U.S. Department of Agriculture/ 

Food Safety and Inspection Service 

FY2022 Public Health Regulations 

July 2021 

(Revised November 22, 2021) 
 

 

 

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

4.1.2 Salmonella in Intact Turkey......................................................................................... 16 

4.1.3 Salmonella in Ground Beef.......................................................................................... 17 

4.1.4 Salmonella in Intact Beef............................................................................................. 18 

4.1.5 Salmonella in Comminuted Chicken ........................................................................... 21 

4.1.6 Salmonella in Comminuted Turkey............................................................................. 22 

4.1.7 Salmonella in Intact Pork............................................................................................. 23 

4.1.8 Salmonella in Comminuted Pork................................................................................. 25 

4.1.9 Salmonella in Chicken Parts ........................................................................................ 26 

4.1.10 Salmonella in Siluriformes ........................................................................................ 27 

4.1.11 Salmonella in RTE..................................................................................................... 27 

4.2 E. Coli ................................................................................................................................. 27 

4.2.1 E. coli O157:H7 ........................................................................................................... 27 

4.2.2 Non-O157 STEC.......................................................................................................... 28 

4.3 Listeria monocytogenes ...................................................................................................... 29 

4.4 Campylobacter.................................................................................................................... 30 

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

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

4.4.3 Campylobacter in Comminuted Chicken..................................................................... 33 

4.4.4 Campylobacter in Comminuted Turkey ...................................................................... 34 

4.4.5 Campylobacter in Chicken Parts ................................................................................. 35 

4.5 Enforcement Actions .......................................................................................................... 36 

5.0 List of FY2022 PHRs.............................................................................................................. 41 

6.0 Cut Points for FY2022 PHRs.................................................................................................. 45 

7.0 Conclusion .............................................................................................................................. 48 

8.0 References............................................................................................................................... 49 

Appendix A: FY2022 PHR Regulations....................................................................................... 50 

Appendix B: FY2022 Candidate Regulations............................................................................... 52 

Appendix C: Comparison of FY2022 PHR List with FY2021 PHR List..................................... 68 

Appendix D: Methodology and Calculation of PHR Cut Points .................................................. 69 

Revision History ........................................................................................................................... 72 

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List of Figures and Tables 

Table S-1 FY2022 PHR Upper Cut Points ..................................................................................... 6 

Table 4-1 Comparison of Noncompliance Rates 3 Months before a Salmonella Positive with 

Table 4-2 Comparison of Noncompliance Rates 3 Months before an Intact Chicken Salmonella 

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

Table 4-4 Comparison of Noncompliance Rates 3 Months before a Ground Beef Salmonella 

Table 4-5 Comparison of Noncompliance Rates 3 Months before an Intact Beef Salmonella 

Table 4-6 Comparison of Noncompliance Rates 3 Months before a Comminuted Chicken 

Salmonella Positive with Those for Establishments with No Comminuted Chicken Salmonella 

Table 4-7 Comparison of Noncompliance Rates 3 Months before a Comminuted Turkey 

Salmonella Positive with Those for Establishments with No Comminuted Turkey Salmonella 

Table 4-8 Comparison of Noncompliance Rates 3 Months before an Intact Pork Salmonella 

Table 4-9 Comparison of Noncompliance Rates 3 Months before a Comminuted Pork 

Salmonella Positive with those for Establishments with No Comminuted Pork Salmonella 

Table 4-10 Comparison of Noncompliance Rates 3 Months before a Chicken Parts Salmonella 

Table 4-11 Comparison of Noncompliance Rates 3 Months before an E. coli O157:H7 Positive 

Table 4-12 Comparison of Noncompliance Rates 3 Months before a Non-O157 STEC Positive 

Table 4-13 Comparison of Noncompliance Rates 3 Months before a Listeria monocytogenes 

Table 4-14 Comparison of Noncompliance Rates 3 Months before a Campylobacter Positive 

Table 4-15 Comparison of Noncompliance Rates 3 Months before a Campylobacter Intact 

Chicken Positive with Those for Establishments with No Campylobacter Intact Chicken Positive 

Table 4-16 Comparison of Noncompliance Rates 3 Months before a Campylobacter Intact 

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

Table 4-17 Comparison of Noncompliance Rates 3 Months before a Comminuted Chicken 

Campylobacter Positive with Those for Establishments with No Comminuted Chicken 

Table 4-18 Comparison of Noncompliance Rates 3 Months before a Comminuted Turkey 

Campylobacter Positive with those for Establishments with No Comminuted Turkey 

Table S-2 FY2022 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................. 15 

Positive with Those for Establishments with No Intact Turkey Salmonella Positive .................. 16 

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

Positive with Those for Establishments with No Intact Beef Salmonella Positive ...................... 19 

Positive.......................................................................................................................................... 22 

Positive.......................................................................................................................................... 23 

Positive with Those for Establishments with No Intact Pork Salmonella Positive ...................... 24 

Positive.......................................................................................................................................... 25 

Positive with Those for Establishments with No Chicken Parts Salmonella Positive.................. 26 

with Those for Establishments with E. coli O157:H7 Positive .................................................... 28 

with Those for Establishments with No Non-O157 STEC Positive............................................. 29 

Positive with Those for Establishments with No Listeria monocytogenes Positive..................... 30 

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

....................................................................................................................................................... 32 

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

Campylobacter Positive................................................................................................................ 35 

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Table 4-19 Comparison of Noncompliance Rates 3 Months before a Chicken Parts 

Campylobacter Positive with Those for Establishments with No Chicken Parts Campylobacter 

Positive.......................................................................................................................................... 36 

Table 4-20 Comparison of Noncompliance Rates 3 Months before an Enforcement Action with 

Table 5-3 Regulations Triggered for Inclusion in the FY2022 PHR List by Only a Single Event 

Table 6-5 Classification of Establishments Based on Operation Type and Only the PHR Criterion 

Table C-1 Regulations from the FY2021 PHR List That Are No Longer on the FY2022 PHR List 

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 

Those for Establishments with No Enforcement Action .............................................................. 37 

Table 5-1 List of FY2022 PHRs ................................................................................................... 41 

Table 5-2 Events That Triggered Inclusion of a Regulation in the FY2022 PHR List ................ 44 

....................................................................................................................................................... 45 

Table 6-1 Mean and Standard Deviation of Quarterly FY2022 PHR Rate .................................. 46 

Table 6-2 FY2022 PHR Upper Level Cut Points ......................................................................... 47 

Table 6-3 FY2022 PHR Lower Level Cut Points......................................................................... 47 

Table 6-4 Classification of Establishments Based Solely on the PHR Criterion ......................... 47 

....................................................................................................................................................... 47 

Table 7-1 FY2022 PHR Upper-Level Cut Points......................................................................... 48 

Table 7-2 FY2022 PHR Lower-Level Cut Points......................................................................... 48 

Table A-1 List of FY2022 PHRs .................................................................................................. 50 

....................................................................................................................................................... 68 

Table C-2 Regulations on the FY2022 PHR List That Were Not on the FY2021 PHR List ....... 68 

Verifications 3 Months before a Pathogen Positive or Enforcement Action................................ 69 

Figure D-2 Goodness of Fit for Normal Distribution of the Log Transformation........................ 70 

Table D-1 Quarterly PHR Mean, Standard Deviation and Level Distribution............................. 70 

Plant Type ..................................................................................................................................... 71 

Table D-3 FY2022 Upper and Lower Cut Points ......................................................................... 71 

Table D-4 March 2021 Level Distribution Based on the PHR Criteria Only............................... 71 

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SUMMARY 

Public Health Regulations (PHRs) are verified regulations1 with statistically higher individual 

noncompliance rates in establishments in the 3 months prior to a microbiological positive or a 

public health-related enforcement action than in establishments with no positives or enforcement 

actions2

. This statistical association does not inherently imply that a particular regulation 

constitutes a more serious food safety concern but gives a statistical association to better align 

scheduling criteria and agency resources. PHRs are not the only important food safety and public 

health-related regulations; noncompliance with many other regulations are critical indicators of 

public health concern but may not be statistically associated with the outlined criteria. This 

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

October 1, 2021, to September 30, 2022, (FY2022) to prioritize certain FY2022 FSIS inspection 

activities. 

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

(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 PHR noncompliance rate threshold 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 levels are announced 

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

The updated list of FY2022 PHRs is based on January 1, 2020, to December 31, 2020, (CY2020) 

verification inspection results and will be implemented in FY2022. If an establishment is 

prioritized 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. 

For inclusion in the FY2022 PHR list, 9 CFR regulations from a curated list of candidate 

regulations were evaluated individually to determine whether noncompliance with each 

regulation occurred at a more frequent rate in establishments in the 3-month period 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 FY2022 PHRs consists 

of 62 regulations that have higher rates of noncompliance 3 months before a pathogen positive or 

enforcement action. This compares with 56 regulations that were identified in the October 1, 

2020, to September 30, 2021, (FY2021) PHR list. The full list of FY2022 PHRs is listed in 

Appendix A. Forty-nine regulations from the FY2021 PHR list remain on the FY2022 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. 

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The 62 FY2022 PHRs comprise 9 regulations and 54 provisions of regulations. The 62 FY2022 

PHRs represent 29 regulations, with the majority of FY2022 PHRs being provisions of 

regulations that provide greater specificity as to the nature of the noncompliance associated with 

a regulation violation. The provisions of regulations may be independent of the full regulations, 

that a single provision of a regulation can vary from year-to-year and if a regulation has 

provisions all provisions are not necessarily included. 

The average noncompliance rate of FY2022 PHR regulations 3 months before a pathogen 

positive or enforcement action is 18.3 times higher than the average FY2022 PHR 

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

Noncompliance with a single FY2022 PHR does not indicate a loss of process control. The 

aggregate set of PHRs is used to identify establishments that significantly deviate from the 3-

month rolling average noncompliance rate for all similar establishments. The aggregate FY2022 

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 FY2022 cut points are computed by determining the mean and standard deviation of the log 

transformed non-zero FY2022 PHR rates for each of the four quarters in CY2020 (the log 

transform of the non-zero FY2022 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 6 months. 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 non-compliance. Tables S-1 and S-2 

present the Upper and Lower FY2022 PHR cut points for the non-transformed PHR 

noncompliance data for each of the two establishment operation types. The FY2021 PHR cut 

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

Table S-1 FY2022 PHR Upper Cut Points 

Operation Type FY2022 PHR Cut Points FY2021 PHR Cut Points 

Processing 3.63% 3.73% 

Combination 7.33% 9.84% 

Table S-2 FY2022 PHR Lower Cut Points 

Operation Type FY2022 PHR Cut Points FY2021 PHR Cut Points 

Processing 2.44% 2.50% 

Combination 4.60% 5.85% 

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Table S-3 presents the number of establishments in each level from January 1, 2021, toMarch 

31, 2021, based on the PHR criterion. The period used for calculating the noncompliance rate of 

the PHRs was January 1, 2021, to March 31, 2021. The number of “for cause” PHREs for Upper 

establishments is approximately the same as in previous years. 

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

Level Processing Combination Total 

Upper 35 13 48 

Mid 58 32 60 

Lower 4,143 1,036 5,179 

Total 4,236 1,081 5,137 

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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 prioritized 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 FY2022 PHRs (PHRs that will be used for the time period October 1, 

2021, to September 30, 2022). 

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 FY2022 PHR list is the same as that used for the 

FY2021 PHR list. For inclusion in the FY2022 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 3-month period before Salmonella, E. coli O157: H7, 

Non-O157 STEC, Listeria monocytogenes (Lm), Campylobacter positives or enforcement 

actions than in establishments without positives or enforcement actions3

. The analysis was based 

on 1 year of FSIS verification inspection results recorded in PHIS from January 1 to December 

31, 2020 (CY2020). Candidate regulations related to egg products are not included in this report. 

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 

3 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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establishments that need to be scheduled for an FSA or a PHRE. The final FY2022 PHR list is 

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

PHRs. Appendix C describes the differences between the FY2022 PHR list and FY2021 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 than in establishments in the 3-month period 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 3 months 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 3-month 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. 

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

considered candidate regulations. 

• Establish and Maintain HACCP 

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o Failure to maintain adequate HACCP Plan. 

o Adequacy of 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. 

• Corrective Actions 

o Procedures for and selection of appropriate corrective actions. 

o Document corrective actions. 

o Identify and eliminate the cause. 

o Establish measures to prevent recurrence. 

o Reassess hazard analysis. 

In addition to these criteria, regulations relating to operation of establishments in a way that does 

not deter FSIS’ ability to conduct verification inspections are also included. Inclusion of 9 CFR 

regulations in the list of candidate regulations errs on the side of inclusiveness. 

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 3 months before the occurrence of a pathogen 

positive during FSIS sampling or enforcement action. The 3-month time period 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 3 months before a Salmonella, E. coli 

O157:H7, Non-O157 STEC, Lm, Campylobacter positive or enforcement actions than the 

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

Non-O157 STEC, Lm, Campylobacter positive or 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 155 9 CFR regulations were selected as being 

indicators of a potential loss of food safety process control. The list of 155 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, Listeria monocytogenes, 

Campylobacter positives during FSIS verification testing or enforcement actions. The 

noncompliance rate of each of the FY2022 155 candidate regulations in establishments 3 months 

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 CY2020. Those with more than 30 verifications in a year, an odds 

ratio of 3.0 or greater, and for which there is an 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 3 months 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 3 months 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 2,088 establishments with Salmonella testing data, of which 800 had 

5,871 Salmonella positives and 1,288 did not have Salmonella positives. There were 63,304 total 

Salmonella tests performed. 

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Table 4-1 presents the 34 regulations that had more than 30 verifications in a year, an odds ratio 

of 3.0 or greater, and for which there is an 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 3 months prior to a Salmonella positive is higher than the average noncompliance 

rate for establishments with no Salmonella positive for CY2020. 

Table 4-1 Comparison of Noncompliance Rates 3 Months before a Salmonella Positive with 

Those for Establishments with No Salmonella Positive 

Regulation 

Verified Description 

On 

FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 

Months before a 

Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

301.2_Adulterated Adulterated Yes 39.36% 2.38% 26.58 3.00E150 

310.18(c) 

Written procedures to 

prevent 

contamination; all 

swine slaughter 

No 1.51% 0.26% 5.87 4.00E07 

310.18(d) 

Daily records 

sufficient to 

document the 

implementation and 

monitoring of 

contamination control 

procedures 

No 0.96% 0.05% 19.23 1.70E15 

310.22(b) 

Inedible and 

prohibited SRM for 

use as human food 

Yes 2.49% 0.14% 17.93 7.00E05 

310.22(c) Disposal of SRM Yes 5.09% 0.29% 18.56 5.00E129 

310.22(e)(1) 

Written procedures 

for removal, 

segregation, and 

disposition of SRMs 

Yes 6.61% 1.52% 4.59 7.40E22 

310.22(e)(2) Appropriate 

corrective actions Yes 1.23% 0.37% 3.30 4.65E02 

310.22(e)(3) 

Evaluate 

effectiveness of 

procedures for 

removal, segregation, 

and disposition of 

SRMs 

Yes 21.19% 1.07% 24.89 2.00E122 

310.22(f)(2) 

Use of routine 

operational sanitation 

procedures on 

equipment used to cut 

through SRMs 

Yes 1.00% 0.10% 10.03 1.50E08 

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Regulation 

Verified Description 

On 

FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 

Months before a 

Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

318.2(d) 

Removal of U.S. 

retained by 

authorized Program 

employees only 

Yes 0.72% 0.16% 4.62 3.60E04 

381.65(a) 

Clean and sanitary 

practices; products 

not adulterated 

Yes 0.93% 0.18% 5.28 6.60E11 

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

verification in NPIS Yes 8.17% 1.71% 5.12 5.10E05 

381.91(b) 

Reprocessing of 

carcasses accidentally 

contaminated with 

digestive tract 

contents. 

Yes 1.52% 0.36% 4.25 1.87E02 

416.1 

Operate in a manner 

to prevent insanitary 

conditions 

Yes 2.34% 0.66% 3.60 8.00E301 

416.13(a) Conduct pre-op 

procedures Yes 6.85% 1.20% 6.03 0.00E+ 00 

416.13(b) 

Conduct other 

procedures listed in 

the plan 

Yes 0.60% 0.14% 4.41 5.00E302 

416.13(c) 

Plant monitors 

implementation of 

SSOP procedures 

Yes 4.56% 0.90% 5.28 0.00E+ 

00 

416.14 

Evaluate 

effectiveness of 

SSOP's & maintain 

plan 

Yes 0.52% 0.16% 3.26 4.00E168 

416.15(a) Appropriate 

corrective actions Yes 4.42% 1.18% 3.89 4.80E47 

416.15(b) Corrective action, 

procedures for Yes 9.93% 3.47% 3.06 9.80E49 

416.3(b) 

Constructed, located 

& operated in a 

manner that does not 

deter inspection 

Yes 1.18% 0.38% 3.15 5.10E19 

416.3(c) 

Receptacles for 

storing inedible 

material must 

identify permitted use 

Yes 3.53% 0.89% 4.08 9.30E66 

13 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation 

Verified Description 

On 

FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 

Months before a 

Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

416.4(a) 

Food contact surface, 

cleaning & sanitizing 

as frequency 

Yes 16.12% 3.34% 5.56 0.00E+ 

00 

416.4(d) 

Product processing, 

handling, storage, 

loading, unloading, 

and during 

transportation must 

be protected 

Yes 17.42% 4.00% 5.06 0.00E+ 

00 

416.5(c) 

Employees who 

appear to have any 

abnormal source of 

microbial 

contamination 

No 0.10% 0.02% 6.82 4.44E02 

416.6 

Only FSIS program 

employee may 

remove "U.S. 

Rejected" tag 

Yes 9.62% 2.89% 3.57 2.00E07 

417.2(c)(4) List of procedures & 

frequency Yes 0.90% 0.23% 3.87 0.00E+ 00 

417.3(a)(1) Identify and 

eliminate the cause Yes 13.41% 2.61% 5.77 1.30E56 

417.3(a)(2) CCP is under control Yes 1.44% 0.33% 4.35 9.10E60 

417.3(a)(3) Establish measures to 

prevent recurrence 

Yes 20.91% 5.04% 4.98 1.20E58 

417.3(a)(4) 

No adulterated 

product enters 

commerce. 

No 1.09% 0.26% 4.23 2.20E11 

417.3(b)(3) 

No adulterated 

product enters 

commerce 

Yes 0.96% 0.30% 3.27 4.20E05 

417.5(a)(2) Written HACCP plan Yes 0.24% 0.07% 3.37 4.80E77 

418.2 

Notification of 

adulterated or 

misbranded product 

in commerce 

Yes 22.18% 3.27% 8.42 3.50E16 

14 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.1.1 Salmonella in Intact Chicken 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 206 

establishments with Intact Chicken Salmonella testing data, of which 169 had 453 Salmonella 

positives and 37 did not have Salmonella positives. There were 9,723 total Intact Chicken 

Salmonella tests performed. 

Table 4-2 presents the 16 regulations that had more than 30 verifications in a year, an odds ratio 

of 3.0 or greater, and for which there is an 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 3 months prior to an Intact Chicken Salmonella positive is higher than the 

average noncompliance rate for establishments with no Intact Chicken Salmonella positive for 

CY2020. 

Table 4-2 Comparison of Noncompliance Rates 3 Months before an Intact Chicken 

Salmonella Positive with Those for Establishments with No Intact Chicken Salmonella 

Positive 

Regulation 

Verified Description 

On FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

318.2(a) 

All products subject 

to reinspection by 

program employees 

Yes 9.21% 0.71% 14.20 3.06E-03 

381.193(a) 

Poultry not intended 

for human food in 

commerce 

No 24.14% 2.56% 12.09 1.40E-03 

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

verification in NPIS Yes 5.96% 1.56% 3.98 1.60E-06 

416.15(b) Corrective action, 

procedures for Yes 19.06% 6.70% 3.28 1.39E-10 

417.2(a)(1) Hazard analysis Yes 2.34% 0.36% 6.63 7.39E-08 

417.2(c)(4) List of procedures & 

frequency Yes 1.74% 0.58% 3.06 1.37E-58 

417.3(a)(1) Identify and 

eliminate the cause Yes 2.86% 0.83% 3.52 8.56E-03 

417.3(a)(2) CCP is under control Yes 0.37% 0.11% 3.32 1.60E-04 

417.3(a)(3) Establish measures 

to prevent recurrence Yes 4.50% 1.46% 3.18 4.32E-03 

417.3(a)(4) 

No adulterated 

product enters 

commerce. 

No 1.86% 0.12% 16.22 4.28E-11 

417.3(b)(3) 

No adulterated 

product enters 

commerce 

Yes 1.91% 0.08% 23.97 2.37E-06 

417.3(b)(4) Reassessment Yes 3.09% 0.38% 8.48 2.79E-04 

417.3(c) Document corrective 

actions Yes 4.27% 0.49% 8.98 1.41E-04 

15 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation 

Verified Description 

On FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

417.4(a) 

Adequacy of 

HACCP in 

controlling food 

safety hazards 

Yes 3.03% 0.32% 9.88 1.29E-03 

417.5(a)(1) Written hazard 

analysis Yes 0.56% 0.14% 4.11 1.31E-18 

417.5(a)(2) Written HACCP 

plan Yes 0.12% 0.03% 3.59 4.07E-04 

4.1.2 Salmonella in Intact Turkey 

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

establishments with Intact Turkey Salmonella testing data, of which 12 establishments had 18 

Salmonella positives and 30 establishments did not have Salmonella positives. There were 1,731 

total Intact Turkey Salmonella tests performed. 

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

of 3.0 or greater, and for which there is an 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 3 months prior to an Intact Turkey Salmonella positive is higher than the average 

noncompliance rate for establishments with no Intact Turkey Salmonella positive for CY2020. 

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

Salmonella Positive with Those for Establishments with No Intact Turkey Salmonella 

Positive 

Regulation 

Verified Description 

On 

FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 Months 

before a 

Salmonella Positive 

Noncompliance 

Rate for 

Establishments 

with no Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

381.91(b) 

Reprocessing of 

carcasses 

accidentally 

contaminated with 

digestive tract 

contents. 

Yes 3.27% 0.35% 9.53 6.50E-07 

417.3(c) Document 

corrective actions Yes 37.50% 0.84% 71.16 8.24E-05 

16 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.1.3 Salmonella in Ground Beef 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 1,215 

establishments with Ground Beef Salmonella testing data, of which 108 establishments had 166 

Salmonella positives and 1,107 establishments did not have Salmonella positives. There were 

10,718 total Ground Beef Salmonella tests performed. 

Table 4-4 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 an 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 3 months prior to a Ground Beef Salmonella positive is higher than the average 

noncompliance rate for establishments with no Ground Beef Salmonella positive for CY2020. 

Table 4-4 Comparison of Noncompliance Rates 3 Months before a Ground Beef Salmonella 

Positive with Those for Establishments with No Ground Beef Salmonella Positive 

Regulation 

Verified Description 

On FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

301.2_Adulterated Adulterated Yes 8.70% 2.90% 3.18 4.86E-02 

310.18(a) 

Carcasses, organs, 

and other parts 

handled in a 

sanitary manner 

Yes 4.02% 1.04% 3.97 1.11E-78 

310.22(e)(1) 

Written procedures 

for removal, 

segregation, and 

disposition of 

SRMs 

Yes 7.56% 2.44% 3.27 4.88E-05 

310.22(f)(2) 

Use of routine 

operational 

sanitation 

procedures on 

equipment used to 

cut through SRMs 

Yes 2.85% 0.19% 15.50 2.55E-10 

316.6 

Products not to be 

removed from 

official 

establishments 

unless marked in 

accordance with 

the regulations 

No 6.00% 0.66% 9.67 7.49E-06 

318.1(b) 

Only inspected and 

passed poultry 

product to enter 

official 

establishment 

No 0.22% 0.01% 38.92 4.96E-02 

17 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation 

Verified Description 

On FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

381.65(g) 

Procedures for 

controlling 

contamination 

throughout the 

slaughter and 

dressing operation 

Yes 6.67% 1.14% 6.20 8.51E-03 

416.4(a) 

Food contact 

surface, cleaning & 

sanitizing as 

frequency 

Yes 10.68% 3.14% 3.68 1.48E-64 

416.6 

Only FSIS program 

employee may 

remove "U.S. 

Rejected" tag 

Yes 22.22% 2.94% 9.43 3.18E-02 

417.2(c)(4) List of procedures 

& frequency Yes 1.72% 0.24% 7.40 2.85E-102 

417.3(b)(1) 

Segregate and hold 

the affected 

product 

Yes 10.00% 1.38% 7.97 3.60E-02 

418.2 

Notification of 

adulterated or 

misbranded product 

in commerce 

Yes 33.33% 4.06% 11.82 2.63E-02 

4.1.4 Salmonella in Intact Beef 

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

There are 907 establishments with Intact Beef Salmonella testing data, of which 90 

establishments had 177 Salmonella positives and 817 establishments did not have Salmonella 

positives. There were 6,417 total Intact Beef Salmonella tests performed. 

Table 4-5 presents the 31 regulations that had more than 30 verifications in a year, an odds ratio 

of 3.0 or greater, and for which there is an 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 3 months prior to an Intact Beef Salmonella positive is higher than the average 

noncompliance rate for establishments with no Intact Beef Salmonella positive for CY2020. 

18 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Table 4-5 Comparison of Noncompliance Rates 3 Months before an Intact Beef Salmonella 

Positive with Those for Establishments with No Intact Beef Salmonella Positive 

Regulation 

Verified Description 

On 

FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 

Months before a 

Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

301.2_Adulterated Adulterated Yes 25.13% 2.82% 11.59 6.91E-39 

310.18(a) 

Carcasses, organs, 

and other parts 

handled in a 

sanitary manner 

Yes 3.99% 1.02% 4.02 1.44E-158 

310.22(b) 

Inedible and 

prohibited SRM 

for use as human 

food 

Yes 7.06% 0.24% 31.85 1.14E-06 

310.22(c) Disposal of SRM Yes 3.04% 0.30% 10.53 1.59E-35 

310.22(e)(1) 

Written 

procedures for 

removal, 

segregation, and 

disposition of 

SRMs 

Yes 10.25% 1.67% 6.73 7.42E-27 

310.22(e)(2) Appropriate 

corrective actions Yes 15.31% 0.53% 33.80 4.46E-13 

310.22(e)(3) 

Evaluate 

effectiveness of 

procedures for 

removal, 

segregation, and 

disposition of 

SRMs 

Yes 10.11% 1.11% 9.99 1.49E-22 

310.22(f)(2) 

Use of routine 

operational 

sanitation 

procedures on 

equipment used to 

cut through SRMs 

Yes 0.58% 0.16% 3.75 2.34E-02 

316.6 

Products not to be 

removed from 

official 

establishments 

unless marked in 

accordance with 

the regulations 

No 4.48% 0.56% 8.29 4.73E-04 

318.2(d) 

Removal of U.S. 

retained by 

authorized 

Program 

employees only 

Yes 4.71% 0.06% 79.38 5.90E-06 

19 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation 

Verified Description 

On 

FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 

Months 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 

No 4.22% 0.83% 5.27 1.16E-04 

416.1 

Operate in a 

manner to prevent 

insanitary 

conditions 

Yes 2.69% 0.73% 3.79 9.94E-38 

416.12(d) 

Plan list 

frequency for 

each procedure & 

responsible 

individual 

No 1.82% 0.05% 40.81 2.21E-05 

416.13(a) Conduct pre-op 

procedures Yes 3.93% 1.25% 3.23 6.30E-48 

416.13(b) 

Conduct other 

procedures listed 

in the plan 

Yes 0.74% 0.12% 6.21 7.56E-51 

416.13(c) 

Plant monitors 

implementation of 

SSOP procedures 

Yes 4.89% 0.87% 5.86 0.00E+00 

416.15(a) Appropriate 

corrective actions Yes 5.72% 1.35% 4.43 3.63E-09 

416.15(b) Corrective action, 

procedures for Yes 18.75% 2.06% 10.95 6.32E-27 

416.3(b) 

Constructed, 

located & 

operated in a 

manner that does 

not deter 

inspection 

Yes 1.64% 0.31% 5.35 3.46E-05 

416.4(a) 

Food contact 

surface, cleaning 

& sanitizing as 

frequency 

Yes 9.77% 3.07% 3.42 1.94E-70 

416.4(d) 

Product 

processing, 

handling, storage, 

loading, 

unloading, and 

during 

transportation 

must be protected 

Yes 19.97% 3.71% 6.47 1.46E-261 

416.6 

Only FSIS 

program 

employee may 

remove "U.S. 

Rejected" tag 

Yes 20.51% 3.07% 8.15 1.26E-04 

417.2(a)(1) Hazard analysis Yes 3.65% 1.24% 3.03 2.49E-05 

20 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation 

Verified Description 

On 

FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 

Months before a 

Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

417.2(c)(4) List of procedures 

& frequency Yes 1.43% 0.27% 5.33 9.45E-78 

417.3(a)(2) CCP is under 

control Yes 1.89% 0.35% 5.44 2.09E-10 

417.3(a)(3) 

Establish 

measures to 

prevent 

recurrence 

Yes 21.33% 4.70% 5.49 1.16E-06 

417.3(a)(4) 

No adulterated 

product enters 

commerce. 

No 3.48% 0.20% 18.01 2.26E-07 

417.4(a) 

Adequacy of 

HACCP in 

controlling food 

safety hazards 

Yes 88.89% 2.71% 287.13 1.59E-22 

417.4(a)(1) Initial validation No 22.22% 5.57% 4.84 1.84E-02 

417.5(a)(1) Written hazard 

analysis Yes 0.65% 0.21% 3.14 1.60E-19 

418.2 

Notification of 

adulterated or 

misbranded 

product in 

commerce 

Yes 90.00% 3.36% 258.75 2.79E-11 

4.1.5 Salmonella in Comminuted Chicken 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 91 

establishments with Comminuted Chicken Salmonella testing data, of which 79 establishments 

had 536 Salmonella positives and 12 establishments did not have Salmonella positives. There 

were 2,111 total Comminuted 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 an 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 3 

months before a Comminuted Chicken Salmonella positive is higher than the average 

noncompliance rate for establishments with no Comminuted Chicken Salmonella positive for 

CY2020. 

21 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Table 4-6 Comparison of Noncompliance Rates 3 Months before a Comminuted Chicken 

Salmonella Positive with Those for Establishments with No Comminuted Chicken 

Salmonella Positive 

Regulation 

Verified Description 

On 

FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 Months 

before a Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments with 

no Salmonella 

Positive 

Odds 

Ratio 

Two-Sided 

Fisher 

Exact p 

Value 

310.18(a) 

Carcasses, 

organs, and 

other parts 

handled in a 

sanitary manner 

Yes 2.08% 0.63% 3.36 2.37E-02 

416.13(a) Conduct pre-op 

procedures Yes 9.33% 2.25% 4.47 4.47E-33 

416.13(b) 

Conduct other 

procedures listed 

in the plan 

Yes 0.66% 0.17% 3.90 1.04E-06 

416.4(a) 

Food contact 

surface, cleaning 

& sanitizing as 

frequency 

Yes 29.58% 6.79% 5.77 1.90E-33 

417.2(c)(4) 

List of 

procedures & 

frequency 

Yes 1.55% 0.08% 20.68 1.59E-21 

417.3(a)(3) 

Establish 

measures to 

prevent 

recurrence 

Yes 11.76% 0.72% 18.40 2.45E-05 

417.5(a)(2) Written HACCP 

plan Yes 0.74% 0.15% 5.01 6.32E-07 

4.1.6 Salmonella in Comminuted Turkey 

There are 49 establishments with Comminuted Turkey Salmonella testing data, of which 40 

establishments had 280 Salmonella positives and 9 establishments did not have Salmonella 

positives. There were 1,525 total Comminuted Turkey Salmonella tests performed. 

Table 4-7 presents the 9 regulations that had more than 30 verifications in a year, an odds ratio of 

3.0 or greater, and for which there is an 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 3 

months before a Comminuted Turkey Salmonella positive is higher than the average 

noncompliance rate for establishments with no Comminuted Turkey Salmonella positive for 

CY2020. 

22 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Table 4-7 Comparison of Noncompliance Rates 3 Months before a Comminuted Turkey 

Salmonella Positive with Those for Establishments with No Comminuted Turkey 

Salmonella Positive 

Regulation 

Verified Description 

On 

FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 Months 

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 14.68% 1.75% 9.67 2.09E-53 

416.13(c) Plant monitors 

implementation of 

SSOP procedures 

Yes 5.89% 1.02% 6.07 7.06E-73 

416.16(a) Daily records 

required, responsible 

individual, initialed 

and dated 

Yes 0.35% 0.03% 10.79 6.58E-07 

416.3(b) Constructed, located 

& operated in a 

manner that does not 

deter inspection 

Yes 3.23% 0.65% 5.15 1.03E-02 

416.3(c) Receptacles for 

storing inedible 

material must identify 

permitted use 

Yes 8.86% 1.30% 7.37 4.46E-07 

416.4(a) Food contact surface, 

cleaning & sanitizing 

as frequency 

Yes 23.82% 2.08% 14.70 4.89E-56 

416.4(d) Product processing, 

handling, storage, 

loading, unloading, 

and during 

transportation must be 

protected 

Yes 17.82% 3.42% 6.12 1.06E-32 

417.2(c)(4) List of procedures & 

frequency Yes 0.75% 0.08% 9.86 1.68E-06 

417.5(a)(3) Records 

documentation and 

monitoring of CCP's 

and Critical Limits 

Yes 0.73% 0.10% 7.56 1.13E-06 

4.1.7 Salmonella in Intact Pork 

There are 87 establishments with Intact Pork Salmonella testing data, of which 32 establishments 

had 215 Salmonella positives and 55 establishments did not have Salmonella positives. There 

were 2,070 total Intact Pork Salmonella tests performed. 

Table 4-8 presents the 9 regulations that had more than 30 verifications in a year, an odds ratio of 

3.0 or greater, and for which there is an 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 3 

23 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

months before an Intact Pork Salmonella positive is higher than the average noncompliance rate 

for establishments with no Intact Pork Salmonella positive for CY2020. 

Table 4-8 Comparison of Noncompliance Rates 3 Months before an Intact Pork Salmonella 

Positive with Those for Establishments with No Intact Pork Salmonella Positive 

Regulation 

Verified Description 

On 

FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 Months 

before a 

Salmonella Positive 

Noncompliance 

Rate for 

Establishments 

with no Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

416.1 

Operate in a 

manner to prevent 

insanitary 

conditions 

Yes 2.54% 0.70% 3.71 8.06E-20 

416.14 

Evaluate 

effectiveness of 

SSOP's & 

maintain plan 

Yes 1.18% 0.26% 4.56 1.25E-28 

416.16(a) 

Daily records 

required, 

responsible 

individual, 

initialed and dated 

Yes 0.36% 0.10% 3.52 1.94E-13 

416.3(b) 

Constructed, 

located & 

operated in a 

manner that does 

not deter 

inspection 

Yes 1.12% 0.10% 11.05 3.57E-03 

416.3(c) 

Receptacles for 

storing inedible 

material must 

identify permitted 

use 

Yes 2.84% 0.95% 3.05 7.95E-05 

416.4(a) 

Food contact 

surface, cleaning 

& sanitizing as 

frequency 

Yes 13.08% 4.12% 3.50 1.43E-45 

417.3(b)(4) Reassessment Yes 5.28% 1.19% 4.65 1.17E-02 

417.3(c) Document 

corrective actions Yes 17.39% 1.30% 16.00 9.50E-03 

418.2 

Notification of 

adulterated or 

misbranded 

product in 

commerce 

Yes 50.00% 7.69% 12.00 3.29E-02 

24 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.1.8 Salmonella in Comminuted Pork 

There are 299 establishments with Comminuted Pork Salmonella testing data, of which 146 

establishments had 1,340 Salmonella positives and 153 establishments did not have Salmonella 

positives. There were 6,196 total Comminuted Pork Salmonella tests performed. 

Table 4-9 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 an 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 3 months before a Comminuted Pork Salmonella positive is higher than the 

average noncompliance rate for establishments with no Comminuted Pork Salmonella positive 

for CY2020. 

Table 4-9 Comparison of Noncompliance Rates 3 Months before a Comminuted Pork 

Salmonella Positive with those for Establishments with No Comminuted Pork Salmonella 

Positive 

Regulation 

Verified Description 

On 

FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 Months 

before a 

Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

301.2_Adulterated Adulterated Yes 66.85% 35.71% 3.63 3.79E-02 

310.18(c) 

Written 

procedures to 

prevent 

contamination; 

all swine 

slaughter 

No 1.74% 0.17% 10.49 1.73E-03 

310.22(c) Disposal of SRM Yes 12.41% 0.11% 125.87 4.96E-52 

310.22(e)(3) 

Evaluate 

effectiveness of 

procedures for 

removal, 

segregation, and 

disposition of 

SRMs 

Yes 39.89% 0.49% 136.05 4.34E-27 

416.1 

Operate in a 

manner to 

prevent insanitary 

conditions 

Yes 2.37% 0.59% 4.11 1.44E-56 

25 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.1.9 Salmonella in Chicken Parts 

There are 473 establishments with Chicken Parts Salmonella testing data, of which 361 

establishments had 1,103 Salmonella positives and 112 establishments did not have Salmonella 

positives. There were 13,856 total Chicken Parts Salmonella tests performed. 

Table 4-10 presents the 8 regulations that had more than 30 verifications in a year, an odds ratio 

of 3.0 or greater, and for which there is an 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 3 months before an Chicken Parts Salmonella positive is higher than the average 

noncompliance rate for establishments with no Chicken Parts Salmonella positive for CY2020. 

Table 4-10 Comparison of Noncompliance Rates 3 Months before a Chicken Parts 

Salmonella Positive with Those for Establishments with No Chicken Parts Salmonella 

Positive 

Regulation 

Verified Description 

On FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

Two-Sided 

Fisher 

Exact p 

Value 

381.76(b)(6)(ii)(D) 

Ready-to-Cook 

verification in 

NPIS 

Yes 4.00% 0.27% 15.28 2.86E-05 

416.13(a) Conduct preop procedures Yes 10.28% 3.25% 3.41 1.14E-178 

416.13(b) 

Conduct other 

procedures 

listed in the 

plan 

Yes 0.83% 0.20% 4.30 4.92E-56 

416.14 

Evaluate 

effectiveness 

of SSOP's & 

maintain plan 

Yes 0.83% 0.25% 3.28 4.34E-35 

417.3(a)(3) 

Establish 

measures to 

prevent 

recurrence 

Yes 7.27% 1.19% 6.51 3.08E-06 

417.3(b)(3) 

No adulterated 

product enters 

commerce 

Yes 1.03% 0.24% 4.30 2.75E-02 

417.3(b)(4) Reassessment Yes 2.90% 0.21% 13.92 2.23E-07 

417.5(a)(2) Written 

HACCP plan Yes 0.56% 0.05% 11.82 1.75E-44 

26 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.1.10 Salmonella in Siluriformes 

There are 74 establishments with Siluriformes Salmonella testing data, of which 21 

establishments had 23 Salmonella positives and 53 establishments did not have Salmonella 

positives. There were 590 total Siluriformes Salmonella tests performed. 

There were no regulations that had more than 30 verifications in a year, an odds ratio of 3.0 or 

greater, and for which there is an 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 

3 months before a Siluriformes Salmonella positive is higher than the average noncompliance 

rate for establishments with no Siluriformes Salmonella positive for CY2020. 

4.1.11 Salmonella in RTE 

There are 2,199 establishments with RTE Salmonella testing data, of which 3 establishments had 

3 Salmonella positives and 2,196 establishments did not have Salmonella positives. There were 

14,018 total RTE Salmonella tests performed. 

There were no 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 an 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 3 months before an RTE Salmonella positive is higher than the average 

noncompliance rate for establishments with no RTE Salmonella positives for CY2020. 

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), MT54 (components and other trim), MT55 (bench trim) and MT60 (beef or veal trim). The 

dataset used in the analysis consists of candidate PHR noncompliance rates for the 1,372 

establishments with E. coli O157:H7 testing data, of which 22 establishments had 22 E. coli 

O157:H7 positives and 1,350 establishments did not have E. coli O157:H7 positives. There were 

17,134 total E. coli O157:H7 tests performed. 

Table 4-11 presents the 12 regulations that had more than 30 verifications in a year, an odds ratio 

of 3.0 or greater, and there is an 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 3 months 

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

establishments with no E. coli O157:H7 positive for CY2020. 

27 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Table 4-11 Comparison of Noncompliance Rates 3 Months before an E. coli O157:H7 

Positive with Those for Establishments with E. coli O157:H7 Positive 

Regulation 

Verified Description 

On 

FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 

Months before a 

E. coli O157:H7 

Positive 

Noncompliance 

Rate for 

Establishments 

with no E. coli 

O157:H7 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

301.2_Adulterated Adulterated Yes 66.67% 5.37% 35.21 8.56E-03 

310.22(e)(1) 

Written procedures for 

removal, segregation, 

and disposition of 

SRMs 

Yes 19.35% 3.06% 7.59 3.37E-04 

310.22(e)(3) 

Evaluate effectiveness 

of procedures for 

removal, segregation, 

and disposition of 

SRMs 

Yes 10.34% 2.29% 4.93 2.90E-02 

416.13(c) 

Plant monitors 

implementation of 

SSOP procedures 

Yes 3.45% 1.08% 3.26 2.19E-20 

416.14 

Evaluate effectiveness 

of SSOP's & maintain 

plan 

Yes 0.67% 0.17% 3.88 3.78E-04 

416.15(a) Appropriate corrective 

actions Yes 10.00% 2.07% 5.26 3.92E-03 

416.15(b) Corrective action, 

procedures for Yes 30.77% 5.00% 8.44 3.19E-03 

416.4(d) 

Product processing, 

handling, storage, 

loading, unloading, 

and during 

transportation must be 

protected 

Yes 25.23% 5.22% 6.12 1.06E-32 

417.2(c) Contents of HACCP 

Plan Yes 6.25% 0.26% 25.76 4.21E-02 

417.2(c)(4) List of procedures & 

frequency Yes 1.16% 0.31% 3.71 1.28E-06 

417.3(a)(2) CCP is under control Yes 3.28% 0.38% 8.79 2.38E-02 

417.4(a) 

Adequacy of HACCP 

in controlling food 

safety hazards 

Yes 40.00% 3.48% 18.47 1.17E-02 

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 MT55 (bench trim) 

and 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 483 establishments with Non-O157 

STEC testing data, of which 17 establishments had 18 Non- O157 STEC positives and 466 

28 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

establishments did not have Non-O157 STEC positives. There were 3,919 total Non-O157 STEC 

tests performed. 

Table 4-12 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 an 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 3 months before an Non-O157 STEC positive is higher than the average 

noncompliance rate for establishments with no Non-O157 STEC positive for CY2020. 

Table 4-12 Comparison of Noncompliance Rates 3 Months before a Non-O157 STEC 

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

Regulation 

Verified Description 

On 

FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 

Months before a 

Non-O157 

STEC Positive 

Noncompliance 

Rate for 

Establishments 

with no NonO157 STEC 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

310.22(c) Disposal of SRM Yes 2.38% 0.71% 3.41 1.87E-02 

310.3 Carcasses and parts in certain 

instances to be retained. Yes 38.89% 14.72% 3.69 1.18E-02 

416.6 

Only FSIS program 

employee may remove "U.S. 

Rejected" tag 

Yes 75.00% 6.09% 46.24 1.16E-03 

4.3 Listeria monocytogenes 

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

regulations and Listeria monocytogenes. The dataset used in the analysis consists of candidate 

PHR noncompliance rates for the 2,199 establishments with Listeria monocytogenes testing data, 

of which 24 establishments had 25 Listeria monocytogenes positives and 2,175 establishments 

did not have Listeria monocytogenes positives. There were 14,019 total Listeria monocytogenes 

tests performed. 

Table 4-13 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 regulation in the 3 months 

before a Listeria monocytogenes positive is higher than the noncompliance rate for 

establishments with no Listeria monocytogenes positive for CY2020. 

29 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Table 4-13 Comparison of Noncompliance Rates 3 Months before a Listeria monocytogenes 

Positive with Those for Establishments with No Listeria monocytogenes Positive 

Regulation 

Verified Description 

On 

FY2021 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a Listeria 

monocytogenes 

Positive 

Noncompliance 

Rate for 

Establishments 

with no Listeria 

monocytogenes 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

381.65(f) Procedures for controlling 

visible fecal contamination No 2.54% 0.81% 3.21 4.52E-07 

416.14 Evaluate effectiveness of 

SSOP's & maintain plan Yes 0.96% 0.14% 6.84 1.52E-08 

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 593 establishments with Campylobacter testing data, of which 

455 establishments had 4,388 Campylobacter positives and 138 establishments did not have 

Campylobacter positives. There were 28,934 total Campylobacter tests performed. 

Table 4-14 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 the 3 months 

before a Campylobacter positive is higher than the noncompliance rate for establishments with 

no Campylobacter positive for CY2020. 

Table 4-14 Comparison of Noncompliance Rates 3 Months before a Campylobacter Positive 

with Those for Establishments with No Campylobacter Positive 

Regulation 

Verified Description 

On 

FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a 

Campylobacter 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

318.2(a) 

All products subject 

to reinspection by 

program employees 

Yes 5.36% 0.09% 63.96 2.63E-17 

381.65(a) 

Clean and sanitary 

practices; products 

not adulterated 

Yes 1.74% 0.48% 3.68 1.94E-07 

381.65(g) 

Procedures for 

controlling 

contamination 

throughout the 

slaughter and 

dressing operation 

Yes 1.16% 0.29% 4.02 9.26E-07 

30 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation 

Verified Description 

On 

FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 

Months 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 0.55% 0.04% 12.65 8.49E-05 

416.1 

Operate in a manner 

to prevent insanitary 

conditions 

Yes 2.99% 0.89% 3.42 1.85E-63 

416.13(b) 

Conduct other 

procedures listed in 

the plan 

Yes 0.70% 0.09% 7.50 2.33E-89 

416.14 

Evaluate 

effectiveness of 

SSOP's & maintain 

plan 

Yes 1.06% 0.18% 5.85 1.86E-96 

416.16(a) 

Daily records 

required, responsible 

individual, initialed 

and dated 

Yes 0.45% 0.11% 4.21 4.13E-61 

416.3(b) 

Constructed, located 

& operated in a 

manner that does not 

deter inspection 

Yes 5.89% 0.56% 11.11 1.21E-32 

416.3(c) 

Receptacles for 

storing inedible 

material must 

identify permitted 

use 

Yes 8.07% 2.20% 3.90 4.96E-20 

417.2(c)(4) List of procedures & 

frequency Yes 1.40% 0.18% 7.77 3.92E-139 

4.4.1 Campylobacter in Intact Chicken 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 206 

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

1,931 Campylobacter positives and 4 establishments did not have Campylobacter positives. 

There were 9,687 total Intact Chicken Campylobacter tests performed. 

Table 4-15 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 regulation in the 3 months 

before a Campylobacter positive is higher than the noncompliance rate for establishments with 

no Campylobacter positive for CY2020. 

31 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Table 4-15 Comparison of Noncompliance Rates 3 Months before a Campylobacter Intact 

Chicken Positive with Those for Establishments with No Campylobacter Intact Chicken 

Positive 

Regulation 

Verified Description 

On FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 

Months before a 

Campylobacter 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

416.14 Evaluate effectiveness of 

SSOP's & maintain plan Yes 1.15% 0.23% 4.99 4.91E-05 

417.2(c)(4) List of procedures & 

frequency Yes 1.51% 0.13% 11.77 1.17E-11 

4.4.2 Campylobacter in Intact Turkey 

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

establishments with Intact Turkey Campylobacter testing data, of which 19 establishments had 

32 Campylobacter positives and 23 establishments did not have Campylobacter positives. There 

were 1,727 total Intact Turkey Campylobacter tests performed. 

Table 4-16 presents the 8 regulation 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 the 3 months 

before an Intact Turkey Campylobacter positive is higher than the noncompliance rate for 

establishments with no Intact Turkey Campylobacter positive for CY2020. 

Table 4-16 Comparison of Noncompliance Rates 3 Months before a Campylobacter Intact 

Turkey Positive with Those for Establishments with No Campylobacter Intact Turkey 

Positive 

Regulation 

Verified Description 

On 

FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 

Months 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 0.72% 0.08% 8.62 9.06E-04 

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

verification in NPIS Yes 13.54% 4.70% 3.18 1.71E-02 

381.91(b) 

Reprocessing of 

carcasses accidentally 

contaminated with 

digestive tract 

contents. 

Yes 5.23% 1.14% 4.78 3.26E-04 

32 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation 

Verified Description 

On 

FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a 

Campylobacter 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

416.3(b) 

Constructed, located 

& operated in a 

manner that does not 

deter inspection 

Yes 6.74% 1.60% 4.46 9.75E-03 

417.3(a)(1) Identify and eliminate 

the cause Yes 44.44% 2.20% 35.63 9.20E-20 

417.3(a)(2) CCP is under control Yes 5.37% 0.42% 13.61 5.44E-15 

417.3(a)(3) Establish measures to 

prevent recurrence Yes 51.72% 5.59% 18.09 2.86E-16 

417.3(c) Document corrective 

actions Yes 15.00% 1.03% 16.91 2.34E-03 

4.4.3 Campylobacter in Comminuted Chicken 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 91 

establishments with Comminuted Chicken Campylobacter testing data, of which 44 

establishments had 163 Campylobacter positives and 47 establishments did not have 

Campylobacter positives. There were 2,097 total Comminuted Chicken Campylobacter tests 

performed. 

Table 4-17 presents the 8 regulations that had more than 30 verifications in a year, an odds ratio 

of 3.0 or greater, and for which there is an 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 3 months before a Comminuted Chicken Campylobacter positive is higher than 

the average noncompliance rate for establishments with no Comminuted Chicken Campylobacter 

positive for CY2020. 

Table 4-17 Comparison of Noncompliance Rates 3 Months before a Comminuted Chicken 

Campylobacter Positive with Those for Establishments with No Comminuted Chicken 

Campylobacter Positive 

Regulation 

Verified Description 

On 

FY2021 

PHR 

List 

Noncompliance 

Rate in 3 

Months before a 

Campylobacter 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

381.65(a) 

Clean and sanitary 

practices; products not 

adulterated 

Yes 2.27% 0.40% 5.81 4.25E-03 

33 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation 

Verified Description 

On 

FY2021 

PHR 

List 

Noncompliance 

Rate in 3 

Months 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 2.90% 0.31% 9.46 2.11E-14 

416.13(b) Conduct other procedures 

listed in the plan Yes 1.26% 0.28% 4.49 7.01E-28 

416.14 Evaluate effectiveness of 

SSOP's & maintain plan Yes 1.84% 0.46% 4.02 2.69E-29 

416.3(b) 

Constructed, located & 

operated in a manner that 

does not deter inspection 

Yes 12.87% 0.52% 27.98 3.49E-10 

416.4(a) 

Food contact surface, 

cleaning & sanitizing as 

frequency 

Yes 48.54% 16.73% 4.69 3.03E-114 

416.4(d) 

Product processing, 

handling, storage, 

loading, unloading, and 

during transportation 

must be protected 

Yes 40.77% 17.87% 3.16 2.67E-71 

417.5(a)(2) Written HACCP plan Yes 0.73% 0.07% 11.01 1.08E-21 

4.4.4 Campylobacter in Comminuted Turkey 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 49 

establishments with Comminuted Turkey Campylobacter testing data, of which 15 

establishments had 42 Campylobacter positives and 34 establishments did not have 

Campylobacter positives. There were 1,517 total Comminuted Turkey Campylobacter tests 

performed. 

Table 4-18 presents the 7 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 an 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 3 months before a Comminuted Turkey Campylobacter positive is higher than the 

average noncompliance rate for establishments with no Comminuted Turkey Campylobacter 

positive for CY2020. 

34 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Table 4-18 Comparison of Noncompliance Rates 3 Months before a Comminuted Turkey 

Campylobacter Positive with those for Establishments with No Comminuted Turkey 

Campylobacter Positive 

Regulation 

Verified Description 

On 

FY2021 

PHR 

List 

Noncompliance 

Rate in 3 Months 

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 12.65% 4.00% 3.47 4.25E-35 

416.13(b) 

Conduct other 

procedures listed in the 

plan 

Yes 0.72% 0.18% 4.10 6.13E-09 

416.13(c) 

Plant monitors 

implementation of 

SSOP procedures 

Yes 5.40% 1.78% 3.15 6.32E-57 

416.3(b) 

Constructed, located & 

operated in a manner 

that does not deter 

inspection 

Yes 4.79% 0.99% 5.03 4.47E-03 

416.3(c) 

Receptacles for storing 

inedible material must 

identify permitted use 

Yes 10.58% 3.41% 3.35 4.52E-04 

417.5(a)(3) 

Records documentation 

and monitoring of CCP's 

and Critical Limits 

Yes 0.78% 0.24% 3.31 1.34E-08 

417.5(f) Official Review Yes 1.53% 0.11% 13.52 1.74E-03 

4.4.5 Campylobacter in Chicken Parts 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 473 

establishments with Chicken Parts Campylobacter testing data, of which 379 establishments had 

2,193 Campylobacter positives and 94 establishments did not have Campylobacter positives. 

There were 13,805 total Chicken Parts Campylobacter tests performed. 

Table 4-19 presents the 13 regulations which had more than 30 verifications in a year, an odds 

ratio of 3.0 or greater, and for which there is an 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 3 months before an Chicken Parts Campylobacter positive is higher than the 

average noncompliance rate for establishments with no Chicken Parts Campylobacter positive 

for CY2020. 

35 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Table 4-19 Comparison of Noncompliance Rates 3 Months before a Chicken Parts 

Campylobacter Positive with Those for Establishments with No Chicken Parts 

Campylobacter Positive 

Regulation 

Verified Description 

On FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 Months 

before a 

Campylobacter 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

381.65(a) 

Clean and sanitary 

practices; products not 

adulterated 

Yes 1.78% 0.58% 3.10 7.23E-04 

416.13(a) Conduct pre-op 

procedures Yes 9.43% 1.59% 6.46 2.09E-239 

416.13(b) Conduct other procedures 

listed in the plan Yes 0.68% 0.07% 9.23 1.05E-63 

416.14 Evaluate effectiveness of 

SSOP's & maintain plan Yes 0.93% 0.15% 6.23 2.55E-59 

416.15(b) Corrective action, 

procedures for Yes 10.03% 3.25% 3.32 1.11E-04 

416.16(a) 

Daily records required, 

responsible individual, 

initialed and dated 

Yes 0.42% 0.11% 3.73 2.40E-34 

416.3(b) 

Constructed, located & 

operated in a manner that 

does not deter inspection 

Yes 4.91% 0.86% 5.94 9.69E-12 

416.3(c) 

Receptacles for storing 

inedible material must 

identify permitted use 

Yes 6.85% 2.25% 3.19 3.00E-08 

416.4(a) 

Food contact surface, 

cleaning & sanitizing as 

frequency 

Yes 23.95% 6.93% 4.23 3.03E-160 

416.4(d) 

Product processing, 

handling, storage, 

loading, unloading, and 

during transportation must 

be protected 

Yes 28.18% 7.98% 4.53 1.27E-204 

417.2(c)(4) List of procedures & 

frequency Yes 1.31% 0.09% 15.17 2.58E-105 

417.3(b)(4) Reassessment Yes 1.16% 0.25% 4.61 2.00E-02 

417.5(a)(2) Written HACCP plan Yes 0.33% 0.09% 3.54 5.11E-13 

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. Plant management does 

not have to be notified in advance. When a deficiency does not pose an imminent threat to public 

36 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

health, a Notice of Intended Enforcement (NOIE) is issued to a plant indicating that FSIS is 

considering withholding the marks of inspection or suspending the assignment of inspectors if 

not corrected. The plant is requested to provide immediate corrective action and to specify 

preventive measures to prevent recurrence. FSIS determines further action based on the response 

provided. Only public health related NOIEs or suspensions are included in this analysis. These 

are NOIEs or suspensions that result 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 FY2022 PHRs. The enforcement action list consists of candidate 9 CFR 

regulations in which noncompliances occurs at a more frequent rate in establishments in the 3-

month period prior to an NOIE or suspension than in establishments without an NOIE or 

suspension for CY2020. The dataset used in the analysis consists of candidate PHR 

noncompliance rates for the 5,588 active meat and poultry establishments, of which 99 

establishments had 113 enforcement actions and 5,489 establishments did not have any 

enforcement actions. 

Table 4-20 presents the 41 regulations which 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 the 3 

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

with no enforcement action for CY2020. 

Table 4-20 Comparison of Noncompliance Rates 3 Months before an Enforcement Action 

with Those for Establishments with No Enforcement Action 

Regulation 

Verified Description 

On FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

an 

Enforcement 

Action 

Noncompliance 

Rate for 

Establishments 

with no 

Enforcement 

Action 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

301.2_Adulterated Adulterated Yes 94.12% 3.20% 484.13 4.49E-23 

310.18(a) 

Carcasses, organs, 

and other parts 

handled in a sanitary 

manner 

Yes 4.89% 1.54% 3.29 3.92E-41 

310.22(c) Disposal of SRM Yes 2.72% 0.54% 5.20 1.97E-05 

310.22(e)(1) 

Written procedures 

for removal, 

segregation, and 

disposition of SRMs 

Yes 12.82% 2.47% 5.80 2.74E-05 

310.22(e)(3) 

Evaluate 

effectiveness of 

procedures for 

removal, 

Yes 8.70% 2.17% 4.30 1.83E-02 

37 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation 

Verified Description 

On FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

an 

Enforcement 

Action 

Noncompliance 

Rate for 

Establishments 

with no 

Enforcement 

Action 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

segregation, and 

disposition of SRMs 

310.22(f)(2) 

Use of routine 

operational 

sanitation 

procedures on 

equipment used to 

cut through SRMs 

Yes 1.53% 0.25% 6.31 4.56E-02 

310.25(a) 

Verification criteria 

for E. coli testing 

meat 

Yes 8.39% 0.92% 9.91 6.32E-16 

310.3 

Carcasses and parts 

in certain instances 

to be retained. 

Yes 38.10% 9.02% 6.21 3.38E-04 

318.2(a) 

All products subject 

to reinspection by 

program employees 

Yes 3.37% 0.13% 26.98 2.52E-04 

416.1 

Operate in a manner 

to prevent insanitary 

conditions 

Yes 10.28% 0.90% 12.60 3.08E145 

416.13(a) Conduct pre-op 

procedures Yes 6.41% 1.98% 3.39 1.71E-42 

416.13(b) 

Conduct other 

procedures listed in 

the plan 

Yes 1.29% 0.19% 6.93 4.30E-44 

416.13(c) 

Plant monitors 

implementation of 

SSOP procedures 

Yes 5.37% 1.53% 3.66 7.05E136 

416.15(a) Appropriate 

corrective actions Yes 19.88% 1.92% 12.69 9.82E-23 

416.15(b) Corrective action, 

procedures for Yes 43.59% 3.12% 24.00 4.13E-30 

416.16(a) 

Daily records 

required, 

responsible 

individual, initialed 

and dated 

Yes 0.61% 0.13% 4.67 4.85E-23 

416.3(b) 

Constructed, located 

& operated in a 

manner that does 

not deter inspection 

Yes 6.13% 0.66% 9.80 1.98E-07 

416.3(c) 

Receptacles for 

storing inedible 

material must 

identify permitted 

use 

Yes 12.23% 1.38% 9.96 1.55E-11 

38 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation 

Verified Description 

On FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

an 

Enforcement 

Action 

Noncompliance 

Rate for 

Establishments 

with no 

Enforcement 

Action 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

416.4(a) 

Food contact 

surface, cleaning & 

sanitizing as 

frequency 

Yes 21.63% 5.11% 5.13 6.97E-76 

416.4(d) 

Product processing, 

handling, storage, 

loading, unloading, 

and during 

transportation must 

be protected 

Yes 35.06% 7.10% 7.06 8.39E144 

416.5(c) 

Employees who 

appear to have any 

abnormal source of 

microbial 

contamination 

No 4.00% 0.05% 86.41 1.28E-02 

417.2(a)(1) Hazard analysis Yes 16.13% 0.96% 19.93 2.18E-52 

417.2(c) Contents of HACCP 

Plan Yes 20.45% 0.21% 123.52 1.04E-15 

417.2(c)(4) List of procedures & 

frequency Yes 2.36% 0.43% 5.57 7.68E-47 

417.3(a)(1) Identify and 

eliminate the cause Yes 66.67% 5.47% 34.57 2.12E-13 

417.3(a)(2) CCP is under 

control Yes 2.84% 0.48% 6.11 7.62E-08 

417.3(a)(3) 

Establish measures 

to prevent 

recurrence 

Yes 79.31% 9.62% 36.01 1.63E-18 

417.3(b)(2) 

Determine the 

acceptability of the 

affected product 

Yes 50.00% 2.46% 39.57 3.10E-04 

417.3(b)(4) Reassessment Yes 6.10% 0.53% 12.27 8.73E-05 

417.3(c) Document 

corrective actions Yes 42.86% 5.09% 13.98 3.99E-05 

417.4(a) 

Adequacy of 

HACCP in 

controlling food 

safety hazards 

Yes 90.91% 2.30% 424.59 1.65E-30 

417.4(a)(1) Initial validation No 80.00% 5.82% 64.79 8.35E-13 

417.5(a)(1) Written hazard 

analysis Yes 1.92% 0.25% 7.94 3.50E-53 

417.5(a)(2) Written HACCP 

plan Yes 0.86% 0.10% 8.80 6.48E-24 

417.5(a)(3) 

Records 

documentation and 

monitoring of CCP's 

and Critical Limits 

Yes 1.19% 0.22% 5.58 8.27E-26 

39 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation 

Verified Description 

On FY 

2021 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

an 

Enforcement 

Action 

Noncompliance 

Rate for 

Establishments 

with no 

Enforcement 

Action 

Odds 

Ratio 

TwoSided 

Fisher 

Exact p 

Value 

418.2 

Notification of 

adulterated or 

misbranded product 

in commerce 

Yes 23.53% 5.49% 5.30 1.31E-02 

418.3 Recall Plans No 2.94% 0.18% 16.85 7.33E-03 

430.4(a) Lm, post-lethality 

exposed RTE Yes 0.31% 0.02% 12.80 1.15E-02 

430.4(b)(2) 

Alternative 2: The 

establishment uses a 

PLT to reduce or 

eliminate Lm in the 

product or the 

establishment uses 

an AMAP to limit or 

suppress growth of 

Lm in the product. 

No 12.50% 0.35% 40.36 2.84E-02 

430.4(c)(3) 

Lm, maintain 

sanitation in postlethality processing 

environment 

Yes 0.32% 0.05% 6.17 4.34E-02 

430.4(c)(6) 

Lm, prerequisite 

program 

requirements 

No 50.00% 0.77% 129.24 1.57E-02 

40 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5.0 LIST OF FY2022 PHRS 

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

PHRs into a single FY2022 PHR list. Table 5-1 presents the complete list of the 62 FY2022 

PHRs. These 62 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 3 months 

before Salmonella, E. coli O157:H7, Non-O157 STEC, Lm, Campylobacter positives or 

enforcement actions than in establishments with no positives or enforcement actions. 

The 62 FY2022 PHRs are composed of 9 regulations and 54 provisions of regulations. The 62 

FY2022 PHRs represent 29 regulations, with the majority of FY2022 PHRs being provisions of 

regulations that provide greater specificity as to the nature of the noncompliance associated with 

a regulation violation. 

Table 5-1 List of FY2022 PHRs 

Regulation 

Verified Description 

On FY 

2021 

PHR 

List 

Average Odds 

Ratio 

Average of 

Two-Sided 

Fisher Exact p 

Value 

301.2_Adulterated Adulterated Yes 94.05 1.59E-02 

310.18(a) Carcasses, organs, and other parts 

handled in a sanitary manner 

Yes 3.66 5.93E-03 

310.18(c) Written procedures to prevent 

contamination; all swine slaughter 

No 8.18 8.65E-04 

310.18(d) Daily records sufficient to document the 

implementation and monitoring of 

contamination control procedures 

No 19.23 1.73E-15 

310.22(b) Inedible and prohibited SRM for use as 

human food 

Yes 24.89 3.58E-05 

310.22(c) Disposal of SRM Yes 32.71 3.75E-03 

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

segregation, and disposition of SRMs 

Yes 5.6 8.26E-05 

310.22(e)(2) Appropriate corrective actions Yes 18.55 2.32E-02 

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

removal, segregation, and disposition of 

SRMs 

Yes 36.03 9.47E-03 

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

procedures on equipment used to cut 

through SRMs 

Yes 8.9 1.72E-02 

310.25(a) Verification criteria for E. coli testing 

meat 

Yes 9.91 6.32E-16 

310.3 Carcasses and parts in certain instances 

to be retained. 

Yes 4.95 6.05E-03 

316.6 Products not to be removed from official 

establishments unless marked in 

accordance with the regulations 

No 8.98 2.40E-04 

41 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation 

Verified Description 

On FY 

2021 

PHR 

List 

Average Odds 

Ratio 

Average of 

Two-Sided 

Fisher Exact p 

Value 

318.1(b) Only inspected and passed poultry 

product to enter official establishment 

No 38.92 4.96E-02 

318.2(a) All products subject to reinspection by 

program employees 

Yes 35.05 1.10E-03 

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

Program employees only 

Yes 42 1.82E-04 

381.193(a) Poultry not intended for human food in 

commerce 

No 12.09 1.40E-03 

381.65(a) Clean and sanitary practices; products 

not adulterated 

Yes 4.47 1.24E-03 

381.65(f) Procedures for controlling visible fecal 

contamination 

No 4.24 5.80E-05 

381.65(g) Procedures for controlling 

contamination throughout the slaughter 

and dressing operation 

Yes 6.56 2.84E-03 

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

Reprocessing 

Yes 10.63 4.95E-04 

381.76(b)(6)(ii)(D) Ready-to-Cook verification in NPIS Yes 6.89 4.29E-03 

381.91(b) Reprocessing of carcasses accidentally 

contaminated with digestive tract 

contents. 

Yes 6.18 6.34E-03 

416.1 Operate in a manner to prevent 

insanitary conditions 

Yes 5.2 1.34E-20 

416.12(d) Plan list frequency for each procedure & 

responsible individual 

No 40.81 2.21E-05 

416.13(a) Conduct pre-op procedures Yes 5.02 5.64E-34 

416.13(b) Conduct other procedures listed in the 

plan 

Yes 5.67 1.17E-07 

416.13(c) Plant monitors implementation of SSOP 

procedures 

Yes 4.55 3.65E-21 

416.14 Evaluate effectiveness of SSOP's & 

maintain plan 

Yes 4.77 4.75E-05 

416.15(a) Appropriate corrective actions Yes 6.57 9.79E-04 

416.15(b) Corrective action, procedures for Yes 8.84 5.51E-04 

416.16(a) Daily records required, responsible 

individual, initialed and dated 

Yes 5.39 1.32E-07 

416.3(b) Constructed, located & operated in a 

manner that does not deter inspection 

Yes 8.9 2.82E-03 

416.3(c) Receptacles for storing inedible material 

must identify permitted use 

Yes 4.99 7.60E-05 

416.4(a) Food contact surface, cleaning & 

sanitizing as frequency 

Yes 5.63 2.11E-34 

42 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation 

Verified Description 

On FY 

2021 

PHR 

List 

Average Odds 

Ratio 

Average of 

Two-Sided 

Fisher Exact p 

Value 

416.4(d) Product processing, handling, storage, 

loading, unloading, and during 

transportation must be protected 

Yes 5.51 3.02E-33 

416.5(c) Employees who appear to have any 

abnormal source of microbial 

contamination 

No 46.62 2.86E-02 

416.6 Only FSIS program employee may 

remove "U.S. Rejected" tag 

Yes 16.85 8.27E-03 

417.2(a)(1) Hazard analysis Yes 9.86 8.32E-06 

417.2(c) Contents of HACCP Plan Yes 74.64 2.11E-02 

417.2(c)(4) List of procedures & frequency Yes 8.56 2.69E-07 

417.3(a)(1) Identify and eliminate the cause Yes 19.87 2.14E-03 

417.3(a)(2) CCP is under control Yes 6.94 3.99E-03 

417.3(a)(3) Establish measures to prevent recurrence Yes 13.24 6.22E-04 

417.3(a)(4) No adulterated product enters 

commerce. 

No 12.82 7.52E-08 

417.3(b)(1) Segregate and hold the affected product Yes 7.97 3.60E-02 

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

affected product 

Yes 39.57 3.10E-04 

417.3(b)(3) No adulterated product enters commerce Yes 10.51 9.19E-03 

417.3(b)(4) Reassessment Yes 8.78 6.43E-03 

417.3(c) Document corrective actions Yes 25.41 2.42E-03 

417.4(a) Adequacy of HACCP in controlling 

food safety hazards 

Yes 185.02 3.25E-03 

417.4(a)(1) Initial validation No 34.82 9.19E-03 

417.5(a)(1) Written hazard analysis Yes 5.06 4.91E-19 

417.5(a)(2) Written HACCP plan Yes 6.73 5.82E-05 

417.5(a)(3) Records documentation and monitoring 

of CCP's and Critical Limits 

Yes 5.48 3.82E-07 

417.5(f) Official Review Yes 13.52 1.74E-03 

418.2 Notification of adulterated or 

misbranded product in commerce 

Yes 59.26 1.44E-02 

418.3 Recall Plans No 16.85 7.33E-03 

430.4(a) Lm, post-lethality exposed RTE Yes 12.8 1.15E-02 

430.4(b)(2) Alternative 2: The establishment uses a 

PLT to reduce or eliminate Lm in the 

product or the establishment uses an 

AMAP to limit or suppress growth of 

Lm in the product. 

No 40.36 2.84E-02 

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

processing environment 

Yes 6.17 4.34E-02 

430.4(c)(6) Lm, prerequisite program requirements No 129.24 1.57E-02 

43 
 

 

 

 

 

 

 

 

Forty-nine of the previous 56 FY2021 PHRs are included in the FY2022 PHRs. There are seven 

regulations on the FY2021 PHR list that are not in the FY2022 PHR list (See Appendix C). 

There are 13 regulations that are on the FY2022 PHR list that were not on the FY2021 PHR list. 

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

for inclusion in the FY2022 PHR list. Most regulations were triggered by multiple events. 

Similar to the FY2021 PHR list, Salmonella pathogen positives and enforcement actions 

triggered the most regulations. 

Table 5-2 Events That Triggered Inclusion of a Regulation in the FY2022 PHR List 

Product Number of Regulations 

Campylobacter 11 

Campylobacter Chicken Parts 13 

Campylobacter Ground Chicken 8 

Campylobacter Ground Turkey 7 

Campylobacter Intact Chicken 2 

Campylobacter Intact Turkey 8 

Enforcements 41 

Listeria 2 

Non-O157 E. coli 3 

O157 E. coli 12 

Salmonella 34 

Salmonella Chicken Parts 8 

Salmonella Ground Beef 12 

Salmonella Ground Chicken 7 

Salmonella Ground Pork 5 

Salmonella Ground Turkey 9 

Salmonella Intact Beef 31 

Salmonella Intact Chicken 16 

Salmonella Intact Pork 9 

Salmonella Intact Turkey 2 

Salmonella Siluriformes 0 

RTE Salmonella 0 

There were 13 regulations triggered by a single type of event: Seven were from Enforcement 

Actions, two were from Salmonella in Ground Beef, one was from Salmonella in Intact Beef, 

one was from Salmonella in Intact Chicken, one was Salmonella, and one was from 

Campylobacter in Ground Turkey. Table 5-3 presents the regulations triggered for inclusion in 

the FY2022 PHR list by only single pathogen product or enforcement action type (event). 

44 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Table 5-3 Regulations Triggered for Inclusion in the FY2022 PHR List by Only a Single 

Event 

Regulation 

Verified Description Event 

310.18(d) Daily records sufficient to document the implementation 

and monitoring of contamination control procedures 

Salmonella 

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

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

establishment 

Salmonella Ground Beef 

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

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

individual 

Salmonella Intact Beef 

417.3(b)(1) Segregate and hold the affected product Salmonella Ground Beef 

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

417.5(f) Official Review Campylobacter Ground Turkey 

418.3 Recall Plans Enforcements 

430.4(a) Lm, post-lethality exposed RTE Enforcements 

430.4(b)(2) Alternative 2: The establishment uses a PLT to reduce or 

eliminate Lm in the product or the establishment uses an 

AMAP to limit or suppress growth of Lm in the product. 

Enforcements 

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

environment 

Enforcements 

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

6.0 CUT POINTS FOR FY2022 PHRS 

The FY2022 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 FY2022 PHR does not indicate a loss of process control. The 

aggregate set of PHRs is used to identify establishments that significantly deviate from the 3-

month 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 

45 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

90-day period together into a single aggregate ratio. The aggregate FY2022 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 two non-compliances 

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 FY2022 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 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 number between zero and one 

(the non-zero PHR noncompliance rates). 

Table 6-1 Mean and Standard Deviation of Quarterly FY2022 PHR Rate 

Timeframe 

Mean of Natural Log 

FY2022PHR Rate 

Standard Deviation 

FY2022 PHR Rate 

Processing Combination Processing Combination 

Jan-Mar 2020 -4.89 -4.51 0.82 0.96 

Apr-Jun 2020 -4.72 -4.46 0.74 0.90 

July-Sept 2020 -4.99 -4.52 0.80 0.98 

Oct-Dec 2020 -5.01 -4.57 0.81 0.95 

Average -4.90 -4.51 0.79 0.95 

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 example4, the upper cut 

point for the log transformed data for Combination establishments is -4.51 + 2*0.95 = -4.51 + 

1.9 = -2.61. The cut point of the original, non-transformed PHR noncompliance data is the 

antilog of -2.61 or Exp(-2.61) = 7.33%. Establishments that are below the Upper level threshold 

but meet or exceed the Lower level threshold will be notified by inspection personnel of an 

elevated level of non-compliance. 

The PHR cut points are defined as follows for each of the two plant 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 

4 This is an illustrative example. Exact numbers may vary due to rounding. 

46 
 

 

 

 

 

 

 

 

 

 

 

continue to receive routine inspection procedures and be alerted through inspection 

personnel of elevated PHR noncompliance levels. 

• 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 6 months are 

recommended for a PHRE to determine if an FSA is appropriate. 

Tables 6-2 and 6-3 present the FY2022 PHR upper and lower cut points for each of the two 

establishment operation types. The FY2020 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 2021. 

Table 6-2 FY2022 PHR Upper Level Cut Points 

Operation 

Type 

FY2022 PHR Cut 

Points 

FY2021 PHR Cut 

Points 

FY2020 PHR Cut 

Points 

Processing 3.63% 3.73% 3.86% 

Combination 7.33% 9.84% 8.83% 

Table 6-3 FY2022 PHR Lower Level Cut Points 

Operation 

Type 

FY2022 PHR Cut 

Points 

FY2021 PHR Cut 

Points 

FY2020 PHR Cut 

Points 

Processing 2.44% 2.50% 2.58% 

Combination 4.60% 5.85% 5.42% 

Table 6-4 presents the number of establishments in each level based solely on the FY2022 PHR 

criterion and the cut points in Table 6-2. When applying the cut points to establishments with 

less than 20 verifications, establishments that qualify for the Upper level but only have one 

noncompliance are moved to the Mid level. Forty-eight establishments are in the Upper level and 

candidates to receive recommended for a for cause PHREs. Table 6-4 is based on regulatory 

noncompliances for the period January 1-March 31, 2021. 

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

Classification Number of Establishments 

Upper 48 

Mid 90 

Lower 5,179 

Total 5,317 

Table 6-5 shows the number of establishments by operation type. 

Table 6-5 Classification of Establishments Based on Operation 

Type and Only the PHR Criterion 

Classification Processing Combination 

Upper 35 13 

Mid 58 32 

Lower 4,143 1,036 

Total 4,236 1,081 

47 
 

 

 

 

 

 

 

 

 

 

 

 

7.0 CONCLUSION 

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

FY2022 PHR regulations used to prioritize certain FY2022 FSIS inspection activities. This 

process involves (1) selecting a list of candidate regulations related to food safety process 

control, selecting a subset of these regulations whose noncompliance rates are higher in 

establishments 3 months prior to a pathogen positive or enforcement action and (2) 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 FY2022 PHRs has 62 regulations whose individual noncompliance rates are higher in 

establishments 3 months before Salmonella, E. coli O157:H7, Non-O157 STEC, Listeria 

monocytogenes, Campylobacter positives or enforcement action than in establishments without 

positives or enforcement actions. Forty-nine regulations on the FY2021 PHR list are also on the 

FY2022 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 scheduled to receive a PHRE and become candidates to receive a for-cause 

FSA. FSAs are performed when the District Office determines that one is appropriate based on 

its analysis of the PHRE as described in FSIS Directive 5100.4. 

Tables 7-1 and 7-2 present the FY2022 PHR upper and lower cut points. The FY2021 PHR 

upper cut points are included for comparison although they are not directly comparable since 

they are based on different sets of PHRs. 

Table 7-1 FY2022 PHR Upper-Level Cut Points 

Operation Type FY2022 PHR Cut 

Points 

FY2021 PHR Cut 

Points 

Processing 3.63% 3.73% 

Combination 7.33% 9.84% 

Table 7-2 FY2022 PHR Lower-Level Cut Points 

Operation Type FY2022 PHR Cut 

Points 

FY2021PHR Cut 

Points 

Processing 2.44% 2.50% 

Combination 4.60% 5.85% 

48 
 

 

 

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) 2020, FY2021 Public Health Regulations. 

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

Subcommittee Two, Issue Two: Data Analysis. 

49 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

APPENDIX A: FY2022 PHR REGULATIONS 

Table A-1 presents the list of 62 FY2022 Public Health Regulations (PHRs). On average, these 

PHR regulations have noncompliance rates 3 months prior to a pathogen positive or enforcement 

action that is 18.3 times higher than the PHR noncompliance rates for establishments with no 

pathogen positive or enforcement action. 

Table A-1 List of FY2022 PHRs 

Regulation Description 

301.2_Adulterated Adulterated 

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(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(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 

310.3 Carcasses and parts in certain instances to be retained. 

316.6 Products not to be removed from official establishments unless marked in 

accordance with the regulations 

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 

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

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 

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

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

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

416.1 Operate in a manner to prevent insanitary conditions 

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

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 

50 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation Description 

416.15(b) Corrective action, procedures for 

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

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 

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

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)(2) Determine the acceptability of 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 

417.4(a)(1) Initial validation 

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 

417.5(f) Official Review 

418.2 Notification of adulterated or misbranded product in commerce 

418.3 Recall Plans 

430.4(a) Lm, post-lethality exposed RTE 

430.4(b)(2) Alternative 2: The establishment uses a PLT to reduce or eliminate Lm in the 

product or the establishment uses an AMAP to limit or suppress growth of Lm in 

the product. 

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

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

51 
 

 

 

 

 

 

 

 

 

 

 

APPENDIX B: FY2022 CANDIDATE REGULATIONS 

Table B-1 presents the list of candidate regulations. Of the 155 candidate regulations, four 

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, 2020, through December 31, 2020. 

Table B-1 FY2022 List of Candidate Regulations 

Regulation Description FY2021 

PHR 

Mandatory 

Regulation1 

Total 

Regulations 

Verified 

Total Noncompliant 

Regulations 

Verified 

PHR Noncompliance 

Rate 

301.2_Adulterated Adulterated Yes No 6,350 204 3.21% 

304.3(a) Develop written 

SSOP 

No No 531 1 0.19% 

304.3(c) Conduct hazard 

analysis & 

develop HACCP 

plan for new 

product 

No No 1,188 5 0.42% 

309.19(a) Market hog 

sorting activities 

No No 1,637 0 0.00% 

309.19(c) Sorted and 

removed hogs 

identified; 

written 

procedures 

No No 1,278 1 0.08% 

309.19(d) Records of 

animals disposed 

of per day 

No No 2,691 2 0.07% 

309.19(e) Notifiable animal 

disease 

No No 69 0 0.00% 

309.2(a) Livestock 

suspected of 

being diseased or 

affected with 

certain 

conditions; 

identifying 

suspects 

No No 342 4 1.17% 

52 
 

 

 

 

 

 

 

 

 

 

Regulation Description FY2021 

PHR 

Mandatory 

Regulation1 

Total 

Regulations 

Verified 

Total Noncompliant 

Regulations 

Verified 

PHR Noncompliance 

Rate 

309.3 (Modernized 

ONLY) Dead, 

dying, disabled 

or diseased and 

similar livestock 

No No 248 4 1.61% 

309.3(e) Establishment 

notify IPP of 

non-ambulatory 

livestock; Prompt 

condemnation 

and disposal 

No No 227 3 1.32% 

309.4 (Modernized 

ONLY) 

Livestock 

showing 

symptoms of 

metabolic, toxic, 

nervous, or 

diseases 

No No 203 1 0.49% 

309.5 (Modernized 

ONLY) Swine; 

disposal because 

of hog cholera 

No No 171 0 0.00% 

309.9 (Modernized 

ONLY) Swine 

erysipelas 

No No 174 0 0.00% 

310.18(a) Carcasses, 

organs, and other 

parts handled in a 

sanitary manner 

Yes Yes 345,676 4,456 1.29% 

310.18(b) Brains, cheek 

meat, head 

trimmings from 

animals 

slaughtered by 

gunshot 

No No 21,556 4 0.02% 

53 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation Description FY2021 

PHR 

Mandatory 

Regulation1 

Total 

Regulations 

Verified 

Total Noncompliant 

Regulations 

Verified 

PHR Noncompliance 

Rate 

310.18(c) Written 

procedures to 

prevent 

contamination; 

all swine 

slaughter 

No No 7,086 16 0.23% 

310.18(c)(1) Sampling 

locations 

No No 1,030 1 0.10% 

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

establishments 

No No 2,068 0 0.00% 

310.18(c)(2)(i) Sampling 

frequency 

No No 1,556 2 0.13% 

310.18(c)(2)(ii) Sampling 

frequency for 

very low volume 

establishments 

No No 925 1 0.11% 

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

results for 

sampling 

program 

No No 9,694 3 0.03% 

310.18(d) Daily records 

sufficient to 

document the 

implementation 

and monitoring 

of contamination 

control 

procedures 

No No 18,341 26 0.14% 

310.22(b) Inedible and 

prohibited SRM 

for use as human 

food 

Yes No 3,431 13 0.38% 

310.22(c) Disposal of SRM Yes Yes 53,355 220 0.41% 

310.22(d)(2) Exports have 

equivalent level 

of protection 

from human 

exposure to BSE 

as similar US 

products 

No No 101 0 0.00% 

54 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation Description FY2021 

PHR 

Mandatory 

Regulation1 

Total 

Regulations 

Verified 

Total Noncompliant 

Regulations 

Verified 

PHR Noncompliance 

Rate 

310.22(e)(1) Written 

procedures for 

removal, 

segregation, and 

disposition of 

SRMs 

Yes No 14,295 273 1.91% 

310.22(e)(2) Appropriate 

corrective actions 

Yes No 3,618 54 1.49% 

310.22(e)(3) Evaluate 

effectiveness of 

procedures for 

removal, 

segregation, and 

disposition of 

SRMs 

Yes No 8,910 155 1.74% 

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

records 

Yes No 78,045 175 0.22% 

310.22(f)(2) Use of routine 

operational 

sanitation 

procedures on 

equipment used 

to cut through 

SRMs 

Yes No 15,046 33 0.22% 

310.22(g)(1) Maintain positive 

control of beef 

carcasses with 

the vertebral 

columns to 

another federal 

inspected 

establishment 

No No 1,144 6 0.52% 

310.22(g)(4) Maintain records 

of official 

establishment 

showing proper 

disposition of 

vertebral 

columns 

No No 3,736 11 0.29% 

310.25(a) Verification 

criteria for E. coli 

testing meat 

Yes No 28,548 320 1.12% 

55 
 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation Description FY2021 

PHR 

Mandatory 

Regulation1 

Total 

Regulations 

Verified 

Total Noncompliant 

Regulations 

Verified 

PHR Noncompliance 

Rate 

310.25(b) Pathogen 

reduction 

performance 

standards; 

Salmonella 

No No 233 1 0.43% 

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

Failure to 

maintain 

adequate HACCP 

Plan 

No No 84 0 0.00% 

310.26(b) Carcass sorting 

and disposition 

No Yes 2,451 56 2.28% 

310.26(d)(2) Document 

number of 

carcasses 

disposed of per 

day 

No No 1,705 1 0.06% 

310.3 Carcasses and 

parts in certain 

instances to be 

retained. 

Yes No 2,655 238 8.96% 

311.14 Abrasions, 

bruises, 

abscesses, pus, 

etc. 

Yes No 26,364 9 0.03% 

311.16 (Modernized 

ONLY) 

Carcasses so 

infected that 

consumption of 

the meat may 

cause food 

poisoning. 

No No 268 29 10.82% 

311.17 (Modernized 

ONLY) 

Necrobacillosis, 

pyemia, 

septicemia. 

No No 357 0 0.00% 

311.24 (Modernized 

ONLY) Hogs 

affected with 

tapeworm cysts. 

No No 153 0 0.00% 

315.2 Carcasses and 

parts passed for 

cooking 

No No 68 0 0.00% 

56 
 

 

 

 

 

Regulation Description FY2021 

PHR 

Mandatory 

Regulation1 

Total 

Regulations 

Verified 

Total Noncompliant 

Regulations 

Verified 

PHR Noncompliance 

Rate 

316.6 Products not to 

be removed from 

official 

establishments 

unless marked in 

accordance with 

the regulations 

No No 12,736 50 0.39% 

317.24(a) Packaging 

materials 

composed of 

poisonous or 

deleterious 

substances 

No No 2,398 12 0.50% 

318.1(b) Only inspected 

and passed 

poultry product 

to enter official 

establishment 

No No 105,049 14 0.01% 

318.14(a) Product and 

ingredients 

rendered 

adulterated by 

polluted water 

shall be 

condemned 

No No 700 1 0.14% 

318.14(b) Establishment 

shall be 

thoroughly 

cleaned and 

disinfected under 

FSIS supervision 

No No 1,073 0 0.00% 

318.14(c) Hermetically 

sealed 

contaminated 

containers shall 

be 

examined/rehandl 

ed under FSIS 

supervision 

No No 368 0 0.00% 

57 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation Description FY2021 

PHR 

Mandatory 

Regulation1 

Total 

Regulations 

Verified 

Total Noncompliant 

Regulations 

Verified 

PHR Noncompliance 

Rate 

318.16(b) Pesticides, 

chemicals & 

other residues in 

products not to 

exceed FD&C 

Act levels - Meat 

ingredients 

No No 543 0 0.00% 

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

Stabilization 

requirements for 

cooked beef 

No No 2,659 1 0.04% 

318.17(b) Lethality and 

Stabilization 

processes other 

than HACCP for 

cooked beef 

No No 732 0 0.00% 

318.17(c) Validation of 

new or altered 

process schedules 

(for cooked beef) 

No No 110 0 0.00% 

318.2(a) All products 

subject to 

reinspection by 

program 

employees 

Yes No 47,103 62 0.13% 

318.2(d) Removal of U.S. 

retained by 

authorized 

Program 

employees only 

Yes No 9,407 44 0.47% 

318.23(b)(1) Time/Temperatur 

e for heatprocessing 

combinations of 

fully-cooked 

meat patties 

No No 574 2 0.35% 

318.23(b)(3) Heat deviations 

for meat patties 

No No 45 1 2.22% 

318.23(c)(1) Stabilization 

requirements for 

meat patties 

No No 411 0 0.00% 

58 
 

 

 

 

 

 

 

 

 

 

Regulation Description FY2021 

PHR 

Mandatory 

Regulation1 

Total 

Regulations 

Verified 

Total Noncompliant 

Regulations 

Verified 

PHR Noncompliance 

Rate 

318.23(c)(2) Stabilization 

processes for 

meat patties other 

than HACCP 

No No 12 0 0.00% 

318.23(c)(4) Labeling 

statement for 

partially cooked 

patties 

No No 412 0 0.00% 

318.23(c)(5) Labeling 

statement for 

char-marked 

patties 

No No 218 0 0.00% 

318.24 Product prepared 

using advanced 

meat/bone 

separation 

machinery; 

process control 

No No 2,490 12 0.48% 

318.6(b)(1) Requirements for 

use of casings, 

used as 

containers 

No No 2,095 2 0.10% 

318.6(b)(4) Detached spinal 

cords 

No No 9,783 0 0.00% 

318.6(b)(6) Tonsils No No 11,680 1 0.01% 

318.6(b)(8) Intestines as 

ingredients 

No No 348 0 0.00% 

319.5(b) Mechanically 

separated (beef) -

prohibited for use 

in human food 

No No 204 0 0.00% 

354.242(b) All equipment 

and utensils clean 

and sanitary 

No No 62 0 0.00% 

59 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation Description FY2021 

PHR 

Mandatory 

Regulation1 

Total 

Regulations 

Verified 

Total Noncompliant 

Regulations 

Verified 

PHR Noncompliance 

Rate 

354.242(h) Tools and 

equipment used 

in preparation to 

be kept clean and 

sanitary 

No No 31 0 0.00% 

354.243(a) No handling or 

storage of 

objectionable 

materials 

No No 15 0 0.00% 

381.1_Adulterated Adulterated No No 5,269 29 0.55% 

381.144(a) Packaging 

materials not to 

be composed of 

any poisonous or 

deleterious 

substance 

No No 2,181 0 0.00% 

381.150(a) Lethality and 

Stabilization 

requirements for 

cooked poultry 

No No 1,478 1 0.07% 

381.150(c) Lethality and 

Stabilization 

processes other 

than HACCP for 

cooked poultry 

No No 121 0 0.00% 

381.150(d) Validation of 

new or altered 

process schedules 

by scientifically 

supportable 

means (cooked 

poultry) 

No No 27 0 0.00% 

381.151(a) Product and 

ingredients 

rendered 

adulterated by 

polluted water 

shall be 

condemned 

No No 383 0 0.00% 

60 
 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation Description FY2021 

PHR 

Mandatory 

Regulation1 

Total 

Regulations 

Verified 

Total Noncompliant 

Regulations 

Verified 

PHR Noncompliance 

Rate 

381.193(a) Poultry not 

intended for 

human food in 

commerce 

No No 184 7 3.80% 

381.22(a) Develop written 

SSOP 

No No 228 0 0.00% 

381.22(b) Conduct hazard 

analysis & 

develop and 

validate HACCP 

plan 

No No 1,237 0 0.00% 

381.22(c) Conduct hazard 

analysis & 

develop HACCP 

plan for new 

product 

No No 527 1 0.19% 

381.37(a) Product not 

produced under 

supervision of 

program 

employee 

No No 1,845 18 0.98% 

381.65(a) Clean and 

sanitary 

practices; 

products not 

adulterated 

Yes No 34,571 245 0.71% 

381.65(f) Procedures for 

controlling 

visible fecal 

contamination 

No No 1,484,173 11,033 0.74% 

381.65(g) Procedures for 

controlling 

contamination 

throughout the 

slaughter and 

dressing 

operation 

Yes No 120,126 995 0.83% 

381.71(a) Condemnation on 

ante mortem 

inspection 

Yes No 1,389 22 1.58% 

381.72(a) Poultry No No 258 0 0.00% 

61 
 

 

 

 

 

 

 

 

Regulation Description FY2021 

PHR 

Mandatory 

Regulation1 

Total 

Regulations 

Verified 

Total Noncompliant 

Regulations 

Verified 

PHR Noncompliance 

Rate 

381.72(b) Ratites No No 2 0 0.00% 

381.76(a) Post-mortem 

inspection, when 

required, extent 

No No 10,973 176 1.60% 

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

Trimming, and 

Reprocessing 

Yes No 60,227 299 0.50% 

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

reprocessing and 

salvage 

No No 76,233 74 0.10% 

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

septicemia/toxem 

ia 

No No 1,256,847 143 0.01% 

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

verification in 

NPIS 

Yes No 3,990 249 6.24% 

381.83 Septicemia or 

toxemia 

No No 1,143,642 137 0.01% 

381.85 Special Diseases 

(organisms or 

toxins dangerous 

to the consumer) 

No No 30 0 0.00% 

381.91(a) Certain 

contaminated 

carcasses to be 

condemned 

No No 3,768 4 0.11% 

381.91(b) Reprocessing of 

carcasses 

accidentally 

contaminated 

with digestive 

tract contents. 

Yes No 11,177 175 1.57% 

381.94(a) Verification 

criteria for E. coli 

testing ratites 

No No 993 5 0.50% 

62 
 

 

 

 

 

 

 

 

 

 

 

Regulation Description FY2021 

PHR 

Mandatory 

Regulation1 

Total 

Regulations 

Verified 

Total Noncompliant 

Regulations 

Verified 

PHR Noncompliance 

Rate 

416.1 Operate in a 

manner to 

prevent 

insanitary 

conditions 

Yes Yes 607,961 5,770 0.95% 

416.12(c) Plan identifies 

procedures for 

pre-op 

Yes No 45,757 60 0.13% 

416.12(d) Plan list 

frequency for 

each procedure & 

responsible 

individual 

No No 63,333 75 0.12% 

416.13(a) Conduct pre-op 

procedures 

Yes Yes 749,910 13,611 1.82% 

416.13(b) Conduct other 

procedures listed 

in the plan 

Yes Yes 1,886,131 3,513 0.19% 

416.13(c) Plant monitors 

implementation 

of SSOP 

procedures 

Yes Yes 2,701,496 38,358 1.42% 

416.14 Evaluate 

effectiveness of 

SSOP's & 

maintain plan 

Yes Yes 1,652,069 3,642 0.22% 

416.15(a) Appropriate 

corrective actions 

Yes Yes 63,512 995 1.57% 

416.15(b) Corrective action, 

procedures for 

Yes Yes 39,458 1,040 2.64% 

416.16(a) Daily records 

required, 

responsible 

individual, 

initialed and 

dated 

Yes Yes 2,905,631 4,183 0.14% 

63 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regulation Description FY2021 

PHR 

Mandatory 

Regulation1 

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 80,649 524 0.65% 

416.3(c) Receptacles for 

storing inedible 

material must 

identify 

permitted use 

Yes No 68,457 912 1.33% 

416.4(a) Food contact 

surface, cleaning 

& sanitizing as 

frequency 

Yes No 279,852 13,687 4.89% 

416.4(d) Product 

processing, 

handling, storage, 

loading, 

unloading, and 

during 

transportation 

must be protected 

Yes No 267,088 17,608 6.59% 

416.5(c) Employees who 

appear to have 

any abnormal 

source of 

microbial 

contamination 

No No 37,002 20 0.05% 

416.6 Only FSIS 

program 

employee may 

remove "U.S. 

Rejected" tag 

Yes No 2,614 106 4.06% 

417.2(a)(1) Hazard analysis Yes Yes 127,373 1,423 1.12% 

417.2(c) Contents of 

HACCP Plan 

Yes No 30,421 79 0.26% 

417.2(c)(4) List of 

procedures & 

frequency 

Yes Yes 1,320,027 5,318 0.40% 

64 
 

 

 

 

 

 

 

 

 

 

 

 

Regulation Description FY2021 

PHR 

Mandatory 

Regulation1 

Total 

Regulations 

Verified 

Total Noncompliant 

Regulations 

Verified 

PHR Noncompliance 

Rate 

417.3(a)(1) Identify and 

eliminate the 

cause 

Yes No 9,403 514 5.47% 

417.3(a)(2) CCP is under 

control 

Yes No 131,023 638 0.49% 

417.3(a)(3) Establish 

measures to 

prevent 

recurrence 

Yes No 6,611 652 9.86% 

417.3(a)(4) No adulterated 

product enters 

commerce 

No No 27,665 158 0.57% 

417.3(b)(1) Segregate and 

hold the affected 

product 

Yes No 3,243 74 2.28% 

417.3(b)(2) Determine the 

acceptability of 

the affected 

product 

Yes No 2,681 72 2.69% 

417.3(b)(3) No adulterated 

product enters 

commerce 

Yes No 17,897 79 0.44% 

417.3(b)(4) Reassessment Yes Yes 28,992 171 0.59% 

417.3(c) Document 

corrective actions 

Yes No 4,439 251 5.65% 

417.4(a) Adequacy of 

HACCP in 

controlling food 

safety hazards 

Yes No 7,438 214 2.88% 

417.4(a)(1) Initial validation No No 6,280 302 4.81% 

417.4(b) Reassessment of 

hazard analysis 

No Yes 30,786 57 0.19% 

417.5(a)(1) Written hazard 

analysis 

Yes Yes 1,381,468 3,556 0.26% 

417.5(a)(2) Written HACCP 

plan 

Yes Yes 1,223,486 1,300 0.11% 

65 
 

 

 

 

 

 

 

 

 

 

Regulation Description FY2021 

PHR 

Mandatory 

Regulation1 

Total 

Regulations 

Verified 

Total Noncompliant 

Regulations 

Verified 

PHR Noncompliance 

Rate 

417.5(a)(3) Records 

documentation 

and monitoring 

of CCP's and 

Critical Limits 

Yes Yes 1,392,959 3,510 0.25% 

417.5(f) Official Review Yes No 87,292 97 0.11% 

417.6 Inadequate 

HACCP systems 

Yes No 552 156 28.26% 

418.2 Notification of 

adulterated or 

misbranded 

product in 

commerce 

Yes No 1,726 98 5.68% 

418.3 Recall Plans No No 23,995 52 0.22% 

430.4(a) Lm, postlethality exposed 

RTE 

Yes Yes 300,023 102 0.03% 

430.4(b)(1) Alternative 1 No No 745 7 0.94% 

430.4(b)(2) Alternative 2 No No 14,186 61 0.43% 

430.4(b)(3) Alternative 3 Yes No 20,540 254 1.24% 

430.4(c)(2) Lm, 

documentation 

that supports 

decision in 

hazard analysis 

Yes Yes 293,422 156 0.05% 

430.4(c)(3) Lm, maintain 

sanitation in 

post-lethality 

processing 

environment 

Yes Yes 296,943 154 0.05% 

430.4(c)(4) Lm, validate and 

verify control 

measures in 

HACCP plan 

No No 3,640 12 0.33% 

430.4(c)(5) Lm, evaluate 

control measures 

in Sanitation 

SOP 

No No 5,696 23 0.40% 

66 
 

 

 

 

 

 

Regulation Description FY2021 

PHR 

Mandatory 

Regulation1 

Total 

Regulations 

Verified 

Total Noncompliant 

Regulations 

Verified 

PHR Noncompliance 

Rate 

430.4(c)(6) Lm, prerequisite 

program 

requirements 

No No 5,081 51 1.00% 

431.11 Personnel and 

training 

No No 68 0 0.00% 

431.12 Recall procedure No No 62 0 0.00% 

431.4 Critical factors 

and the 

application of the 

process schedule 

No Yes 10,427 8 0.08% 

431.9(b) Procedures for 

handling of 

process 

deviations 

No Yes 9,311 2 0.02% 

431.9(c)(1) Process 

deviations 

identified inprocess 

No No 152 1 0.66% 

431.9(c)(2) Process 

deviations 

identified 

through record 

review 

No No 79 2 2.53% 

431.9(d) Process deviation 

file 

No No 165 0 0.00% 

1

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

perform the task. 

67 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

APPENDIX C: COMPARISON OF FY2022 PHR LIST WITH FY2021 PHR LIST 

There are seven regulations from the FY2021 PHR list that no longer appear in the FY2022 PHR 

list. These are shown in Table C-1. 

Table C-1 Regulations from the FY2021 PHR List That Are No Longer on the FY2022 

PHR List 

List of FY2021 PHRs Description 

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

311.14 Abrasions, bruises, abscesses, pus, etc. 

381.71(a) Condemnation on ante mortem inspection 

416.12(c) Plan identifies procedures for pre-op 

417.6 Inadequate HACCP systems 

430.4(b)(3) Alternative 3: The establishment relies on sanitation alone to 

prevent Lm in the processing environment and on the product. 

There are separate requirements for deli meat and hot dogs 

under this alternative. 

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

There are 13 regulations on the FY2022 PHR list that were not on the FY2021 PHR list. 

Table C-2 Regulations on the FY2022 PHR List That Were Not on the FY2021 PHR List 

List of FY2022 PHRs Description 

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

slaughter 

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

monitoring of contamination control procedures 

316.6 Products not to be removed from official establishments 

unless marked in accordance with the regulations 

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

establishment 

381.65(f) Procedures for controlling visible fecal contamination 

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

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

417.4(a)(1) Initial validation 

418.3 Recall plans 

430.4(b)(2) Alternative 2: The establishment uses a PLT to reduce or 

eliminate Lm in the product or the establishment uses an 

AMAP to limit or suppress growth of Lm in the product. 

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

68 
 

 

 

 

 

0.0 

C: 

Q) 

le' 7.5 Q) 

Q_ 

5.0 

2.5 

-7.05 -6.45 -5.85 -5.25 

Distribution of Log 

-4. 65 -4. 05 

Log 

-3.4 5 -2.85 

Curve --- Norm al(Mu=-4 882 Sigma=0 8508) 

-2.25 -1.65 

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 3 months of establishment verification inspection data: 

TTNNRRNNNN NNNNNNNNNNNNNNNNNNNNNNRR PPPPPPPP

PPPPPP NNNNNNNNNNNNNNNNNNNNNNNNNN PPNNRRNN = TTNNRRNNNN PPPPPPPP VVNNVVNNVVNNNNVV

Establishments are categorized into one of two plant types: (1) Processing Only and (2) 

Slaughter/Processing; named Processing, and Combination in the main body of the report). The 

plant 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 two noncompliances are considered. 

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

Verifications 3 Months before a Pathogen Positive or Enforcement Action 

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

Figure D-2, indicate near-normality. 

69 
 

 

 

 

 

 

 

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 0.04327940 Pr > D <0.010 

Cramer-von Mises W-Sq 1.18116754 Pr > W-Sq <0.005 

Anderson-Darling A-Sq 7.41746090 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 plants, mean and standard deviation for each plant 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/ 

Plant Type 

Number of 

Establishments Mean Standard Deviation Level 

Tier 

Distribution 

(Number of 

Establishments) 

Q1CY2020 Upper 64 

Both 1,050 -4.51 0.96 Mid 98 

Processing 4,260 -4.89 0.82 Lower 5,148 

Q2CY2020 Upper 46 

Both 1,055 -4.46 0.9 Mid 65 

Processing 4,134 -4.72 0.74 Lower 5,078 

Q3CY2020 Upper 61 

Both 1,047 -4.52 0.98 Mid 93 

Processing 4,213 -4.99 0.8 Lower 5,106 

Q4CY2020 Upper 54 

Both 1,034 -4.57 0.95 Mid 85 

Processing 4,246 -5.01 0.81 Lower 5,141 

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

rate over four quarters for each plant type based on the quarterly data in Table D-1. Table D-3 

shows the upper and lower cut points for FY2022 PHRs. Table D-4 show the distribution of 

establishments using data from January to March 2021 utilizing the proposed FY2022 PHRs. 

70 
 

 

 

 

 

Table D-2 Average Mean and Standard Deviation of Log 

Transformed Non-Zero PHR Rates by Plant Type 

Statistic Combination Processing 

Mean -4.51 -4.90 

Standard Deviation 0.95 0.79 

Table D-3 FY2022 Upper and Lower Cut Points 

Operation 

Type 

FY2022 

PHR 

Upper Cut 

Points 

FY2022 

PHR 

Lower Cut 

Points 

Processing 3.63% 2.44% 

Combination 7.33% 4.60% 

Table D-4 March 2021 Level Distribution Based on the PHR 

Criteria Only 

(Note: Establishments with less than 20 verifications or 

establishments that have only one noncompliance are moved 

to the Mid Level Classification). 

Classification Plants 

Upper 39 

Mid 78 

Lower 5,200 

Total 5,317 

71 
 

 

 

REVISION HISTORY 

Version Date Author Change Description 

1.0 7/1/2021 Kim Quigley 

Karyn Roark 

Initial Document 

2.0 11/22/2021 Kim Quigley 

Karyn Roark 

• Added Section 4.1.11 for Salmonella in 

RTE 

• Added Section 4.4.4 and Table 4-18 for 

Campylobacter in Comminuted Turkey 

• In Appendix Table B-1, FY2022 List of 

Candidate Regulations, the column was 

changed from “Total FSIS 

Verifications”, that included only 

compliant regulations, to “Total 

Regulations Verified” which includes 

compliant and noncompliant 

regulations. This change simplifies the 

calculation of the PHR noncompliance 

rate for the reader. 

• Updated text and tables in Appendix D 

to be consistent with text in the body of 

the report 

• Updated the PHR noncompliance 

formula in Appendix D from ‘Number 

of PHR Noncompliances divided by 

Total Number of PHR Inspection 

Procedures’ to ‘Total Noncompliant 

PHRs divided by Total PHRs Verified’ 

to emphasize this rate is based on 

regulations verified, not individual 

inspection tasks. 

• Minor edits to text and formats, such as 

updating the Table of Contents and List 

of Figures 

72