared to establishments 

without positives or enforcement actions. 

The final list of FY2024 PHRs (see Appendix A) consists of 63 regulations that have higher rate 

of noncompliance in the 90 days before a pathogen positive or enforcement action. Of the 71

PHRs identified for FY2023, 56 remain on the FY2024 PHRs list.

The average noncompliance rate of FY2024 PHRs in the 90 days before a pathogen positive or 

enforcement action is 5.64 times higher than the average FY2024 PHRs noncompliance rate for 

establishments with no pathogen positive and no enforcement action. Noncompliance with a 

1 The term “regulation” is meant to include both regulations and the provisions of regulations. The Code of Federal 

Regulations (CFR) is composed of a set of regulations and the provisions of the regulations that define in greater 

detail the specific requirements of a regulation. The inclusion of provisions of regulations in the PHRs list allows 

FSIS to focus on specific health-related provisions of regulations that may be most informative for prioritizing 

public health risk evaluations (PHREs).

2 Hereafter, the term “enforcement action” refers to a public health-related Notice of Intended Enforcement (NOIE) 

or Notice of Suspension (NOS) that results from a Sanitation Standard Operating Procedure (SSOP), Hazard 

Analysis and Critical Control Point (HACCP), or Sanitation Performance Standards (SPS) violation. 

3

If an establishment is selected for a PHRE, the District Office first performs the evaluation as described in FSIS 

Directive 5100.4 "Enforcement, Investigations and Analysis Officer (EIAO) Public Health Risk Evaluation (PHRE) 

Methodology” to review the operational and compliance history of the establishment to decide if a Food Safety 

Assessment (FSA) or enforcement action is appropriate.
6

single FY2024 PHR does not indicate a loss of process control. The aggregate set of PHRs is 

used to identify establishments that significantly deviate from the 90-day rolling average 

noncompliance rate for all similar establishments. The aggregate FY2024 PHRs noncompliance 

rate by establishments is evaluated and compared to thresholds (also referred to as cut points) for 

two broad categories of establishment operations: “Processing” (processing only) and 

“Combination” (both slaughter and processing).

The FY2024 cut points are computed by determining the mean and standard deviation of the log 

transformed non-zero FY2024 PHRs rates for each of the four quarters in CY2022 (the log 

transformation of the non-zero FY2024 PHRs rates is taken to obtain an approximately normal 

distribution). The mean and standard deviation are averaged over the four quarters, and the upper

cut point is defined as the mean plus two times the standard deviation of the log transformed 

non-zero PHRs rates. The antilog is then taken to obtain the upper cut point of the nontransformed PHRs noncompliance data. If an establishment’s PHRs noncompliance rates exceed 

the upper cut point for similar establishments, it is classified as “Upper” and may be subject to a 

for-cause PHRE if it has not had one in the last 180 days. The lower cut point is defined as the 

mean plus one and a half times the standard deviation of the log transformed non-zero PHRs

rates. Establishments that have PHRs noncompliance rates below the lower cut point for similar 

establishments are classified as “Lower. As outlined in FSIS Directive 5100.5, establishments 

with a PHRs noncompliance rate between the upper and lower cut points will be notified by FSIS 

inspection program personnel that the establishment is at an elevated level of noncompliance.

Tables S-1 and S-2 present the upper and lower FY2024 PHRs cut points for the nontransformed PHRs noncompliance data for each of the two establishment operation types. The 

FY2023 and FY2022 PHRs cut points are included for comparison (See Section 6 and Appendix 

D).

Table S-1 PHRs Upper Cut Points

Operation Type FY2024 FY2023 FY2022

Processing 3.76% 3.65% 3.63%

Combination 7.17% 7.48% 7.33%

Table S-2 PHRs Lower Cut Points

Operation Type FY2024 FY2023 FY2022

Processing 2.49% 2.45% 2.44%

Combination 4.44% 4.59% 4.60%

Table S-3 presents the number of establishments in each level from January 1, 2023, to March 

31, 2023, based on the PHRs criterion. The period used for calculating the noncompliance rate of 

the PHRs was January 1, 2023, to March 31, 2023. The number of for-cause PHREs for Upper

cut point establishments is approximately the same as in previous years.
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Table S-3 Number of Establishments in Levels Based Solely on the PHRs Criterion

Level Processing Combination Total

Upper 43 14 57

Mid 64 25 89

Lower 4,213 1,117 5,330

Total 4,320 1,156 5,476
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1.0 INTRODUCTION

In January 2008, the Food Safety and Inspection Service (FSIS) published a decision tree 

methodology and a set of seven public health-based decision criteria for use in prioritizing 

establishments for Public Health Risk Evaluations (PHREs). The decision criteria include 

pathogen testing results, recalls, outbreaks, regulatory findings, and a record of noncompliance 

with certain regulations in Title 9 of the Code of Federal Regulations (CFR). The purpose of a

PHRE is to review an establishment’s food safety system to verify that the establishment can

produce safe and wholesome meat or poultry products in accordance with FSIS statutory and 

regulatory requirements. If an establishment is selected for a PHRE, the FSIS district office first 

performs the evaluation as described in FSIS Directive 5100.4 (Public Health Risk Evaluation 

Methodology) to review the operational and compliance history of the establishment to decide if 

a food safety assessment (FSA) or enforcement action is appropriate.

The purpose of this report is to update the list of PHRs for fiscal year (FY) 2024 based on FSIS

verification inspection data from the FSIS public health information system (PHIS). The updated 

FY2024 PHRs list will prioritize certain inspection activities for the fiscal year spanning October 

1, 2023, to September 30, 2024.

The CFR is composed of a set of regulations and the provisions of the regulations; therefore, the 

use of “regulation” in this report describes both regulations and their provisions. These 

provisions define in greater detail the specific requirements of a regulation. Including provisions 

in the PHRs list allows FSIS to focus on specific public health-related provisions that may be 

most informative for prioritizing PHREs.

FSIS used the same methodology to develop the FY2024 PHRs list as last year. For inclusion in 

the FY2024 PHRs list, each candidate 9 CFR regulation was evaluated to determine whether 

noncompliance with the verified regulation had occurred at a more frequent rate in 

establishments in the 90 days before Salmonella, Escherichia coli (E. coli) O157: H7, non-O157 

Shiga toxin-producing E. coli (STEC), Listeria monocytogenes (Lm), or Campylobacter positives 

or enforcement actions than in establishments without positives or enforcement actions4. The 

analysis was based on one calendar year (CY) of FSIS verification inspection results recorded in 

PHIS, from January 1 to December 31, 2022 (CY2022). Candidate regulations related to egg 

products are not included in this report because hazard analysis and critical control point

(HACCP) implementation was not required in egg establishments until October 2022.

The body of this report describes the agency’s data-driven approach to select the PHRs. Sections 

Two and Three identify how the candidate regulations are selected and outline the analysis 

results for selecting the appropriate PHRs from those regulations; Section Four summarizes the 

final list of PHRs; and Section Five explains the calculation of the cut points used for notifying 

districts of establishments that need to be scheduled for an FSA or a PHRE. The final FY2024

PHRs list is presented in Appendix A; Appendix B lists the candidate regulations evaluated to 

determine PHRs; Appendix C describes the differences between the FY2024 PHRs list and 

4 As noted above, the term “enforcement action” refers to a public health-related Notice of Intended Enforcement 

(NOIE) or Notice of Suspension (NOS) that results from a Sanitation Standard Operating Procedure (SSOP), Hazard 

Analysis and Critical Control Point (HACCP), or Sanitation Performance Standards (SPS) violation.
9

FY2023 PHRs list; and Appendix D explains the methodology and calculations used to 

determine the PHRs cut points.

The FY2024 PHRs list, as well as the upper and lower thresholds that inform PHREs and alert 

FSIS inspection program personnel of elevated PHRs noncompliance are anticipated to be 

implemented beginning October 2023.

2.0 SELECTION OF PHRS

The PHRs candidate list will consist of verified 9 CFR regulations with which noncompliance 

occurs at a more frequent rate in establishments in the 90 days before Salmonella, E. coli 

O157:H7, non-O157 STEC, Lm, or Campylobacter positives or enforcement actions than in 

establishments without positives or enforcement actions. Not all regulations are related to 

pathogen positives or enforcement actions. Therefore, to facilitate the analysis and to focus on 

the most relevant regulations, the list of regulations is narrowed to those related to verifying

HACCP food safety process control.

Thus, the selection of PHRs is a two-step process:

1. Develop a candidate list of 9 CFR regulations related to verifying food safety process 

control; and

2. From this list, select the subset of regulations whose individual noncompliance rates are

statistically higher in establishments in the 90 days before a Salmonella, E. coli O157:H7, 

non-O157 STEC, Lm, or Campylobacter positive or enforcement actions than in 

establishments without positives or enforcement actions.

Noncompliance with a single PHR does not indicate a loss of process control. The aggregate set 

of PHRs is used to identify establishments that significantly deviate from the 90-day rolling 

average noncompliance rate for all similar establishments.

2.1 Criteria for Selection of Candidate Regulations

The purpose of the list of candidate regulations is to identify a subset of 9 CFR regulations that 

are more directly related to a possible loss of process control. Process control refers to

procedures designed by an establishment to control operating conditions necessary to produce

safe, wholesome food.

Regulations are selected for the candidate list if noncompliance with the regulation provides 

evidence that establishments are not satisfying one of the four criteria:

1. Establish and maintain HACCP plan and critical control points (CCPs),

2. Establish and maintain sanitary conditions,

3. Prevent adulteration, or

4. Implement effective corrective actions.

The following are examples of the types of regulations under each criterion that would be 

considered candidate regulations.

• Establish and Maintain HACCP Plan and CCPs

o Failure to maintain an adequate HACCP plan.

o Adequacy of the HACCP plan in controlling food safety hazards.
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o Critical factors specified in the process schedule shall be measured, controlled,

and recorded.

o CCPs are under control.

• Establish and Maintain Sanitary Conditions

o Products are prepared, packed, or held under sanitary conditions.

o Products do not contain any filthy, putrid, or decomposed substance.

o Products do not contain foreign material.

o Operates in a manner that does not deter inspection to determine sanitary 

conditions.

• Prevent Adulteration

o No adulterated product enters commerce.

o Product and ingredients rendered adulterated by polluted water shall be 

condemned.

o Container composed of any poisonous or deleterious substance.

o Dead, dying, disabled or diseased and similar livestock shall be condemned.

o Lethality and stabilization requirements for cooked beef.

o Time/temperature for heat-processing combinations of fully cooked meat patties.

o Positive E. coli O157:H7 during FSIS verification testing.

• Implement Effective Corrective Actions

o Select appropriate procedures and corrective actions.

o Document corrective actions.

o Identify and eliminate the cause.

o Establish measures to prevent recurrence.

o Reassess hazard analysis.

2.2 Relationship with Pathogen Positives and Enforcement Actions

The second step in selecting a list of PHRs is to determine which candidate regulations are 

related to a higher rate of noncompliance in the 90 days before the occurrence of a pathogen 

positive during FSIS sampling or an enforcement action. The time period of 90 days is chosen as 

it is long enough to have sufficient FSIS verification data for analysis and short enough to 

indicate establishment operating conditions before a pathogen positive or enforcement action. A 

candidate regulation will be included in the final list of PHRs if the noncompliance rate for the 

regulation is higher in establishments in the 90 days before a Salmonella, E. coli O157:H7, nonO157 STEC, Lm, or Campylobacter positive or an enforcement action than the average 

noncompliance rate in establishments that do not have a Salmonella, E. coli O157:H7, non-O157 

STEC, Lm, or Campylobacter positive or an enforcement action.
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3.0 CANDIDATE REGULATIONS

All regulations in 9 CFR were individually reviewed to determine if they satisfied any of the four 

criteria delineated in Section 2.1. A set of 159 9 CFR regulations were selected to indicate a 

potential loss of food safety process control. The list of 159 candidate regulations that are 

indicators of a potential loss of HACCP food safety process control is presented in Appendix B.

4.0 RELATIONSHIP BETWEEN CANDIDATE REGULATIONS AND PATHOGEN

POSITIVES AND ENFORCEMENT ACTIONS

The purpose of this section is to provide the results of the analysis between the list of candidate 

regulations and Salmonella, E. coli O157:H7, non-O157 STEC, Lm, or Campylobacter positives

during FSIS verification testing or enforcement actions. The noncompliance rate of each of the 

FY2024 159 candidate regulations in establishments in the 90 days prior to a pathogen positive 

or enforcement action was compared with the average noncompliance rate of establishments that 

received FSIS verification testing but had no positives or enforcement actions for CY2022.

Regulations that received more than 30 verifications within a year and have a rates ratio of 3.0 or 

higher, along with a 95% probability (determined by a two-sided Fisher's Exact Test p value of 

less than 0.05), indicating that the noncompliance rate of the regulation in establishments during 

the 90 days before a pathogen positive or enforcement action is statistically higher than the 

noncompliance rate for establishments with no positives, are classified as PHRs

Candidate regulations with less than or equal to 30 verifications in the 90 days prior to a specific 

pathogen positive or enforcement action are excluded from consideration for that specific 

pathogen or enforcement action since the noncompliance rate associated with these regulations is

highly uncertain. The candidate regulation is still considered for pathogens or enforcement 

actions with more the 30 verifications.

A rates ratio is one of several statistics useful as an effect-size measure, especially when 

statistical significance of dichotomous data is computed using the Fisher’s Exact test. The odds 

of an event occurring is calculated as the number of events divided by the number of non-events.

A rates ratio is calculated by dividing the odds of a test group (in this case, the odds of receiving 

a noncompliance of a candidate regulation for establishments with a pathogen positive or 

enforcement action) by the odds in the control group (in this case, the odds of receiving a 

noncompliance of a candidate regulation for establishments without a pathogen positive or 

enforcement action). There is no definitive rule for determining a meaningful rates ratio size. In 

this report, a rates ratio size of 3.0 is taken as the threshold for a meaningful rates ratio size.

4.1 Salmonella

The purpose of this section is to provide the results of the analysis between the list of candidate 

regulations and Salmonella positives. The dataset used in the analysis consists of candidate PHRs

noncompliance rates for the 2,166 establishments with Salmonella testing data. There were 777

establishments that had 4,000 Salmonella positives. There were 1,389 establishments that did not 

have any Salmonella positives. There were 55,359 total Salmonella tests performed.

Table 4-1 presents the 24 regulations that had more than 30 verifications in a year, a rates ratio of 

3.0 or greater, and for which there is a 95% probability (as determined by a two-sided Fisher’s

Exact Test p value of less than 0.05) that the noncompliance rate of the regulation in 
12

establishments in the 90 days prior to a Salmonella positive is higher than the average 

noncompliance rate for establishments with no Salmonella positive for CY2022. 

Table 4-1 Comparison of Noncompliance Rates 90 Days before a Salmonella Positive with 

Those for Establishments with No Salmonella Positives

Regulation 

Verified

Description1 On 

FY

2023

PHR 

List

Noncompliance 

Rate 90 Days

before a 

Salmonella

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella

Positives

Rates 

ratio

TwoSided 

Fisher 

Exact p

Value

310.22(c) Disposal of 

specified risk 

materials (SRM)

Yes 0.04 0.00 8.40 2.10E-61

310.22(e)(1) Written procedures 

for removal,

segregation, and 

disposition of SRMs

Yes 0.12 0.03 5.03 5.50E-27

310.22(e)(3) Evaluate 

effectiveness of 

procedures for

removal, 

segregation, and 

disposition of

SRMs

Yes 0.19 0.01 17.84 5.12E-68

310.22(f)(2) Use of routine 

operational 

sanitation

procedures on 

equipment used to 

cut

through SRMs

No 0.01 0.00 3.50 9.31E-04

318.2(d) Removal of U.S. 

retained by 

authorized

Program employees 

only

Yes 0.04 0.01 3.85 1.07E-06

381.65(a) Clean and sanitary 

practices; products 

not

adulterated

Yes 0.01 0.00 3.46 2.33E-08

381.71(a) Condemnation on 

ante-mortem 

inspection

Yes 0.06 0.01 8.17 8.31E-03

381.91(b) Reprocessing of 

carcasses 

accidentally

contaminated with 

digestive tract 

contents.

Yes 0.16 0.00 39.07 2.19E-108

416.13(a) Conduct pre-op 

procedures

Yes 0.08 0.02 5.25 0.00E+00
13

Regulation 

Verified

Description1 On 

FY

2023

PHR 

List

Noncompliance 

Rate 90 Days

before a 

Salmonella

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella

Positives

Rates 

ratio

TwoSided 

Fisher 

Exact p

Value

416.13(b) Conduct other 

procedures listed in 

the plan

Yes 0.01 0.00 4.80 0.00E+00

416.13(c) Plant monitors 

implementation of 

sanitation standard 

operating 

procedures (SSOP)

procedures

Yes 0.04 0.01 4.63 0.00E+00

416.15(b) Corrective action, 

procedures for

Yes 0.10 0.02 4.68 2.06E-74

416.2(a) Grounds and Pest 

Control

Yes 0.13 0.03 5.21 0.00E+00

416.2(b)(1) Sound construction, 

good repair &

sufficient size

Yes 0.12 0.03 3.68 0.00E+00

416.2(b)(2) Walls/floors/ceilings 

durable, impervious,

cleaned & sanitized

Yes 0.11 0.04 3.23 0.00E+00

416.2(b)(4) Inedible from edible 

separated by time or

space

Yes 0.02 0.00 6.11 4.56E-60

416.3(b) Constructed, located 

& operated in a

manner that does 

not deter inspection

Yes 0.01 0.00 3.21 3.56E-19

416.3(c) Receptacles for 

storing inedible 

material

must identify 

permitted use

Yes 0.03 0.01 3.43 4.11E-41

416.4(a) Food contact 

surface, cleaning &

sanitizing as 

frequency

Yes 0.11 0.03 3.42 0.00E+00

416.4(d) Product processing, 

handling, storage,

loading, unloading, 

and during

transportation must 

be protected

Yes 0.15 0.05 3.46 0.00E+00

417.2(c)(4) List of procedures & 

frequency

Yes 0.01 0.00 3.09 3.79E-219

417.3(a)(2) CCP is under 

control

Yes 0.01 0.00 3.68 6.13E-44

381.76(b)(6)(ii)(A

)

New poultry 

inspection system 

(NPIS)Sorting, 

Yes 0.01 0.00 12.17 7.58E-25
14

Regulation 

Verified

Description1 On 

FY

2023

PHR 

List

Noncompliance 

Rate 90 Days

before a 

Salmonella

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella

Positives

Rates 

ratio

TwoSided 

Fisher 

Exact p

Value

Trimming, and

Reprocessing

310.18(c) Written procedures 

to prevent

Contamination; all 

swine slaughter

Yes 0.01 0.00 6.91 8.20E-06

1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions.

4.1.1 Salmonella in Intact Chicken

The dataset used in the analysis consists of candidate PHRs noncompliance rates for the 207

establishments with intact chicken Salmonella testing data, of which 154 had 427 Salmonella

positives, and 53 did not have Salmonella positives. There were 9,676 total intact chicken

Salmonella tests performed.

Table 4-2 presents the two regulations that had more than 30 verifications in a year, a rates ratio

of 3.0 or greater, and for which there is a 95% probability (as determined by a two-sided Fisher’s

Exact p value of less than 0.05) that the noncompliance rate of the regulation in establishments in 

the 90 days prior to an intact chicken Salmonella positive is higher than the average 

noncompliance rate for establishments with no intact chicken Salmonella positive for CY2022.

Table 4-2 Comparison of Noncompliance Rates 90 Days before an Intact Chicken 

Salmonella Positive with Those for Establishments with No Intact Chicken 

Salmonella Positives

Regulation 

Verified

Description1 On FY

2023

PHRs

List

Noncompliance 

Rate 90 Days

before a 

Salmonella

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella

Positives

Rates 

ratio

TwoSided 

Fisher 

Exact p

Value

381.91(a) Certain contaminated

carcasses to be

condemned

No 0.01 0.00 15.09 2.00E-03T

381.76(a) Post-mortem 

inspection,

when required, extent

Yes 0.01 0.00 8.14 2.00E-02

1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions.

4.1.2 Salmonella in Intact Turkey

The dataset used in the analysis consists of candidate PHRs noncompliance rates for the 42

establishments with intact turkey Salmonella testing data, of which four establishments had four 

Salmonella positives and 38 establishments did not have Salmonella positives. There were 1,598

total intact turkey Salmonella tests performed.
15

Table 4-3 presents the one regulation that had more than 30 verifications in a year, a rates ratio

of 3.0 or greater, and for which there is a 95% probability (as determined by a two-sided Fisher’s

Exact Test p value of less than 0.05) that the noncompliance rate of the regulations in 

establishments in the 90 days prior to an intact turkey Salmonella positive is higher than the 

average noncompliance rate for establishments with no intact turkey Salmonella positive for

CY2022.

Table 4-3 Comparison of Noncompliance Rates 90 Days before an Intact Turkey 

Salmonella Positive with Those for Establishments with No Intact Turkey Salmonella

Positives

Regulation 

Verified

Description1 On FY

2023

PHRs

List

Noncompliance 

Rate 90 Days

before a 

Salmonella

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positives

Rates 

ratio

TwoSided 

Fisher 

Exact p

Value

416.2(b)(4) Inedible from edible

separated by time or

space

Yes 0.18 0.01 32.71 3.26E-04

1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions.

4.1.3 Salmonella in Ground Beef

The dataset used in the analysis consists of candidate PHRs noncompliance rates for the 1,246

establishments with ground beef Salmonella testing data, of which 117 establishments had 182

Salmonella positives and 1,129 establishments did not have Salmonella positives. There were 

11,028 total ground beef Salmonella tests performed.

Table 4-4 presents the 11 regulations that had more than 30 verifications in a year, a rates ratio of 

3.0 or greater, and for which there is a 95% probability (as determined by a two-sided Fisher’s

Exact Test p value of less than 0.05) that the noncompliance rate of the regulation in 

establishments in the 90 days prior to a ground beef Salmonella positive is higher than the 

average noncompliance rate for establishments with no ground beef Salmonella positive for

CY2022.

Table 4-4 Comparison of Noncompliance Rates 90 Days before a Ground Beef Salmonella

Positive with Those for Establishments with No Ground Beef Salmonella Positives

Regulation 

Verified

Description1 On 

FY

2023

PHRs

List

Noncompliance 

Rate 90 Days

before a 

Salmonella

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella

Positives

Rates 

ratio

TwoSided 

Fisher 

Exact p

Value

310.22(e)(1) Written procedures 

for removal,

segregation, and 

disposition of

SRMs

Yes 0.11 0.03 4.04 4.94E-09
16

Regulation 

Verified

Description1 On 

FY

2023

PHRs

List

Noncompliance 

Rate 90 Days

before a 

Salmonella

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella

Positives

Rates 

ratio

TwoSided 

Fisher 

Exact p

Value

318.2(a) All products 

subject to

reinspection by 

program

employees

Yes 0.01 0.00 3.76 9.48E-03

416.12(c) Plan identifies 

procedures for

pre-op

Yes 0.02 0.00 10.63 2.00E-02

416.13(c) Plant monitors 

implementation of

SSOP procedures

Yes 0.03 0.01 3.47 8.65E-136

417.2(c)(4) List of procedures 

& frequency

Yes 0.02 0.00 9.47 7.49E-119

417.3(a)(2) CCP is under 

control

Yes 0.03 0.00 11.00 4.33E-13

417.3(a)(3) Establish measures 

to prevent

recurrence

Yes 0.22 0.04 6.96 5.49E-07

417.3(a)(4) No adulterated 

product enters

commerce.

Yes 0.05 0.00 17.04 1.72E-04

417.4(a) Adequacy of 

HACCP in

controlling food 

safety hazards

Yes 0.37 0.03 19.26 1.25E-06

417.4(b) Reassessment of 

hazard analysis

No 0.01 0.00 6.50 1.74E-02

310.18(a) Carcasses, organs, 

and other parts

handled in a 

sanitary manner

Yes 0.06 0.01 5.25 1.02E-139

1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions.

4.1.4 Salmonella in Intact Beef

FSIS tests beef trim and beef manufacturing trimmings as a surrogate for testing intact beef.

There were 956 establishments with intact beef Salmonella testing data, of which 71

establishments had 138 Salmonella positives and 885 establishments did not have Salmonella

positives. There were 6,348 total intact beef Salmonella tests performed.

Table 4-5 presents the 26 regulations that had more than 30 verifications in a year, a rates ratio of 

3.0 or greater, and for which there is a 95% probability (as determined by a two-sided Fisher’s

Exact Test p value of less than 0.05) that the noncompliance rate of the regulation in 

establishments 90 days prior to an intact beef Salmonella positive is higher than the average 

noncompliance rate for establishments with no intact beef Salmonella positive for CY2022.
17

Table 4-5 Comparison of Noncompliance Rates 90 Days before an Intact Beef Salmonella

Positive with Those for Establishments with No Intact Beef Salmonella Positives

Regulation 

Verified

Description1 On FY

2023

PHRs

List

Noncompliance 

Rate 90 Days 

before a 

Salmonella

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella

Positives

Rates 

ratio

TwoSided 

Fisher 

Exact p 

Value

301.2_Adulterated Adulterated Yes 41.55% 3.00% 23.00 6.32E-56

310.18(a) Carcasses, organs, 

and other parts 

handled in a

sanitary manner

Yes 5.22% 1.13% 4.82 8.37E-227

310.22(c) Disposal of SRM Yes 6.55% 0.46% 15.00 3.37E-79

310.22(e)(1) Written 

procedures for 

removal, 

segregation, and

disposition of 

SRMs

Yes 10.77% 2.59% 4.54 2.23E-15

310.22(e)(2) Appropriate 

corrective actions

Yes 16.13% 5.50% 3.30 4.31E-04

310.22(e)(3) Evaluate 

effectiveness of 

procedures for 

removal,

segregation, and

disposition of 

SRMs

Yes 15.75% 1.33% 13.82 7.41E-35

310.3 Carcasses and 

parts in certain 

instances to be

retained.

Yes 39.55% 13.53% 4.18 4.48E-11

311.14 Abrasions, 

bruises, abscesses, 

pus, etc.

No 0.26% 0.01% 29.38 2.97E-03

381.65(f) Procedures for 

controlling visible 

fecal

contamination

Yes 4.19% 0.80% 5.45 2.14E-03

416.13(c) Plant monitors 

implementation of 

SSOP

procedures

Yes 4.75% 0.94% 5.23 0.00E+00

416.14 Evaluate 

effectiveness of 

SSOPs & 

maintain plan

Yes 0.82% 0.16% 5.04 5.18E-38
18

Regulation 

Verified

Description1 On FY

2023

PHRs

List

Noncompliance 

Rate 90 Days 

before a 

Salmonella

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella

Positives

Rates 

ratio

TwoSided 

Fisher 

Exact p 

Value

416.15(b) Procedures for 

corrective action

Yes 8.82% 2.58% 3.66 7.75E-05

416.2(a) Grounds and pest 

control

No 14.46% 3.54% 4.61 3.35E-35

416.2(b)(4) Inedible from 

edible separated 

by time or space

No 2.20% 0.24% 9.50 1.55E-07

416.3(b) Constructed, 

located & 

operated in a 

manner that

does not deter 

inspection

Yes 3.70% 0.47% 8.15 5.21E-07

416.3(c) Receptacles for 

storing inedible 

material must

identify permitted 

use

Yes 2.61% 0.77% 3.44 1.09E-02

416.4(d) Product 

processing, 

handling, storage, 

loading,

unloading, and 

during 

transportation 

must be

protected

Yes 17.38% 4.37% 4.61 1.40E-141

416.6 Only FSIS 

program 

employee may 

remove "U.S.

Rejected" tag

Yes 38.46% 3.98% 15.09 1.75E-04

417.2(c)(4) List of procedures 

& frequency

Yes 2.33% 0.27% 8.75 3.08E-154

417.3(a)(1) Identify and 

eliminate the 

cause

Yes 19.79% 3.63% 6.55 1.49E-08
19

Regulation 

Verified

Description1 On FY

2023

PHRs

List

Noncompliance 

Rate 90 Days 

before a 

Salmonella

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella

Positives

Rates 

ratio

TwoSided 

Fisher 

Exact p 

Value

417.3(a)(2) CCP is under 

control

Yes 1.58% 0.33% 4.87 5.08E-06

417.3(a)(3) Establish 

measures to 

prevent recurrence

Yes 32.86% 8.49% 5.27 3.53E-08

417.3(a)(4) No adulterated 

product enters 

commerce

Yes 2.04% 0.38% 5.50 2.18E-02

417.3(b)(1) Segregate and 

hold the affected 

product

Yes 6.58% 1.45% 4.78 1.50E-02

417.4(a) Adequacy of 

HACCP in 

controlling food 

safety hazards

Yes 70.00% 2.41% 94.62 6.97E-18

418.2 Notification of 

adulterated or 

misbranded 

product in 

commerce

Yes 71.43% 4.02% 59.72 6.02E-10

1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions.

4.1.5 Salmonella in Ground Chicken

The dataset used in the analysis consists of candidate PHRs noncompliance rates for the 135

establishments with ground chicken Salmonella testing data, of which 86 establishments had 537

Salmonella positives and 49 establishments did not have Salmonella positives. There were 2,002

total ground chicken Salmonella tests performed.

Table 4-6 presents the nine regulations that had more than 30 verifications in a year, a rates ratio

of 3.0 or greater, and for which there is a 95% probability (as determined by a two-sided Fisher’s

Exact p value of less than 0.05) that the noncompliance rate of the regulation in establishments

90 days before a ground chicken Salmonella positive is higher than the average noncompliance 

rate for establishments with no ground chicken Salmonella positive for CY2022.

Table 4-6 Comparison of Noncompliance Rates 90 Days before a Ground Chicken 

Salmonella Positive with Those for Establishments with No Ground Chicken 

Salmonella Positives
20

Regulation 

Verified

Description1 On 

FY

2023

PHRs

List

Noncompliance 

Rate 90 Days

before a 

Salmonella

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella

Positives

Rates 

ratio

TwoSided 

Fisher 

Exact p

Value

310.22(e)(3) Evaluate 

effectiveness of 

procedures

for removal, 

segregation, and

disposition of 

SRMs

Yes 0.89 0.27 22.00 1.63E-04

381.91(b) Reprocessing of 

carcasses

accidentally 

contaminated with

digestive tract 

contents.

Yes 0.34 0.01 73.09 3.74E-151

416.15(a) Appropriate 

corrective actions

Yes 0.18 0.04 5.75 4.62E-21

417.3(a)(1) Identify and 

eliminate the cause

Yes 0.09 0.00 32.16 1.67E-22

417.3(a)(2) CCP is under 

control

Yes 0.01 0.00 8.66 2.20E-11

417.4(a)(1) Initial validation No 0.08 0.00 31.27 1.17E-02

417.5(a)(2) Written HACCP 

plan

Yes 0.00 0.00 5.08 3.33E-07

381.76(b)(6)(ii)(A) NPIS Sorting, 

Trimming, and

Reprocessing

Yes 0.02 0.00 4.59 2.33E-17

381.76(b)(6)(ii)(B) NPIS reprocessing 

and salvage

Yes 0.00 0.00 9.76 7.05E-11

1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions.

4.1.6 Salmonella in Ground Turkey

The dataset used in the analysis consists of candidate PHRs noncompliance rates for the 46

establishments with ground turkey Salmonella testing data, of which 34 establishments had 234

Salmonella positives and 12 establishments did not have Salmonella positives. There were 1,345

total ground turkey Salmonella tests performed.

Table 4-7 presents the seven regulations that had more than 30 verifications in a year, a rates 

ratio of 3.0 or greater, and for which there is a 95% probability (as determined by a two-sided 

Fisher’s Exact p value of less than 0.05) that the noncompliance rate of the regulation in 

establishments 90 days before a ground turkey Salmonella positive is higher than the average 

noncompliance rate for establishments with no ground turkey Salmonella positive for CY2022.

Table 4-7 Comparison of Noncompliance Rates 90 Days before a Ground Turkey 

Salmonella Positive with Those for Establishments with No Ground Turkey Salmonella

Positives
21

Regulation 

Verified

Description1 On FY

2023

PHRs

List

Noncompliance 

Rate 90 Days

before a 

Salmonella

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella

Positives

Rates 

ratio

TwoSided 

Fisher 

Exact p

Value

416.13(a) Conduct pre-op 

procedures

Yes 0.15 0.05 3.35 1.34E-32

416.13(c) Plant monitors 

implementation of SSOP

procedures

Yes 0.05 0.02 3.57 1.30E-44

416.2(a) Grounds and Pest 

Control

Yes 0.12 0.04 3.80 7.52E-12

416.2(b)(2) Walls/floors/ceilings 

durable, impervious,

cleaned & sanitized

Yes 0.16 0.02 8.76 2.57E-35

416.4(a) Food contact surface, 

cleaning & sanitizing

as frequency

Yes 0.25 0.04 7.24 5.55E-31

416.4(d) Product processing, 

handling, storage,

loading, unloading, and 

during

transportation must be 

protected

Yes 0.20 0.05 4.56 1.66E-16

417.3(a)(2) CCP is under control Yes 0.24 0.00 251.2

0

8.50E-78

1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions.

4.1.7 Salmonella in Intact Pork

The dataset used in the analysis consists of candidate PHRs noncompliance rates for the 102

establishments with intact pork Salmonella testing data, of which 32 establishments had 177

Salmonella positives and 70 establishments did not have Salmonella positives. There were 2,347

total intact pork Salmonella tests performed.

Table 4-8 presents the nine regulations that had more than 30 verifications in a year, a rates ratio

of 3.0 or greater, and for which there is a 95% probability (as determined by a two-sided Fisher’s

Exact p value of less than 0.05) that the noncompliance rate of the regulation in establishments 

90 days before an intact pork Salmonella positive is higher than the average noncompliance rate 

for establishments with no intact pork Salmonella positive for CY2022.
22

Table 4-8 Comparison of Noncompliance Rates 90 Days before an Intact Pork Salmonella

Positive with Those for Establishments with No Intact Pork Salmonella Positives

1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions.

4.1.8 Salmonella in Ground Pork

The dataset used in the analysis consists of candidate PHRs noncompliance rates for the 310

establishments with ground pork Salmonella testing data, of which 133 establishments had 1,166

Salmonella positives and 177 establishments did not have Salmonella positives. There were 

6,357 total ground pork Salmonella tests performed.

Table 4-9 presents the 11 regulations that had more than 30 verifications in a year, a rates ratio of 

3.0 or greater, and for which there is a 95% probability (as determined by a two-sided Fisher’s

Exact p value of less than 0.05) that for which the noncompliance rate of the regulation in 

Regulation 

Verified

Description1 On 

FY

2023

PHRs

List

Noncompliance 

Rate 90 Days

before a 

Salmonella

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella

Positives

Rates 

ratio

TwoSided 

Fisher 

Exact p 

Value

310.3 Carcasses and parts in 

certain

instances to be retained.

Yes 0.60 0.25 4.51 1.80E-05

416.15(b) Corrective action, 

procedures

for

Yes 0.33 0.07 6.43 4.00E-15

416.16(a) Daily records required,

responsible individual, 

initialed

and dated

Yes 0.00 0.00 3.60 1.86E-09

417.2(c)(4) List of procedures & 

frequency

Yes 0.01 0.00 3.55 1.42E-19

417.3(a)(1) Identify and eliminate the 

cause

Yes 0.33 0.07 6.84 2.77E-04

417.3(a)(2) CCP is under control Yes 0.05 0.00 18.01 4.91E-13

417.3(a)(3) Establish measures to 

prevent

recurrence

Yes 0.38 0.06 8.93 2.25E-07

417.3(a)(4) No adulterated product 

enters

commerce.

Yes 0.07 0.01 8.45 2.83E-03

417.3(c) Document corrective 

actions

Yes 0.26 0.01 33.53 1.77E-04
23

establishments 90 days before a ground pork Salmonella positive is higher than the average 

noncompliance rate for establishments with no ground pork Salmonella positive for CY2022.

Table 4-9 Comparison of Noncompliance Rates 90 Days before a Ground Pork Salmonella

Positive with those for Establishments with No Ground Pork Salmonella Positives

Regulation 

Verified

Description1 On FY

2023

PHRs

List

Noncompliance 

Rate 90 Days

before a 

Salmonella

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella

Positives

Rates 

ratio

TwoSided 

Fisher 

Exact p

Value

310.22(c) Disposal of SRM Yes 0.11 0.00 30.53 1.14E-26

310.22(e)(3) Evaluate 

effectiveness of 

procedures for

removal, 

segregation, and 

disposition of

SRMs

Yes 0.41 0.01 46.59 1.82E-18

318.2(d) Removal of U.S. 

retained by 

authorized

Program 

employees only

Yes 0.04 0.01 3.08 2.46E-02

416.13(a) Conduct pre-op 

procedures

Yes 0.04 0.01 3.53 2.18E-93

416.6 Only FSIS 

program 

employee may

remove "U.S. 

Rejected" tag

Yes 0.13 0.03 5.53 1.49E-02

417.2(c) Contents of 

HACCP Plan

Yes 0.01 0.00 12.33 3.96E-04

417.2(c)(4) List of 

procedures & 

frequency

Yes 0.01 0.00 4.30 3.28E-43

417.3(a)(3) Establish 

measures to 

prevent

recurrence

Yes 0.21 0.05 5.57 1.79E-06

417.3(b)(3) No adulterated 

product enters 

commerce

Yes 0.13 0.00 44.62 4.99E-12

417.5(a)(2) Written HACCP 

plan

Yes 0.00 0.00 3.85 1.10E-11

310.18(a) Carcasses, 

organs, and other 

parts

handled in a 

sanitary manner

Yes 0.02 0.01 4.31 6.44E-70

1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions.
24

4.1.9 Salmonella in Chicken Parts

The dataset used in the analysis consists of candidate PHRs noncompliance rates for the 491

establishments with chicken parts Salmonella testing data, of which 377 establishments had 

1,135 Salmonella positives and 114 establishments did not have Salmonella positives. There 

were 14,520 total chicken parts Salmonella tests performed.

Table 4-10 presents the five regulations that had more than 30 verifications in a year, a rates ratio

of 3.0 or greater, and for which there is a 95% probability (as determined by a two-sided Fisher’s

Exact p value of less than 0.05) that the noncompliance rate of the regulation in establishments 

90 days before a chicken parts Salmonella positive is higher than the average noncompliance rate 

for establishments with no chicken parts Salmonella positive for CY2022.

Table 4-10 Comparison of Noncompliance Rates 90 Days before a Chicken Parts 

Salmonella Positive with Those for Establishments with No Chicken Parts Salmonella

Positives

Regulation 

Verified

Description1 On 

FY

2023

PHRs

List

Noncomplianc

e Rate 90 Days

before a 

Salmonella

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella

Positives

Rates 

ratio

TwoSided 

Fisher 

Exact p 

Value

318.2(d) Removal of U.S. 

retained by

authorized Program 

employees only

Yes 0.16 0.02 11.20 7.06E-03

381.91(b) Reprocessing of 

carcasses

accidentally 

contaminated with

digestive tract 

contents.

Yes 0.02 0.00 9.98 9.61E-08

416.13(b) Conduct other 

procedures listed in

the plan

Yes 0.02 0.01 3.15 1.22E112

416.2(b)(4) Inedible from edible 

separated by

time or space

Yes 0.03 0.01 3.06 1.66E-07

381.76(b)(6)(ii)(A) NPIS Sorting, 

Trimming, and

Reprocessing

Yes 0.01 0.00 3.07 5.81E-11

1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions.

4.1.10 Salmonella in Siluriformes

The dataset used in the analysis consists of candidate PHRs noncompliance rates for the 64

establishments with siluriformes Salmonella testing data, of which 3 establishments had three

Salmonella positives and 61 establishments did not have Salmonella positives. There were 308

total siluriformes Salmonella tests performed.
25

Table 4-11 presents the 1 regulation that had more than 30 verifications in a year, a rates ratio of 

3.0 or greater, and for which there is a 95% probability (as determined by a two-sided Fisher’s 

Exact p value of less than 0.05) that the noncompliance rate of the regulation in establishments 

90 days before a siluriformes Salmonella positive is higher than the average noncompliance rate 

for establishments with no siluriformes Salmonella positive for CY2022.

Table 4-11 Comparison of Noncompliance Rates 90 Days before a Siluriformes Salmonella

Positive with Those for Establishments with No Siluriformes Salmonella Positives

Regulation 

Verified

Description1 On 

FY

2023

PHRs

List

Noncompliance 

Rate 90 Days

before a 

Salmonella

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella

Positives

Rates 

ratio

TwoSided 

Fisher 

Exact p

Value

416.4(a) Food contact surface,

cleaning & sanitizing 

as

frequency

Yes 0.55 0.05 21.65 9.69E-06

1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions.

4.1.11 Salmonella in Ready-to-Eat Products

The dataset used in the analysis consists of candidate PHRs noncompliance rates for the 2,240

establishments with RTE Salmonella testing data, of which nine establishments had 10

Salmonella positives and 2,231 establishments did not have Salmonella positives. There were 

14,787 total RTE Salmonella tests performed.

There were 0 regulations that had more than 30 verifications in a year in total, a rates ratio of 3.0 

or greater, and for which there is a 95% probability (as determined by a two-sided Fisher’s Exact 

p value of less than 0.05) that for which the noncompliance rate of the regulation in 

establishments 90 days before an RTE Salmonella positive is higher than the average 

noncompliance rate for establishments with no RTE Salmonella positives for CY2022.

4.2 E. coli

4.2.1 E. coli O157:H7

The purpose of this section is to provide the results of the analysis between the candidate 

regulations and E. coli O157:H7 positives in the following products: MT43 (raw ground beef and 

veal), MT60 (beef or veal trim), MT64 (raw ground beef or beef patty components, other than 

trim), and MT65 (bench trim for further use in any raw, non-intact beef products). The dataset 

used in the analysis consists of candidate PHRs noncompliance rates for the 1,435 establishments 

with E. coli O157:H7 testing data, of which 17 establishments had 17 E. coli O157:H7 positives 

and 1,418 establishments did not have E. coli O157:H7 positives. There were 17,207 total E. coli

O157:H7 tests performed.

Table 4-12 presents the 10 regulations that had more than 30 verifications in a year, a rates ratio

of 3.0 or greater, and there is a 95% probability (as determined by a two-sided Fisher’s Exact p 

value of less than 0.05) that the noncompliance rate of the regulation in establishments 90 days
26

before an E. coli O157:H7 positive is higher than the average noncompliance rate for 

establishments with no E. coli O157:H7 positive for CY2022.

Table 4-12 Comparison of Noncompliance Rates 90 Days before an E. coli O157:H7 

Positive with Those for Establishments with no E. coli O157:H7 Positives

Regulation 

Verified

Description1 On 

FY

2023

PHRs

List

Noncompliance 

Rate 90 Days

before a E. coli 

O157:H7

Positive

Noncompliance 

Rate for 

Establishments 

with no E. coli 

O157:H7

Positives

Rates 

ratio

TwoSided 

Fisher 

Exact p

Value

318.2(a) All products subject to

reinspection by program

employees

Yes 0.02 0.00 11.26 1.59E-02

416.13(b) Conduct other 

procedures listed in

the plan

Yes 0.01 0.00 3.25 8.21E-04

416.13(c) Plant monitors 

implementation of

SSOP procedures

Yes 0.03 0.01 3.57 1.68E-20

416.14 Evaluate effectiveness of 

SSOP's

& maintain plan

Yes 0.01 0.00 5.24 1.45E-05

416.15(a) Appropriate corrective 

actions

Yes 0.20 0.02 13.17 1.44E-02

416.15(b) Corrective action, 

procedures for

Yes 0.67 0.03 63.42 2.79E-03

416.3(b) Constructed, located & 

operated

in a manner that does not 

deter

inspection

Yes 0.03 0.00 6.14 4.56E-02

416.3(c) Receptacles for storing 

inedible

material must identify 

permitted

use

Yes 0.09 0.01 8.77 6.21E-03

417.2(c)(4) List of procedures & 

frequency

Yes 0.02 0.00 7.84 1.61E-17

417.3(a)(2) CCP is under control Yes 0.06 0.00 15.81 8.17E-03

1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions.

4.2.2 Non-O157 STEC

The purpose of this section is to provide the results of the analysis between the candidate 

regulations and non-O157 STEC positives in MT60 (beef or veal trim). FSIS has declared six 

non-O157 STEC adulterants in raw non-intact beef products and product components. On June 

4, 2012, FSIS began testing for these six non-O157 STECs in beef manufacturing trimmings.

The dataset used in the analysis consists of candidate PHRs noncompliance rates for the 549

establishments with non-O157 STEC testing data, of which 16 establishments had 16 non-O157

STEC positives and 533 establishments did not have non-O157 STEC positives. There were 

3,615 total non-O157 STEC tests performed.
27

Table 4-13 presents the three regulations that had more than 30 verifications in a year, a rates 

ratio of 3.0 or greater, and for which there is a 95% probability (as determined by a two-sided 

Fisher’s Exact p value of less than 0.05) that the noncompliance rate of the regulation in 

establishments 90 days before a non-O157 STEC positive is higher than the average 

noncompliance rate for establishments with no non-O157 STEC positive for CY2022.

Table 4-13 Comparison of Noncompliance Rates 90 Days before a non-O157 STEC Positive 

with Those for Establishments with No non-O157 STEC Positives

Regulation 

Verified

Description1 On FY

2023

PHRs

List

Noncompliance 

Rate 90 Days

before a nonO157 STEC 

Positive

Noncompliance 

Rate for 

Establishments 

with no nonO157 STEC 

Positives

Rates 

ratio

Two-Side

Fisher 

Exact p 

Value

416.13(a) Conduct pre-op

procedures

Yes 0.07 0.02 3.21 1.91E-0

416.13(b) Conduct other

procedures listed in

the plan

Yes 0.02 0.00 4.79 6.34E-0

416.2(a) Grounds and pest

control

Yes 0.25 0.06 4.77 1.14E-0

1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions.

4.3 Listeria monocytogenes

The purpose of this section is to provide the results of the analysis between the candidate 

regulations and Lm. The dataset used in the analysis consists of candidate PHRs noncompliance 

rates for the 2,240 establishments with Lm testing data, of which 42 establishments had 46 Lm

positives and 2,198 establishments did not have Lm positives. There were 15,059 total Lm tests 

performed.

Table 4-14 presents the seven regulations that had more than 30 verifications in a year, a rates 

ratio of 3.0 or greater, and for which there is 95% probability (as determined by a two-sided 

Fisher’s Exact p value of less than 0.05) that the noncompliance rate of the regulation in 

establishments 90 days before a Lm positive is higher than the noncompliance rate for 

establishments with no Lm positive for CY2022.

Table 4-14 Comparison of Noncompliance Rates 90 Days before a Lm Positive with Those 

for Establishments with No Lm Positives

Regulation 

Verified

Description1 On FY

2023

PHRs

List

Noncompliance 

Rate 90 Days

before a Lm

Positive

Noncompliance 

Rate for 

Establishments 

with no Lm

Positives

Rates 

ratio

TwoSided 

Fisher 

Exact p 

Value

416.15(a) Appropriate 

corrective

actions

Yes 0.13 0.02 9.85 1.74E-05
28

Regulation 

Verified

Description1 On FY

2023

PHRs

List

Noncompliance 

Rate 90 Days

before a Lm

Positive

Noncompliance 

Rate for 

Establishments 

with no Lm

Positives

Rates 

ratio

TwoSided 

Fisher 

Exact p 

Value

416.4(a) Food contact surface,

cleaning & sanitizing 

as

frequency

Yes 0.11 0.03 3.74 1.17E-09

417.4(a) Adequacy of HACCP 

in

controlling food 

safety

hazards

Yes 0.33 0.03 14.44 3.02E-03

430.4(a) Lm, post-lethality 

exposed

RTE

Yes 0.00 0.00 5.81 4.90E-02

430.4(b)(3) Alternative 3 Yes 0.10 0.01 8.34 1.55E-04

430.4(c)(2) Lm, documentation 

that

supports decision in 

hazard

analysis

No 0.00 0.00 6.45 4.07E-02

430.4(c)(3) Lm, maintain 

sanitation in

post-lethality 

processing

environment

No 0.00 0.00 5.80 4.90E-02

1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions.

4.4 Campylobacter

The purpose of this section is to provide the results of the analysis between the candidate 

regulations and Campylobacter positives. The dataset used in the analysis consists of candidate 

PHRs noncompliance rates for the 609 establishments with Campylobacter testing data, of which 

478 establishments had 4,737 Campylobacter positives and 131 establishments did not have 

Campylobacter positives. There were 29,089 total Campylobacter tests performed.

Table 4-15 presents the 15 regulations that had more than 30 verifications in a year, a rates ratio

of 3.0 or greater, and for which there is 95% probability (as determined by a two-sided Fisher’s

Exact p value of less than 0.05) that the noncompliance rate of the regulation in establishments

90 days before a Campylobacter positive is higher than the noncompliance rate for 

establishments with no Campylobacter positive for CY2022.
29

Table 4-15 Comparison of Noncompliance Rates 90 Days before a Campylobacter Positive 

with Those for Establishments with No Campylobacter Positives

Regulation 

Verified

Description1 On 

FY

2023

PHRs

List

Noncomplianc

e Rate 90 Days

before a 

Campylobacter

Positive

Noncomplianc

e Rate for 

Establishments 

with no 

Campylobacter

Positives

Rates 

ratio

TwoSided 

Fisher 

Exact p

Value

381.65(a) Clean and sanitary 

practices; products

not adulterated

Yes 0.02 0.01 3.55 8.06E-08

381.91(b) Reprocessing of 

carcasses accidentally

contaminated with 

digestive tract

contents.

Yes 0.03 0.01 4.32 5.05E-08

416.13(b) Conduct other 

procedures listed in the

plan

Yes 0.02 0.01 4.48 1.68E-202

416.14 Evaluate effectiveness 

of SSOP's &

maintain plan

Yes 0.01 0.00 5.37 1.79E-46

416.15(b) Procedures for 

corrective action

Yes 0.12 0.02 6.97 2.67E-15

416.2(a) Grounds and pest 

control

Yes 0.24 0.03 8.79 1.34E-282

416.2(b)(1) Sound construction, 

good repair &

sufficient size

Yes 0.25 0.06 5.36 2.70E-167

416.2(b)(2) Walls/floors/ceilings 

durable, impervious,

cleaned & sanitized

Yes 0.23 0.04 6.71 2.15E-252

416.2(b)(4) Inedible from edible 

separated by time or

space

Yes 0.05 0.01 6.74 6.41E-28

416.3(b) Constructed, located & 

operated in a

manner that does not 

deter inspection

Yes 0.05 0.02 3.16 6.45E-08

416.3(c) Receptacles for storing 

inedible material

must identify permitted 

use

Yes 0.10 0.03 3.76 1.97E-19

416.4(a) Food contact surface, 

cleaning &

sanitizing as frequency

Yes 0.20 0.04 5.35 1.81E-228

416.4(d) Product processing, 

handling, storage,

loading, unloading, and 

during

transportation must be 

protected

Yes 0.26 0.06 5.74 6.44E-302

417.2(c)(4) List of procedures & 

frequency

Yes 0.01 0.00 3.63 2.55E-52
30

Regulation 

Verified

Description1 On 

FY

2023

PHRs

List

Noncomplianc

e Rate 90 Days

before a 

Campylobacter

Positive

Noncomplianc

e Rate for 

Establishments 

with no 

Campylobacter

Positives

Rates 

ratio

TwoSided 

Fisher 

Exact p

Value

381.76(b)(6)(ii)(

A)

NPIS Sorting, 

Trimming, and

Reprocessing

Yes 0.01 0.00 11.93 4.32E-08

1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions.

4.4.1 Campylobacter in Intact Chicken

The dataset used in the analysis consists of candidate PHRs noncompliance rates for the 207

establishments with intact chicken Campylobacter testing data, of which 199 establishments had 

2,025 Campylobacter positives and eight establishments did not have Campylobacter positives.

There were 9,659 total intact chicken Campylobacter tests performed.

Table 4-16 presents the five regulations that had more than 30 verifications in a year, a rates ratio

of 3.0 or greater, and for which there is 95% probability (as determined by a two-sided Fisher’s

Exact p value of less than 0.05) that the noncompliance rate of the regulation in establishments 

90 days before a Campylobacter positive is higher than the noncompliance rate for 

establishments with no Campylobacter positive for CY2022.

Table 4-16 Comparison of Noncompliance Rates 90 Days before a Campylobacter Intact 

Chicken Positive with Those for Establishments with No Campylobacter Intact Chicken 

Positives

Regulation 

Verified

Description1 On FY

2023

PHRs

List

Noncompliance 

Rate 90 Days

before a 

Campylobacter

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter

Positives

Rates 

ratio

TwoSided 

Fisher 

Exact p

Value

416.13(b) Conduct other procedures 

listed in the plan

Yes 0.03 0.01 4.54 5.43E-22

416.2(b)(1) Sound construction, good 

repair &

sufficient size

Yes 0.33 0.09 4.98 2.14E-11

416.2(b)(2) Walls/floors/ceilings 

durable, impervious,

cleaned & sanitized

Yes 0.27 0.07 4.96 1.35E-13

416.4(a) Food contact surface, 

cleaning & sanitizing

as frequency

Yes 0.23 0.08 3.50 8.59E-13

416.4(d) Product processing, 

handling, storage,

loading, unloading, and 

during

transportation must be 

protected

Yes 0.32 0.13 3.09 2.66E-15

1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions.
31

4.4.2 Campylobacter in Intact Turkey

The dataset used in the analysis consists of candidate PHRs noncompliance rates for the 42

establishments with intact turkey Campylobacter testing data, of which seven establishments had 

nine Campylobacter positives and 35 establishments did not have Campylobacter positives.

There were 1,596 total intact turkey Campylobacter tests performed.

Table 4-17 presents the 4 regulations that had more than 30 verifications in a year, a rates ratio of 

3.0 or greater, and for which there is 95% probability (as determined by a two-sided Fisher’s

Exact p value of less than 0.05) that the noncompliance rate of the regulations in establishments 

90 days before an intact turkey Campylobacter positive is higher than the noncompliance rate for 

establishments with no intact turkey Campylobacter positive for CY2022.

Table 4-17 Comparison of Noncompliance Rates 90 Days before a Campylobacter

Intact Turkey Positive with Those for Establishments with No Campylobacter Intact 

Turkey Positives

Regulation 

Verified

Description1 On 

FY

2023

PHRs

List

Noncomplianc

e Rate 90 Days

before a 

Campylobacter 

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter

Positives

Rates 

ratio

TwoSided 

Fisher 

Exact p

Value

416.14 Evaluate effectiveness 

of

SSOP's & maintain 

plan

Yes 0.01 0.00 3.16 4.99E-04

416.16(a) Daily records 

required,

responsible 

individual, initialed

and dated

Yes 0.01 0.00 4.37 1.86E-06

416.2(b)(4) Inedible from edible 

separated

by time or space

Yes 0.04 0.01 5.20 3.50E-02

417.2(c)(4) List of procedures & 

frequency

Yes 0.04 0.00 13.18 1.67E-31

1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions.

4.4.3 Campylobacter in Ground Chicken

The dataset used in the analysis consists of candidate PHRs noncompliance rates for the 87

establishments with ground chicken Campylobacter testing data, of which 48 establishments had 

192 Campylobacter positives and 48 establishments did not have Campylobacter positives.

There were 1,907 total ground chicken Campylobacter tests performed.

Table 4-18 presents the three regulations that had more than 30 verifications in a year, a rates 

ratio of 3.0 or greater, and for which there is a 95% probability (as determined by a two-sided 

Fisher’s Exact p value of less than 0.05) that the noncompliance rate of the regulation in 

establishments 90 days before a ground chicken Campylobacter positive is higher than the 

average noncompliance rate for establishments with no ground chicken Campylobacter positive 

for CY2022.
32

Table 4-18 Comparison of Noncompliance Rates 90 Days before a Ground Chicken 

Campylobacter Positive with Those for Establishments with No Ground Chicken 

Campylobacter Positives

Regulation 

Verified

Description1 On 

FY2023

PHRs

List

Noncompliance 

Rate 90 Days

before a 

Campylobacter

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter

Positives

Rates 

ratio

TwoSided 

Fisher 

Exact p

Value

310.22(c) Disposal of SRM Yes 0.26 0.02 16.80 2.43E-03

416.13(b) Conduct other

procedures listed in the

plan

Yes 0.02 0.00 6.52 7.65E-55

416.2(b)(1) Sound construction, 

good

repair & sufficient size

Yes 0.24 0.07 4.26 2.82E-21

1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions.

4.4.4 Campylobacter in Ground Turkey

The dataset used in the analysis consists of candidate PHRs noncompliance rates for the 46

establishments with ground turkey Campylobacter testing data, of which 11 establishments had 

41 Campylobacter positives and 35 establishments did not have Campylobacter positives. There 

were 1,344 total ground turkey Campylobacter tests performed.

Table 4-19 presents the 11 regulations that had more than 30 verifications in a year in total, a 

rates ratio of 3.0 or greater, and for which there is a 95% probability (as determined by a twosided Fisher’s Exact p value of less than 0.05) that the noncompliance rate of the regulations in 

establishments 90 days before a ground turkey Campylobacter positive is higher than the average 

noncompliance rate for establishments with no ground turkey Campylobacter positive for

CY2022.

Table 4-19 Comparison of Noncompliance Rates 90 Days before a Ground Turkey 

Campylobacter Positive with those for Establishments with No Ground Turkey 

Campylobacter Positives

Regulation 

Verified

Description1 On 

FY2023

PHRs

List

Noncompliance 

Rate 90 Days

before a 

Campylobacter

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter

Positives

Rates 

ratio

TwoSided 

Fisher 

Exact p

Value

416.13(a) Conduct pre-op procedures Yes 0.18 0.05 4.09 1.57E-56

416.14 Evaluate effectiveness of 

SSOP's &

maintain plan

Yes 0.01 0.00 5.42 5.04E-10

416.16(a) Daily records required, 

responsible

individual, initialed and 

dated

Yes 0.01 0.00 3.13 1.72E-08
33

Regulation 

Verified

Description1 On 

FY2023

PHRs

List

Noncompliance 

Rate 90 Days

before a 

Campylobacter

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter

Positives

Rates 

ratio

TwoSided 

Fisher 

Exact p

Value

416.2(a) Grounds and pest control Yes 0.13 0.04 3.20 1.80E-06

416.2(b)(2) Walls/floors/ceilings 

durable, impervious,

cleaned & sanitized

Yes 0.17 0.04 4.88 1.64E-15

416.2(b)(4) Inedible from edible 

separated by time or

space

Yes 0.03 0.00 6.50 2.72E-03

416.3(b) Constructed, located & 

operated in a

manner that does not deter 

inspection

Yes 0.08 0.02 3.68 1.70E-02

416.4(a) Food contact surface, 

cleaning & sanitizing

as frequency

Yes 0.25 0.08 3.93 1.21E-10

416.4(d) Product processing, 

handling, storage,

loading, unloading, and 

during

transportation must be 

protected

Yes 0.26 0.10 3.23 1.49E-14

417.3(a)(2) CCP is under control Yes 0.25 0.02 15.66 3.18E-66

381.76(a) Post-mortem inspection, 

when required,

extent

Yes 0.10 0.01 13.40 2.53E-04

1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions.

4.4.5 Campylobacter in Chicken Parts

The dataset used in the analysis consists of candidate PHRs noncompliance rates for the 497

establishments with chicken parts Campylobacter testing data, of which 408 establishments had

2,470 Campylobacter positives and 89 establishments did not have Campylobacter positives.

There were 14,583 total chicken parts Campylobacter tests performed.

Table 4-20 presents the 10 regulations which had more than 30 verifications in a year, a rates 

ratio of 3.0 or greater, and for which there is a 95% probability (as determined by a two-sided 

Fisher’s Exact p value of less than 0.05) that the noncompliance rate of the regulation in 

establishments 90 days before a chicken parts Campylobacter positive is higher than the average 

noncompliance rate for establishments with no chicken parts Campylobacter positive for

CY2022.

Table 4-20 Comparison of Noncompliance Rates 90 Days before a Chicken Parts 

Campylobacter Positive with Those for Establishments with No Chicken Parts 

Campylobacter Positives
34

Regulation 

Verified

Description1 On FY

2023

PHRs

List

Noncomplianc

e Rate 90 

Days before a 

Campylobacter

Positive

Noncomplia

nce Rate for 

Establishme

nts with no 

Campylobact

er Positives

Rates 

ratio

TwoSided 

Fisher 

Exact p 

Value

381.91(b) Reprocessing of carcasses

accidentally contaminated 

with

digestive tract contents.

Yes 0.02 0.00 5.14 4.25E05

416.13(b) Conduct other procedures 

listed in

the plan

Yes 0.02 0.00 4.83 1.19E126

416.14 Evaluate effectiveness of 

SSOP's

& maintain plan

Yes 0.00 0.00 4.34 5.49E26

416.15(b) Corrective action, 

procedures for

Yes 0.11 0.02 7.26 7.33E08

416.2(a) Grounds and pest control Yes 0.18 0.04 5.50 1.22E104

416.2(b)(1) Sound construction, good 

repair &

sufficient size

Yes 0.20 0.07 3.07 4.06E50

416.2(b)(2) Walls/floors/ceilings 

durable,

impervious, cleaned & 

sanitized

Yes 0.19 0.05 4.34 3.31E105

416.2(b)(4) Inedible from edible 

separated by

time or space

Yes 0.04 0.01 4.27 1.69E09

416.4(a) Food contact surface, 

cleaning &

sanitizing as frequency

Yes 0.16 0.06 3.04 4.80E75

381.76(b)(6)(ii)(

D)

Ready-to-Cook 

verification in

NPIS

Yes 0.05 0.02 3.30 2.55E02

1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions.

4.5 Enforcement Actions

The purpose of this section is to investigate the relationship between the candidate regulations 

and public health-related enforcement actions at meat and poultry establishments. FSIS

enforcement actions, as defined in the Rules of Practice (9 CFR 500.1), include regulatory 

control actions, withholding actions, and suspensions. A regulatory control action is taken by 

FSIS inspectors when immediate correction of a deficiency is required. Establishment 

management does not have to be notified in advance. When a deficiency does not pose an 

imminent threat to public health, a notice of intended enforcement (NOIE) is issued to an

establishment indicating that FSIS is considering withholding the marks of inspection or 

suspending the assignment of inspectors if not corrected. The establishment is requested to 

provide immediate corrective action and to specify preventive measures to prevent recurrence.

FSIS determines further action based on the response provided. Only public health related

NOIEs or suspensions are included in this analysis. These are NOIEs or suspensions that result 
35

from a sanitation standard operating procedure (SSOP), HACCP, or sanitation performance 

standards violation.

The enforcement action list of regulations is selected from the same list of candidate regulations 

used to select all other FY2024 PHRs. The enforcement action list consists of candidate 9 CFR 

regulations in which noncompliances occur at a more frequent rate in establishments 90 days

prior to an NOIE or suspension than in establishments without an NOIE or suspension for 

CY2022. The dataset used in the analysis consists of candidate PHRs noncompliance rates for 

the 5,770 active meat and poultry establishments, of which 96 establishments had 110

enforcement actions and 5,674 establishments did not have any enforcement actions.

Table 4-21 presents the 38 regulations that had more than 30 verifications in a year, a rates ratio

of 3.0 or greater, and for which there is 95% probability (as determined by a two-sided Fisher’s

Exact p value of less than 0.05) that the noncompliance rate of the regulation in establishments

90 days before an enforcement action is higher than the noncompliance rate for establishments 

with no enforcement action for CY2022.

Table 4-21 Comparison of Noncompliance Rates 90 Days before an Enforcement Action 

with Those for Establishments with No Enforcement Actions

Regulation 

Verified

Description1 On 

FY

2023

PHRs

List

Noncompliance 

Rate 90 Days 

before an 

Enforcement 

Action

Noncompliance 

Rate for 

Establishments 

with no 

Enforcement 

Actions

Rates 

ratio

TwoSided 

Fisher 

Exact p

Value

310.3 Carcasses and 

parts in certain 

instances to be

retained.

Yes 0.60 0.12 10.67 1.58E-02

318.2(d) Removal of U.S. 

retained by 

authorized

Program 

employees only

Yes 0.50 0.01 97.17 6.52E-04

416.1 Operate in a 

manner to prevent 

insanitary

conditions

Yes 0.02 0.01 3.78 5.55E-14

416.13(b) Conduct other 

procedures listed 

in the plan

Yes 0.02 0.00 4.68 4.89E-37

416.14 Evaluate 

effectiveness of 

SSOP's & 

maintain

plan

Yes 0.01 0.00 3.32 4.66E-09

416.15(a) Appropriate 

corrective actions

Yes 0.17 0.02 11.81 8.65E-26

416.15(b) Procedures for 

corrective action

Yes 0.38 0.03 18.59 4.29E-28
36

Regulation 

Verified

Description1 On 

FY

2023

PHRs

List

Noncompliance 

Rate 90 Days 

before an 

Enforcement 

Action

Noncompliance 

Rate for 

Establishments 

with no 

Enforcement 

Actions

Rates 

ratio

TwoSided 

Fisher 

Exact p

Value

416.16(a) Daily records 

required, 

responsible 

individual,

initialed and dated

Yes 0.01 0.00 4.82 9.52E-24

416.2(a) Grounds and pest 

control

Yes 0.12 0.04 3.40 1.56E-22

416.2(b)(4) Inedible from 

edible separated 

by time or

space

Yes 0.03 0.00 7.47 1.92E-07

416.3(b) Constructed, 

located & 

operated in a 

manner

that does not deter 

inspection

Yes 0.04 0.01 7.84 1.35E-06

416.4(a) Food contact 

surface, cleaning 

& sanitizing as

frequency

Yes 0.13 0.04 3.19 3.46E-23

416.4(d) Product 

processing, 

handling, storage,

loading, 

unloading, and 

during 

transportation

must be protected

Yes 0.16 0.06 3.26 1.37E-28

416.6 Only FSIS 

program 

employee may 

remove

"U.S. Rejected" 

tag

Yes 0.60 0.04 31.90 8.89E-04

417.2(a)(1) Hazard analysis Yes 0.05 0.01 5.64 1.60E-10

417.2(c)(4) List of procedures 

& frequency

Yes 0.02 0.00 4.83 2.00E-29

417.3(a)(1) Identify and 

eliminate the 

cause

Yes 0.32 0.02 23.98 2.65E-10

417.3(a)(2) CCP is under 

control

Yes 0.04 0.00 8.89 1.55E-06

417.3(a)(3) Establish 

measures to 

prevent recurrence

Yes 0.40 0.03 24.06 9.11E-12

417.3(a)(4) No adulterated 

product enters 

commerce.

Yes 0.05 0.00 19.06 1.45E-06
37

Regulation 

Verified

Description1 On 

FY

2023

PHRs

List

Noncompliance 

Rate 90 Days 

before an 

Enforcement 

Action

Noncompliance 

Rate for 

Establishments 

with no 

Enforcement 

Actions

Rates 

ratio

TwoSided 

Fisher 

Exact p

Value

417.3(b)(4) Reassessment Yes 0.10 0.00 33.56 5.27E-09

417.3(c) Document 

corrective actions

Yes 0.29 0.01 55.56 7.56E-09

417.4(a) Adequacy of 

HACCP in 

controlling food

safety hazards

Yes 0.73 0.03 95.25 1.63E-14

417.4(a)(1) Initial validation No 0.82 0.06 70.96 5.81E-10

417.5(a)(1) Written hazard 

analysis

Yes 0.02 0.00 8.52 2.26E-56

417.5(a)(2) Written HACCP 

plan

Yes 0.00 0.00 4.33 4.16E-06

417.5(a)(3) Records 

documentation 

and monitoring of

CCP's and Critical 

Limits

Yes 0.01 0.00 6.16 1.65E-30

430.4(a) Lm, post-lethality 

exposed RTE

Yes 0.00 0.00 7.37 8.88E-03

430.4(b)(3) Alternative 3 Yes 0.17 0.01 15.80 5.12E-09

430.4(c)(2) Lm, 

documentation 

that supports 

decision in

hazard analysis

No 0.00 0.00 10.70 6.86E-04

430.4(c)(3) Lm, maintain 

sanitation in postlethality

processing 

environment

No 0.00 0.00 10.55 7.16E-04

430.4(c)(5) Lm, evaluate 

control measures 

in Sanitation

SOP

Yes 0.07 0.00 66.20 8.28E-04

418.2 Notification of 

adulterated or 

misbranded

product in 

commerce

Yes 0.33 0.04 11.76 2.31E-02

381.65(f) Procedures for 

controlling visible 

fecal

contamination

Yes 0.16 0.01 26.66 3.79E-22

381.65(g) Procedures for 

controlling 

contamination

throughout the 

slaughter and 

Yes 0.10 0.01 19.19 1.90E-07
38

Regulation 

Verified

Description1 On 

FY

2023

PHRs

List

Noncompliance 

Rate 90 Days 

before an 

Enforcement 

Action

Noncompliance 

Rate for 

Establishments 

with no 

Enforcement 

Actions

Rates 

ratio

TwoSided 

Fisher 

Exact p

Value

dressing

operation

381.65(h) Recordkeeping 

requirements

Yes 0.50 0.00 2767.0

0

6.66E-28

310.18(c

)(2)(iii)

Records of test 

results for 

sampling program

No 0.01 0.00 44.84 1.51E-03

310.18(d) Daily records 

sufficient to 

document the

implementation 

and monitoring of

contamination 

control procedures

Yes 0.01 0.00 9.37 2.23E-02

1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions.

5.0 LIST OF FY2024 PHRS

The purpose of this section is to combine the above lists of pathogen-specific and enforcement

PHRs into a single FY2024 PHRs list. Table 5-1 presents the complete list of the 63 FY2024

PHRs. These 63 PHRs were selected since they were verified more than 30 times in a year, had a 

rates ratio of 3.0 or greater, and had higher noncompliance rates in establishments 90 days before 

Salmonella, E. coli O157:H7, non-O157 STEC, Lm, Campylobacter positives or enforcement 

actions than in establishments with no positives or enforcement actions.

Table 5-1 List of FY2024 PHRs

Regulation 

Verified

Description1 On FY

2023

PHRs

List

Average Rates 

ratio

Average of 

Two-Sided 

Fisher Exact p 

Value

310.18(a) Carcasses, organs, and other parts 

handled in a sanitary manner

Yes 4.50 2.15E-70

310.18(c) Written procedures to prevent 

contamination; all swine slaughter

Yes 6.91 8.20E-06

310.18(c)(2)(iii) Records of test results for sampling 

program

No 44.84 1.51E-03

310.18(d) Daily records sufficient to document the 

implementation and monitoring of 

contamination control procedures

Yes 9.37 2.23E-02

310.22(c) Disposal of SRM Yes 15.50 6.06E-04

310.22(e)(1) Written procedures for removal, 

segregation, and disposition of SRMs

Yes 5.83 1.65E-09

310.22(e)(2) Appropriate corrective actions Yes 3.84 5.50E-04
39

Regulation 

Verified

Description1 On FY

2023

PHRs

List

Average Rates 

ratio

Average of 

Two-Sided 

Fisher Exact p 

Value

310.22(e)(3) Evaluate effectiveness of procedures for 

removal, segregation, and disposition of 

SRMs

Yes 25.15 4.07E-05

310.22(f)(2) Use of routine operational sanitation 

procedures on equipment used to cut 

through SRMs

No 5.01 4.99E-04

310.3 Carcasses and parts in certain instances 

to be retained.

Yes 7.59 7.89E-03

318.2(a) All products subject to reinspection by 

program employees

Yes 7.51 1.27E-02

318.2(d) Removal of U.S. retained by authorized 

Program employees only

Yes 28.83 8.08E-03

381.65(a) Clean and sanitary practices; products 

not adulterated

Yes 3.51 5.19E-08

381.65(f) Procedures for controlling visible fecal 

contamination

Yes 26.66 3.79E-22

381.65(g) Procedures for controlling 

contamination throughout the slaughter 

and dressing operation

Yes 19.19 1.90E-07

381.65(h) Recordkeeping requirements Yes 2767.00 6.66E-28

381.71(a) Condemnation on ante mortem 

inspection

Yes 8.17 8.31E-03

381.76(a) Post-mortem inspection, when required, 

extent

Yes 10.77 7.74E-03

381.76(b)(6)(ii)(A) NPIS Sorting, Trimming, and 

Reprocessing

Yes 7.94 1.08E-08

381.76(b)(6)(ii)(B) NPIS reprocessing and salvage Yes 9.76 7.05E-11

381.76(b)(6)(ii)(D) Ready-to-Cook verification in NPIS Yes 3.30 2.55E-02

381.91(a) Certain contaminated carcasses to be 

condemned

No 15.09 1.91E-03

381.91(b) Reprocessing of carcasses accidentally 

contaminated with digestive tract 

contents.

Yes 26.32 8.53E-06

416.1 Operate in a manner to prevent 

insanitary conditions

Yes 3.78 5.55E-14

416.12(c) Plan identifies procedures for pre-op Yes 10.63 2.00E-02

416.13(a) Conduct pre-op procedures Yes 3.86 3.19E-08

416.13(b) Conduct other procedures listed in the 

plan

Yes 4.46 8.21E-05

416.13(c) Plant monitors implementation of SSOP 

procedures

Yes 3.96 3.36E-21

416.14 Evaluate effectiveness of SSOP's & 

maintain plan

Yes 4.62 7.33E-05

416.15(a) Appropriate corrective actions Yes 10.15 3.60E-03

416.15(b) Procedures for corrective action Yes 15.90 9.15E-04

416.16(a) Daily records required, responsible 

individual, initialed and dated

Yes 3.98 4.70E-07

416.2(a) Grounds and pest control Yes 4.80 1.65E-06
40

Regulation 

Verified

Description1 On FY

2023

PHRs

List

Average Rates 

ratio

Average of 

Two-Sided 

Fisher Exact p 

Value

416.2(b)(1) Sound construction, good repair & 

sufficient size

Yes 4.27 4.28E-12

416.2(b)(2) Walls/floors/ceilings durable, 

impervious, cleaned & sanitized

Yes 5.48 2.27E-14

416.2(b)(4) Inedible from edible separated by time 

or space

Yes 9.01 4.76E-03

416.3(b) Constructed, located & operated in a 

manner that does not deter inspection

Yes 4.81 1.25E-02

416.3(c) Receptacles for storing inedible material 

must identify permitted use

Yes 4.81 1.85E-03

416.4(a) Food contact surface, cleaning & 

sanitizing as frequency

Yes 6.12 1.08E-06

416.4(d) Product processing, handling, storage, 

loading, unloading, and during 

transportation must be protected

Yes 3.77 2.53E-15

416.6 Only FSIS program employee may 

remove ""U.S. Rejected"" tag

Yes 18.72 7.90E-03

417.2(a)(1) Hazard analysis Yes 5.64 1.60E-10

417.2(c) Contents of HACCP Plan Yes 12.33 3.96E-04

417.2(c)(4) List of procedures & frequency Yes 6.25 1.80E-18

417.3(a)(1) Identify and eliminate the cause Yes 20.99 9.22E-05

417.3(a)(2) CCP is under control Yes 37.82 9.09E-04

417.3(a)(3) Establish measures to prevent 

recurrence

Yes 11.38 6.42E-07

417.3(a)(4) No adulterated product enters 

commerce.

Yes 14.85 1.00E-03

417.3(b)(3) No adulterated product enters commerce Yes 44.62 4.99E-12

417.3(b)(4) Reassessment Yes 33.56 5.27E-09

417.3(c) Document corrective actions Yes 44.54 8.87E-05

417.4(a) Adequacy of HACCP in controlling 

food safety hazards

Yes 107.08 7.54E-04

417.4(a)(1) Initial validation No 51.12 5.85E-03

417.4(b) Reassessment of hazard analysis No 6.50 1.74E-02

417.5(a)(1) Written hazard analysis Yes 8.52 2.26E-56

417.5(a)(2) Written HACCP plan Yes 4.42 1.50E-06

417.5(a)(3) Records documentation and monitoring 

of CCP's and critical limits

Yes 6.16 1.65E-30

418.2 Notification of adulterated or 

misbranded product in commerce

Yes 11.76 2.31E-02

430.4(a) Lm, post-lethality exposed RTE Yes 6.59 2.89E-02

430.4(b)(3) Alternative 3 Yes 12.07 7.75E-05

430.4(c)(2) Lm, documentation that supports 

decision in hazard analysis

No 8.58 2.07E-02

430.4(c)(3) Lm, maintain sanitation in post-lethality 

processing environment

No 8.18 2.49E-02
41

Regulation 

Verified

Description1 On FY

2023

PHRs

List

Average Rates 

ratio

Average of 

Two-Sided 

Fisher Exact p 

Value

430.4(c)(5) Lm, evaluate control measures in 

Sanitation SOP

Yes 66.20 8.28E-04

1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions.

In FY2023 there were 71 PHRs, 56 of which are FY2024 PHRs. There are 15 regulations on the 

FY2023 PHRs list that are not on the FY2024 PHRs list (see Appendix C). There are seven

regulations that are on the FY2024 PHRs list that were not on the FY2023 PHRs list.

Table 5-2 lists the number of regulations triggered by different pathogens or enforcement actions

for inclusion in the FY2024 PHRs list. Most regulations were triggered by multiple events.

Similar to the FY2023 PHRs list, Salmonella pathogen positives and enforcement actions 

triggered the most regulations.

Table 5-2 Events That Triggered Inclusion of a Regulation in the FY2024 PHRs List

Product Number of Regulations

Campylobacter 15

Campylobacter Chicken Parts 10

Campylobacter Ground Chicken 3

Campylobacter Ground Turkey 11

Campylobacter Intact Chicken 5

Campylobacter Intact Turkey 4

Enforcements 38

Lm 7

NonO157 E. coli 3

O157 E. coli 10

Salmonella 24

Salmonella Chicken Parts 5

Salmonella Ground Beef 11

Salmonella Ground Chicken 9

Salmonella Ground Pork 11

Salmonella Ground Turkey 7

Salmonella Intact Beef 17

Salmonella Intact Chicken 2

Salmonella Intact Pork 9

Salmonella Intact Turkey 1

Salmonella RTE 0

Salmonella Siluriformes 1

There were 22 regulations triggered by a single type of event: 12 were from Enforcement

Actions, 2 were from Salmonella, two were from Salmonella in ground beef, two were from 
42

Salmonella ground pork, one was from Salmonella in intact beef, one was from Salmonella in 

ground chicken, one was from Salmonella in intact chicken, and one was from Campylobacter in 

chicken parts. Table 5-3 presents the regulations triggered for inclusion in the FY2024 PHRs list 

by only a single pathogen product or enforcement action type (event).

Table 5-3 Regulations Triggered for Inclusion in the FY2024 PHRs List by Only a

Single Event

Regulation 

Verified

Description1 Event

310.18(c) Written procedures to prevent contamination; all swine 

slaughter

Salmonella

310.18(c)(2)(iii) Records of test results for sampling program Enforcements

310.18(d) Daily records sufficient to document the 

implementation and monitoring of contamination 

control procedures

Enforcements

310.22(e)(2) Appropriate corrective actions Salmonella Intact Beef

381.65(f) Procedures for controlling visible fecal contamination Enforcements

381.65(g) Procedures for controlling contamination throughout the 

slaughter and dressing operation

Enforcements

381.65(h) Recordkeeping requirements Enforcements

381.71(a) Condemnation on ante mortem inspection Salmonella

381.76(b)(6)(ii)(B) NPIS reprocessing and salvage Salmonella Ground Chicken

381.76(b)(6)(ii)(D) Ready-to-Cook verification in NPIS Campylobacter Chicken 

Parts

381.91(a) Certain contaminated carcasses to be condemned Salmonella Intact Chicken

416.1 Operate in a manner to prevent insanitary conditions Enforcements

416.12(c) Plan identifies procedures for pre-op Salmonella Ground Beef

417.2(a)(1) Hazard analysis Enforcements

417.2(c) Contents of HACCP plan Salmonella Ground Pork

417.3(b)(3) No adulterated product enters commerce Salmonella Ground Pork

417.3(b)(4) Reassessment Enforcements

417.4(b) Reassessment of hazard analysis Salmonella Ground Beef

417.5(a)(1) Written hazard analysis Enforcements

417.5(a)(3) Records documentation and monitoring of CCP's and 

critical limits

Enforcements

418.2 Notification of adulterated or misbranded product in 

commerce

Enforcements

430.4(c)(5) Lm, evaluate control measures in Sanitation SOP Enforcements

1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions.

6.0 CUT POINTS FOR FY2024 PHRS

The FY2024 PHRs are one of seven public health-based decision criteria that are used in 

prioritizing PHREs. Other decision criteria for PHREs include pathogen testing results, recalls, 

outbreaks, regulatory findings, and inspection results. The decision criteria are intended for use 

in identifying establishments that may pose a greater risk to public health than other 

establishments and thus warrant certain prioritized inspection activities by FSIS inspection 

program personnel.
43

Noncompliance with a single FY2024 PHRs may not indicate a loss of process control. The 

aggregate set of PHRs is used to identify establishments that significantly deviate from the 90-

day rolling average noncompliance rate for all similar establishments. The rate is calculated as 

the number of times PHRs regulations are cited as non-compliant divided by the number of times 

the PHRs regulations are verified. This combines the verifications for all the PHRs regulations in 

a 90-day period together into a single aggregate ratio. The aggregate FY2024 PHRs

noncompliance rate by establishments is compared to cut points that have been set for two broad 

categories of establishment operations: processing and combination). Only establishments with 

20 or more verifications and at least two noncompliances were considered when developing cut 

points.

The aggregate non-zero PHRs noncompliance rates are approximately log normally distributed, 

so the rates can be log transformed to obtain an approximately normal distribution (see Appendix 

D). Then to determine a set of annual FY2024 cut points, the mean and standard deviation of the 

log transformed rates (for establishments having more than 20 verifications in the past 90 days

and at least two noncompliances) for each of the four quarters and each of the two types of 

establishment operation are computed. These results are given in Table 6-1. Notice that the 

means are negative since they are the means of the natural log of a number between zero and one 

(the non-zero PHRs noncompliance rates).

Table 6-1 Mean and Standard Deviation of Quarterly FY2024 PHRs Rate

CY2022 Mean of Natural Log PHRs

Rate

Standard Deviation PHRs

Rate

Processing Combination Processing Combination

Jan-Mar -4.94 -4.58 0.84 0.93

Apr-Jun -4.92 -4.54 0.82 0.96

Jul-Sept -4.87 -4.52 0.82 0.96

Oct-Dec -4.96 -4.56 0.82 0.95

Average -4.93 -4.55 0.82 0.96

The mean and standard deviation are averaged over the four quarters, and the annual upper cut 

point is defined as the mean plus two standard deviations. Establishments with PHRs

noncompliance rates higher than the upper cut point for similar establishments are classified as 

the Upper level and are candidates to receive a for-cause PHRE. For example, the upper cut point 

for the log transformed data for Combination establishments is -4.54884 + 2*0.95651 = -4.54884

+ 1.91302 = -2.63582. The cut point of the original, non-transformed PHRs noncompliance data 

is the antilog of -2.63582 or Exp(-2.63582) = 7.17%. Establishments that are below the upperlevel threshold but meet or exceed the lower-level threshold will be notified by FSIS inspection 

program personnel of an elevated level of noncompliance.

The PHRs cut points are defined as follows for each of the two establishment types: (1) 

processing and (2) slaughter/processing combination:

• Any establishment with a PHRs rate less than the lower cut point for all establishments 

with the same type would continue receiving routine inspection procedures. These 
44

establishments are performing better on average than their peers with respect to 

compliance with the PHRs regulations.

• Establishments with a PHRs rate greater than or equal to the lower cut point but less than 

the upper cut point for all establishments with the same establishment type would 

continue to receive routine inspection procedures and be alerted through FSIS inspection 

program personnel of elevated PHRs noncompliance levels.

• Establishments with a PHRs rate greater than the upper cut point for establishments with 

the same establishment type that have not had an FSA in the last 180 days are prioritized 

for a PHRE.

Tables 6-2 and 6-3 present the FY2024 PHRs upper and lower cut points for each of the two 

establishment operation types. The FY2023 and FY2022 PHRs cut points are included for 

comparison. (see Appendix D). The cut points are determined once a year. The next update to the 

cut points is planned for October 2024.

Table 6-2 FY2024 PHRs Upper-Level Cut Points

Operation Type FY2024 PHRs

Cut Points

FY2023 PHRs

Cut Points

FY2022 PHRs

Cut Points

Processing 3.76% 3.65% 3.63%

Combination 7.17% 7.48% 7.33%

Table 6-3 FY2024 PHRs Lower-Level Cut Points

Operation Type FY2024 PHRs

Cut Points

FY2023 PHRs

Cut Points

FY2022 PHRs

Cut Points

Processing 2.49% 2.45% 2.44%

Combination 4.44% 4.59% 4.60%

Table 6-4 presents the number of establishments in each level based solely on the FY2024 PHRs

criterion and the cut points in Tables 6-2 and 6-3. Establishments that qualify for the upper level 

but have less than 20 verifications or only one noncompliance are moved to the mid-level 

classification. Fifty-seven establishments are in the upper level, and candidates are to receive a 

recommendation for a for-cause PHRE. Table 6-4 is based on regulatory noncompliances from

January 1 to March 31, 2023.

Table 6-4 Classification of Establishments Based Solely on the PHRs Criterion

Classification Processing Combination Total

Upper 43 14 57

Mid 64 25 89

Lower 4,213 1,117 5,330

Total 4320 1,156 5476
45

7.0 CONCLUSION

The purpose of this report is to develop a transparent and data-driven approach for selecting 

FY2024 PHRs regulations used to prioritize certain FY2024 FSIS inspection activities. This 

process involves:

(1) Selecting a list of candidate regulations related to food safety process control.

(2) Selecting a subset of these regulations whose noncompliance rates are higher in 

establishments 90 days prior to a pathogen positive or enforcement action.

(3) Using this subset to determine cut points to determine which establishments should be 

flagged for a PHRE or an alert throughout the year. 

The list of FY2024 PHRs has 63 regulations whose individual noncompliance rates are higher in 

establishments 90 days before Salmonella, E. coli O157:H7, non-O157 STEC, Lm, or 

Campylobacter positives or enforcement action than in establishments without positives or 

enforcement actions. Fifty-six regulations on the FY2023 PHRs list are also on the FY2024

PHRs list.

Establishments that have PHRs noncompliance rates higher than the antilog of the mean plus two 

standard deviations of the log transformed distribution of the non-zero PHRs rates for similar 

establishments are recommended to receive a PHRE. Upon completion of a PHRE, the FSIS

district office may perform an FSA or take enforcement actions as appropriate based on its 

analysis of establishment performance as described in FSIS Directive 5100.4.
46

APPENDIX A: FY2024 PHRS REGULATIONS

Table A-1 presents the list of 63 FY2024 Public Health Regulations (PHRs). On average, these 

PHRs have noncompliance rates 90 days prior to a pathogen positive or enforcement action 

that is 5.64 times higher than the PHRs noncompliance rates for establishments with no 

pathogen positive or enforcement action.

Table A-1 List of FY2024 PHRs

Regulation Description1

310.18(a) Carcasses, organs, and other parts handled in a sanitary manner

310.18(c) Written procedures to prevent contamination; all swine slaughter

310.18(c)(2)(iii) Records of test results for sampling program

310.18(d) Daily records sufficient to document the implementation and monitoring 

of contamination control procedures

310.22(c) Disposal of SRM

310.22(e)(1) Written procedures for removal, segregation, and disposition of SRMs

310.22(e)(2) Appropriate corrective actions

310.22(e)(3) Evaluate effectiveness of procedures for removal, segregation, and 

disposition of SRMs

310.22(f)(2) Use of routine operational sanitation procedures on equipment used to cut 

through SRMs

310.3 Carcasses and parts in certain instances to be retained.

318.2(a) All products subject to reinspection by program employees

318.2(d) Removal of U.S. retained by authorized Program employees only

381.65(a) Clean and sanitary practices; products not adulterated

381.65(f) Procedures for controlling visible fecal contamination

381.65(g) Procedures for controlling contamination throughout the slaughter and 

dressing operation

381.65(h) Recordkeeping requirements

381.71(a) Condemnation on ante mortem inspection

381.76(a) Post-mortem inspection, when required, extent

381.76(b)(6)(ii)(A) NPIS Sorting, Trimming, and Reprocessing

381.76(b)(6)(ii)(B) NPIS reprocessing and salvage

381.76(b)(6)(ii)(D) Ready-to-Cook verification in NPIS

381.91(a) Certain contaminated carcasses to be condemned

381.91(b) Reprocessing of carcasses accidentally contaminated with digestive tract 

contents.

416.1 Operate in a manner to prevent insanitary conditions

416.12(c) Plan identifies procedures for pre-op
47

416.13(a) Conduct pre-op procedures

416.13(b) Conduct other procedures listed in the plan

416.13(c) Plant monitors implementation of SSOP procedures

416.14 Evaluate effectiveness of SSOP's & maintain plan

416.15(a) Appropriate corrective actions

416.15(b) Procedures for corrective action

416.16(a) Daily records required, responsible individual, initialed and dated

416.2(a) Grounds and Pest Control

416.2(b)(1) Sound construction, good repair & sufficient size

416.2(b)(2) Walls/floors/ceilings durable, impervious, cleaned & sanitized

416.2(b)(4) Inedible from edible separated by time or space

416.3(b) Constructed, located & operated in a manner that does not deter 

inspection

416.3(c) Receptacles for storing inedible material must identify permitted use

416.4(a) Food contact surface, cleaning & sanitizing as frequency

416.4(d) Product processing, handling, storage, loading, unloading, and during 

transportation must be protected

416.6 Only FSIS program employee may remove ""U.S. Rejected"" tag

417.2(a)(1) Hazard analysis

417.2(c) Contents of HACCP Plan

417.2(c)(4) List of procedures & frequency

417.3(a)(1) Identify and eliminate the cause

417.3(a)(2) CCP is under control

417.3(a)(3) Establish measures to prevent recurrence

417.3(a)(4) No adulterated product enters commerce.

417.3(b)(3) No adulterated product enters commerce

417.3(b)(4) Reassessment

417.3(c) Document corrective actions

417.4(a) Adequacy of HACCP in controlling food safety hazards

417.4(a)(1) Initial validation

417.4(b) Reassessment of hazard analysis

417.5(a)(1) Written hazard analysis

417.5(a)(2) Written HACCP plan

417.5(a)(3) Records documentation and monitoring of CCP's and critical limits

418.2 Notification of adulterated or misbranded product in commerce
48

430.4(a) Lm, post-lethality exposed RTE

430.4(b)(3) Alternative 3

430.4(c)(2) Lm, documentation that supports decision in hazard analysis

430.4(c)(3) Lm, maintain sanitation in post-lethality processing environment

430.4(c)(5) Lm, evaluate control measures in Sanitation SOP

1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions.

APPENDIX B: FY2024 CANDIDATE REGULATIONS

Table B-1 presents the list of candidate regulations. Of the 159 candidate regulations, two 

regulations did not have any verifications for the time period as they were replaced with a new 

regulation or removed from possible verifications prior to this analysis. The noncompliance rates 

in Table B-1 are based on Public Health Information System (PHIS) data from January 1 through 

December 31, 2022.

Table B-1 FY2024 List of Candidate Regulations

Regulation1 Description2

FY

2023

PHRs

Mandatory 

Regulation3

Total 

Regulations 

Verified

Total 

Noncompliant 

Regulations 

Verified

PHRs

Noncompliance 

Rate

301.2_Adulterated Adulterated Yes No 3198 146 4.57%

304.3(a) Develop written 

SSOP

No No 369 0 0.00%

304.3(c) Conduct hazard 

analysis & 

develop

HACCP plan 

for new product

No No 157 4 2.55%

309.2(a) Livestock 

suspected of 

being diseased 

or

affected with 

certain 

conditions;

identifying 

suspects

No No 150 0 0.00%

309.3 (Modernized 

ONLY) Dead, 

dying,

disabled or 

diseased and 

similar

livestock.

No No 278 3 1.08%

309.4 (Modernized 

ONLY) 

Livestock 

showing

symptoms of 

metabolic, 

No No 172 2 1.16%
49

Regulation1 Description2

FY

2023

PHRs

Mandatory 

Regulation3

Total 

Regulations 

Verified

Total 

Noncompliant 

Regulations 

Verified

PHRs

Noncompliance 

Rate

toxic, nervous,

or diseases

309.5 (Modernized 

ONLY) Swine; 

disposal

because of hog 

cholera

No No 96 0 0.00%

309.9 (Modernized 

ONLY) Swine 

erysipelas

No No 95 0 0.00%

310.22(b) Inedible and 

prohibited SRM 

for use as

human food

Yes No 2441 10 0.41%

310.22(c) Disposal of 

SRM

Yes Yes 53625 254 0.47%

310.22(d)(2) Exports have 

equivalent level 

of

protection from 

human 

exposure to 

BSE

as similar U.S.

products

No No 17 0 0.00%

310.22(e)(1) Written 

procedures for 

removal,

segregation, and 

disposition of 

SRMs

Yes No 10682 240 2.25%

310.22(e)(2) Appropriate 

corrective 

actions

Yes No 1744 53 3.04%

310.22(e)(3) Evaluate 

effectiveness of 

procedures for

removal, 

segregation, and 

disposition of

SRMs

Yes No 7601 124 1.63%

310.22(e)(4)(i) Maintain daily 

records

No No 67847 125 0.18%

310.22(f)(2) Use of routine 

operational 

sanitation

procedures on 

equipment used 

No No 14009 35 0.25%
50

Regulation1 Description2

FY

2023

PHRs

Mandatory 

Regulation3

Total 

Regulations 

Verified

Total 

Noncompliant 

Regulations 

Verified

PHRs

Noncompliance 

Rate

to cut

through SRMs

310.22(g)(1) Maintain 

positive control 

of beef

carcasses with 

the vertebral 

columns to

another federal 

inspected 

establishment

Yes No 935 4 0.43%

310.22(g)(4) Maintain 

records of 

official

establishment 

showing proper

disposition of 

vertebral 

columns

Yes No 3382 17 0.50%

310.25(a) Verification 

criteria for E. 

coli testing

meat

No No 27810 330 1.19%

310.25(b) Pathogen 

reduction 

performance

standards; 

Salmonella

No No 180 0 0.00%

310.25(b)(3)(ii) PR livestock -

Failure to 

maintain

adequate 

HACCP Plan

No No 11 1 9.09%

310.3 Carcasses and 

parts in certain 

instances

to be retained.

Yes No 2065 230 11.14%

311.16 (Modernized 

ONLY) 

Carcasses so

infected that 

consumption of 

the meat

may cause food 

poisoning.

No No 394 22 5.58%

311.17 (Modernized 

ONLY) 

Necrobacillosis,

No No 376 3 0.80%
51

Regulation1 Description2

FY

2023

PHRs

Mandatory 

Regulation3

Total 

Regulations 

Verified

Total 

Noncompliant 

Regulations 

Verified

PHRs

Noncompliance 

Rate

pyemia, 

septicemia.

311.24 (Modernized 

ONLY) Hogs 

affected

with tapeworm 

cysts.

No No 123 0 0.00%

315.2 Carcasses and 

parts passed for 

cooking

No No 13 0 0.00%

316.6 Products not to 

be removed 

from official

establishments 

unless marked 

in

accordance with 

the regulations

No No 12802 60 0.47%

317.24(a) Packaging 

materials 

composed of

poisonous or 

deleterious 

substances

No No 1664 11 0.66%

318.1(b) Only inspected 

and passed 

poultry

product to enter 

official 

establishment

Yes No 102044 11 0.01%

318.14(a) Product and 

ingredients 

rendered

adulterated by 

polluted water 

shall be

condemned

No No 153 0 0.00%

318.14(b) Establishment 

shall be 

thoroughly

cleaned and 

disinfected 

under FSIS

supervision

No No 513 0 0.00%

318.14(c) Hermetically 

sealed 

contaminated

containers shall 

be 

examined/rehan

dled

No No 62 0 0.00%
52

Regulation1 Description2

FY

2023

PHRs

Mandatory 

Regulation3

Total 

Regulations 

Verified

Total 

Noncompliant 

Regulations 

Verified

PHRs

Noncompliance 

Rate

under FSIS 

supervision

318.16(b) Pesticides 

chemicals & 

other residues 

in

products not to 

exceed FD&C 

Act levels

- Meat 

ingredients

No No 135 0 0.00%

318.17(a)(1)(2) Lethality and 

Stabilization 

requirements

for cooked beef

No No 2172 3 0.14%

318.17(b) Lethality and 

Stabilization 

processes

other than 

HACCP for 

cooked beef

No No 446 0 0.00%

318.17(c) Validation of 

new or altered 

process

schedules (for 

cooked beef)

No No 28 0 0.00%

318.2(a) All products 

subject to 

reinspection by

program 

employees

Yes No 41323 69 0.17%

318.2(d) Removal of 

U.S. retained by 

authorized

Program 

employees only

Yes No 5953 52 0.87%

318.23(b)(1) Time/Temperat

ure for heatprocessing

combinations of 

fully-cooked 

meat

patties

No No 358 1 0.28%

318.23(b)(3) Heat deviations 

for meat patties

No No 44 3 6.82%

318.23(c)(1) Stabilization 

requirements 

for meat

patties

No No 179 0 0.00%
53

Regulation1 Description2

FY

2023

PHRs

Mandatory 

Regulation3

Total 

Regulations 

Verified

Total 

Noncompliant 

Regulations 

Verified

PHRs

Noncompliance 

Rate

318.23(c)(2) Stabilization 

processes for 

meat patties

other than 

HACCP

No No 61 0 0.00%

318.23(c)(4) Labeling 

statement for 

partially cooked

patties

No No 193 0 0.00%

318.23(c)(5) Labeling 

statement for 

char-marked

patties

No No 46 0 0.00%

318.24 Product 

prepared using 

advanced

meat/bone 

separation 

machinery;

process control

No No 2604 19 0.73%

318.6(b)(1) Requirements 

for use of 

casings, used as

containers

No No 1609 0 0.00%

318.6(b)(4) Detached spinal 

cords

No No 8977 1 0.01%

318.6(b)(6) Tonsils No No 9955 1 0.01%

318.6(b)(8) Intestines as 

ingredients

No No 203 0 0.00%

319.5(b) Mechanically 

separated (beef) 

-

prohibited for 

use in human 

food

No No 243 0 0.00%

381.1_Adulterated Adulterated Yes No 2481 73 2.94%

381.144(a) Packaging 

materials not to 

be composed

of any 

poisonous or 

deleterious

substance

No No 1805 0 0.00%

381.150(a) Lethality and 

Stabilization 

requirements

for cooked 

poultry

No No 944 3 0.32%

381.150(c) Lethality and 

Stabilization 

processes

No No 50 0 0.00%
54

Regulation1 Description2

FY

2023

PHRs

Mandatory 

Regulation3

Total 

Regulations 

Verified

Total 

Noncompliant 

Regulations 

Verified

PHRs

Noncompliance 

Rate

other than 

HACCP for 

cooked poultry

381.150(d) Validation of 

new or altered 

process

schedules by 

scientifically 

supportable

means (cooked 

poultry)

No No 14 0 0.00%

381.151(a) Product and 

ingredients 

rendered

adulterated by 

polluted water 

shall be

condemned

No No 432 0 0.00%

381.22(a) Develop written 

SSOP

No No 176 1 0.57%

381.22(b) Conduct hazard 

analysis & 

develop and

validate 

HACCP plan

No No 1007 2 0.20%

381.22(c) Conduct hazard 

analysis & 

develop

HACCP plan 

for new product

No No 221 1 0.45%

381.37(a) Product not 

produced under 

supervision

of program 

employee

No No 1280 13 1.02%

381.65(a) Clean and 

sanitary 

practices; 

products

not adulterated

Yes No 26841 165 0.61%

381.71(a) Condemnation 

on ante mortem

inspection

Yes No 933 15 1.61%

381.72(a) Poultry No No 211 0 0.00%

381.72(b) Ratites No No 57 0 0.00%

381.83 Septicemia or 

toxemia

No No 1339159 65 0.00%

381.85 Special 

Diseases 

(organisms or 

toxins

No No 114 0 0.00%
55

Regulation1 Description2

FY

2023

PHRs

Mandatory 

Regulation3

Total 

Regulations 

Verified

Total 

Noncompliant 

Regulations 

Verified

PHRs

Noncompliance 

Rate

dangerous to 

the consumer)

381.91(a) Certain 

contaminated 

carcasses to be

condemned

No No 4669 11 0.24%

381.91(b) Reprocessing of 

carcasses 

accidentally

contaminated 

with digestive 

tract

contents.

Yes No 8862 228 2.57%

416.1 Operate in a 

manner to 

prevent

insanitary 

conditions

Yes Yes 623867 4270 0.68%

416.12(c)

pPlan identifies 

procedures for 

pre-op

Yes No 39691 67 0.17%

416.12(d) Plan list 

frequency for 

each procedure 

&

responsible 

individual

No No 57581 73 0.13%

416.13(a) onduct pre-op 

procedures

Yes Yes 782372 15510 1.98%

416.13(b) Conduct other 

procedures 

listed in the

plan

Yes Yes 1976382 6512 0.33%

416.13(c) Plant monitors 

implementation 

of SSOP

procedures

Yes Yes 2802361 30565 1.09%

416.14 Evaluate 

effectiveness of 

SSOP's &

maintain plan

Yes Yes 1724591 2863 0.17%

416.15(a) Appropriate 

corrective 

actions

Yes Yes 62388 739 1.18%

416.15(b) Procedures for 

corrective 

actionI

Yes Yes 39372 953 2.42%

416.16(a) Daily records 

required, 

Yes Yes 2982522 4297 0.14%
56

Regulation1 Description2

FY

2023

PHRs

Mandatory 

Regulation3

Total 

Regulations 

Verified

Total 

Noncompliant 

Regulations 

Verified

PHRs

Noncompliance 

Rate

responsible

individual, 

initialed and 

dated

416.2(a) Grounds and 

pest control

Yes No 185698 6753 3.64%

416.2(b)(1) Sound 

construction, 

good repair &

sufficient size

Yes No 145806 6572 4.51%

416.2(b)(2) Walls/floors/cei

lings durable,

impervious, 

cleaned & 

sanitized

Yes No 197480 8778 4.45%

416.2(b)(4) Inedible from 

edible separated 

by time

or space

Yes No 110626 478 0.43%

416.3(b) Constructed, 

located & 

operated in a

manner that 

does not deter 

inspection

Yes No 78650 429 0.55%

416.3(c) Receptacles for 

storing inedible 

material

must identify 

permitted use

Yes No 66282 781 1.18%

416.4(a) Food contact 

surface, 

cleaning &

sanitizing as 

frequency

Yes No 262460 10679 4.07%

416.4(d) Product 

processing, 

handling, 

storage,

loading, 

unloading, and 

during

transportation 

must be 

protected

Yes No 241439 12676 5.25%

416.5(c) Employees who 

appears to have 

any

abnormal 

source of 

No No 33075 10 0.03%
57

Regulation1 Description2

FY

2023

PHRs

Mandatory 

Regulation3

Total 

Regulations 

Verified

Total 

Noncompliant 

Regulations 

Verified

PHRs

Noncompliance 

Rate

microbial

contamination

416.6 Only FSIS 

program 

employee may

remove "U.S. 

Rejected" tag

Yes No 2635 119 4.52%

417.2(a)(1) Hazard analysis Yes Yes 125136 1485 1.19%

417.2(c) Contents of 

HACCP Plan

Yes No 27178 54 0.20%

417.2(c)(4) List of 

procedures & 

frequency

Yes Yes 1349538 4371 0.32%

417.3(a)(1) Identify and 

eliminate the 

cause

Yes No 24884 529 2.13%

417.3(a)(2) CCP is under 

control

Yes No 140997 639 0.45%

417.3(a)(3) Establish 

measures to 

prevent 

recurrence

Yes No 22630 641 2.83%

417.3(a)(4) No adulterated 

product enters

commerce.

Yes No 42034 136 0.32%

417.3(b)(1) Segregate and 

hold the 

affected product

Yes No 18715 66 0.35%

417.3(b)(2) Determine the 

acceptability of 

the

affected product

No No 18435 62 0.34%

417.3(b)(3) No adulterated 

product enters 

commerce

Yes No 29894 58 0.19%

417.3(b)(4) Reassessment Yes Yes 42851 183 0.43%

417.3(c) Document 

corrective 

actions

Yes No 20740 174 0.84%

417.4(a) Adequacy of 

HACCP in 

controlling

food safety 

hazards

Yes No 6208 197 3.17%

417.4(a)(1) Initial 

validation

No No 5454 294 5.39%

417.4(b) Reassessment 

of hazard 

analysis

No Yes 28408 81 0.29%
58

Regulation1 Description2

FY

2023

PHRs

Mandatory 

Regulation3

Total 

Regulations 

Verified

Total 

Noncompliant 

Regulations 

Verified

PHRs

Noncompliance 

Rate

417.5(a)(1) Written hazard 

analysis

Yes Yes 1429037 3508 0.25%

417.5(a)(2) Written 

HACCP plan

Yes Yes 1268134 1113 0.09%

417.5(a)(3) Records 

documentation 

and monitoring

of CCP's and 

Critical Limits

Yes Yes 1401482 3449 0.25%

417.5(f) Official Review No No 89274 61 0.07%

417.6 Inadequate 

HACCP 

systems

Yes No 428 103 24.07%

430.4(a) Lm, postlethality 

exposed RTE

Yes Yes 300653 121 0.04%

430.4(b)(1) Alternative 1 No No 700 5 0.71%

430.4(b)(2) Alternative 2 Yes No 13063 55 0.42%

430.4(b)(3) Alternative 3 Yes No 17012 276 1.62%

430.4(c)(2) Lm, 

documentation 

that supports

decision in 

hazard analysis

No Yes 293279 116 0.04%

430.4(c)(3) Lm, maintain 

sanitation in 

post-lethality

processing 

environment

No Yes 293022 104 0.04%

430.4(c)(4) Lm, validate 

and verify 

control

measures in 

HACCP plan

No No 3250 6 0.18%

430.4(c)(5) Lm, evaluate 

control 

measures in

Sanitation SOP

Yes No 4558 8 0.18%

430.4(c)(6) Lm, prerequisite 

program 

requirements

Yes No 4076 50 1.23%

310.18(a) Carcasses, 

organs, and 

other parts

handled in a 

sanitary manner

Yes Yes 372189 4727 1.27%

310.18(b) Brains, cheek 

meat, head 

trimmings

from animals 

No No 21415 7 0.03%
59

Regulation1 Description2

FY

2023

PHRs

Mandatory 

Regulation3

Total 

Regulations 

Verified

Total 

Noncompliant 

Regulations 

Verified

PHRs

Noncompliance 

Rate

slaughtered by 

gunshot

418.2 Notification of 

adulterated or

misbranded 

product in 

commerce

Yes No 2054 85 4.14%

418.3 Recall Plans Yes No 22713 45 0.20%

354.242(b) All equipment 

and utensils 

clean and

sanitary

No No 51 0 0.00%

354.242(h) Tools and 

equiment used 

in preparation

to be kept clean 

and sanitary

No No 21 1 4.76%

354.243(a) No handling or 

storage of 

objectionable

materials

No No 6 0 0.00%

381.193(a) Poultry not 

intended for 

human food in

commerce

No No 233 10 4.29%

381.65(f) Procedures for 

controlling 

visible fecal

contamination

Yes No 1627861 11364 0.70%

381.65(g) Procedures for 

controlling

contamination 

throughout the 

slaughter

and dressing 

operation

Yes No 115573 666 0.58%

381.65(h) Recordkeeping 

requirements

Yes No 26944 24 0.09%

381.76(a) Post-mortem 

inspection, 

when required,

extent

Yes No 7378 81 1.10%

381.94(a) Verification 

criteria for E. 

coli testing

ratites

No No 1000 5 0.50%

381.76(b)(6)(ii)(A) NPIS Sorting, 

Trimming, and

Reprocessing

Yes No 64270 394 0.61%
60

Regulation1 Description2

FY

2023

PHRs

Mandatory 

Regulation3

Total 

Regulations 

Verified

Total 

Noncompliant 

Regulations 

Verified

PHRs

Noncompliance 

Rate

381.76(b)(6)(ii)(D) Ready-to-Cook 

verification in 

NPIS

Yes No 4407 225 5.11%

381.76(b)(6)(ii)(C) NPIS 

septicemia/toxe

mia

No No 1459226 67 0.00%

381.76(b)(6)(ii)(B) NPIS 

reprocessing 

and salvage

Yes No 71949 68 0.09%

537.1 Basic 

Requirements

No No 25662 98 0.38%

311.14 Abrasions, 

bruises, 

abscesses, pus, 

etc.

Yes No 27713 16 0.06%

309.3(e) Establishment 

notify 

Inspection 

Program 

Personnel (IPP)

of

non-ambulatory 

livestock; 

Prompt

condemnation 

and disposal

No No 33 4 12.12%

431.4 Critical factors 

and the 

application of 

the

process 

schedule

No Yes 10053 17 0.17%

431.9(b) Procedures for 

handling of 

process

deviations

No Yes 8800 0 0.00%

431.9(c)(1) Process 

deviations 

identified inprocess

No No 77 1 1.30%

431.9(c)(2) Process 

deviations 

identified 

through

record review

No No 19 1 5.26%

431.9(d) Process 

deviation file

No No 101 0 0.00%

431.11 Personnel and 

training

No No 33 1 3.03%

431.12 Recall 

procedure

No No 65 0 0.00%
61

Regulation1 Description2

FY

2023

PHRs

Mandatory 

Regulation3

Total 

Regulations 

Verified

Total 

Noncompliant 

Regulations 

Verified

PHRs

Noncompliance 

Rate

309.19(a) Market hog 

sorting 

activities

No No 1395 2 0.14%

309.19(c ) Sorted and 

removed hogs 

identified;

written 

procedures

No No 935 0 0.00%

309.19(d) Records of 

animals 

disposed of per 

day

Yes No 4445 1 0.02%

309.19(e ) Notifiable 

animal disease

No No 134 0 0.00%

310.18(c ) Written 

procedures to 

prevent

contamination; 

all swine 

slaughter

Yes No 9752 38 0.39%

310.18(c )(1) Sampling 

locations

No No 1787 3 0.17%

310.18(c )(1)(i) Very low 

volume 

establishments

No No 3133 0 0.00%

310.18(c )(2)(i) Sampling 

frequency

Yes No 2945 4 0.14%

310.18(c )(2)(ii) Sampling 

frequency for 

very low

volume 

establishments

No No 1958 2 0.10%

310.18(c )(2)(iii) Records of test 

results for 

sampling

program

No No 23314 14 0.06%

310.18(d) Daily records 

sufficient to 

document the

implementation 

and monitoring 

of

contamination 

control 

procedures

Yes No 37928 32 0.08%

310.26(b) Carcass sorting 

and disposition

Yes Yes 3389 38 1.12%

310.26(d)(2) Document 

number of 

carcasses 

No No 2565 2 0.08%
62

Regulation1 Description2

FY

2023

PHRs

Mandatory 

Regulation3

Total 

Regulations 

Verified

Total 

Noncompliant 

Regulations 

Verified

PHRs

Noncompliance 

Rate

disposed

of per day

1Regulations 417.3(a) and 417.4(a)(3) are not included in this table as they had zero regulations verified in CY2022.

2Refer to the 2021 Code of Federal Regulations for complete regulation descriptions.

3Mandatory Regulations are the regulatory requirements that must be verified each time IPP perform the task.
63

APPENDIX C: COMPARISON OF FY2023 PHRS LIST WITH FY2024 PHRS LIST

There are 15 regulations from the FY2023 PHRs list that no longer appear in the FY2024 PHRs

list. These are shown in Table C-1.

Table C-1 Regulations on the FY2023 PHRs List No Longer on the FY2024 PHRs List

FY2023 PHRs Description1

301.2_Adulterated Adulterated

310.22(b) Inedible and prohibited SRM for use as human food

310.22(g)(1) Maintain positive control of beef carcasses with the vertebral 

columns to another federal inspected establishment

310.22(g)(4) Maintain records of official establishment showing proper 

disposition of vertebral columns

318.1(b) Only inspected and passed poultry product to enter official 

establishment

381.1_Adulterated Adulterated

417.3(b)(1) Segregate and hold the affected product

417.6 Inadequate HACCP systems

430.4(b)(2) Alternative 2

430.4(c)(6) Lm, prerequisite program requirements

418.3 Recall Plans

311.14 Abrasions, bruises, abscesses, pus, etc.

309.19(d) Records of animals disposed of per day

310.18(c )(2)(i) Sampling frequency

310.26(b) Carcass sorting and disposition

1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions.

There are seven regulations on the FY2024 PHRs list that were not on the FY2023 PHRs list.

Table C-2 Regulations on the FY2024 PHRs List That Were Not on the FY2023 PHRs List

FY2024 PHRs Description1

310.22(f)(2) Use of routine operational sanitation procedures on equipment used 

to cut through SRMs

381.91(a) Certain contaminated carcasses to be condemned

417.4(a)(1) Initial validation

417.4(b) Reassessment of hazard analysis

430.4(c)(2) Lm, documentation that supports decision in hazard analysis

430.4(c)(3) Lm, maintain sanitation in post-lethality processing environment

310.18(c)(2)(iii)* Records of test results for sampling program

1Refer to the 2021 Code of Federal Regulations for complete regulation descriptions.

*

Indicates first time regulation qualified for PHRs list.
64

APPENDIX D: METHODOLOGY AND CALCULATION OF PHRS CUT POINTS

The purpose of this appendix is to explain the methodology and calculations used to develop the 

PHRs cut points. The PHRs noncompliance rate is calculated by the following formula using the 

most recent 90 days of establishment verification inspection data:

sPHR Noncompliance Rate =

Total Noncompliant PHRs

Total PHRs Verified

Establishments are categorized into one of two establishment types: (1) processing only and (2)

slaughter/processing; named processing, and combination in the main body of the report. The 

establishment type is determined from the type of HACCP inspection task codes performed at 

each establishment. If an establishment has only 03A through 03I codes, it is classified as a 

processing only establishment. If an establishment has a combination of 03A through 03J codes,

it is classified as a slaughter/processing establishment.

The aggregate non-zero PHRs noncompliance rates are approximately log normally distributed.

That means that the natural logarithm of the non-zero PHRs noncompliance rates is

approximately normally distributed. Figure D-1 presents a histogram for the log transformed 

non-zero PHRs noncompliance data. Only establishments with greater than or equal to 20 

verifications and at least 2 noncompliances are considered.

Figure D-1 Log Transformed Non-Zero Noncompliance Rates of PHRs with 20 or More 

Verifications 90 Days before a Pathogen Positive or Enforcement Action
65

This distribution is approximately normally distributed. Three goodness of fit tests, shown in 

Figure D-2, indicate near-normality. 

Figure D-2 Goodness of Fit for Normal Distribution of the Log Transformation

Goodness-of-Fit Tests for Normal Distribution

Test Statistic p Value

Kolmogorov-Smirnov D 0.03067772 Pr > D <0.010

Cramer-von Mises W-Sq 0.63813471 Pr > W-Sq <0.005

Anderson-Darling A-Sq 4.12389603 Pr > A-Sq <0.005

The final list of log-transformed cut points is derived from the average of the mean and standard 

deviation of the log transformed non-zero PHRs rate from four quarters of PHRs data. (The 

antilog of these cut points is taken to obtain the cut points of the non-transformed PHRs

noncompliance data). Table D-1 shows the number of establishments, mean and standard 

deviation for each establishment type as well as the level distribution (based only on PHRs

noncompliances) using the quarterly cut points.

Table D-1 Quarterly PHRs Mean, Standard Deviation and Level Distribution

Quarter/

Establishment 

Type

Number of 

Establishments

Mean Standard 

Deviation

Level Tier Distribution 

(Number of 

Establishments)

Q1CY2022

Upper 80

Combination 1,128 -4.57674 0.93148 Mid 92

Processing 4,325 -4.94081 0.83789 Lower 5,281

Q2CY2022

Upper 69

Combination 1,157 -4.53727 0.95592 Mid 106

Processing 4,338 -4.92279 0.81704 Lower 5,320

Q3CY2022

Upper 70

Combination 1,161 -4.52175 0.98877 Mid 111

Processing 4,336 -4.87322 0.81869 Lower 5,316

Q4CY2022

Upper 68

Combination 1,165 -4.55961 0.94987 Mid 85

Processing 4,337 -4.96510 0.81607 Lower 5,349
66

Table D-2 shows the average mean and standard deviation of the log transformed non-zero PHRs

rate over four quarters for each establishment type based on the quarterly data in Table D-1.

Table D-3 shows the upper and lower cut points for FY2024 PHRs. Table D-4 show the 

distribution of establishments using data from January to March 2023 utilizing the proposed 

FY2024 PHRs.

Table D-2 Average Mean and Standard Deviation of Log 

Transformed Non-Zero PHRs Rates by Establishment Type

Statistic Combination Processing

Mean -4.54884 -4.92548

Standard Deviation 0.95651 0.822422

Table D-3 FY2024 PHRs Upper and Lower Cut Points

Operation 

Type

Upper Cut 

Points

Lower Cut 

Points

Processing 3.76% 2.49%

Combination 7.17% 4.44%

Table D-4 March 2023 Level Distribution Based on the 

Previous Year’s (FY2023) PHRs Cut Points

(Note: Establishments that qualify for the upper level but with 

less than 20 verifications or only one noncompliance are 

moved to the mid-level classification).

Classification Establishments

Upper 57

Mid 90

Lower 5,330

Total 5,477