U.S. Department of Agriculture/ 

Food Safety and Inspection Service 

FY2023 Public Health Regulations 

July 2022 

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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......................................................................................... 15 

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

4.1.4 Salmonella in Intact Beef............................................................................................. 17 

4.1.5 Salmonella in Ground Chicken.................................................................................... 20 

4.1.6 Salmonella in Ground Turkey...................................................................................... 21 

4.1.7 Salmonella in Intact Pork............................................................................................. 22 

4.1.8 Salmonella in Ground Pork.......................................................................................... 23 

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

4.1.10 Salmonella in Siluriformes ........................................................................................ 25 

4.1.11 Salmonella in Ready-to-Eat (RTE)............................................................................ 26 

4.2 E. coli .................................................................................................................................. 26 

4.2.1 E. coli O157:H7 ........................................................................................................... 26 

4.2.2 Non-O157 STEC.......................................................................................................... 27 

4.3 Listeria monocytogenes ...................................................................................................... 28 

4.4 Campylobacter.................................................................................................................... 29 

4.4.1 Campylobacter in Intact Chicken ................................................................................ 31 

4.4.2 Campylobacter in Intact Turkey .................................................................................. 32 

4.4.3 Campylobacter in Ground Chicken ............................................................................. 33 

4.4.4 Campylobacter in Ground Turkey............................................................................... 33 

4.4.5 Campylobacter in Chicken Parts ................................................................................. 34 

4.5 Enforcement Actions .......................................................................................................... 35 

5.0 List of FY2023 PHRs.............................................................................................................. 40 

6.0 Cut Points for FY2023 PHRs.................................................................................................. 44 

7.0 Conclusion .............................................................................................................................. 47 

8.0 References............................................................................................................................... 48 

Appendix A: FY2023 PHR Regulations....................................................................................... 49 

Appendix B: FY2023 Candidate Regulations............................................................................... 52 

Appendix C: Comparison of FY2022 PHR List with FY2023 PHR List..................................... 67 

Appendix D: Methodology and Calculation of PHR Cut Points .................................................. 68 

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List of Figures and Tables 

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

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

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

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

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

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

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

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

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

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

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

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

Table 4-12 Comparison of Noncompliance Rates 90 Days before a RTE Salmonella Positive 

Table 4-13 Comparison of Noncompliance Rates 90 Days before an E. coli O157:H7 Positive 

Table 4-14 Comparison of Noncompliance Rates 90 Days before a Non-O157 STEC Positive 

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

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

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

Chicken Positive with Those for Establishments with No Campylobacter Intact 

Table 4-18 Comparison of Noncompliance Rates 90 Days before a Campylobacter Intact 

Turkey Positive with Those for Establishments with No Campylobacter Intact Turkey Positive32 

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

Campylobacter Positive with Those for Establishments with No Ground Chicken 

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

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

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

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

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

Positive with Those for Establishments with No Ground Beef Salmonella Positive ................... 16 

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

Positive with Those for Establishments with No Ground Chicken Salmonella Positive ............. 20 

Positive with Those for Establishments with No Ground Turkey Salmonella Positive ............... 21 

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

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

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

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

with Those for Establishments with No RTE Salmonella ............................................................ 26 

with Those for Establishments with no E. coli O157:H7 Positive ............................................... 27 

with Those for Establishments with No Non-O157 STEC Positive............................................. 28 

for Establishments with No Lm Positive....................................................................................... 28 

with Those for Establishments with No Campylobacter Positive ................................................ 30 

Chicken Positive ........................................................................................................................... 31 

Campylobacter Positive................................................................................................................ 33 

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Table 4-20 Comparison of Noncompliance Rates 90 Days before a Ground Turkey 

Campylobacter Positive with those for Establishments with No Ground Turkey 

Campylobacter Positive................................................................................................................ 34 

Table 4-21 Comparison of Noncompliance Rates 90 Days before a Chicken Parts 

Campylobacter Positive with Those for Establishments with No Chicken Parts Campylobacter 

Table 4-22 Comparison of Noncompliance Rates 90 Days before an Enforcement Action with 

Table 5-3 Regulations Triggered for Inclusion in the FY2023 PHR List by Only a 

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

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

Table D-4 March 2022 Level Distribution Based on the Previous Year’s (FY2022) PHR 

Positive.......................................................................................................................................... 34 

Those for Establishments with No Enforcement Action .............................................................. 36 

Table 5-1 List of FY2023 PHRs ................................................................................................... 40 

Table 5-2 Events That Triggered Inclusion of a Regulation in the FY2023 PHR List ................ 43 

Single Event.................................................................................................................................. 44 

Table 6-1 Mean and Standard Deviation of Quarterly FY2023 PHR Rate .................................. 45 

Table 6-2 FY2023 PHR Upper-Level Cut Points......................................................................... 46 

Table 6-3 FY2023 PHR Lower-Level Cut Points......................................................................... 46 

Table 6-4 Classification of Establishments Based Solely on the PHR Criterion ......................... 46 

Table 7-1 FY2023 PHR Cut Points .............................................................................................. 47 

Table A-1 List of FY2023 PHRs .................................................................................................. 49 

Table B-1 FY2023 List of Candidate Regulations ....................................................................... 52 

Table C-1 Regulations on the FY2022 PHR List No Longer on the FY2023 PHR List.............. 67 

Table C-2 Regulations on the FY2023 PHR List That Were Not on the FY2022 PHR List ....... 67 

Verifications 90 Days before a Pathogen Positive or Enforcement Action.................................. 68 

Figure D-2 Goodness of Fit for Normal Distribution of the Log Transformation........................ 69 

Table D-1 Quarterly PHR Mean, Standard Deviation and Level Distribution............................. 69 

Establishment Type....................................................................................................................... 70 

Table D-3 FY2023 PHR Upper and Lower Cut Points ................................................................ 70 

Cut Points...................................................................................................................................... 70 

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SUMMARY 

Public Health Regulations (PHRs) are regulations1 that have significantly higher individual 

noncompliance rates at establishments within a 90 day period prior to identification of a 

pathogen-positive laboratory sample or a public health-related enforcement action. The 

comparison is to establishments with no positives or enforcement actions2

. This correlation does 

not inherently imply that a particular regulation constitutes a more serious food safety concern, 

but gives a guide to better assign agency resources. 

This report describes the data-driven approach used to select the PHRs that will be used for the 

period October 1, 2022, to September 30, 2023, (FY2023) to prioritize certain FY2023 FSIS 

inspection activities. 

FSIS uses decision criteria to prioritize establishments for Public Health Risk Evaluations3 

(PHREs), which are reviews of FSIS information for an establishment and are used to determine 

the need for a Food Safety Assessment (FSA) or enforcement action. The decision criteria 

include exceeding an upper threshold for PHR noncompliance rate and other factors such as 

pathogen testing results, recalls, outbreaks, regulatory findings, and inspection results. Updates 

to the list of PHRs, as well as the upper and lower thresholds used to prioritize establishments for 

PHREs and to alert inspection personnel of elevated PHR noncompliance rate, are announced 

around July 1 each year with a targeted implementation month of October. 

The updated list of FY2023 PHRs is based on January 1, 2021, to December 31, 2021, (CY2021) 

verification inspection results and will be implemented in FY2023. For inclusion in the FY2023 

PHR list, a curated list of candidate regulations from 9 CFR was evaluated to determine whether 

noncompliance with each regulation occurred at a more frequent rate in establishments in the 90 

days before Salmonella, E. coli O157:H7, Non-O157 Shiga toxin-producing Escherichia coli 

(STEC), Listeria monocytogenes (Lm), Campylobacter positives or enforcement actions than in 

establishments without positives or enforcement actions. 

The final list of FY2023 PHRs consists of 71 regulations that have higher rate of noncompliance 

in the 90 days before a pathogen positive or enforcement action. This compares with 62 

regulations that were identified in the prior fiscal year PHR list. The full list of FY2023 PHRs is 

given in Appendix A. Fifty-two regulations from the FY2022 PHR list remain on the FY2023 

PHR list. 

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 PHR list allows 

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

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. 

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The average noncompliance rate of FY2023 PHR regulations in the 90 days before a pathogen 

positive or enforcement action is 7.37 times higher than the average FY2023 PHR 

noncompliance rate for establishments with no pathogen positive and no enforcement action. 

Noncompliance with a single FY2023 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 FY2023 

PHR noncompliance rate by establishments is evaluated and compared to thresholds (also 

referred to as cut points), that have been set for two broad categories of establishment operations: 

Processing Only and both Slaughter and Processing, labeled respectively as Processing and 

Combination in the main body of the report. 

The FY2023 cut points are computed by determining the mean and standard deviation of the log 

transformed non-zero FY2023 PHR rates for each of the four quarters in CY2021 (the log 

transform of the non-zero FY2023 PHR 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 PHR rates. The antilog is then taken to obtain the upper cut point of the nontransformed PHR noncompliance data. Establishments that have PHR noncompliance rates 

higher than the upper cut point for similar establishments are classified as Upper and are 

considered for a “for cause” PHRE if they have not had a PHRE 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 PHR rates. Establishments that have PHR noncompliance rates below the 

lower cut point for similar establishments are classified as Lower. Establishments with a PHR 

noncompliance rate between the Upper and Lower cut points will be notified by FSIS inspection 

personnel that the establishment is at an elevated level of noncompliance. Tables S-1 and S-2 

present the Upper and Lower FY2023 PHR cut points for the non-transformed PHR 

noncompliance data for each of the two establishment operation types. The FY2022 and FY2021 

PHR cut points are included for comparison. (See Section 6 and Appendix D for more details.) 

Table S-1 PHR Upper Cut Points 

Operation Type FY2023 FY2022 FY2021 

Processing 3.65% 3.63% 3.73% 

Combination 7.48% 7.33% 9.84% 

Table S-2 PHR Lower Cut Points 

Operation Type FY2023 FY2022 FY2021 

Processing 2.45% 2.44% 2.50% 

Combination 4.59% 4.60% 5.85% 

Table S-3 presents the number of establishments in each level from January 1, 2022, to March 

31, 2022, based on the PHR criterion. The period used for calculating the noncompliance rate of 

the PHRs was January 1, 2022, to March 31, 2022. 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 PHR Criterion 

Level Processing Combination Total 

Upper 65 14 79 

Mid 69 22 91 

Lower 4,143 1,087 5,230 

Total 4,277 1,123 5,400 

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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 factors 

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

noncompliance with certain 9 CFR regulations. These criteria are described in detail in FSIS' 

Public Health Decision Criteria Report (FSIS 2010). 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 District Office first performs the 

evaluation as described in FSIS Directive 5100.4 to review the operational and compliance 

history of the establishment to decide if a Food Safety Assessment (FSA) or enforcement action 

is appropriate. 

The subset of 9 CFR regulations used to schedule PHREs was initially called W3NR regulations 

to indicate they are the most serious noncompliance. In January 2012, FSIS developed a more 

transparent and data-driven approach to refine the list of W3NR regulations (FSIS 2012). The 

updated list of regulations was called Public Health Regulations (PHRs). In January 2013, FSIS 

submitted plans to the National Advisory Committee on Meat and Poultry Inspection (NACMPI) 

to implement the PHRs. NACMPI endorsed the use of PHRs and suggested that the PHR list be 

updated annually (NACMPI 2013). The purpose of this report is to update the list of PHRs using 

current verification inspection results from the Public Health Information System (PHIS). The 

updated list is called the FY2023 PHRs (PHRs that will be used for the time period October 1, 

2022, to September 30, 2023). 

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

The inclusion of provisions in the PHR list allows FSIS to focus on specific public health-related 

provisions that may be most informative for prioritizing PHREs. 

The methodology used in developing the FY2023 PHR list is the same as that used for the 

FY2022 PHR list. For inclusion in the FY2023 PHR 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, E. coli O157: H7, NonO157 STEC, Listeria monocytogenes (Lm), Campylobacter positives or enforcement actions than 

in establishments without positives or enforcement actions4

. The analysis was based on 1 year of 

FSIS verification inspection results recorded in PHIS from January 1 to December 31, 2021 

(CY2021). Candidate regulations related to egg products are not included in this report as one 

calendar year of data is required for inclusion in this analysis. HACCP in egg establishments is 

not required to be implemented until October 2022. 

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. 

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Sections Two and Three detail how candidate regulations were determined and the results of the 

analysis to select the PHRs from the candidate 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 FY2023 PHR list is 

presented in Appendix A. Appendix B lists the candidate regulations evaluated to determine 

PHRs. Appendix C describes the differences between the FY2023 PHR list and FY2022 PHR 

list. Appendix D explains the methodology and calculations used to determine the PHR cut 

points. 

2.0 SELECTION OF PHRS 

The PHR 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, 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 HACCP 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, 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 provide control of operating conditions that are 

necessary to produce safe, wholesome food. 

FSIS requires that establishments develop HACCP plans for controlling food safety hazards that 

can affect their products. These plans delineate a system of process control for each 

establishment’s operation. 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. 

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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. 

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 of the 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 be 

indicative of 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, Non-O157 STEC, Lm, 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, 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 as being 

indicators of 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 are 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, Campylobacter positives 

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

FY2023 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 CY2021. 

Those with more than 30 verifications in a year, an odds 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 before a 

pathogen positive or enforcement action is statistically higher than the noncompliance rate for 

establishments with no positives are selected 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. 

An odds 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. 

An odds ratio is calculated by dividing the odds of a test group (in our 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 our 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 odds ratio size. In 

this report, an odds ratio size of 3.0 is taken as the threshold for a meaningful odds 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 PHR 

noncompliance rates for the 2,161 establishments with Salmonella testing data. There were 791 

establishments that had 4,189 Salmonella positives. There were 1,370 establishments that did not 

have any Salmonella positives. There were 56,002 total Salmonella tests performed. 

Table 4-1 presents the 32 regulations that had more than 30 verifications in a year, an odds ratio 

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

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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 Salmonella positive is higher than the average 

noncompliance rate for establishments with no Salmonella positive for CY2021. 

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

Those for Establishments with No Salmonella Positive 

Regulation 

Verified 

Description1 On 

FY 

2022 

PHR 

List 

Noncompliance 

Rate 90 Days 

before a 

Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

301.2_Adulterated Adulterated Yes 51.58% 2.47% 42.09 1.34E-136 

310.18(c) Written procedures 

to prevent 

contamination; all 

swine slaughter 

Yes 0.88% 0.23% 3.94 1.07E-04 

310.18(c)(2)(i) Sampling 

frequency 

No 2.26% 0.10% 22.36 1.72E-04 

310.22(c) Disposal of SRM Yes 5.93% 0.45% 13.95 9.91E-119 

310.22(e)(1) Written procedures 

for removal, 

segregation, and 

disposition of 

SRMs 

Yes 7.51% 2.46% 3.22 1.83E-12 

310.22(e)(3) Evaluate 

effectiveness of 

procedures for 

removal, 

segregation, and 

disposition of 

SRMs 

Yes 18.44% 1.22% 18.25 3.77E-73 

310.26(b) Carcass sorting and 

disposition 

No 2.08% 0.12% 17.86 7.05E-06 

311.14 Abrasions, bruises, 

abscesses, pus, etc. 

No 0.12% 0.01% 12.73 3.91E-03 

318.1(b) Only inspected and 

passed poultry 

product to 

enter official 

establishment 

Yes 0.07% 0.02% 3.45 3.09E-02 

381.1_Adulterated Adulterated No 4.01% 0.87% 4.79 8.59E-03 

416.12(c) Plan identifies 

procedures for preop 

No 0.37% 0.11% 3.39 3.87E-04 

416.13(a) Conduct pre-op 

procedures 

Yes 7.98% 1.44% 5.92 0.00E+00 

416.13(b) Conduct other 

procedures listed in 

the plan 

Yes 0.69% 0.19% 3.64 6.40E-271 

416.13(c) Plant monitors 

implementation of 

SSOP procedures 

Yes 4.67% 0.96% 5.07 0.00E+00 

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Regulation 

Verified 

Description1 On 

FY 

2022 

PHR 

List 

Noncompliance 

Rate 90 Days 

before a 

Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

416.14 Evaluate 

effectiveness of 

SSOP's & maintain 

plan 

Yes 0.70% 0.13% 5.41 0.00E+00 

416.15(b) Corrective action, 

procedures for 

Yes 9.87% 3.05% 3.48 8.04E-61 

416.2(a) Grounds and pest 

control 

No 12.23% 3.33% 4.04 0.00E+00 

416.2(b)(1) Sound 

construction, good 

repair & sufficient 

size 

No 11.70% 3.43% 3.72 0.00E+00 

416.2(b)(2) Walls/floors/ 

ceilings durable, 

impervious, 

cleaned & sanitized 

No 11.44% 3.89% 3.20 0.00E+00 

416.2(b)(4) Inedible from 

edible separated by 

time or space 

No 1.59% 0.32% 5.04 6.41E-50 

416.3(c) Receptacles for 

storing inedible 

material must 

identify permitted 

use 

Yes 4.65% 0.88% 5.52 6.04E-96 

416.4(a) Food contact 

surface, cleaning & 

sanitizing as 

frequency 

Yes 12.99% 3.60% 4.00 0.00E+00 

416.4(d) Product processing, 

handling, storage, 

loading, unloading, 

and during 

transportation must 

be protected 

Yes 16.67% 4.45% 4.30 0.00E+00 

417.2(c)(4) List of procedures 

& frequency 

Yes 0.66% 0.21% 3.19 4.34E-198 

417.3(a)(1) Identify and 

eliminate the cause 

Yes 15.26% 2.46% 7.13 1.85E-79 

417.3(a)(2) CCP is under 

control 

Yes 1.57% 0.30% 5.25 5.66E-77 

417.3(a)(3) Establish measures 

to prevent 

recurrence 

Yes 20.54% 7.34% 3.27 7.66E-34 

417.3(b)(1) Segregate and hold 

the affected 

product 

Yes 5.54% 1.54% 3.75 4.57E-06 

417.6 Inadequate 

HACCP systems 

No 32.61% 10.87% 3.97 3.47E-04 

13 
 

 

 

 

 

 

 

 

 

 

 

Regulation 

Verified 

Description1 On 

FY 

2022 

PHR 

List 

Noncompliance 

Rate 90 Days 

before a 

Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

430.4(b)(2) Alternative 2 Yes 2.06% 0.32% 6.62 1.09E-03 

430.4(c)(5) Lm, evaluate 

control measures in 

Sanitation SOP 

No 2.20% 0.09% 24.81 1.73E-03 

430.4(c)(6) Lm, prerequisite 

program 

requirements 

Yes 7.27% 0.72% 10.86 2.06E-03 

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 PHR noncompliance rates for the 210 

establishments with Intact Chicken Salmonella testing data, of which 155 had 403 Salmonella 

positives and 55 did not have Salmonella positives. There were 9,626 total Intact Chicken 

Salmonella tests performed. 

Table 4-2 presents the 3 regulations that had more than 30 verifications in a year, an odds 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 CY2021. 

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

Salmonella Positive with Those for Establishments with No Intact Chicken 

Salmonella Positive 

Regulation 

Verified 

Description1 On FY 

2022 

PHR 

List 

Noncompliance 

Rate 90 Days 

before a 

Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

381.71(a) Condemnation on 

ante mortem 

inspection 

No 5.58% 0.90% 6.50 4.25E-02 

381.91(b) Reprocessing of 

carcasses accidentally 

contaminated with 

digestive tract 

contents. 

Yes 1.94% 0.63% 3.14 1.73E-03 

417.5(a)(2) Written HACCP plan Yes 0.08% 0.03% 3.01 4.98E-03 

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

14 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.1.2 Salmonella in Intact Turkey 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 43 

establishments with Intact Turkey Salmonella testing data, of which 4 establishments had 8 

Salmonella positives and 39 establishments did not have Salmonella positives. There were 1,691 

total Intact Turkey Salmonella tests performed. 

Table 4-3 presents the 6 regulations that had more than 30 verifications in a year, an odds 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 

CY2021. 

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

Salmonella Positive with Those for Establishments with No Intact Turkey Salmonella 

Positive 

Regulation 

Verified 

Description1 On FY 

2022 

PHR 

List 

Noncompliance 

Rate 90 Days 

before a 

Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

381.65(f) Procedures for 

controlling visible 

fecal contamination 

Yes 7.27% 1.14% 6.81 3.12E-27 

416.2(a) Grounds and pest 

control 

No 50.00% 9.30% 9.75 1.89E-07 

416.2(b)(4) Inedible from edible 

separated by time 

or space 

No 17.07% 0.85% 24.01 2.95E-07 

416.3(b) Constructed, located & 

operated in a 

manner that does not 

deter inspection 

Yes 40.00% 1.49% 44.10 1.85E-05 

417.2(c)(4) List of procedures & 

frequency 

Yes 5.00% 0.41% 12.90 3.41E-37 

417.5(a)(1) Written hazard 

analysis 

Yes 1.95% 0.27% 7.32 2.28E-08 

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 PHR noncompliance rates for the 1,252 

establishments with Ground Beef Salmonella testing data, of which 121 establishments had 180 

Salmonella positives and 1,131 establishments did not have Salmonella positives. There were 

11,311 total Ground Beef Salmonella tests performed. 

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

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

15 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 

CY2021. 

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

Positive with Those for Establishments with No Ground Beef Salmonella Positive 

Regulation 

Verified 

Description1 On 

FY 

2022 

PHR 

List 

Noncompliance 

Rate 90 Days 

before a 

Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

301.2_Adulterated Adulterated Yes 35.06% 3.46% 15.05 2.10E-18 

310.18(a) Carcasses, organs, 

and other parts 

handled 

in a sanitary 

manner 

Yes 5.76% 1.11% 5.44 5.75E-149 

310.22(c) Disposal of SRM Yes 4.40% 0.34% 13.54 8.75E-30 

310.22(e)(1) Written procedures 

for removal, 

segregation, and 

disposition of 

SRMs 

Yes 8.92% 2.36% 4.05 3.95E-05 

310.22(e)(3) Evaluate 

effectiveness of 

procedures for 

removal, 

segregation, and 

disposition of 

SRMs 

Yes 8.28% 0.96% 9.28 1.21E-08 

416.13(b) Conduct other 

procedures listed in 

the plan 

Yes 0.63% 0.20% 3.24 1.07E-22 

416.2(b)(4) Inedible from 

edible separated by 

time or 

space 

No 0.80% 0.21% 3.78 2.45E-03 

416.3(b) Constructed, 

located & operated 

in a manner 

that does not deter 

inspection 

Yes 2.84% 0.49% 5.93 8.59E-06 

416.6 Only FSIS program 

employee may 

remove "U.S. 

Rejected" tag 

Yes 30.77% 2.95% 14.64 6.76E-04 

417.2(c)(4) List of procedures 

& frequency 

Yes 1.28% 0.25% 5.13 2.76E-58 

417.3(a)(2) CCP is under 

control 

Yes 2.48% 0.29% 8.62 2.31E-08 

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

16 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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, an odds 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 CY2021. 

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

Positive with Those for Establishments with No Intact Beef Salmonella Positive 

Regulation Description1 On FY Noncompliance Noncompliance Odds TwoVerified 2022 Rate 90 Days Rate for Ratio Sided 

PHR before a Establishments Fisher 

List Salmonella with no Exact p 

Positive Salmonella Value 

Positive 

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 

17 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation Description1 On FY Noncompliance Noncompliance Odds TwoVerified 2022 Rate 90 Days Rate for Ratio Sided 

PHR before a Establishments Fisher 

List Salmonella with no Exact p 

Positive Salmonella Value 

Positive 

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 

SSOP's & 

maintain plan 

Yes 0.82% 0.16% 5.04 5.18E-38 

416.15(b) Corrective action, 

procedures for 

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 

18 
 

 

 

 

 

 

 

 

 

 

 

Regulation Description1 On FY Noncompliance Noncompliance Odds TwoVerified 2022 Rate 90 Days Rate for Ratio Sided 

PHR before a Establishments Fisher 

List Salmonella with no Exact p 

Positive Salmonella Value 

Positive 

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 

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. 

19 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.1.5 Salmonella in Ground Chicken 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 148 

establishments with Ground Chicken Salmonella testing data, of which 90 establishments had 

661 Salmonella positives and 58 establishments did not have Salmonella positives. There were 

2,197 total Ground Chicken Salmonella tests performed. 

Table 4-6 presents the 7 regulations that had more than 30 verifications in a year, an odds 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 CY2021. 

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

Salmonella Positive with Those for Establishments with No Ground Chicken 

Salmonella Positive 

Regulation Description1 On Noncompliance Noncompliance Odds TwoVerified FY Rate 90 Days Rate for Ratio Sided 

2022 before a Establishments Fisher 

PHR Salmonella with no Exact p 

List Positive Salmonella Value 

Positive 

310.22(c) Disposal of SRM Yes 7.27% 1.15% 6.75 3.08E-02 

381.1_Adulterated Adulterated No 13.90% 0.87% 18.48 6.65E-11 

381.65(g) Procedures for 

controlling 

contamination 

throughout the 

slaughter and 

dressing 

operation 

Yes 1.41% 0.21% 6.83 1.18E-42 

381.71(a) Condemnation on 

ante mortem 

inspection 

No 18.75% 0.72% 31.73 1.89E-05 

381.76(a) Post-mortem 

inspection, when 

required, 

extent 

No 21.36% 0.61% 44.61 3.08E-20 

381.91(b) Reprocessing of 

carcasses 

accidentally 

contaminated with 

digestive tract 

contents. 

Yes 17.66% 0.32% 66.76 7.30E-84 

417.3(a)(1) Identify and 

eliminate the cause 

Yes 1.53% 0.33% 4.63 2.30E-02 

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

20 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.1.6 Salmonella in Ground Turkey 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 52 

establishments with Ground Turkey Salmonella testing data, of which 38 establishments had 236 

Salmonella positives and 14 establishments did not have Salmonella positives. There were 1,463 

total Ground Turkey Salmonella tests performed. 

Table 4-7 presents the 10 regulations that had more than 30 verifications in a year, an odds 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 CY2021. 

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

Salmonella Positive with Those for Establishments with No Ground Turkey Salmonella 

Positive 

Regulation 

Verified 

Description1 On FY 

2022 

PHR 

List 

Noncompliance 

Rate 90 Days 

before a 

Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

416.13(a) Conduct pre-op 

procedures 

Yes 15.65% 4.03% 4.42 5.29E-51 

416.13(c) Plant monitors 

implementation of 

SSOP procedures 

Yes 5.90% 1.24% 4.98 4.83E-89 

416.14 Evaluate effectiveness of 

SSOP's & maintain plan 

Yes 0.96% 0.02% 41.83 1.41E-15 

416.16(a) Daily records required, 

responsible individual, 

initialed and dated 

Yes 0.33% 0.07% 5.03 1.05E-06 

416.2(a) Grounds and pest control No 8.44% 2.71% 3.31 1.23E-06 

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

durable, impervious, 

cleaned & sanitized 

No 12.40% 3.15% 4.35 4.72E-15 

416.4(a) Food contact surface, 

cleaning & sanitizing as 

frequency 

Yes 18.39% 3.85% 5.63 2.84E-32 

417.3(a)(1) Identify and eliminate 

the cause 

Yes 29.18% 2.33% 17.31 1.06E-05 

417.3(a)(2) CCP is under control Yes 12.80% 0.20% 73.26 3.34E-27 

417.5(a)(1) Written hazard analysis Yes 0.39% 0.09% 4.18 8.94E-04 

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

21 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.1.7 Salmonella in Intact Pork 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 90 

establishments with Intact Pork Salmonella testing data, of which 38 establishments had 191 

Salmonella positives and 52 establishments did not have Salmonella positives. There were 2,272 

total Intact Pork Salmonella tests performed. 

Table 4-8 presents the 12 regulations that had more than 30 verifications in a year, an odds 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 CY2021. 

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

Positive with Those for Establishments with No Intact Pork Salmonella Positive 

Regulation 

Verified 

Description1 On 

FY 

2022 

PHR 

List 

Noncompliance 

Rate 90 Days 

before a 

Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

310.18(c) Written procedures to 

prevent contamination; all 

swine slaughter 

Yes 1.43% 0.15% 9.77 2.79E-02 

310.3 Carcasses and parts in 

certain instances to be 

retained. 

Yes 34.78% 10.19% 4.70 8.08E-04 

318.2(a) All products subject to 

reinspection by program 

employees 

Yes 0.88% 0.07% 12.74 3.97E-03 

416.14 Evaluate effectiveness of 

SSOP's &maintain plan 

Yes 1.93% 0.38% 5.10 9.56E-45 

416.16(a) Daily records required, 

responsible individual, 

initialed and dated 

Yes 0.46% 0.12% 3.80 1.90E-16 

416.2(a) Grounds and pest control No 19.55% 3.84% 6.09 9.17E-53 

416.2(b)(1) Sound construction, good 

repair & sufficient size 

No 16.80% 3.62% 5.38 2.54E-46 

416.2(b)(4) Inedible from edible 

separated by time or space 

No 4.48% 0.48% 9.72 1.70E-14 

417.3(a)(2) CCP is under control Yes 3.05% 0.48% 6.54 1.44E-03 

417.3(a)(3) Establish measures to 

prevent recurrence 

Yes 71.43% 5.80% 40.63 1.30E-04 

417.3(b)(4) Reassessment Yes 5.37% 0.34% 16.44 3.89E-04 

417.3(c) Document corrective 

actions 

Yes 16.67% 4.73% 4.03 3.26E-02 

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

22 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.1.8 Salmonella in Ground Pork 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 308 

establishments with Ground Pork Salmonella testing data, of which 147 establishments had 

1,275 Salmonella positives and 161 establishments did not have Salmonella positives. There 

were 6,314 total Ground Pork Salmonella tests performed. 

Table 4-9 presents the 10 regulations that had more than 30 verifications in a year, an odds 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 a Ground Pork Salmonella positive is higher than the average 

noncompliance rate for establishments with no Ground Pork Salmonella positive for CY2021. 

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

Positive with those for Establishments with No Ground Pork Salmonella Positive 

Regulation Description1 On FY Noncompliance Noncompliance Odds TwoVerified 2022 Rate 90 Days Rate for Ratio Sided 

PHR before a Establishments Fisher 

List Salmonella with no Exact p 

Positive Salmonella Value 

Positive 

301.2_Adulterated Adulterated Yes 92.68% 33.33% 25.33 1.20E-03 

310.18(a) Carcasses, 

organs, and other 

parts handled 

in a sanitary 

manner 

Yes 1.94% 0.55% 3.60 1.85E-41 

310.22(c) Disposal of SRM Yes 11.46% 0.13% 96.96 7.86E-44 

310.22(e)(3) Evaluate 

effectiveness of 

procedures for 

removal, 

segregation, and 

disposition of 

SRMs 

Yes 47.83% 0.40% 228.25 1.38E-31 

416.1 Operate in a 

manner to 

prevent 

insanitary 

conditions 

Yes 2.12% 0.33% 6.55 1.26E-63 

416.13(a) Conduct pre-op 

procedures 

Yes 4.16% 1.07% 4.01 5.92E-110 

416.13(c) Plant monitors 

implementation 

of SSOP 

procedures 

Yes 2.50% 0.55% 4.66 1.01E-283 

23 
 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation 

Verified 

Description1 On FY 

2022 

PHR 

List 

Noncompliance 

Rate 90 Days 

before a 

Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

416.14 Evaluate 

effectiveness of 

SSOP's & 

maintain plan 

Yes 0.59% 0.05% 11.85 2.48E-66 

416.2(b)(4) Inedible from 

edible separated 

by time or 

space 

No 0.51% 0.17% 3.12 7.29E-03 

417.3(b)(3) No adulterated 

product enters 

commerce 

Yes 3.62% 0.37% 10.03 5.43E-03 

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

4.1.9 Salmonella in Chicken Parts 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 484 

establishments with Chicken Parts Salmonella testing data, of which 342 establishments had 

1,078 Salmonella positives and 142 establishments did not have Salmonella positives. There 

were 14,186 total Chicken Parts Salmonella tests performed. 

Table 4-10 presents the 6 regulations that had more than 30 verifications in a year, an odds 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 CY2021. 

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

Salmonella Positive with Those for Establishments with No Chicken Parts Salmonella 

Positive 

Regulation 

Verified 

Description1 On 

FY 

2022 

PHR 

List 

Noncompliance 

Rate 90 Days 

before a 

Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

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

verification in New 

Poultry Inspection 

System (NPIS) 

Yes 15.61% 2.16% 8.37 2.95E-27 

416.15(b) Corrective action, 

procedures for 

Yes 13.40% 3.59% 4.15 7.28E-20 

416.3(c) Receptacles for 

storing inedible 

material must 

identify permitted use 

Yes 8.14% 1.79% 4.86 1.32E-22 

24 
 

 

 

 

 

 

 

 

 

417.3(a)(1) Identify and 

eliminate the cause 

Yes 1.60% 0.54% 3.00 4.70E-02 

417.3(b)(1) Segregate and hold 

the affected 

product 

Yes 17.70% 3.70% 5.59 2.90E-03 

417.3(b)(4) Reassessment Yes 2.28% 0.53% 4.38 8.35E-04 

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 PHR noncompliance rates for the 74 

establishments with Siluriformes Salmonella testing data, of which 11 establishments had 19 

Salmonella positives and 63 establishments did not have Salmonella positives. There were 594 

total Siluriformes Salmonella tests performed. 

Table 4-11 presents the 3 regulations that had more than 30 verifications in a year, an odds 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 CY2021. 

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

Positive with Those for Establishments with No Siluriformes Salmonella 

Regulation 

Verified 

Description1 On 

FY 

2022 

PHR 

List 

Noncompliance 

Rate 90 Days 

before a 

Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

416.2(b)(1) Sound construction, 

good repair & 

sufficient size 

No 20.00% 2.30% 10.64 2.34E-02 

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

durable, impervious, 

cleaned & sanitized 

No 30.00% 2.47% 16.95 1.21E-05 

416.3(b) Constructed, located 

& operated in a 

manner that does not 

deter inspection 

Yes 50.00% 0.30% 335.00 8.89E-03 

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

25 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.1.11 Salmonella in Ready-to-Eat (RTE) 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 2,257 

establishments with RTE Salmonella testing data, of which 4 establishments had 4 Salmonella 

positives and 2,253 establishments did not have Salmonella positives. There were 14,835 total 

RTE Salmonella tests performed. 

There was 1 regulation that had more than 30 verifications in a year in total, an odds 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 CY2021. 

Table 4-12 Comparison of Noncompliance Rates 90 Days before a RTE Salmonella Positive 

with Those for Establishments with No RTE Salmonella 

Regulation 

Verified 

Description On 

FY 

2022 

PHR 

List 

Noncompliance 

Rate 90 Days 

before a RTE 

Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no RTE 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

416.4(a) Food contact surface, 

cleaning & sanitizing 

as frequency 

Yes 66.67% 3.24% 59.67 3.09E-03 

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 PHR noncompliance rates for the 1,425 establishments 

with E. coli O157:H7 testing data, of which 16 establishments had 16 E. coli O157:H7 positives 

and 1,409 establishments did not have E. coli O157:H7 positives. There were 17,659 total E. coli 

O157:H7 tests performed. 

Table 4-13 presents the 8 regulations that had more than 30 verifications in a year, an odds 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 

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

establishments with no E. coli O157:H7 positive for CY2021. 

26 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Table 4-13 Comparison of Noncompliance Rates 90 Days before an E. coli O157:H7 

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

Regulation Description1 On Noncompliance Noncompliance Odds TwoVerified FY Rate 90 Days Rate for Ratio Sided 

2022 before a E. coli Establishments Fisher 

PHR O157:H7 with no E. coli Exact p 

List Positive O157:H7 Positive Value 

310.22(c) Disposal of SRM Yes 2.75% 0.70% 4.00 4.29E-02 

416.13(a) Conduct pre-op 

procedures 

Yes 4.42% 1.46% 3.12 1.76E-05 

416.2(a) Grounds and pest control No 18.87% 3.04% 7.43 4.05E-06 

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

durable, impervious, 

cleaned & sanitized 

No 17.31% 3.60% 5.60 9.36E-05 

416.2(b)(4) Inedible from edible 

separated by time or 

space 

No 9.09% 0.25% 39.94 2.75E-02 

416.3(c) Receptacles for storing 

inedible material must 

identify permitted use 

Yes 50.00% 0.79% 126.35 9.96E-06 

416.4(a) Food contact surface, 

cleaning & sanitizing as 

frequency 

Yes 18.58% 3.40% 6.49 2.64E-10 

416.4(d) Product processing, 

handling, storage, 

loading, unloading, and 

during transportation 

must be protected 

Yes 31.88% 5.17% 8.59 2.88E-12 

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 Shiga toxin-producing E. coli (STEC) positives in MT60 (beef or veal 

trim). FSIS has declared there are 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 

PHR noncompliance rates for the 534 establishments with Non-O157 STEC testing data, of 

which 20 establishments had 23 Non-O157 STEC positives and 514 establishments did not have 

Non-O157 STEC positives. There were 3,861 total Non-O157 STEC tests performed. 

Table 4-14 presents the 5 regulations that had more than 30 verifications in a year, an odds 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 CY2021. 

27 
 

 

 

 

 

 

 

 

Table 4-14 Comparison of Noncompliance Rates 90 Days before a Non-O157 STEC 

Positive with Those for Establishments with No Non-O157 STEC Positive 

Regulation 

Verified 

Description1 On FY 

2022 

PHR 

List 

Noncompliance 

Rate 90 Days 

before a NonO157 STEC 

Positive 

Noncompliance 

Rate for 

Establishments 

with no NonO157 STEC 

Positive 

Odds 

Ratio 

Two-Sided 

Fisher 

Exact p 

Value 

310.22(c) Disposal of SRM Yes 4.09% 0.76% 5.53 1.19E-05 

310.22(e)(1) Written procedures 

for removal, 

segregation, and 

disposition of 

SRMs 

Yes 19.18% 3.53% 6.48 3.63E-07 

310.22(e)(2) Appropriate 

corrective actions 

Yes 30.00% 5.85% 6.90 2.04E-02 

417.2(c)(4) List of procedures & 

frequency 

Yes 1.88% 0.57% 3.33 2.59E-08 

417.3(a)(3) Establish measures 

to prevent recurrence 

Yes 80.00% 16.65% 20.02 3.49E-03 

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 PHR noncompliance 

rates for the 2,257 establishments with Lm testing data, of which 37 establishments had 40 Lm 

positives and 2,220 establishments did not have Lm positives. There were 15,134 total Lm tests 

performed. 

Table 4-15 presents the 11 regulations that had more than 30 verifications in a year, an odds 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 CY2021. 

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

for Establishments with No Lm Positive 

Regulation 

Verified 

Description1 On FY 

2022 

PHR 

List 

Noncompliance 

Rate 90 Days 

before a Lm 

Positive 

Noncompliance 

Rate for 

Establishments 

with no Lm 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

381.76(b)(6) 

(ii)(A) 

NPIS sorting, 

trimming, and 

reprocessing 

Yes 33.33% 1.54% 32.00 4.85E-02 

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

durable, impervious, 

cleaned & sanitized 

No 11.20% 3.66% 3.32 1.35E-07 

28 
 

 

 

 

 

 

 

 

 

 

 

 

Regulation Description1 On FY Noncompliance Noncompliance Odds TwoVerified 2022 Rate 90 Days Rate for Ratio Sided 

PHR before a Lm Establishments Fisher 

List Positive with no Lm Exact p 

Positive Value 

416.3(b) Constructed, located 

& operated in 

a manner that does 

not deter inspection 

Yes 3.17% 0.52% 6.28 4.34E-02 

417.2(c) Contents of HACCP 

plan 

Yes 10.00% 0.32% 34.69 3.22E-02 

417.4(a) Adequacy of HACCP 

in controlling 

food safety hazards 

Yes 75.00% 3.71% 77.89 2.19E-04 

417.5(a)(2) Written HACCP plan Yes 0.39% 0.09% 4.48 1.23E-03 

417.5(a)(3) Records 

documentation and 

monitoring of CCP's 

and critical 

limits 

Yes 0.80% 0.21% 3.91 7.30E-06 

430.4(a) Lm, post-lethality 

exposed RTE 

Yes 0.45% 0.02% 18.53 8.87E-05 

430.4(b)(3) Alternative 3 No 4.23% 1.00% 4.35 3.58E-02 

430.4(c)(5) Lm, evaluate control 

measures in 

Sanitation SOP 

No 8.33% 0.11% 80.85 1.60E-02 

430.4(c)(6) Lm, prerequisite 

program 

requirements 

Yes 50.00% 0.67% 148.68 1.37E-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 

PHR noncompliance rates for the 613 establishments with Campylobacter testing data, of which 

465 establishments had 4,278 Campylobacter positives and 148 establishments did not have 

Campylobacter positives. There were 29,124 total Campylobacter tests performed. 

Table 4-16 presents the 19 regulations that had more than 30 verifications in a year, an odds 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 CY2021. 

29 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

with Those for Establishments with No Campylobacter Positive 

Regulation 

Verified 

Description1 On 

FY 

2022 

PHR 

List 

Noncompliance 

Rate 90 Days 

before a 

Campylobacter 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

318.2(d) Removal of U.S. 

retained by 

authorized Program 

employees only 

Yes 9.26% 0.75% 13.47 7.33E-04 

381.65(a) Clean and sanitary 

practices; products 

not adulterated 

Yes 1.79% 0.33% 5.53 4.46E-08 

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

trimming, and 

reprocessing 

Yes 0.68% 0.17% 4.11 6.08E-04 

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

verification in NPIS 

Yes 12.27% 3.62% 3.72 9.05E-04 

416.13(b) Conduct other 

procedures listed in 

the plan 

Yes 1.17% 0.29% 4.04 1.63E-103 

416.14 Evaluate 

effectiveness of 

SSOP's & maintain 

plan 

Yes 0.82% 0.18% 4.70 2.47E-68 

416.15(b) Corrective action, 

procedures for 

Yes 14.24% 2.22% 7.31 1.35E-36 

416.16(a) Daily records 

required, responsible 

individual, initialed 

and dated 

Yes 0.38% 0.07% 5.19 4.38E-63 

416.2(a) Grounds and pest 

control 

No 23.67% 4.01% 7.43 1.65E-232 

416.2(b)(1) Sound construction, 

good repair & 

sufficient size 

No 27.12% 5.19% 6.80 5.12E-213 

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

durable, impervious, 

cleaned & sanitized 

No 24.59% 4.43% 7.03 1.35E-274 

416.2(b)(4) Inedible from edible 

separated by time 

or space 

No 4.32% 0.81% 5.53 2.76E-26 

416.3(b) Constructed, located 

& operated in a 

manner that does not 

deter inspection 

Yes 4.75% 0.45% 10.96 6.91E-27 

416.3(c) Receptacles for 

storing inedible 

material must 

identify permitted 

use 

Yes 10.98% 1.55% 7.85 3.31E-54 

30 
 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation 

Verified 

Description1 On 

FY 

2022 

PHR 

List 

Noncompliance 

Rate 90 Days 

before a 

Campylobacter 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

416.6 Only FSIS program 

employee may 

remove "U.S. 

Rejected" tag 

Yes 23.49% 2.21% 13.61 1.82E-10 

417.2(c)(4) List of procedures & 

frequency 

Yes 1.13% 0.18% 6.30 1.41E-107 

417.3(a)(3) Establish measures 

to prevent 

recurrence 

Yes 3.82% 1.08% 3.64 4.93E-02 

417.6 Inadequate HACCP 

systems 

No 84.00% 18.75% 22.75 9.51E-07 

430.4(b)(3) Alternative 3 No 4.28% 1.30% 3.39 2.76E-02 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 PHR noncompliance rates for the 210 

establishments with Intact Chicken Campylobacter testing data, of which 202 establishments had 

1,819 Campylobacter positives and 8 establishments did not have Campylobacter positives. 

There were 9,618 total Intact Chicken Campylobacter tests performed. 

Table 4-17 presents the 6 regulations that had more than 30 verifications in a year, an odds 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 CY2021. 

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

Chicken Positive with Those for Establishments with No Campylobacter Intact Chicken 

Positive 

Regulation 

Verified 

Description1 On FY 

2022 

PHR 

List 

Noncompliance 

Rate 90 Days 

before a 

Campylobacter 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

381.65(g) Procedures for controlling 

contamination 

throughout the slaughter 

and dressing 

operation 

Yes 0.61% 0.14% 4.34 3.11E-04 

416.13(c) Plant monitors 

implementation of SSOP 

procedures 

Yes 7.79% 2.49% 3.30 5.78E-48 

31 
 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation 

Verified 

Description1 On FY 

2022 

PHR 

List 

Noncompliance 

Rate 90 Days 

before a 

Campylobacter 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

416.2(a) Grounds and pest control No 27.83% 8.13% 4.36 3.28E-14 

416.4(a) Food contact surface, 

cleaning & sanitizing 

as frequency 

Yes 25.87% 9.44% 3.35 1.05E-14 

417.2(c)(4) List of procedures & 

frequency 

Yes 1.37% 0.38% 3.68 7.99E-06 

417.5(a)(1) Written hazard analysis Yes 0.42% 0.09% 4.83 8.05E-03 

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

4.4.2 Campylobacter in Intact Turkey 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 43 

establishments with Intact Turkey Campylobacter testing data, of which 10 establishments had 

17 Campylobacter positives and 33 establishments did not have Campylobacter positives. There 

were 1,693 total Intact Turkey Campylobacter tests performed. 

Table 4-18 presents the 2 regulations that had more than 30 verifications in a year, an odds 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 CY2021. 

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

Intact Turkey Positive with Those for Establishments with No Campylobacter Intact 

Turkey Positive 

Regulation 

Verified 

Description1 On 

FY 

2022 

PHR 

List 

Noncompliance 

Rate 90 Days 

before a 

Campylobacter 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

417.2(c)(4) List of procedures & 

frequency 

Yes 3.28% 0.50% 6.72 2.81E-22 

417.3(c) Document corrective 

actions 

Yes 27.27% 2.91% 12.53 5.37E-03 

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

32 
 

 

 

 

 

 

 

 

 

4.4.3 Campylobacter in Ground Chicken 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 95 

establishments with Ground Chicken Campylobacter testing data, of which 50 establishments 

had 204 Campylobacter positives and 45 establishments did not have Campylobacter positives. 

There were 2,097 total Ground Chicken Campylobacter tests performed. 

Table 4-19 presents the 2 regulations that had more than 30 verifications in a year, an odds 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 

CY2021. 

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

Campylobacter Positive with Those for Establishments with No Ground Chicken 

Campylobacter Positive 

Regulation 

Verified 

Description1 On 

FY2022 

PHR 

List 

Noncompliance 

Rate 90 Days 

before a 

Campylobacter 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

381.76(b)(6) 

(ii)(A) 

NPIS sorting, trimming, 

and reprocessing 

Yes 0.61% 0.06% 10.61 7.71E-06 

417.3(b)(4) Reassessment Yes 8.93% 1.49% 6.47 1.12E-03 

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 PHR noncompliance rates for the 52 

establishments with Ground Turkey Campylobacter testing data, of which 18 establishments had 

52 Campylobacter positives and 34 establishments did not have Campylobacter positives. There 

were 1,457 total Ground Turkey Campylobacter tests performed. 

Table 4-20 presents the 4 regulations that had more than 30 verifications in a year in total, an 

odds 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 CY2021. 

33 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Table 4-20 Comparison of Noncompliance Rates 90 Days before a Ground Turkey 

Campylobacter Positive with those for Establishments with No Ground Turkey 

Campylobacter Positive 

Regulation 

Verified 

Description1 On 

FY2022 

PHR 

List 

Noncompliance 

Rate 90 Days 

before a 

Campylobacter 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

416.13(a) Conduct pre-op procedures Yes 13.97% 5.05% 3.05 1.14E-33 

416.14 Evaluate effectiveness of 

SSOP's & maintain plan 

Yes 1.17% 0.19% 6.22 4.75E-15 

417.3(a)(2) CCP is under control Yes 4.61% 1.10% 4.34 6.93E-07 

417.3(a)(3) Establish measures to 

prevent recurrence 

Yes 37.72% 11.43% 4.69 1.41E-05 

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 PHR noncompliance rates for the 490 

establishments with Chicken Parts Campylobacter testing data, of which 390 establishments had 

2,186 Campylobacter positives and 100 establishments did not have Campylobacter positives. 

There were 14,259 total Chicken Parts Campylobacter tests performed. 

Table 4-21 presents the 15 regulations which had more than 30 verifications in a year, an odds 

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 

CY2021. 

Table 4-21 Comparison of Noncompliance Rates 90 Days before a Chicken Parts 

Campylobacter Positive with Those for Establishments with No Chicken Parts 

Campylobacter Positive 

Regulation 

Verified 

Description1 On FY 

2022 

PHR 

List 

Noncompliance 

Rate 90 Days 

before a 

Campylobacter 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

416.1 Operate in a manner to 

prevent insanitary 

conditions 

Yes 1.66% 0.54% 3.09 1.79E-20 

416.13(b) Conduct other procedures 

listed in the plan 

Yes 1.11% 0.09% 12.83 2.56E-116 

416.14 Evaluate effectiveness of 

SSOP's & maintain plan 

Yes 0.79% 0.26% 3.10 1.76E-30 

34 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation 

Verified 

Description1 On FY 

2022 

PHR 

List 

Noncompliance 

Rate 90 Days 

before a 

Campylobacter 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

416.15(b) Corrective action, 

procedures for 

Yes 14.24% 3.87% 4.13 2.86E-13 

416.16(a) Daily records required, 

responsible individual, 

initialed and dated 

Yes 0.36% 0.09% 4.04 1.88E-32 

416.2(a) Grounds and pest control No 21.43% 4.55% 5.72 9.94E-105 

416.2(b)(1) Sound construction, good 

repair & sufficient size 

No 23.91% 6.18% 4.77 9.42E-82 

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

durable, impervious, 

cleaned & sanitized 

No 22.96% 6.08% 4.60 1.21E-104 

416.2(b)(4) Inedible from edible 

separated by time or space 

No 3.75% 0.56% 6.93 1.86E-14 

416.3(b) Constructed, located & 

operated in a manner that 

does not deter inspection 

Yes 4.00% 0.73% 5.65 7.57E-11 

416.3(c) Receptacles for storing 

inedible material must 

identify permitted use 

Yes 9.38% 1.31% 7.77 4.99E-28 

416.4(a) Food contact surface, 

cleaning & sanitizing as 

frequency 

Yes 21.11% 7.18% 3.46 5.50E-119 

416.4(d) Product processing, 

handling, storage, 

loading, unloading, and 

during transportation must 

be protected 

Yes 22.60% 8.14% 3.30 2.11E-98 

417.2(c)(4) List of procedures & 

frequency 

Yes 0.95% 0.27% 3.51 2.24E-38 

417.3(b)(4) Reassessment Yes 2.69% 0.78% 3.52 2.61E-03 

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. 

35 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 

from a Sanitation Standard Operating Procedure (SSOP), HACCP, or Sanitation Performance 

Standards (SPS) violation. 

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

used to select all other FY2023 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 

CY2021. The dataset used in the analysis consists of candidate PHR noncompliance rates for the 

5,681 active meat and poultry establishments, of which 70 establishments had 80 enforcement 

actions and 5,611 establishments did not have any enforcement actions. 

Table 4-22 presents the 48 regulations that had more than 30 verifications in a year, an odds 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 CY2021. 

Table 4-22 Comparison of Noncompliance Rates 90 Days before an Enforcement Action 

with Those for Establishments with No Enforcement Action 

Regulation 

Verified 

Description1 On 

FY 

2022 

PHR 

List 

Noncompliance 

Rate 90 Days 

before an 

Enforcement 

Action 

Noncompliance 

Rate for 

Establishments 

with no 

Enforcement 

Action 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

301.2_Adulterated Adulterated Yes 36.36% 3.77% 14.59 5.66E-04 

309.19(d) Records of 

animals disposed 

of per day 

No 14.29% 0.03% 590.50 3.94E-03 

310.18(d) Daily records 

sufficient to 

document the 

implementation 

and monitoring of 

contamination 

control procedures 

Yes 2.38% 0.07% 32.67 2.14E-03 

310.22(b) Inedible and 

prohibited SRM 

for use as human 

food 

Yes 33.33% 0.75% 66.53 2.34E-02 

310.22(c) Disposal of SRM Yes 2.15% 0.70% 3.13 4.32E-02 

310.22(e)(1) Written 

procedures for 

removal, 

segregation, and 

disposition of 

SRMs 

Yes 23.53% 2.83% 10.55 4.42E-06 

36 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation Description1 On Noncompliance Noncompliance Odds TwoVerified FY Rate 90 Days Rate for Ratio Sided 

2022 before an Establishments Fisher 

PHR Enforcement with no Exact p 

List Action Enforcement Value 

Action 

310.22(g)(1) Maintain positive 

control of beef 

carcasses with the 

vertebral columns 

to another federal 

inspected 

establishment 

No 20.00% 0.70% 35.56 4.27E-02 

310.22(g)(4) Maintain records 

of official 

establishment 

showing proper 

disposition of 

vertebral columns 

No 20.00% 0.50% 49.28 2.74E-02 

318.1(b) Only inspected 

and passed 

poultry product to 

enter 

official 

establishment 

Yes 0.34% 0.01% 24.04 4.39E-02 

318.2(d) Removal of U.S. 

retained by 

authorized 

Program 

employees only 

Yes 33.33% 0.53% 93.45 1.64E-02 

381.65(g) Procedures for 

controlling 

contamination 

throughout the 

slaughter and 

dressing operation 

Yes 5.28% 0.53% 10.41 9.37E-28 

381.65(h) Recordkeeping 

requirements 

No 2.98% 0.08% 36.16 7.66E-07 

381.76(a) Post-mortem 

inspection, when 

required, extent 

No 6.67% 2.18% 3.21 4.32E-02 

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

reprocessing and 

salvage 

No 0.35% 0.06% 5.79 1.75E-02 

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

verification in 

NPIS 

Yes 56.82% 3.45% 36.83 1.48E-24 

381.91(b) Reprocessing of 

carcasses 

accidentally 

contaminated with 

digestive tract 

contents. 

Yes 9.50% 1.38% 7.49 2.00E-10 

37 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation 

Verified 

Description1 On 

FY 

2022 

PHR 

List 

Noncompliance 

Rate 90 Days 

before an 

Enforcement 

Action 

Noncompliance 

Rate for 

Establishments 

with no 

Enforcement 

Action 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

416.1 Operate in a 

manner to prevent 

insanitary 

conditions 

Yes 2.26% 0.75% 3.05 3.59E-08 

416.12(c) Plan identifies 

procedures for 

pre-op 

No 3.80% 0.12% 33.58 1.38E-04 

416.13(a) Conduct pre-op 

procedures 

Yes 9.43% 2.07% 4.93 1.15E-65 

416.13(b) Conduct other 

procedures listed 

in the plan 

Yes 0.89% 0.25% 3.58 1.43E-12 

416.13(c) Plant monitors 

implementation of 

SSOP procedures 

Yes 5.13% 1.35% 3.94 7.23E-104 

416.14 Evaluate 

effectiveness of 

SSOP's & 

maintain plan 

Yes 0.61% 0.20% 3.04 8.27E-07 

416.15(a) Appropriate 

corrective actions 

Yes 16.67% 1.75% 11.23 1.64E-16 

416.15(b) Corrective action, 

procedures for 

Yes 19.51% 3.07% 7.65 6.94E-13 

416.16(a) Daily records 

required, 

responsible 

individual, 

initialed and dated 

Yes 0.77% 0.13% 5.91 2.34E-26 

416.2(a) Grounds and pest 

control 

No 19.93% 3.98% 6.00 7.83E-47 

416.2(b)(1) Sound 

construction, good 

repair & sufficient 

size 

No 20.71% 4.77% 5.22 9.17E-31 

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

gs durable, 

impervious, 

cleaned & 

sanitized 

No 21.06% 4.65% 5.47 2.93E-43 

416.2(b)(4) Inedible from 

edible separated 

by time or space 

No 3.33% 0.47% 7.25 2.47E-05 

416.3(b) Constructed, 

located & 

operated in a 

manner that 

does not deter 

inspection 

Yes 9.52% 0.66% 15.91 7.44E-11 

38 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation 

Verified 

Description1 On 

FY 

2022 

PHR 

List 

Noncompliance 

Rate 90 Days 

before an 

Enforcement 

Action 

Noncompliance 

Rate for 

Establishments 

with no 

Enforcement 

Action 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

416.3(c) Receptacles for 

storing inedible 

material must 

identify permitted 

use 

Yes 5.26% 1.43% 3.84 1.69E-03 

416.4(a) Food contact 

surface, cleaning 

& sanitizing as 

frequency 

Yes 13.24% 4.59% 3.17 2.55E-26 

416.4(d) Product 

processing, 

handling, storage, 

loading, 

unloading, and 

during 

transportation 

must be 

protected 

Yes 17.76% 6.21% 3.26 1.38E-32 

416.6 Only FSIS 

program 

employee may 

remove "U.S. 

Rejected" tag 

Yes 50.00% 4.25% 22.52 1.05E-02 

417.2(a)(1) Hazard analysis Yes 4.72% 1.04% 4.70 1.98E-05 

417.2(c)(4) List of procedures 

& frequency 

Yes 1.14% 0.36% 3.21 2.95E-12 

417.3(a)(2) CCP is under 

control 

Yes 3.06% 0.54% 5.82 6.11E-06 

417.3(a)(4) No adulterated 

product enters 

commerce. 

Yes 15.22% 0.62% 28.64 1.91E-08 

417.3(b)(4) Reassessment Yes 2.42% 0.57% 4.35 3.51E-02 

417.3(c) Document 

corrective actions 

Yes 25.00% 4.80% 6.61 2.27E-03 

417.4(a) Adequacy of 

HACCP in 

controlling food 

safety 

hazards 

Yes 62.50% 3.30% 48.82 2.18E-06 

417.5(a)(1) Written hazard 

analysis 

Yes 1.63% 0.24% 6.87 6.86E-37 

417.5(a)(2) Written HACCP 

plan 

Yes 0.40% 0.09% 4.65 8.32E-07 

39 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation 

Verified 

Description1 On 

FY 

2022 

PHR 

List 

Noncompliance 

Rate 90 Days 

before an 

Enforcement 

Action 

Noncompliance 

Rate for 

Establishments 

with no 

Enforcement 

Action 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

417.5(a)(3) Records 

documentation 

and monitoring of 

CCP's 

and Critical 

Limits 

Yes 1.17% 0.22% 5.45 2.19E-20 

418.3 Recall plans Yes 3.13% 0.21% 15.06 9.01E-03 

430.4(a) Lm, post-lethality 

exposed RTE 

Yes 0.22% 0.03% 8.04 2.72E-02 

430.4(b)(2) Alternative 2 Yes 10.81% 0.41% 29.22 2.03E-05 

430.4(b)(3) Alternative 3 No 11.54% 0.99% 13.08 2.18E-03 

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

5.0 LIST OF FY2023 PHRS 

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

PHRs into a single FY2023 PHR list. Table 5-1 presents the complete list of the 71 FY2023 

PHRs. These 71 PHRs were selected since they were verified more than 30 times in a year, had 

an odds 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 FY2023 PHRs 

Regulation 

Verified 

Description1 On FY 

2022 

PHR 

List 

Average Odds 

Ratio 

Average of 

Two-Sided 

Fisher Exact p 

Value 

301.2_Adulterated Adulterated Yes 24.01 3.53E-04 

309.19(d) Records of animals disposed of per day No 590.50 3.94E-03 

310.18(a) Carcasses, organs, and other parts 

handled in a sanitary manner 

Yes 4.62 6.15E-42 

310.18(c) Written procedures to prevent 

contamination; all swine slaughter 

Yes 6.85 1.40E-02 

310.18(c)(2)(i) Sampling frequency No 22.36 1.72E-04 

310.18(d) Daily records sufficient to document the 

implementation and monitoring of 

contamination control procedures 

Yes 32.67 2.14E-03 

310.22(b) Inedible and prohibited SRM for use as 

human food 

Yes 66.53 2.34E-02 

310.22(c) Disposal of SRM Yes 19.86 1.46E-02 

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

segregation, and disposition of SRMs 

Yes 5.77 8.85E-06 

310.22(e)(2) Appropriate corrective actions Yes 5.10 1.04E-02 

40 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation 

Verified 

Description1 On FY 

2022 

PHR 

List 

Average Odds 

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 67.40 3.02E-09 

310.22(g)(1) Maintain positive control of beef 

carcasses with the vertebral columns to 

another federal inspected establishment 

No 35.56 4.27E-02 

310.22(g)(4) Maintain records of official 

establishment showing proper 

disposition of vertebral columns 

No 49.28 2.74E-02 

310.26(b) Carcass sorting and disposition No 17.86 7.05E-06 

310.3 Carcasses and parts in certain instances 

to be retained. 

Yes 4.44 4.04E-04 

311.14 Abrasions, bruises, abscesses, pus, etc. No 21.05 3.44E-03 

318.1(b) Only inspected and passed poultry 

product to enter official establishment 

Yes 13.75 3.74E-02 

318.2(a) All products subject to reinspection by 

program employees 

Yes 12.74 3.97E-03 

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

Program employees only 

Yes 53.46 8.54E-03 

381.1_Adulterated Adulterated No 11.63 4.29E-03 

381.65(a) Clean and sanitary practices; products 

not adulterated 

Yes 5.53 4.46E-08 

381.65(f) Procedures for controlling visible fecal 

contamination 

Yes 6.13 1.07E-03 

381.65(g) Procedures for controlling 

contamination throughout the slaughter 

and dressing operation 

Yes 7.19 1.04E-04 

381.65(h) Recordkeeping requirements No 36.16 7.66E-07 

381.71(a) Condemnation on ante mortem 

inspection 

No 19.12 2.13E-02 

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

extent 

No 23.91 2.16E-02 

381.76(b)(6)(ii)(A) NPIS sorting, trimming, and 

reprocessing 

Yes 15.57 1.64E-02 

381.76(b)(6)(ii)(B) NPIS reprocessing and salvage No 5.79 1.75E-02 

381.76(b)(6)(ii)(D) Ready-to-Cook verification in NPIS Yes 16.31 3.02E-04 

381.91(b) Reprocessing of carcasses accidentally 

contaminated with digestive tract 

contents. 

Yes 25.79 5.77E-04 

416.1 Operate in a manner to prevent 

insanitary conditions 

Yes 4.23 1.20E-08 

416.12(c) Plan identifies procedures for pre-op No 18.49 2.62E-04 

416.13(a) Conduct pre-op procedures Yes 4.24 2.93E-06 

416.13(b) Conduct other procedures listed in the 

plan 

Yes 5.47 2.86E-13 

416.13(c) Plant monitors implementation of SSOP 

procedures 

Yes 4.53 9.64E-49 

41 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation 

Verified 

Description1 On FY 

2022 

PHR 

List 

Average Odds 

Ratio 

Average of 

Two-Sided 

Fisher Exact p 

Value 

416.14 Evaluate effectiveness of SSOP's & 

maintain plan 

Yes 9.59 9.19E-08 

416.15(a) Appropriate corrective actions Yes 11.23 1.64E-16 

416.15(b) Corrective action, procedures for Yes 5.06 1.29E-05 

416.16(a) Daily records required, responsible 

individual, initialed and dated 

Yes 4.79 2.09E-07 

416.2(a) Grounds and pest control No 5.87 5.48E-07 

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

sufficient size 

No 6.09 3.89E-03 

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

impervious, cleaned & sanitized 

No 6.31 1.32E-05 

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

or space 

No 11.48 3.73E-03 

416.3(b) Constructed, located & operated in a 

manner that does not deter inspection 

Yes 54.00 6.53E-03 

416.3(c) Receptacles for storing inedible material 

must identify permitted use 

Yes 22.81 1.80E-03 

416.4(a) Food contact surface, cleaning & 

sanitizing as frequency 

Yes 12.25 4.41E-04 

416.4(d) Product processing, handling, storage, 

loading, unloading, and during 

transportation must be protected 

Yes 4.81 5.76E-13 

416.6 Only FSIS program employee may 

remove ""U.S. Rejected"" tag 

Yes 16.47 2.84E-03 

417.2(a)(1) Hazard analysis Yes 4.70 1.98E-05 

417.2(c) Contents of HACCP Plan Yes 34.69 3.22E-02 

417.2(c)(4) List of procedures & frequency Yes 5.67 8.01E-07 

417.3(a)(1) Identify and eliminate the cause Yes 7.72 1.40E-02 

417.3(a)(2) CCP is under control Yes 15.53 2.08E-04 

417.3(a)(3) Establish measures to prevent 

recurrence 

Yes 12.92 8.82E-03 

417.3(a)(4) No adulterated product enters 

commerce. 

Yes 17.07 1.09E-02 

417.3(b)(1) Segregate and hold the affected product Yes 4.71 5.98E-03 

417.3(b)(3) No adulterated product enters commerce Yes 10.03 5.43E-03 

417.3(b)(4) Reassessment Yes 7.03 8.01E-03 

417.3(c) Document corrective actions Yes 7.72 1.34E-02 

417.4(a) Adequacy of HACCP in controlling 

food safety hazards 

Yes 73.78 7.37E-05 

417.5(a)(1) Written hazard analysis Yes 5.80 2.23E-03 

417.5(a)(2) Written HACCP plan Yes 4.05 2.07E-03 

417.5(a)(3) Records documentation and monitoring 

of CCP's and Critical Limits 

Yes 4.68 3.65E-06 

417.6 Inadequate HACCP systems No 13.36 1.74E-04 

418.2 Notification of adulterated or 

misbranded product in commerce 

Yes 59.72 6.02E-10 

418.3 Recall Plans Yes 15.06 9.01E-03 

430.4(a) Lm, post-lethality exposed RTE Yes 13.28 1.37E-02 

42 
 

 

 

 

 

 

 

 

Regulation 

Verified 

Description1 On FY 

2022 

PHR 

List 

Average Odds 

Ratio 

Average of 

Two-Sided 

Fisher Exact p 

Value 

430.4(b)(2) Alternative 2 Yes 17.92 5.55E-04 

430.4(b)(3) Alternative 3 No 6.94 2.19E-02 

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

Sanitation SOP 

No 52.83 8.88E-03 

430.4(c)(6) Lm, prerequisite program requirements Yes 79.77 7.90E-03 1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions. 

In FY2022 there were 62 PHRs, 52 of which are FY2023 PHRs. There are 10 regulations on the 

FY2022 PHR list that are not on the FY2023 PHR list (See Appendix C). There are 19 

regulations that are on the FY2023 PHR list that were not on the FY2022 PHR list. 

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

for inclusion in the FY2023 PHR list. Most regulations were triggered by multiple events. 

Similar to the FY2022 PHR list, Salmonella pathogen positives and enforcement actions 

triggered the most regulations. 

Table 5-2 Events That Triggered Inclusion of a Regulation in the FY2023 PHR List 

Product Number of Regulations 

Campylobacter 19 

Campylobacter Chicken Parts 15 

Campylobacter Ground Chicken 2 

Campylobacter Ground Turkey 4 

Campylobacter Intact Chicken 6 

Campylobacter Intact Turkey 2 

Enforcements 48 

Lm 11 

NonO157 E. coli 5 

O157 E. coli 8 

Salmonella 32 

Salmonella Chicken Parts 6 

Salmonella Ground Beef 11 

Salmonella Ground Chicken 7 

Salmonella Ground Pork 10 

Salmonella Ground Turkey 10 

Salmonella Intact Beef 26 

Salmonella Intact Chicken 3 

Salmonella Intact Pork 12 

Salmonella Intact Turkey 6 

Salmonella RTE 1 

Salmonella Siluriformes 3 

43 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

There were 18 regulations triggered by a single type of event: 11 were from Enforcement 

Actions, 2 were from Salmonella, 1 was from Salmonella in Intact Beef, 1 was from Salmonella 

Ground Pork, 1 was from Salmonella in Intact Pork, 1 was from Campylobacter, and 1 was from 

Lm. Table 5-3 presents the regulations triggered for inclusion in the FY2023 PHR list by only 

single pathogen product or enforcement action type (event). 

Table 5-3 Regulations Triggered for Inclusion in the FY2023 PHR List by Only a 

Single Event 

Regulation 

Verified 

Description1 Event 

309.19(d) Records of animals disposed of per day Enforcements 

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

310.18(d) Daily records sufficient to document the 

implementation and monitoring of contamination 

control procedures 

Enforcements 

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

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

vertebral columns to another federal inspected 

establishment 

Enforcements 

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

proper disposition of vertebral columns 

Enforcements 

310.26(b) Carcass sorting and disposition Salmonella 

318.2(a) All products subject to reinspection by program 

employees 

Salmonella Intact Pork 

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

381.65(h) Recordkeeping requirements Enforcements 

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

416.15(a) Appropriate corrective actions Enforcements 

417.2(a)(1) Hazard analysis Enforcements 

417.2(c) Contents of HACCP Plan Lm 

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

418.2 Notification of adulterated or misbranded product in 

commerce 

Salmonella Intact Beef 

418.3 Recall plans Enforcements 1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions. 

6.0 CUT POINTS FOR FY2023 PHRS 

The FY2023 PHRs are one of seven public health-based decision criteria that are used in 

prioritizing Public Health Risk Evaluations (PHREs). These seven decision criteria are described 

in detail in FSIS' Public Health Decision Criteria Report (FSIS 2010). 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. 

Noncompliance with a single FY2023 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 rate is calculated as 

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

the PHR regulations are verified. This combines the verifications for all the PHR regulations in a 

44 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

90-day period together into a single aggregate ratio. The aggregate FY2023 PHR noncompliance 

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

establishment operations: Processing and Combination (Slaughter plus Processing). Only 

establishments with greater than or equal to 20 verifications and at least 2 noncompliances were 

considered when developing cut points. 

The aggregate non-zero PHR 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 FY2023 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 PHR noncompliance rates). 

Table 6-1 Mean and Standard Deviation of Quarterly FY2023 PHR Rate 

CY2021 Mean of Natural Log PHR 

Rate 

Standard Deviation PHR 

Rate 

Processing Combination Processing Combination 

Jan-Mar -4.92 -4.58 0.79 0.96 

Apr-Jun -4.93 -4.54 0.78 1.01 

Jul-Sept -4.87 -4.49 0.82 0.97 

Oct-Dec -4.91 -4.57 0.80 0.97 

Average -4.91 -4.55 0.80 0.98 

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 that have PHR 

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 -4.54511 + 2*0.97638 = -4.54511 

+ 1.95276 = -2.59235. The cut point of the original, non-transformed PHR noncompliance data 

is the antilog of -2.59235 or Exp(-2.59235) = 7.48%. Establishments that are below the Upperlevel threshold but meet or exceed the Lower-level threshold will be notified by inspection 

personnel of an elevated level of noncompliance. 

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

Processing and (2) Slaughter/Processing Combination: 

• Any establishment with a PHR rate that is less than the lower cut point for all 

establishments with the same establishment type would continue to receive routine 

inspection procedures. These establishments are performing better on average than their 

peers with respect to compliance with the PHR regulations. 

• Establishments with a PHR rate that is 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 inspection 

personnel of elevated PHR noncompliance levels. 

45 
 

 

 

 

 

 

 

 

 

 

• Establishments with a PHR 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 FY2023 PHR upper and lower cut points for each of the two 

establishment operation types. The FY2022 and FY2021 PHR cut points are included for 

comparison. (See Appendix D for more details). The cut points are determined once a year. The 

next update to the cut points is planned for October 2023. 

Table 6-2 FY2023 PHR Upper-Level Cut Points 

Operation Type FY2023 PHR 

Cut Points 

FY2022 PHR 

Cut Points 

FY2021 PHR 

Cut Points 

Processing 3.65% 3.63% 3.73% 

Combination 7.48% 7.33% 9.84% 

Table 6-3 FY2023 PHR Lower-Level Cut Points 

Operation Type FY2023 PHR 

Cut Points 

FY2022 PHR 

Cut Points 

FY2021 PHR 

Cut Points 

Processing 2.45% 2.44% 2.50% 

Combination 4.59% 4.60% 5.85% 

Table 6-4 presents the number of establishments in each level based solely on the FY2023 PHR 

criterion and the cut points in Table 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. Seventy-nine establishments are in the Upper level and candidates to receive a 

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

period January 1-March 31, 2022. 

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

Classification Processing Combination Total 

Upper 65 14 79 

Mid 69 22 91 

Lower 4,143 1,087 5,230 

Total 4,277 1,123 5,400 

46 
 

 

 

 

 

 

7.0 CONCLUSION 

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

FY2023 PHR regulations used to prioritize certain FY2023 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 and (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 COVID pandemic occurred during this period but no 

significant impacts were observed. 

The list of FY2023 PHRs has 71 regulations whose individual noncompliance rates are higher in 

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

Campylobacter positives or enforcement action than in establishments without positives or 

enforcement actions. Fifty-two regulations on the FY2022 PHR list are also on the FY2023 PHR 

list. 

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

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

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

Table 7-1 presents the FY2023 PHR upper and lower cut points. 

Table 7-1 FY2023 PHR Cut Points 

Operation Type Upper Lower 

Processing 3.65% 2.45% 

Combination 7.48% 4.59% 

47 
 

 

 

8.0 REFERENCES 

1. Food Safety and Inspection Service (FSIS) 2010, “Data-Driven Inspection for Processing 

and Slaughter Establishments, Public Health Decision Criteria.” 

2. Food Safety and Inspection Service (FSIS) 2013, “FSIS Data Analysis and Reporting: 

Public Health Regulations.” 

3. Food Safety and Inspection Service (FSIS) 2021, “FY2022 Public Health Regulations.” 

4. National Advisory Committee on Meat and Poultry Inspection (NACMPI) 2013, 

“Subcommittee Two, Issue Two: Data Analysis.” 

48 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

APPENDIX A: FY2023 PHR REGULATIONS 

Table A-1 presents the list of 71 FY2023 Public Health Regulations (PHRs). On average, these 

PHR regulations have noncompliance rates 90 days prior to a pathogen positive or enforcement 

action that is 7.37 times higher than the PHR noncompliance rates for establishments with no 

pathogen positive or enforcement action. 

Table A-1 List of FY2023 PHRs 

Regulation Description1 

301.2_Adulterated Adulterated 

309.19(d) Records of animals disposed of per day 

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)(i) Sampling frequency 

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

of contamination control procedures 

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

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(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 

310.26(b) Carcass sorting and disposition 

310.3 Carcasses and parts in certain instances to be retained. 

311.14 Abrasions, bruises, abscesses, pus, etc. 

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

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

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

381.1_Adulterated Adulterated 

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 

49 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation Description1 

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 

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) Corrective action, procedures for 

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)(1) Segregate and hold the affected product 

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 

417.5(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 

417.6 Inadequate HACCP systems 

418.2 Notification of adulterated or misbranded product in commerce 

418.3 Recall Plans 

50 
 

 

 

 

Regulation Description1 

430.4(a) Lm, post-lethality exposed RTE 

430.4(b)(2) Alternative 2 

430.4(b)(3) Alternative 3 

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

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

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

51 
 

 

 

 

 

 

 

 

 

APPENDIX B: FY2023 CANDIDATE REGULATIONS 

Table B-1 presents the list of candidate regulations. Of the 159 candidate regulations, 2 

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 PHIS data for January 1, 2021, through December 31, 2021. 

Table B-1 FY2023 List of Candidate Regulations 

Regulation1 Description2 

FY 

2022 

PHR 

Mandatory 

Regulation3 

Total 

Regulations 

Verified 

Total 

Noncompliant 

Regulations 

Verified 

PHR 

Noncompliance 

Rate 

301.2_Adulterated Adulterated Yes No 4,746 185 3.90% 

304.3(a) Develop written 

SSOP 

No No 416 0 0.00% 

304.3(c) Conduct hazard 

analysis & 

develop 

HACCP plan 

for new product 

No No 188 2 1.06% 

309.19(a) Market hog 

sorting 

activities 

No No 1,605 2 0.12% 

309.19(c) Sorted and 

removed hogs 

identified; 

written 

procedures 

No No 1,268 1 0.08% 

309.19(d) Records of 

animals 

disposed of per 

day 

No No 4,090 2 0.05% 

309.19(e) Notifiable 

animal disease 

No No 104 0 0.00% 

309.2(a) Livestock 

suspected of 

being diseased 

or 

affected with 

certain 

conditions; 

identifying 

suspects 

No No 222 5 2.25% 

309.3 (Modernized 

ONLY) Dead, 

dying, disabled 

or diseased and 

similar 

livestock. 

No No 225 0 0.00% 

52 
 

 

 

 

 

 

 

Regulation1 Description2 

FY 

2022 

PHR 

Mandatory 

Regulation3 

Total 

Regulations 

Verified 

Total 

Noncompliant 

Regulations 

Verified 

PHR 

Noncompliance 

Rate 

309.3(e) Establishment 

notify IPP of 

non-ambulatory 

livestock; 

Prompt 

condemnation 

and disposal 

No No 88 1 1.14% 

309.4 (Modernized 

ONLY) 

Livestock 

showing 

symptoms of 

metabolic, 

toxic, nervous, 

or diseases 

No No 153 1 0.65% 

309.5 (Modernized 

ONLY) Swine; 

disposal 

because of hog 

cholera 

No No 137 0 0.00% 

309.9 (Modernized 

ONLY) Swine 

erysipelas 

No No 140 0 0.00% 

310.18(a) Carcasses, 

organs, and 

other parts 

handled in a 

sanitary manner 

Yes Yes 357,444 4,681 1.31% 

310.18(b) Brains, cheek 

meat, head 

trimmings from 

animals 

slaughtered by 

gunshot 

No No 20,998 5 0.02% 

310.18(c) Written 

procedures to 

prevent 

contamination; 

all swine 

slaughter 

Yes No 10,059 26 0.26% 

310.18(c)(1) Sampling 

locations 

No No 1,506 0 0.00% 

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

volume 

establishments 

No No 2,930 1 0.03% 

310.18(c)(2)(i) Sampling 

frequency 

No No 2,506 3 0.12% 

53 
 

 

 

 

 

 

 

 

 

Regulation1 Description2 

FY 

2022 

PHR 

Mandatory 

Regulation3 

Total 

Regulations 

Verified 

Total 

Noncompliant 

Regulations 

Verified 

PHR 

Noncompliance 

Rate 

310.18(c)(2)(ii) Sampling 

frequency for 

very low 

volume 

establishments 

No No 1,626 2 0.12% 

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

results for 

sampling 

program 

No No 19,592 7 0.04% 

310.18(d) Daily records 

sufficient to 

document the 

implementation 

and monitoring 

of 

contamination 

control 

procedures 

Yes No 33,998 35 0.10% 

310.22(b) Inedible and 

prohibited SRM 

for use as 

human food 

Yes No 2,850 20 0.70% 

310.22(c) Disposal of 

SRM 

Yes Yes 52,618 269 0.51% 

310.22(d)(2) Exports have 

equivalent level 

of 

protection from 

human 

exposure to 

BSE as similar 

US products 

No No 56 0 0.00% 

310.22(e)(1) Written 

procedures for 

removal, 

segregation, and 

disposition of 

SRMs 

Yes No 11,834 258 2.18% 

310.22(e)(2) Appropriate 

corrective 

actions 

Yes No 1,683 69 4.10% 

310.22(e)(3) Evaluate 

effectiveness of 

procedures for 

removal, 

segregation, and 

disposition of 

SRMs 

Yes No 8,044 120 1.49% 

54 
 

 

 

 

 

 

 

 

 

 

Regulation1 Description2 

FY 

2022 

PHR 

Mandatory 

Regulation3 

Total 

Regulations 

Verified 

Total 

Noncompliant 

Regulations 

Verified 

PHR 

Noncompliance 

Rate 

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

records 

No No 70,002 138 0.20% 

310.22(f)(2) Use of routine 

operational 

sanitation 

procedures on 

equipment used 

to cut through 

SRMs 

Yes No 14,552 29 0.20% 

310.22(g)(1) Maintain 

positive control 

of beef 

carcasses with 

the vertebral 

columns to 

another 

federally 

inspected 

establishment 

No No 809 7 0.87% 

310.22(g)(4) Maintain 

records of 

official 

establishment 

showing proper 

disposition of 

vertebral 

columns 

No No 3,224 18 0.56% 

310.25(a) Verification 

criteria for E. 

coli testing 

meat 

Yes No 28,164 289 1.03% 

310.25(b) Pathogen 

reduction 

performance 

standards; 

Salmonella 

No No 175 0 0.00% 

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

Failure to 

maintain 

adequate 

HACCP Plan 

No No 37 0 0.00% 

310.26(b) Carcass sorting 

and disposition 

No Yes 3,909 42 1.07% 

310.26(d)(2) Document 

number of 

carcasses 

disposed of per 

day 

No No 2,499 2 0.08% 

55 
 

 

 

 

 

 

 

 

Regulation1 Description2 

FY 

2022 

PHR 

Mandatory 

Regulation3 

Total 

Regulations 

Verified 

Total 

Noncompliant 

Regulations 

Verified 

PHR 

Noncompliance 

Rate 

310.3 Carcasses and 

parts in certain 

instances 

to be retained. 

Yes No 2,086 256 12.27% 

311.14 Abrasions, 

bruises, 

abscesses, pus, 

etc. 

No No 26,568 11 0.04% 

311.16 (Modernized 

ONLY) 

Carcasses so 

infected that 

consumption of 

the meat may 

cause food 

poisoning. 

No No 355 22 6.20% 

311.17 (Modernized 

ONLY) 

Necrobacillosis, 

pyemia, 

septicemia. 

No No 369 1 0.27% 

311.24 (Modernized 

ONLY) Hogs 

affected with 

tapeworm cysts. 

No No 133 0 0.00% 

315.2 Carcasses and 

parts passed for 

cooking 

No No 21 0 0.00% 

316.6 Products not to 

be removed 

from official 

establishments 

unless marked 

in 

accordance with 

the regulations 

Yes No 12,442 46 0.37% 

317.24(a) Packaging 

materials 

composed of 

poisonous or 

deleterious 

substances 

No No 2,237 10 0.45% 

318.1(b) Only inspected 

and passed 

poultry 

product to enter 

official 

establishment 

Yes No 105,500 16 0.02% 

56 
 

 

 

 

 

 

 

 

 

 

 

 

Regulation1 Description2 

FY 

2022 

PHR 

Mandatory 

Regulation3 

Total 

Regulations 

Verified 

Total 

Noncompliant 

Regulations 

Verified 

PHR 

Noncompliance 

Rate 

318.14(a) Product and 

ingredients 

rendered 

adulterated by 

polluted water 

shall be 

condemned 

No No 282 2 0.71% 

318.14(b) Establishment 

shall be 

thoroughly 

cleaned and 

disinfected 

under FSIS 

supervision 

No No 646 0 0.00% 

318.14(c) Hermetically 

sealed 

contaminated 

containers shall 

be 

examined/rehan 

dled 

under FSIS 

supervision 

No No 156 0 0.00% 

318.16(b) Pesticides, 

chemicals & 

other residues 

in 

products not to 

exceed FD&C 

Act levels 

- Meat 

ingredients 

No No 258 0 0.00% 

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

Stabilization 

requirements 

for cooked beef 

No No 2,691 3 0.11% 

318.17(b) Lethality and 

Stabilization 

processes other 

than HACCP 

for cooked beef 

No No 558 1 0.18% 

318.17(c) Validation of 

new or altered 

process 

schedules (for 

cooked beef) 

No No 128 0 0.00% 

318.2(a) All products 

subject to 

reinspection by 

program 

employees 

Yes No 46,004 74 0.16% 

57 
 

 

 

 

 

 

 

 

 

Regulation1 Description2 

FY 

2022 

PHR 

Mandatory 

Regulation3 

Total 

Regulations 

Verified 

Total 

Noncompliant 

Regulations 

Verified 

PHR 

Noncompliance 

Rate 

318.2(d) Removal of 

U.S. retained by 

authorized 

Program 

employees only 

Yes No 7,626 38 0.50% 

318.23(b)(1) Time/Temperat 

ure for heatprocessing 

combinations of 

fully cooked 

meat 

patties 

No No 389 2 0.51% 

318.23(b)(3) Heat deviations 

for meat patties 

No No 82 2 2.44% 

318.23(c)(1) Stabilization 

requirements 

for meat patties 

No No 322 0 0.00% 

318.23(c)(2) Stabilization 

processes for 

meat patties 

other than 

HACCP 

No No 9 0 0.00% 

318.23(c)(4) Labeling 

statement for 

partially cooked 

patties 

No No 286 0 0.00% 

318.23(c)(5) Labeling 

statement for 

char-marked 

patties 

No No 96 0 0.00% 

318.24 Product 

prepared using 

advanced 

meat/bone 

separation 

machinery; 

process 

control 

No No 2,350 17 0.72% 

318.6(b)(1) Requirements 

for use of 

casings, used as 

containers 

No No 1,916 1 0.05% 

318.6(b)(4) Detached spinal 

cords 

No No 9,482 0 0.00% 

318.6(b)(6) Tonsils No No 10,064 0 0.00% 

318.6(b)(8) Intestines as 

ingredients 

No No 224 0 0.00% 

58 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation1 Description2 

FY 

2022 

PHR 

Mandatory 

Regulation3 

Total 

Regulations 

Verified 

Total 

Noncompliant 

Regulations 

Verified 

PHR 

Noncompliance 

Rate 

319.5(b) Mechanically 

separated (beef) 

-

prohibited for 

use in human 

food 

No No 198 0 0.00% 

354.242(b) All equipment 

and utensils 

clean and 

sanitary 

No No 33 0 0.00% 

354.242(h) Tools and 

equipment used 

in preparation 

to be kept clean 

and sanitary 

No No 9 0 0.00% 

354.243(a) No handling or 

storage of 

objectionable 

materials 

No No 1 0 0.00% 

381.1_Adulterated Adulterated No No 3,828 66 1.72% 

381.144(a) Packaging 

materials not to 

be composed 

of any 

poisonous or 

deleterious 

substance 

No No 1,866 0 0.00% 

381.150(a) Lethality and 

stabilization 

requirements 

for cooked 

poultry 

No No 1,283 4 0.31% 

381.150(c) Lethality and 

Stabilization 

processes 

other than 

HACCP for 

cooked poultry 

No No 137 0 0.00% 

381.150(d) Validation of 

new or altered 

process 

schedules by 

scientifically 

supportable 

means (cooked 

poultry) 

No No 78 1 1.28% 

59 
 

 

 

 

 

 

 

 

 

 

Regulation1 Description2 

FY 

2022 

PHR 

Mandatory 

Regulation3 

Total 

Regulations 

Verified 

Total 

Noncompliant 

Regulations 

Verified 

PHR 

Noncompliance 

Rate 

381.151(a) Product and 

ingredients 

rendered 

adulterated by 

polluted water 

shall be 

condemned 

No No 203 0 0.00% 

381.193(a) Poultry not 

intended for 

human food in 

commerce 

Yes No 200 7 3.50% 

381.22(a) Develop written 

SSOP 

No No 196 2 1.02% 

381.22(b) Conduct hazard 

analysis & 

develop and 

validate 

HACCP plan 

No No 846 0 0.00% 

381.22(c) Conduct hazard 

analysis & 

develop 

HACCP plan 

for new product 

No No 206 0 0.00% 

381.37(a) Product not 

produced under 

supervision 

of program 

employee 

No No 1,436 8 0.56% 

381.65(a) Clean and 

sanitary 

practices; 

products 

not adulterated 

Yes No 30,105 205 0.68% 

381.65(f) Procedures for 

controlling 

visible fecal 

contamination 

Yes No 1,612,666 10,891 0.68% 

381.65(g) Procedures for 

controlling 

contamination 

throughout the 

slaughter and 

dressing 

operation 

Yes No 111,278 620 0.56% 

381.65(h) Recordkeeping 

requirements 

No No 27,588 39 0.14% 

381.71(a) Condemnation 

on ante mortem 

inspection 

No No 1,210 14 1.16% 

60 
 

 

 

 

 

 

 

Regulation1 Description2 

FY 

2022 

PHR 

Mandatory 

Regulation3 

Total 

Regulations 

Verified 

Total 

Noncompliant 

Regulations 

Verified 

PHR 

Noncompliance 

Rate 

381.72(a) Poultry No No 414 1 0.24% 

381.72(b) Ratites No No 16 0 0.00% 

381.76(a) Post-mortem 

inspection, 

when required, 

extent 

No No 8,374 184 2.20% 

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

trimming, and 

reprocessing 

Yes No 55,592 350 0.63% 

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

reprocessing 

and salvage 

No No 79,181 48 0.06% 

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

septicemia/ 

toxemia 

No No 1,427,956 90 0.01% 

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

verification in 

NPIS 

Yes No 4,423 336 7.60% 

381.83 Septicemia or 

toxemia 

No No 1,308,067 78 0.01% 

381.85 Special diseases 

(organisms or 

toxins 

dangerous to 

the consumer) 

No No 35 0 0.00% 

381.91(a) Certain 

contaminated 

carcasses to be 

condemned 

No No 4,593 4 0.09% 

381.91(b) Reprocessing of 

carcasses 

accidentally 

contaminated 

with digestive 

tract 

contents. 

Yes No 11,000 164 1.49% 

381.94(a) Verification 

criteria for E. 

coli testing 

ratites 

No No 927 0 0.00% 

416.1 Operate in a 

manner to 

prevent 

insanitary 

conditions 

Yes Yes 611,964 4,744 0.78% 

61 
 

 

 

 

 

 

 

 

 

 

Regulation1 Description2 

FY 

2022 

PHR 

Mandatory 

Regulation3 

Total 

Regulations 

Verified 

Total 

Noncompliant 

Regulations 

Verified 

PHR 

Noncompliance 

Rate 

416.12(c) Plan identifies 

procedures for 

pre-op 

No No 42,430 54 0.13% 

416.12(d) Plan list 

frequency for 

each procedure 

& responsible 

individual 

Yes No 59,149 64 0.11% 

416.13(a) Conduct pre-op 

procedures 

Yes Yes 762,803 14,414 1.89% 

416.13(b) Conduct other 

procedures 

listed in the 

plan 

Yes Yes 1,934,051 4,610 0.24% 

416.13(c) Plant monitors 

implementation 

of SSOP 

procedures 

Yes Yes 2,746,830 34,868 1.27% 

416.14 Evaluate 

effectiveness of 

SSOP's & 

maintain plan 

Yes Yes 1,689,597 3,332 0.20% 

416.15(a) Appropriate 

corrective 

actions 

Yes Yes 64,383 854 1.33% 

416.15(b) Corrective 

action, 

procedures for 

Yes Yes 41,222 1,075 2.61% 

416.16(a) Daily records 

required, 

responsible 

individual, 

initialed and 

dated 

Yes Yes 2,957,432 4,277 0.14% 

416.2(a) Grounds and 

pest control 

No No 177,134 6,911 3.90% 

416.2(b)(1) Sound 

construction, 

good repair & 

sufficient size 

No No 141,974 6,728 4.74% 

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

lings durable, 

impervious, 

cleaned & 

sanitized 

No No 191,398 9,233 4.82% 

416.2(b)(4) Inedible from 

edible separated 

by time or 

space 

No No 107,602 478 0.44% 

62 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation1 Description2 

FY 

2022 

PHR 

Mandatory 

Regulation3 

Total 

Regulations 

Verified 

Total 

Noncompliant 

Regulations 

Verified 

PHR 

Noncompliance 

Rate 

416.3(b) Constructed, 

located & 

operated in a 

manner that 

does not deter 

inspection 

Yes No 79,641 490 0.62% 

416.3(c) Receptacles for 

storing inedible 

material must 

identify 

permitted use 

Yes No 67,212 919 1.37% 

416.4(a) Food contact 

surface, 

cleaning & 

sanitizing as 

frequency 

Yes No 274,603 12,063 4.39% 

416.4(d) Product 

processing, 

handling, 

storage, 

loading, 

unloading, and 

during 

transportation 

must be 

protected 

Yes No 259,797 14,949 5.75% 

416.5(c) Employees who 

appear to have 

any 

abnormal 

source of 

microbial 

contamination 

Yes No 35,536 10 0.03% 

416.6 Only FSIS 

program 

employee may 

remove "U.S. 

Rejected" tag 

Yes No 2,938 118 4.02% 

417.2(a)(1) Hazard analysis Yes Yes 126,952 1,467 1.16% 

417.2(c) Contents of 

HACCP Plan 

Yes No 29,249 69 0.24% 

417.2(c)(4) List of 

procedures & 

frequency 

Yes Yes 1,322,781 4,431 0.33% 

417.3(a)(1) Identify and 

eliminate the 

cause 

Yes No 8,352 554 6.63% 

63 
 

 

 

 

 

 

 

 

Regulation1 Description2 

FY 

2022 

PHR 

Mandatory 

Regulation3 

Total 

Regulations 

Verified 

Total 

Noncompliant 

Regulations 

Verified 

PHR 

Noncompliance 

Rate 

417.3(a)(2) CCP is under 

control 

Yes No 123,379 636 0.52% 

417.3(a)(3) Establish 

measures to 

prevent 

recurrence 

Yes No 6,137 672 10.95% 

417.3(a)(4) No adulterated 

product enters 

commerce. 

Yes No 24,914 160 0.64% 

417.3(b)(1) Segregate and 

hold the 

affected product 

Yes No 2,762 76 2.75% 

417.3(b)(2) Determine the 

acceptability of 

the 

affected product 

Yes No 2,308 58 2.51% 

417.3(b)(3) No adulterated 

product enters 

commerce 

Yes No 16,239 72 0.44% 

417.3(b)(4) Reassessment Yes Yes 27,836 204 0.73% 

417.3(c) Document 

corrective 

actions 

Yes No 4,394 227 5.17% 

417.4(a) Adequacy of 

HACCP in 

controlling food 

safety hazards 

Yes No 6,909 233 3.37% 

417.4(a)(1) Initial 

validation 

Yes No 5,873 280 4.77% 

417.4(b) Reassessment 

of hazard 

analysis 

No Yes 30,129 63 0.21% 

417.5(a)(1) Written hazard 

analysis 

Yes Yes 1,414,192 3,521 0.25% 

417.5(a)(2) Written 

HACCP plan 

Yes Yes 1,242,762 1,152 0.09% 

417.5(a)(3) Records 

documentation 

and monitoring 

of CCP's and 

Critical Limits 

Yes Yes 1,399,595 3,423 0.24% 

417.5(f) Official review Yes No 89,037 80 0.09% 

417.6 Inadequate 

HACCP 

systems 

No No 529 162 30.62% 

64 
 

 

 

 

 

 

 

 

 

Regulation1 Description2 

FY 

2022 

PHR 

Mandatory 

Regulation3 

Total 

Regulations 

Verified 

Total 

Noncompliant 

Regulations 

Verified 

PHR 

Noncompliance 

Rate 

418.2 Notification of 

adulterated or 

misbranded 

product in 

commerce 

Yes No 1,991 97 4.87% 

418.3 Recall plans Yes No 23,419 57 0.24% 

430.4(a) Lm, postlethality 

exposed RTE 

Yes Yes 305,924 114 0.04% 

430.4(b)(1) Alternative 1 No No 643 1 0.16% 

430.4(b)(2) Alternative 2 Yes No 14,356 72 0.50% 

430.4(b)(3) Alternative 3 No No 19,535 235 1.20% 

430.4(c)(2) Lm, 

documentation 

that supports 

decision in 

hazard analysis 

No Yes 298,380 161 0.05% 

430.4(c)(3) Lm, maintain 

sanitation in 

post-lethality 

processing 

environment 

Yes Yes 299,454 152 0.05% 

430.4(c)(4) Lm, validate 

and verify 

control 

measures in 

HACCP plan 

No No 3,541 9 0.25% 

430.4(c)(5) Lm, evaluate 

control 

measures in 

Sanitation SOP 

No No 5,072 10 0.20% 

430.4(c)(6) Lm, prerequisite 

program 

requirements 

Yes No 4,800 44 0.92% 

431.11 Personnel and 

training 

No No 41 1 2.44% 

431.12 Recall 

procedure 

No No 61 0 0.00% 

431.4 Critical factors 

and the 

application of 

the process 

schedule 

No Yes 10,178 8 0.08% 

431.9(b) Procedures for 

handling of 

process 

deviations 

No Yes 9,186 2 0.02% 

65 
 

 

 

Regulation1 Description2 

FY 

2022 

PHR 

Mandatory 

Regulation3 

Total 

Regulations 

Verified 

Total 

Noncompliant 

Regulations 

Verified 

PHR 

Noncompliance 

Rate 

431.9(c)(1) Process 

deviations 

identified inprocess 

No No 107 1 0.93% 

431.9(c)(2) Process 

deviations 

identified 

through 

record review 

No No 60 1 1.67% 

431.9(d) Process 

deviation file 

No No 127 0 0.00% 

537.1 Basic 

requirements 

No No 30,967 78 0.25% 

1

Regulations 417.3(a) and 417.4(a)(3) are not included in this table as they had zero regulations verified in CY2021. 2

Refer to the 2021 Code of Federal Regulations for complete regulation descriptions. 3

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

66 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

APPENDIX C: COMPARISON OF FY2022 PHR LIST WITH FY2023 PHR LIST 

There are 11 regulations from the FY2022 PHR list that no longer appear in the FY2023 PHR 

list. These are shown in Table C-1. 

Table C-1 Regulations on the FY2022 PHR List No Longer on the FY2023 PHR List 

FY2022 PHRs Description1 

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

to cut through SRMs 

310.25(a) Verification criteria for E. coli testing meat 

316.6 Products not to be removed from official establishments unless 

marked in accordance with the regulations 

416.12(d) Plan list frequency for each procedure & responsible individual 

416.5(c) Employees who appear to have any abnormal source of microbial 

contamination 

417.3(b)(2) Determine the acceptability of the affected product 

417.4(a)(1) Initial validation 

417.5(f) Official review 

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

381.193(a) Poultry not intended for human food in commerce 

430.4(c)(2) Lm, documentation that supports decision in hazard analysis 1 Refer to the 2021 Code of Federal Regulations for complete regulation descriptions. 

There are 19 regulations on the FY2023 PHR list that were not on the FY2022 PHR list. 

Table C-2 Regulations on the FY2023 PHR List That Were Not on the FY2022 PHR List 

FY2023 PHRs Description1 

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 

381.1_Adulterated Adulterated 

381.71(a) Condemnation on ante mortem inspection 

416.12(c) Plan identifies procedures for pre-op 

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 

417.6 Inadequate HACCP systems 

430.4(b)(3) Alternative 3 

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

381.65(h) * Recordkeeping requirements 

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

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

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. *

Indicates first time regulation qualified for PHR list. 

67 
 

 

 

 

 

of Log 

15.0 

12.5 

10.0 

1= 

a, 

u 7.5 a, 

(l_ 

5.0 

2.5 

-7.05 -6. 45 -5.85 -5.25 -4.65 -4. 05 -3.45 -2.85 -2.25 -1. 65 

Log 

Curve --- Norm al(M u=-4 811 Sigma=0 8736) 

APPENDIX D: METHODOLOGY AND CALCULATION OF PHR CUT POINTS 

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

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

most recent 90 days of establishment verification inspection data: 

TTNNRRNNNN NNNNNNNNNNNNNNNNNNNNNNRR PPPPPPPP

PPPPPP NNNNNNNNNNNNNNNNNNNNNNNNNN PPNNRRNN = TTNNRRNNNN PPPPPPPP VVNNVVNNVVNNNNVV

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 PHR noncompliance rates are approximately log normally distributed. 

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

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

non-zero PHR 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 

68 
 

 

 

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 0.04305090 Pr > D <0.010 

Cramer-von Mises W-Sq 1.14108074 Pr > W-Sq <0.005 

Anderson-Darling A-Sq 6.89254177 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 PHR rate from four quarters of PHR data. (The antilog 

of these cut points is taken to obtain the cut points of the non-transformed PHR 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 PHR noncompliances) using 

the quarterly cut points. 

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

Quarter/ 

Establishment 

Type 

Number of 

Establishments 

Mean Standard 

Deviation 

Level Tier Distribution 

(Number of 

Establishments) 

Q1CY2021 

Upper 68 

Combination 1,081 -4.57746 0.95572 Mid 112 

Processing 4,240 -4.91922 0.78735 Lower 5,141 

Q2CY2021 

Upper 82 

Combination 1,107 -4.53670 1.00994 Mid 98 

Processing 4,273 -4.93214 0.78459 Lower 5,200 

Q3CY2021 

Upper 78 

Combination 1,125 -4.49354 0.96693 Mid 106 

Processing 4,279 -4.86778 0.82093 Lower 5,220 

Q4CY2021 

Upper 71 

Combination 1,128 -4.57272 0.97291 Mid 112 

Processing 4,334 -4.90955 0.79859 Lower 5,279 

69 
 

 

 

 

 

 

 

 

 

 

 

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

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 FY2023 PHRs. Table D-4 show the 

distribution of establishments using data from January to March 2022 utilizing the proposed 

FY2023 PHRs. 

Table D-2 Average Mean and Standard Deviation of Log 

Transformed Non-Zero PHR Rates by Establishment Type 

Statistic Combination Processing 

Mean -4.54511 -4.90717 

Standard Deviation 0.97638 0.79787 

Table D-3 FY2023 PHR Upper and Lower Cut Points 

Operation 

Type 

Upper Cut 

Points 

Lower Cut 

Points 

Processing 3.65% 2.45% 

Combination 7.48% 4.59% 

Table D-4 March 2022 Level Distribution Based on the 

Previous Year’s (FY2022) PHR 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 81 

Mid 91 

Lower 5,228 

Total 5,400 

70