FY2021 Public Health Regulations 

July 2020 
 

 

 

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....................................................................................... 16 

4.1.2 Salmonella in Intact Turkey......................................................................................... 17 

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

4.1.4 Salmonella in Intact Beef............................................................................................. 19 

4.1.5 Salmonella in Comminuted Chicken ........................................................................... 25 

4.1.6 Salmonella in Comminuted Turkey............................................................................. 27 

4.1.7 Salmonella in Intact Pork............................................................................................. 28 

4.1.8 Salmonella in Comminuted Pork................................................................................. 29 

4.1.9 Salmonella in Chicken Parts ........................................................................................ 30 

4.1.10 Salmonella in Siluriformes ........................................................................................ 32 

4.2 E. Coli ................................................................................................................................. 32 

4.2.1 E. coli O157:H7 ........................................................................................................... 32 

4.2.2 Non-O157 STEC.......................................................................................................... 34 

4.3 Listeria monocytogenes ...................................................................................................... 35 

4.4 Campylobacter.................................................................................................................... 36 

4.4.1 Campylobacter in Intact Chicken ................................................................................ 39 

4.4.2 Campylobacter in Intact Turkey .................................................................................. 40 

4.4.3 Campylobacter in Comminuted Chicken..................................................................... 40 

4.4.5 Campylobacter in Chicken Parts ................................................................................. 42 

4.5 Enforcement Actions .......................................................................................................... 44 

5.0 List of FY2021 PHRs.............................................................................................................. 49 

6.0 Cut Points for FY2021 PHRs.................................................................................................. 54 

7.0 Conclusion .............................................................................................................................. 56 

8.0 References............................................................................................................................... 57 

Appendix A: FY2021 PHR Regulations....................................................................................... 58 

Appendix B: FY2021 Candidate regulations................................................................................ 61 

Appendix C: Comparison of FY2021 PHR List with FY2020 PHR List..................................... 71 

Appendix D: Methodolgy and calculation of PHR cut points ...................................................... 72 

2 
 

 

 

 

 

 

 

 

 

 

 

 

 

List of Figures and Tables 

Table S-1 FY2021 PHR Tier 1 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 4-5 Comparison of Noncompliance Rates 3 Months before an Intact Beef 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 4-10 Comparison of Noncompliance Rates 3 Months before a Chicken Parts Salmonella 

Table 4-12 Comparison of Noncompliance Rates 3 Months before an E. coli O157:H7 Positive 

Table 4-13 Comparison of Noncompliance Rates 3 Months before a Non-O157 STEC Positive 

Table 4-14 Comparison of Noncompliance Rates 3 Months before a Listeria monocytogenes 

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

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

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

Table 4-17 Comparison of Noncompliance Rates 3 Months before a Campylobacter Intact 

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

Campylobacter Positive with Those for Establishments with No Comminuted Chicken 

Table 4-19 Comparison of Noncompliance Rates 3 Months before a Comminuted Turkey 

Campylobacter Positive with those for Establishments with No Comminuted Turkey 

Table 4-20 Comparison of Noncompliance Rates 3 Months before a Chicken Parts 

Campylobacter Positive with Those for Establishments with No Chicken Parts Campylobacter 

Table 4-21 Comparison of Noncompliance Rates 3 Months before an Enforcement Action with 

Table 5-3 Regulations Triggered for Inclusion in the FY2021 PHR List by Only a Single Event 

Table S-2 FY2021 PHR Tier 3 Cut Points...................................................................................... 6 

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

Those for Establishments with No Salmonella Positive............................................................... 13 

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

Positive with Those for Establishments with No Intact Beef Salmonella Positive ...................... 20 

Positive.......................................................................................................................................... 27 

Positive with Those for Establishments with No Intact Pork Salmonella Positive ...................... 28 

Positive with Those for Establishments with No Chicken Parts Salmonella Positive.................. 30 

with Those for Establishments with E. coli O157:H7 Positive .................................................... 33 

with Those for Establishments with No Non-O157 STEC Positive............................................. 34 

Positive with Those for Establishments with No Listeria monocytogenes Positive..................... 35 

with Those for Establishments with No Campylobacter Positive ................................................ 37 

....................................................................................................................................................... 39 

Turkey Positive with Those for Establishments with No Campylobacter Intact Turkey Positive 40 

Campylobacter Positive ................................................................................................................ 41 

Campylobacter Positive ................................................................................................................ 42 

Positive.......................................................................................................................................... 43 

Those for Establishments with No Enforcement Action .............................................................. 45 

Table 5-1 List of FY2021 PHRs ................................................................................................... 49 

Table 5-2 Events That Triggered Inclusion of a Regulation in the FY2021 PHR List ................ 53 

....................................................................................................................................................... 54 

Table 6-1 Mean and Standard Deviation of Quarterly FY2021 PHR Rate .................................. 55 

3 
 

 

 

 

Table 6-2 FY2021 PHR Tier 1 Cut Points.................................................................................... 56 

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

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

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

Table 6-3 FY2021 PHR Tier 3 Cut Points.................................................................................... 56 

Table 6-4 Tier Classification of Establishments Based Solely on the PHR Criterion.................. 56 

Criterion ........................................................................................................................................ 56 

Table 7-1 FY2021 PHR Tier 1 Cut Points.................................................................................... 57 

Table 7-2 FY2021 PHR Tier 3 Cut Points.................................................................................... 57 

Table A-1 List of FY2021 PHRs .................................................................................................. 58 

Table C-1 Regulations from the FY2020 PHR list no longer on the FY2021 PHR list............... 71 

Table C-2 Regulations on the FY2021 PHR list that were not on the FY2020 PHR list ............. 71 

Verifications 3 Months before a Pathogen Positive or Enforcement Action................................ 73 

Figure D-2 Goodness of Fit for Normal Distribution of the Log Transformation........................ 73 

Table D-1 Quarterly PHR Mean, Standard Deviation and Tier Distribution ............................... 73 

Plant Type ..................................................................................................................................... 74 

Table D-3 March 2020 Tier Distribution Based on the PHR Criteria Only ................................. 74 

Table D-4 Distribution of Tier 1 Establishments among Different Product Categories............... 75 

4 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SUMMARY 

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

noncompliance rates in establishments in the three 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 time period October 1, 2020, to September 30, 2021 (FY2021) to prioritize 

certain FY2021 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 PHRs is based on January 1, 2019, to December 31, 2019, (CY2019) 

verification inspection results and will be implemented in FY2021. 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 Public Health Risk 

Evaluation Methodology, to review the operational and compliance history of the establishment 

to decide if a Food Safety Assessment (FSA) or enforcement action is appropriate. For inclusion 

in the FY2021 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 FY2021 PHRs consists of 56 regulations that have higher 

rates of noncompliance 3 months before a pathogen positive or enforcement action. This 

compares with 49 regulations that were identified in the October 1, 2019, to September 30, 2020, 

(FY2020) PHR list. The list of FY2021 PHRs is presented in Appendix A. Forty-three 

regulations from the FY2020 PHR list are included in the FY2021 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. 

5 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The 56 FY2021 PHRs comprise 8 regulations and 48 provisions of regulations. The 48 

provisions fall under 19 different regulations. Thus, the 56 FY2021 PHRs represent 27 

regulations, with the majority of FY2021 PHRs being provisions of regulations that provide 

greater specificity as to the nature of the noncompliance associated with a regulation violation. 

The average noncompliance rate of FY2021 PHR regulations 3 months before a pathogen 

positive or enforcement action is 9.92 times higher than the average FY2021 PHR 

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

Noncompliance with a single FY2021 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 FY2021 

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 FY2021 cut points are computed by determining the mean and standard deviation of the log 

transformed non-zero FY2021 PHR rates for each of the four quarters in CY2019 (the log 

transform of the non-zero FY2021 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 Tier 1 and are 

considered for a “for cause” PHRE if they have not had an 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 Tier 3. Establishments with a PHR 

noncompliance rate between the Tier 1 and Tier 3 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 FY2021 PHR cut points for the non-transformed PHR 

noncompliance data for each of the two establishment operation types. The FY2020 PHR cut 

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

Table S-1 FY2021 PHR Tier 1 Cut Points 

Operation Type FY2021 PHR Cut Points FY2020 PHR Cut Points 

Processing 3.73% 3.86% 

Combination 9.84% 8.83% 

Table S-2 FY2021 PHR Tier 3 Cut Points 

Operation Type FY2021 PHR Cut Points FY2020 PHR Cut Points 

Processing 2.50% 2.58% 

Combination 5.85% 5.42% 

Table S-3 presents the number of establishments in each tier from January 1, 2020, to March 31, 

2020, based on the PHR criterion. The period used for calculating the noncompliance rate of the 

6 
 

 

PHRs was January 1, 2020, to March 31, 2020. The number of “for cause” PHREs for Tier 1 

establishments is approximately the same as in previous years. 

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

Classification Processing Combination Total 

Tier 1 51 8 59 

Tier 2 62 30 92 

Tier 3 4,148 1,012 5,160 

Total 4,261 1,050 5,311 

7 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

plans 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 FY2021 PHRs (PHRs that will be used for the time period October 

1, 2020, to September 30, 2021). 

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 FY2021 PHR list is the same as that used for the 

FY2020 PHR list. For inclusion in the FY2021 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, 2019 (CY2019). Candidate regulations related to egg products are not included in the present 

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 

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. 

8 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

of PHRs and section five explains the calculation of the cut points used for notifying districts of 

establishments that need to be scheduled for an FSA or PHRE. The final FY2021 PHR list is 

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

PHRs. Appendix C describes the differences between the FY2021 PHR list and FY2020 PHR 

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

points. 

2.0 SELECTION OF PHRS 

The purpose of this section is to outline the process for 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. However, 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. 

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 and consist of four elements that are used as the criteria for selecting 

the list of candidate regulations. 

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 

4. Implement Effective Corrective Actions 

9 
 

 

 

 

 

 

 

 

 

 

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

considered candidate regulations. 

• Establish and Maintain HACCP 

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. The current analysis 

10 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

includes the six non-O157 STECs (O26, O45, O103, O111, O121, and O145) that FSIS has 

declared adulterants in non-intact raw beef products and product components. 

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 134 9 CFR regulations were selected as being 

indicators of a potential loss of food safety process control. The list of 134 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 134 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 CY2019. 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 2,110 establishments with Salmonella testing data, of which 771 had 

3,519 Salmonella positives and 1,339 did not have Salmonella positives. There were 51,234 total 

Salmonella tests performed. 

11 
 

 

 

 

Table 4-1 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 a Salmonella positive is higher than the average noncompliance 

rate for establishments with no Salmonella positive for CY2019. 

12 
 

 

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 

FY2020 

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 35.56% 1.65% 32.94 7.49E-193 

310.22(b) 

Inedible and prohibited 

SRM for use as human 

food 

No 1.06% 0.09% 11.79 5.30E-03 

310.22(c) Disposal of SRM Yes 3.92% 0.35% 11.76 4.00E-81 

310.22(e)(1) 

Written procedures for 

removal, segregation, and 

disposition of SRMs 

Yes 12.30% 1.51% 9.13 4.24E-62 

310.22(e)(2) Appropriate corrective 

actions 

Yes 5.34% 1.16% 4.81 5.11E-06 

310.22(e)(3) 

Evaluate effectiveness of 

procedures for removal, 

segregation, and 

disposition of SRMs 

Yes 15.07% 0.85% 20.64 4.81E-80 

310.22(f)(2) 

Use of routine operational 

sanitation procedures on 

equipment used to cut 

through SRMs 

Yes 1.31% 0.18% 7.45 1.23E-07 

318.2(a) 

All products subject to 

reinspection by program 

employees 

Yes 0.36% 0.06% 5.83 7.32E-08 

381.65(a) 

Clean and sanitary 

practices; products not 

adulterated 

Yes 1.38% 0.31% 4.57 1.09E-18 

13 
Regulation Verified Description On 

FY2020 

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 

381.71(a) Condemnation on ante 

mortem inspection 

Yes 6.80% 0.25% 29.12 2.93E-10 

416.13(a) Conduct pre-op procedures Yes 7.10% 1.55% 4.87 0.00E+00 

416.13(b) Conduct other procedures 

listed in the plan 

Yes 0.60% 0.15% 4.10 3.93E-257 

416.13(c) 

Plant monitors 

implementation of SSOP 

procedures 

Yes 6.11% 1.19% 5.41 0.00E+00 

416.15(b) Corrective action, 

procedures for 

Yes 10.76% 2.69% 4.36 9.61E-93 

416.3(b) 

Constructed, located & 

operated in a manner that 

does not deter inspection 

Yes 2.73% 0.54% 5.21 1.11E-52 

416.3(c) 

Receptacles for storing 

inedible material must 

identify permitted use 

Yes 5.52% 0.98% 5.88 3.16E-117 

416.4(a) 

Food contact surface, 

cleaning & sanitizing as 

frequency 

Yes 21.00% 4.08% 6.25 0.00E+00 

416.4(d) 

Product processing, 

handling, storage, loading, 

unloading, and during 

transportation must be 

protected 

Yes 27.48% 5.34% 6.72 0.00E+00 

14 
Regulation Verified Description On 

FY2020 

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 

416.6 

Only FSIS program 

employee may remove 

"U.S. Rejected" tag 

Yes 14.51% 3.32% 4.95 3.18E-12 

417.2(c) Contents of HACCP Plan No 0.85% 0.17% 5.16 1.73E-10 

417.2(c)(4) List of procedures & 

frequency 

Yes 1.30% 0.24% 5.44 0.00E+00 

417.3(a)(1) Identify and eliminate the 

cause 

Yes 17.16% 2.06% 9.87 4.34E-96 

417.3(a)(2) CCP is under control Yes 1.35% 0.29% 4.75 1.30E-59 

417.3(a)(3) Establish measures to 

prevent recurrence 

Yes 26.53% 4.70% 7.33 7.02E-81 

417.3(b)(2) Determine the acceptability 

of the affected product 

Yes 7.23% 1.19% 6.47 4.79E-10 

417.3(b)(4) Reassessment Yes 1.64% 0.53% 3.11 1.99E-08 

417.6 Inadequate HACCP 

systems 

No 24.18% 7.42% 3.98 9.85E-05 

310.18(a) 

Carcasses, organs, and 

other parts handled in a 

sanitary manner 

Yes 4.34% 1.08% 4.16 0.00E+00 

418.2 

Notification of adulterated 

or misbranded product in 

commerce 

No 15.24% 3.51% 4.94 1.53E-06 

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

in NPIS 

Yes 9.57% 2.60% 3.97 9.15E-05 

311.14 Abrasions, bruises, 

abscesses, pus, etc. 

No 0.40% 0.01% 38.45 3.40E-09 

15 
 

 

 

 

 

 

 

 

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 155 had 420 Salmonella positives and 51 did not have Salmonella positives. There were 9,307 total 

Intact Chicken Salmonella tests performed. 

Table 4-2 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 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 CY2019. 

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 

Reg 

ID 

Regulation 

Verified 

Description On 

FY2020 

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 

680 417.5(a)(1) Written 

hazard 

analysis 

Yes 0.52% 0.17% 3.13 2.88E-15 

1332 381.65(g) Procedures 

for 

controlling 

contamination 

throughout 

the slaughter 

and dressing 

operation 

No 1.76% 0.59% 3.03 1.68E-33 

16 
 

 

 

 

 

 

 

 

 

 

 

 

4.1.2 Salmonella in Intact Turkey 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 45 establishments with Intact Turkey 

Salmonella testing data, of which 9 had 10 Salmonella positives and 36 did not have Salmonella positives. There were 1,826 total 

Intact Turkey Salmonella tests performed. 

Table 4-3 presents the one regulation 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 CY2019. 

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 

Reg 

ID 

Regulation 

Verified 

Description On 

FY2020 

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 

527 381.65(a) Clean and 

sanitary 

practices; 

products 

not 

adulterated 

Yes 2.14% 0.42% 5.20 1.21E-02 

4.1.3 Salmonella in Ground Beef 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 1,222 establishments with Ground Beef 

Salmonella testing data, of which 111 had 163 Salmonella positives and 1,111 did not have Salmonella positives. There were 11,198 

total Ground Beef Salmonella tests performed. 

Table 4-4 presents the seven 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 

17 
 

 

 

 

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 CY2019. 

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 

FY2020 

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 

301.2_Adulterated Adulterated Yes 31.15% 2.25% 19.65 1.08E-15 

310.22(e)(1) Written 

procedures 

for removal, 

segregation, 

and 

disposition 

of SRMs 

Yes 8.26% 1.40% 6.34 8.53E-09 

310.22(f)(2) Use of 

routine 

operational 

sanitation 

procedures 

on 

equipment 

used to cut 

through 

SRMs 

Yes 3.03% 0.25% 12.29 1.40E-07 

416.15(b) Corrective 

action, 

procedures 

for 

Yes 16.96% 3.08% 6.44 4.09E-09 

18 
 

 

 

 

 

Regulation 

Verified 

Description On 

FY2020 

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 

417.2(c)(4) List of 

procedures 

& 

frequency 

Yes 2.25% 0.22% 10.23 5.09E-164 

417.3(b)(3) No 

adulterated 

product 

enters 

commerce 

Yes 2.56% 0.35% 7.43 3.86E-02 

310.18(a) Carcasses, 

organs, and 

other parts 

handled in a 

sanitary 

manner 

Yes 5.49% 0.99% 5.84 8.98E-139 

4.1.4 Salmonella in Intact Beef 

FSIS tests beef trim and beef manufacturing trimmings as a surrogate for testing intact beef. There are 908 establishments with Intact 

Beef Salmonella testing data, of which 72 had 147 Salmonella positives and 836 did not have Salmonella positives. There were 6,489 

total Intact Beef Salmonella tests performed. 

Table 4-5 presents the 28 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 CY2019. 

19 
 

 

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 

Reg 

ID 

Regulation 

Verified 

Description On 

FY2020 

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 

29 301.2_Adulterated Adulterated Yes 33.41% 1.93% 25.52 6.11E-121 

77 310.22(b) Inedible and 

prohibited 

SRM for use as 

human food 

No 2.82% 0.21% 13.77 9.73E-04 

78 310.22(c) Disposal of 

SRM 

Yes 5.01% 0.38% 13.69 4.22E-66 

88 310.22(e)(1) Written 

procedures for 

removal, 

segregation, 

and disposition 

of SRMs 

Yes 17.66% 1.62% 13.04 3.55E-72 

89 310.22(e)(2) Appropriate 

corrective 

actions 

Yes 23.36% 0.78% 38.85 5.61E-20 

90 310.22(e)(3) Evaluate 

effectiveness 

of procedures 

for removal, 

segregation, 

and disposition 

of SRMs 

Yes 20.16% 0.94% 26.73 1.76E-72 

20 
Reg 

ID 

Regulation 

Verified 

Description On 

FY2020 

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 

99 310.22(f)(2) Use of routine 

operational 

sanitation 

procedures on 

equipment 

used to cut 

through SRMs 

Yes 0.93% 0.20% 4.65 2.52E-03 

234 318.2(a) All products 

subject to 

reinspection by 

program 

employees 

Yes 0.71% 0.06% 12.22 9.27E-05 

235 318.2(d) Removal of 

U.S. retained 

by authorized 

Program 

employees 

only 

Yes 1.99% 0.10% 19.80 2.06E-03 

591 416.13(c) Plant monitors 

implementation 

of SSOP 

procedures 

Yes 5.71% 0.99% 6.05 0.00E+00 

594 416.15(a) Appropriate 

corrective 

actions 

Yes 22.04% 1.23% 22.73 6.84E-66 

21 
Reg 

ID 

Regulation 

Verified 

Description On 

FY2020 

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 

595 416.15(b) Corrective 

action, 

procedures for 

Yes 50.00% 1.73% 56.81 5.17E-117 

597 416.16(a) Daily records 

required, 

responsible 

individual, 

initialed and 

dated 

Yes 0.51% 0.13% 3.86 1.20E-30 

630 416.3(b) Constructed, 

located & 

operated in a 

manner that 

does not deter 

inspection 

Yes 2.11% 0.45% 4.80 6.47E-05 

631 416.3(c) Receptacles for 

storing inedible 

material must 

identify 

permitted use 

Yes 2.56% 0.84% 3.09 5.15E-04 

22 
Reg 

ID 

Regulation 

Verified 

Description On 

FY2020 

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 

636 416.4(d) Product 

processing, 

handling, 

storage, 

loading, 

unloading, and 

during 

transportation 

must be 

protected 

Yes 15.48% 3.91% 4.50 3.10E-192 

641 416.6 Only FSIS 

program 

employee may 

remove "U.S. 

Rejected" tag 

Yes 28.57% 3.02% 12.87 1.06E-06 

648 417.2(c) Contents of 

HACCP Plan 

No 5.52% 0.21% 28.04 5.93E-15 

649 417.2(c)(4) List of 

procedures & 

frequency 

Yes 1.87% 0.25% 7.51 7.54E-127 

657 417.3(a)(1) Identify and 

eliminate the 

cause 

Yes 7.41% 1.98% 3.97 4.29E-05 

658 417.3(a)(2) CCP is under 

control 

Yes 1.19% 0.29% 4.15 3.28E-05 

23 
Reg 

ID 

Regulation 

Verified 

Description On 

FY2020 

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 

659 417.3(a)(3) Establish 

measures to 

prevent 

recurrence 

Yes 19.90% 4.27% 5.57 4.07E-12 

664 417.3(b)(3) No adulterated 

product enters 

commerce 

Yes 1.24% 0.20% 6.37 2.37E-02 

680 417.5(a)(1) Written hazard 

analysis 

Yes 0.87% 0.25% 3.56 1.28E-25 

705 430.4(c)(2) Lm, 

documentation 

that supports 

decision in 

hazard analysis 

Yes 2.59% 0.06% 47.09 3.45E-07 

717 310.18(a) Carcasses, 

organs, and 

other parts 

handled in a 

sanitary 

manner 

Yes 5.71% 0.99% 6.06 8.86E-296 

1332 381.65(g) Procedures for 

controlling 

contamination 

throughout the 

slaughter and 

dressing 

operation 

No 6.85% 0.89% 8.18 1.03E-03 

24 
 

 

 

 

 

 

 

 

 

Reg 

ID 

Regulation 

Verified 

Description On 

FY2020 

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 

1444 311.14 Abrasions, 

bruises, 

abscesses, pus, 

etc. 

No 0.46% 0.01% 44.14 1.87E-05 

4.1.5 Salmonella in Comminuted Chicken 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 95 establishments with Comminuted Chicken 

Salmonella testing data, of which 82 had 663 Salmonella positives and 13 did not have Salmonella positives. There were 2,245 total 

Comminuted Chicken Salmonella tests performed. 

Table 4-6 presents the 13 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 Comminuted Chicken Salmonella positive is higher than the average noncompliance 

rate for establishments with no Comminuted Chicken Salmonella positive for CY2019. 

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 FY2020 

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 

416.1 Operate in a manner to 

prevent insanitary conditions 

Yes 2.83% 0.24% 12.29 2.72E-15 

416.13(a) Conduct pre-op procedures Yes 7.48% 2.04% 3.88 1.38E-26 

416.13(b) Conduct other procedures 

listed in the plan 

Yes 0.78% 0.13% 6.29 3.91E-11 

25 
Regulation Description On FY2020 Noncompliance Noncompliance Odds Two-Sided 

Verified PHR List Rate in 3 Months 

before a 

Salmonella 

Positive 

Rate for 

Establishments 

with no Salmonella 

Positive 

Ratio Fisher Exact 

p Value 

416.13(c) Plant monitors 

implementation of SSOP 

procedures 

Yes 5.47% 1.02% 5.62 1.06E-100 

416.14 Evaluate effectiveness of 

SSOP's & maintain plan 

Yes 0.39% 0.12% 3.23 1.17E-03 

416.15(a) Appropriate corrective actions Yes 12.61% 2.08% 6.78 2.23E-02 

416.16(a) Daily records required, 

responsible individual, 

initialed and dated 

Yes 0.27% 0.07% 4.08 3.66E-05 

416.3(c) Receptacles for storing 

inedible material must 

identify permitted use 

Yes 7.16% 0.36% 21.37 3.37E-07 

416.4(a) Food contact surface, cleaning 

& sanitizing as frequency 

Yes 30.67% 3.41% 12.53 6.73E-83 

416.4(d) Product processing, handling, 

storage, loading, unloading, 

and during transportation 

must be protected 

Yes 34.19% 11.35% 4.06 2.05E-49 

417.5(a)(1) Written hazard analysis Yes 0.57% 0.17% 3.41 6.02E-04 

417.5(a)(2) Written HACCP plan Yes 0.34% 0.03% 10.84 5.60E-04 

381.65(g) Procedures for controlling 

contamination throughout the 

slaughter and dressing 

operation 

No 1.47% 0.29% 5.12 5.01E-04 

26 
 

 

 

 

 

 

 

 

 

 

 

4.1.6 Salmonella in Comminuted Turkey 

There are 57 establishments with Comminuted Turkey Salmonella testing data, of which 47 had 339 Salmonella positives and 10 did 

not have Salmonella positives. There were 1,562 total Comminuted Turkey Salmonella tests performed. 

Table 4-7 presents the four 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 Comminuted Turkey Salmonella positive is higher than the average noncompliance 

rate for establishments with no Comminuted Turkey Salmonella positive for CY2019. 

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 

FY2020 

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 

416.13(a) 

Conduct pre-op 

procedures 

Yes 7.33% 0.74% 10.64 4.87E-27 

416.15(b) 

Corrective action, 

procedures for 

Yes 10.99% 1.54% 7.90 1.17E-02 

416.16(a) 

Daily records required, 

responsible individual, 

initialed and dated 

Yes 0.35% 0.09% 3.74 6.42E-04 

416.4(d) 

Product processing, 

handling, storage, 

loading, unloading, and 

during transportation 

must be protected 

Yes 21.30% 5.88% 4.33 3.77E-22 

27 
 

 

 

 

 

 

 

4.1.7 Salmonella in Intact Pork 

There are 161 establishments with Intact Pork Salmonella testing data, of which 57 had 235 Salmonella positives and 104 did not have 

Salmonella positives. There were 2,463 total Intact Pork Salmonella tests performed. 

Table 4-8 presents the seven 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 Intact Pork Salmonella positive is higher than the average noncompliance rate for 

establishments with no Intact Pork Salmonella positive for CY2019. 

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 Description On Noncompliance Noncompliance Odds Ratio Two-Sided 

Verified FY2020 

PHR List 

Rate in 3 Months 

before a Salmonella 

Positive 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Fisher 

Exact p 

Value 

416.3(b) Constructed, located & 

operated in a manner 

that does not deter 

inspection 

Yes 4.19% 0.32% 13.51 8.66E-14 

417.2(c) Contents of HACCP 

Plan 

No 5.28% 0.18% 30.48 7.02E-09 

417.2(c)(4) List of procedures & 

frequency 

Yes 0.82% 0.25% 3.30 4.11E-24 

417.3(a)(1) Identify and eliminate 

the cause 

Yes 22.97% 1.63% 17.96 4.05E-11 

417.3(a)(2) CCP is under control Yes 1.48% 0.28% 5.29 6.09E-04 

417.3(a)(3) Establish measures to 

prevent recurrence 

Yes 21.21% 7.81% 3.18 4.54E-02 

417.5(f) Official Review Yes 0.39% 0.08% 4.65 4.44E-02 

28 
 

 

 

 

 

 

 

 

4.1.8 Salmonella in Comminuted Pork 

There are 223 establishments with Comminuted Pork Salmonella testing data, of which 117 had 575 Salmonella positives and 106 did 

not have Salmonella positives. There were 2,360 total Comminuted Pork Salmonella tests performed. 

Table 4-9 presents the four 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 an Comminuted Pork Salmonella positive is higher than the average 

noncompliance rate for establishments with no Comminuted Pork Salmonella positive for CY2019. 

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 

FY2020 

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 

301.2_Adulter 

ated 

Adulterated Yes 25.22% 9.80% 3.10 1.29E-02 

310.22(c) Disposal of SRM Yes 8.13% 0.06% 141.63 1.09E-18 

416.1 

Operate in a manner to 

prevent insanitary 

conditions 

Yes 2.97% 1.01% 3.01 6.03E-34 

417.2(c) 

Contents of HACCP 

Plan 

No 0.82% 0.08% 10.69 6.40E-03 

29 
 

 

 

 

 

 

 

 

 

 

4.1.9 Salmonella in Chicken Parts 

There are 479 establishments with Chicken Parts Salmonella testing data, of which 346 had 949 Salmonella positives and 133 did not 

have Salmonella positives. There were 10,900 total Chicken Parts Salmonella tests performed. 

Table 4-10 presents the 10 regulations that had more than 30 verifications in a year, an odds ratio of 3.0 or greater, and for which there 

is 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 CY2019. 

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 

FY2020 

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 

381.71(a) Condemnation on ante 

mortem inspection 

Yes 15.74% 1.28% 14.45 5.25E-09 

417.2(c)(4) List of procedures & 

frequency 

Yes 1.59% 0.33% 4.89 7.84E-130 

417.3(a)(3) Establish measures to 

prevent recurrence 

Yes 12.58% 3.74% 3.70 1.91E-07 

417.3(b)(1) Segregate and hold the 

affected product 

No 19.87% 3.85% 6.20 1.44E-04 

417.3(b)(2) Determine the 

acceptability of the 

affected product 

Yes 16.67% 2.40% 8.13 4.01E-05 

417.3(b)(3) No adulterated product 

enters commerce 

Yes 1.43% 0.24% 5.99 3.30E-04 

417.3(b)(4) Reassessment Yes 3.30% 0.60% 5.70 1.48E-04 

417.3(c) Document corrective 

actions 

No 8.64% 2.69% 3.42 4.30E-04 

30 
Regulation 

Verified 

Description On 

FY2020 

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) 

(A) 

NPIS Sorting, 

Trimming, and 

Reprocessing 

Yes 1.27% 0.41% 3.12 7.54E-14 

381.76(b)(6)(ii) 

(D) 

Ready-to-Cook 

verification in NPIS 

Yes 8.47% 2.39% 3.79 3.36E-06 

31 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.1.10 Salmonella in Siluriformes 

There are 74 establishments with Siluriformes Salmonella testing data, of which 13 had 18 Salmonella positives and 61 did not have 

Salmonella positives. There were 632 total Siluriformes Salmonella tests performed. 

Table 4-11 presents the one regulation 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 CY2019. 

Table 4-11 Comparison of Noncompliance Rates Three Months before a Siluriformes Salmonella Positive with those for 

Establishments with No Siluriformes Salmonella Positive 

Regulation 

Verified 

Description On 

FY2020 

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 

416.4(a) Food contact surface, 

cleaning & sanitizing 

as frequency 

Yes 13.79% 3.79% 4.06 1.71E-04 

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 1,376 establishments with E. coli 

O157:H7 testing data, of which 12 had 13 E. coli O157:H7 positives and 1,364 did not have E. coli O157:H7 positives. There were 

17,690 total E. coli O157:H7 tests performed. 

Table 4-12 presents the five 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 CY2019. 

32 
 

 

Table 4-12 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 

FY2020 

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 

301.2_Adulterated Adulterated Yes 35.59% 3.04% 17.65 2.92E-16 

310.22(c) Disposal of SRM Yes 7.77% 0.52% 16.25 9.44E-08 

416.14 

Evaluate effectiveness 

of SSOP's & maintain 

plan 

Yes 1.15% 0.21% 5.56 5.38E-05 

416.16(a) 

Daily records required, 

responsible individual, 

initialed and dated 

Yes 0.76% 0.13% 6.02 1.07E-05 

417.5(a)(2) Written HACCP plan Yes 0.36% 0.08% 4.67 2.80E-02 

33 
 

 

 

 

 

 

 

 

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 toxinproducing 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 NonO157 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 34 had 73 Non- O157 STEC positives and 449 did not have NonO157 STEC positives. There were 4,038 total Non-O157 STEC tests performed. 

Table 4-13 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 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 CY2019. 

Table 4-13 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 

FY2020 

PHR List 

Noncompliance 

Rate in 3 Months 

before a NonO157 STEC 

Positive 

Noncompliance 

Rate for 

Establishments with 

no Non-O157 STEC 

Positive 

Odds 

Ratio 

Two-Sided 

Fisher 

Exact p 

Value 

417.3(b)(3) No adulterated product 

enters commerce 

Yes 1.63% 0.08% 20.41 1.03E-04 

417.5(a)(2) Written HACCP plan Yes 0.29% 0.07% 4.07 9.51E-05 

34 
 

 

 

 

 

 

 

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 2,255 establishments with Listeria monocytogenes 

testing data, of which 3 had three Listeria monocytogenes positives and 2,252 did not have Listeria monocytogenes positives. There 

were 2,255 total Listeria monocytogenes tests performed. 

Table 4-14 presents the four 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 CY2019. 

Table 4-14 Comparison of Noncompliance Rates 3 Months before a Listeria monocytogenes Positive with Those for 

Establishments with No Listeria monocytogenes Positive 

Regulation 

Verified 

Description On 

FY2020 

PHR List 

Noncompliance 

Rate in 3 Months 

before a Listeria 

monocytognes 

Positive 

Noncompliance 

Rate for 

Establishments with 

no Listeria 

monocytognes 

Positive 

Odds 

Ratio 

Two-Sided 

Fisher 

Exact p 

Value 

416.13(c) Plant monitors 

implementation of 

SSOP procedures 

Yes 2.90% 0.95% 3.12 1.41E-16 

416.16(a) Daily records 

required, responsible 

individual, initialed 

and dated 

Yes 0.29% 0.11% 2.65 1.27E-02 

416.4(a) Food contact surface, 

cleaning & sanitizing 

as frequency 

Yes 9.39% 3.69% 2.71 4.82E-05 

35 
 

 

 

 

 

 

Regulation 

Verified 

Description On 

FY2020 

PHR List 

Noncompliance 

Rate in 3 Months 

before a Listeria 

monocytognes 

Positive 

Noncompliance 

Rate for 

Establishments with 

no Listeria 

monocytognes 

Positive 

Odds 

Ratio 

Two-Sided 

Fisher 

Exact p 

Value 

416.4(d) Product processing, 

handling, storage, 

loading, unloading, 

and during 

transportation must be 

protected 

Yes 10.67% 3.97% 2.89 5.64E-07 

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 610 establishments with Campylobacter 

testing data, of which 457 had 4,126 Campylobacter positives and 153 did not have Campylobacter positives. There were 25,765 total 

Campylobacter tests performed. 

Table 4-15 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 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 CY2019. 

36 
Table 4-15 Comparison of Noncompliance Rates 3 Months before a Campylobacter Positive with Those for Establishments 

with No Campylobacter Positive 

Regulation Description On FY2020 Noncompliance Noncompliance Odds Ratio Two-Sided 

Verified PHR List Rate in 3 

Months before 

a 

Campylobacter 

Positive 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

Fisher Exact p 

Value 

381.71(a) Condemnation on 

ante mortem 

inspection 

Yes 8.06% 0.55% 15.87 1.03E-05 

381.91(b) Reprocessing of 

carcasses 

accidentally 

contaminated with 

digestive tract 

contents. 

Yes 3.38% 0.57% 6.16 1.09E-06 

416.1 Operate in a 

manner to prevent 

insanitary 

conditions 

Yes 4.58% 1.40% 3.38 1.00E-103 

416.13(b) Conduct other 

procedures listed 

in the plan 

Yes 0.90% 0.20% 4.52 3.44E-94 

416.14 Evaluate 

effectiveness of 

SSOP's & 

maintain plan 

Yes 1.20% 0.13% 9.48 8.16E-150 

416.15(a) Appropriate 

corrective actions 

Yes 7.93% 2.44% 3.44 3.46E-12 

416.16(a) Daily records 

required, 

Yes 0.50% 0.10% 5.30 4.16E-88 

37 
Regulation 

Verified 

Description On FY2020 

PHR List 

Noncompliance 

Rate in 3 

Months before 

a 

Campylobacter 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

Odds Ratio Two-Sided 

Fisher Exact p 

Value 

responsible 

individual, 

initialed and dated 

416.3(b) Constructed, 

located & 

operated in a 

manner that does 

not deter 

inspection 

Yes 5.50% 0.52% 11.18 3.20E-32 

416.3(c) Receptacles for 

storing inedible 

material must 

identify permitted 

use 

Yes 11.18% 2.96% 4.12 7.09E-30 

416.6 Only FSIS 

program 

employee may 

remove "U.S. 

Rejected" tag 

Yes 34.79% 3.97% 12.89 2.76E-16 

417.2(c)(4) List of procedures 

& frequency 

Yes 1.68% 0.12% 14.80 3.11E-237 

417.3(a)(3) Establish 

measures to 

prevent 

recurrence 

Yes 11.41% 2.98% 4.19 6.33E-06 

38 
 

 

 

 

 

 

 

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 198 had 1,907 Campylobacter positives and 8 did not have Campylobacter positives. There 

were 9,281 total Intact Chicken Campylobacter tests performed. 

Table 4-16 presents the four 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 CY2019. 

Table 4-16 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 

FY2020 

PHR List 

Noncompliance 

Rate in 3 Months 

before a 

Campylobacter 

Positive 

Noncompliance 

Rate for 

Establishments with 

no Campylobacter 

Positive 

Odds 

Ratio 

Two-Sided 

Fisher 

Exact p 

Value 

381.91(b) Reprocessing of 

carcasses accidentally 

contaminated with 

digestive tract 

contents. 

Yes 2.99% 0.27% 11.30 3.99E-04 

416.4(a) Food contact surface, 

cleaning & sanitizing 

as frequency 

Yes 33.69% 12.11% 3.69 1.24E-23 

416.4(d) Product processing, 

handling, storage, 

loading, unloading, 

and during 

transportation must 

be protected 

Yes 45.13% 8.68% 8.66 1.19E-65 

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

verification in NPIS 

Yes 7.52% 1.10% 7.32 1.39E-02 

39 
 

 

 

 

 

 

 

 

 

 

4.4.2 Campylobacter in Intact Turkey 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 45 establishments with Intact Turkey 

Campylobacter testing data, of which 17 had 39 Campylobacter positives and 28 did not have Campylobacter positives. There were 

1,827 total Intact Turkey Campylobacter tests performed. 

Table 4-17 presents the one 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 CY2019. 

Table 4-17 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 

FY2020 

PHR List 

Noncompliance 

Rate in 3 Months 

before a 

Campylobacter 

Positive 

Noncompliance 

Rate for 

Establishments with 

no Campylobacter 

Positive 

Odds 

Ratio 

Two-Sided 

Fisher 

Exact p 

Value 

417.2(c)(4) List of procedures & 

frequency 

Yes 1.45% 0.46% 3.20 9.68E-13 

4.4.3 Campylobacter in Comminuted Chicken 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 95 establishments with Comminuted Chicken 

Campylobacter testing data, of which 47 had 182 Campylobacter positives and 48 did not have Campylobacter positives. There were 

2,232 total Comminuted Chicken Campylobacter tests performed. 

Table 4-18 presents the four 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 Comminuted Chicken Campylobacter positive is higher than the average 

noncompliance rate for establishments with no Comminuted Chicken Campylobacter positive for CY2019. 

40 
 

 

 

 

 

Table 4-18 Comparison of Noncompliance Rates 3Months before a Comminuted Chicken Campylobacter Positive with Those 

for Establishments with No Comminuted Chicken Campylobacter Positive 

Regulation 

Verified 

Description On 

FY2020 

PHR List 

Noncompliance 

Rate in 3 Months 

before a 

Campylobacter 

Positive 

Noncompliance 

Rate for 

Establishments with 

no Campylobacter 

Positive 

Odds 

Ratio 

Two-Sided 

Fisher 

Exact p 

Value 

416.14 Evaluate effectiveness 

of SSOP's & maintain 

plan 

Yes 0.75% 0.17% 4.50 6.01E-16 

416.3(c) Receptacles for storing 

inedible material must 

identify permitted use 

Yes 11.59% 2.17% 5.93 8.42E-08 

417.3(a)(3) Establish measures to 

prevent recurrence 

Yes 15.79% 3.26% 5.56 4.40E-03 

417.5(a)(2) Written HACCP plan Yes 0.60% 0.13% 4.75 8.69E-14 

4.4.4 Campylobacter in Comminuted Turkey 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 57 establishments with Comminuted Turkey 

Campylobacter testing data, of which 19 had 71 Campylobacter positives and 38 did not have Campylobacter positives. There were 

1,547 total Comminuted Turkey Campylobacter tests performed. 

Table 4-19 presents the five 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 

regulations in establishments 3 months before an Comminuted Turkey Campylobacter positive is higher than the average 

noncompliance rate for establishments with no Comminuted Turkey Campylobacter positive for CY2019. 

41 
 

 

 

 

 

 

 

Table 4-19 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 

FY2020 

PHR List 

Noncompliance 

Rate in 3 Months 

before a 

Campylobacter 

Positive 

Noncompliance 

Rate for 

Establishments with 

no Campylobacter 

Positive 

TwoSided 

Fisher 

Exact p 

Value 

Odds Ratio 

318.2(a) All products subject to 

reinspection by 

program employees 

Yes 8.33% 0.15% 1.16E-06 61.45 

416.15(a) Appropriate corrective 

actions 

Yes 8.05% 2.39% 1.14E-04 3.58 

416.3(b) Constructed, located 

& operated in a 

manner that does not 

deter inspection 

Yes 7.60% 1.12% 1.71E-05 7.24 

417.3(a)(3) Establish measures to 

prevent recurrence 

Yes 19.78% 5.42% 1.81E-05 4.30 

430.4(c)(3) Lm, maintain 

sanitation in postlethality processing 

environment 

Yes 0.57% 0.04% 1.96E-03 12.94 

4.4.5 Campylobacter in Chicken Parts 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 479 establishments with Chicken Parts 

Campylobacter testing data, of which 373 had 1,927 Campylobacter positives and 106 did not have Campylobacter positives. There 

were 10,878 total Chicken Parts Campylobacter tests performed. 

Table 4-20 presents the nine 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 

42 
 

 

 

 

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 CY2019. 

Table 4-20 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 

FY2020 

PHR List 

Noncompliance 

Rate in 3 Months 

before a 

Campylobacter 

Positive 

Noncompliance 

Rate for 

Establishments with 

no Campylobacter 

Positive 

TwoSided 

Fisher 

Exact p 

Value 

Odds Ratio 

381.91(b) Reprocessing of 

carcasses accidentally 

contaminated with 

digestive tract 

contents. 

Yes 3.95% 0.19% 4.86E-08 21.42 

416.1 Operate in a manner to 

prevent insanitary 

conditions 

Yes 4.57% 1.12% 3.55E-78 4.22 

416.13(b) Conduct other 

procedures listed in 

the plan 

Yes 0.90% 0.15% 5.75E-76 6.24 

416.14 Evaluate effectiveness 

of SSOP's & maintain 

plan 

Yes 1.21% 0.11% 9.28E-103 10.76 

416.16(a) Daily records 

required, responsible 

individual, initialed 

and dated 

Yes 0.49% 0.10% 7.58E-53 4.92 

416.3(b) Constructed, located 

& operated in a 

manner that does not 

deter inspection 

Yes 4.39% 0.90% 7.99E-10 5.03 

43 
 

 

 

 

 

 

 

 

 

 

Regulation 

Verified 

Description On 

FY2020 

PHR List 

Noncompliance 

Rate in 3 Months 

before a 

Campylobacter 

Positive 

Noncompliance 

Rate for 

Establishments with 

no Campylobacter 

Positive 

TwoSided 

Fisher 

Exact p 

Value 

Odds Ratio 

416.3(c) Receptacles for storing 

inedible material must 

identify permitted use 

Yes 10.52% 3.10% 4.02E-14 3.68 

416.4(a) Food contact surface, 

cleaning & sanitizing 

as frequency 

Yes 29.39% 6.68% 3.15E-240 5.82 

417.2(c)(4) List of procedures & 

frequency 

Yes 1.70% 0.12% 3.83E-157 14.95 

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 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 FY2020 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 

CY2019. The dataset used in the analysis consists of candidate PHR noncompliance rates for the 5,300 active meat and poultry 

establishments, of which 138 had 121 enforcement actions and 5,179 did not have any enforcement actions. 

44 
 

 

 

 

Table 4-21 presents the 34 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 CY2019. 

Table 4-21 Comparison of Noncompliance Rates 3 Months before an Enforcement Action with Those for Establishments with 

No Enforcement Action 

Regulation Description On Noncompliance Noncompliance Odds Two-Sided 

Verified FY2020 

PHR 

List 

Rate in 3 Months 

before an 

Enforcement 

Action 

Rate for 

Establishments with 

no Enforcement 

Action 

Ratio Fisher 

Exact p 

Value 

310.22(c) Disposal of SRM Yes 2.56% 0.47% 5.55 1.13E-05 

310.22(e)(1) Written procedures for 

removal, segregation, 

and disposition of 

SRMs 

Yes 8.47% 1.59% 5.75 2.60E-05 

310.22(e)(3) Evaluate effectiveness 

of procedures for 

removal, segregation, 

and disposition of 

SRMs 

Yes 11.76% 1.56% 8.40 1.47E-05 

310.22(e)(4)(i) Maintain daily records No 1.85% 0.18% 10.58 3.65E-05 

310.25(a) Verification criteria 

for E. coli testing meat 

No 2.83% 0.66% 4.37 1.64E-03 

310.3 Carcasses and parts in 

certain instances to be 

retained. 

No 24.24% 6.98% 4.27 1.78E-03 

318.2(d) Removal of U.S. 

retained by authorized 

program employees 

only 

Yes 5.88% 0.52% 11.93 1.46E-02 

45 
 

Regulation Description On Noncompliance Noncompliance Odds Two-Sided 

Verified FY2020 

PHR 

List 

Rate in 3 Months 

before an 

Enforcement 

Action 

Rate for 

Establishments with 

no Enforcement 

Action 

Ratio Fisher 

Exact p 

Value 

416.1 Operate in a manner to 

prevent insanitary 

conditions 

Yes 5.02% 1.25% 4.18 3.85E-41 

416.12(c) Plan identifies 

procedures for pre-op 

No 2.16% 0.17% 12.83 7.07E-05 

416.13(a) Conduct pre-op 

procedures 

Yes 5.90% 1.96% 3.13 3.66E-42 

416.13(b) Conduct other 

procedures listed in 

the plan 

Yes 0.98% 0.19% 5.20 6.07E-33 

416.15(a) Appropriate corrective 

actions 

Yes 12.04% 1.89% 7.10 1.63E-13 

416.15(b) Corrective action, 

procedures for 

Yes 9.05% 2.93% 3.29 1.87E-05 

416.16(a) Daily records 

required, responsible 

individual, initialed 

and dated 

Yes 0.64% 0.14% 4.56 1.70E-28 

416.3(b) Constructed, located 

& operated in a 

manner that does not 

deter inspection 

Yes 5.91% 0.80% 7.80 1.29E-08 

416.3(c) Receptacles for storing 

inedible material must 

identify permitted use 

Yes 4.64% 1.40% 3.43 1.46E-05 

46 
 

Regulation 

Verified 

Description On 

FY2020 

PHR 

List 

Noncompliance 

Rate in 3 Months 

before an 

Enforcement 

Action 

Noncompliance 

Rate for 

Establishments with 

no Enforcement 

Action 

Odds 

Ratio 

Two-Sided 

Fisher 

Exact p 

Value 

416.4(a) Food contact surface, 

cleaning & sanitizing 

as frequency 

Yes 16.12% 6.00% 3.01 1.04E-52 

416.4(d) Product processing, 

handling, storage, 

loading, unloading, 

and during 

transportation must be 

protected 

Yes 22.28% 8.27% 3.18 3.52E-67 

417.2(a)(1) Hazard analysis Yes 8.59% 1.15% 8.08 3.96E-24 

417.2(c) Contents of HACCP 

Plan 

No 2.78% 0.26% 10.93 3.20E-03 

417.2(c)(4) List of procedures & 

frequency 

Yes 2.24% 0.47% 12.51 2.71E-51 

417.3(a)(1) Identify and eliminate 

the cause 

Yes 39.39% 4.94% 9.33 2.83E-09 

417.3(a)(3) Establish measures to 

prevent recurrence 

Yes 50.91% 10.00% 4.86 4.51E-14 

417.3(b)(3) No adulterated product 

enters commerce 

Yes 2.15% 0.45% 5.18 1.13E-02 

417.3(b)(4) Reassessment Yes 2.94% 0.58% 20.77 2.28E-02 

417.4(a) Adequacy of HACCP 

in controlling food 

safety hazards 

Yes 35.00% 2.53% 5.08 9.48E-13 

417.5(a)(1) Written hazard 

analysis 

Yes 1.33% 0.27% 5.72 1.38E-33 

417.5(a)(2) Written HACCP plan Yes 0.53% 0.09% 12.51 8.82E-15 

47 
Regulation 

Verified 

Description On 

FY2020 

PHR 

List 

Noncompliance 

Rate in 3 Months 

before an 

Enforcement 

Action 

Noncompliance 

Rate for 

Establishments with 

no Enforcement 

Action 

Odds 

Ratio 

Two-Sided 

Fisher 

Exact p 

Value 

417.5(a)(3) Records 

documentation and 

monitoring of CCP's 

and Critical Limits 

Yes 1.55% 0.23% 6.76 4.55E-53 

430.4(a) Lm, post-lethality 

exposed RTE 

Yes 0.17% 0.03% 6.17 4.39E-02 

430.4(b)(3) Lm, post-lethality 

exposed RTE -

Alternative 3 

No 2.94% 0.90% 3.33 3.65E-02 

430.4(c)(2) Lm, documentation 

that supports decision 

in hazard analysis 

Yes 0.25% 0.04% 6.10 1.44E-02 

310.18(a) Carcasses, organs, and 

other parts handled in 

a sanitary manner 

Yes 5.55% 1.47% 3.93 2.68E-55 

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

trimming, and 

reprocessing 

Yes 2.17% 0.66% 3.34 2.13E-03 

48 
 

 

 

 

 

 

 

 

 

 

5.0 LIST OF FY2021 PHRS 

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

PHRs into a single FY2021 PHR list. Table 5-1 presents the complete list of the 56 FY2021 

PHRs. These 56 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 56 FY2021 PHRs are composed of eight regulations and 48 provisions of regulations. The 

48 provisions fall under 19 different regulations. Thus, the 56 FY2021 PHRs represent 27 

regulations, with the majority of FY2021 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 FY2021 PHRs 

Regulation Verified Description 

On 

FY2020 

PHR List 

Average 

Odds 

Ratio 

Average 

TwoSided 

Fisher 

Exact p 

Value 

301.2 Adulterated Adulterated Yes 19.77 2.57E-03 

310.22(b) Inedible and prohibited SRM 

for use as human food 

No 12.78 3.14E-03 

310.22(c) Disposal of SRM Yes 37.77 2.28E-06 

310.22(e)(1) Written procedures for 

removal, segregation, and 

disposition of SRMs 

Yes 8.56 6.51E-06 

310.22(e)(2) Appropriate corrective actions Yes 21.83 2.56E-06 

310.22(e)(3) Evaluate effectiveness of 

procedures for removal, 

segregation, and disposition of 

SRMs 

Yes 18.59 4.91E-06 

310.22(e)(4)(i) Maintain daily records No 10.58 3.65E-05 

310.22(f)(2) Use of routine operational 

sanitation procedures on 

equipment used to cut through 

SRMs 

Yes 8.13 8.39E-04 

310.25(a) Verification criteria for E. coli 

testing meat 

No 4.37 1.64E-03 

310.3 Carcasses and parts in certain 

instances to be retained. 

No 4.27 1.78E-03 

318.2(a) All products subject to 

reinspection by program 

employees 

Yes 26.50 3.13E-05 

49 
 

Regulation Verified Description 

On 

FY2020 

PHR List 

Average 

Odds 

Ratio 

Average 

TwoSided 

Fisher 

Exact p 

Value 

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

authorized Program employees 

only 

Yes 15.86 8.34E-03 

381.65(a) Clean and sanitary practices; 

products not adulterated 

Yes 4.88 6.05E-03 

381.71(a) Condemnation on ante mortem 

inspection 

Yes 19.82 3.43E-06 

381.91(b) Reprocessing of carcasses 

accidentally contaminated with 

digestive tract contents. 

Yes 12.96 1.34E-04 

416.1 Operate in a manner to prevent 

insanitary conditions 

Yes 5.41 5.44E-16 

416.12(c) Plan identifies procedures for 

pre-op 

No 12.83 7.07E-05 

416.13(a) Conduct pre-op procedures Yes 5.63 4.66E-27 

416.13(b) Conduct other procedures 

listed in the plan 

Yes 5.27 7.83E-12 

416.13(c) Plant monitors implementation 

of SSOP procedures 

Yes 5.05 3.53E-17 

416.14 Evaluate effectiveness of 

SSOP's & maintain plan 

Yes 6.71 2.45E-04 

416.15(a) Appropriate corrective actions Yes 8.73 4.49E-03 

416.15(b) Corrective action, procedures 

for 

Yes 15.76 2.34E-03 

416.16(a) Daily records required, 

responsible individual, 

initialed and dated 

Yes 4.39 1.67E-03 

416.3(b) Constructed, located & 

operated in a manner that does 

not deter inspection 

Yes 7.82 1.17E-05 

416.3(c) Receptacles for storing 

inedible material must identify 

permitted use 

Yes 6.78 7.57E-05 

416.4(a) Food contact surface, cleaning 

& sanitizing as frequency 

Yes 5.44 3.13E-05 

416.4(d) Product processing, handling, 

storage, loading, unloading, 

Yes 4.90 8.06E-08 

50 
Regulation Verified Description 

On 

FY2020 

PHR List 

Average 

Odds 

Ratio 

Average 

TwoSided 

Fisher 

Exact p 

Value 

and during transportation must 

be protected 

416.6 Only FSIS program employee 

may remove "U.S. Rejected" 

tag 

Yes 10.24 3.53E-07 

417.2(a)(1) Hazard analysis Yes 8.08 3.96E-24 

417.2(c) Contents of HACCP Plan No 17.06 1.92E-03 

417.2(c)(4) List of procedures & 

frequency 

Yes 7.68 1.08E-13 

417.3(a)(1) Identify and eliminate the 

cause 

Yes 11.08 1.07E-05 

417.3(a)(2) CCP is under control Yes 4.73 2.14E-04 

417.3(a)(3) Establish measures to prevent 

recurrence 

Yes 5.40 6.23E-03 

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

product 

No 6.20 1.44E-04 

417.3(b)(2) Determine the acceptability of 

the affected product 

Yes 7.30 2.00E-05 

417.3(b)(3) No adulterated product enters 

commerce 

Yes 9.01 1.48E-02 

417.3(b)(4) Reassessment Yes 4.66 7.66E-03 

417.3(c) Document corrective actions No 3.42 4.30E-04 

417.4(a) Adequacy of HACCP in 

controlling food safety 

hazards 

Yes 20.77 9.48E-13 

417.5(a)(1) Written hazard analysis Yes 3.80 1.50E-04 

417.5(a)(2) Written HACCP plan Yes 6.01 5.74E-03 

417.5(a)(3) Records documentation and 

monitoring of CCP's and 

Critical Limits 

Yes 6.76 4.55E-53 

417.5(f) Official Review Yes 4.65 4.44E-02 

417.6 Inadequate HACCP systems No 3.98 9.85E-05 

430.4(a) Lm, post-lethality exposed 

RTE 

Yes 6.17 4.39E-02 

430.4(b)(3) Lm, post-lethality exposed 

RTE - Alternative 3 

No 3.33 3.65E-02 

51 
 

Regulation Verified Description 

On 

FY2020 

PHR List 

Average 

Odds 

Ratio 

Average 

TwoSided 

Fisher 

Exact p 

Value 

430.4(c)(2) Lm, documentation that 

supports decision in hazard 

analysis 

Yes 26.60 7.22E-03 

430.4(c)(3) Lm, maintain sanitation in 

post-lethality processing 

environment 

Yes 12.94 1.96E-03 

310.18(a) Carcasses, organs, and other 

parts handled in a sanitary 

manner 

Yes 5.00 6.70E-56 

418.2 Notification of adulterated or 

misbranded product in 

commerce 

No 4.94 1.53E-06 

381.65(g) Procedures for controlling 

contamination throughout the 

slaughter and dressing 

operation 

No 5.44 5.10E-04 

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

Reprocessing 

Yes 3.23 1.07E-03 

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

NPIS 

Yes 5.02 4.65E-03 

311.14 Abrasions, bruises, abscesses, 

pus, etc. 

No 41.29 9.36E-06 

Forty-three of the previous 49 FY2020 PHRs are included in the FY2021 PHRs. There are six 

regulations on the FY2020 PHR list that are not in the FY2021 PHR list (See Appendix C). 

There are 13 regulations that are on the FY2021 PHR list that were not on the FY2020 PHR list. 

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

for inclusion in the FY2021 PHR list. Most regulations were triggered by multiple events. 

Similar to the FY2020 PHR list, salmonella pathogen positives and enforcement actions 

triggered the most regulations. 

52 
 

 

 

 

 

Table 5-2 Events That Triggered Inclusion of a Regulation in the FY2021 PHR List 

Product Number of Regulations 

Campylobacter 12 

Campylobacter Chicken Parts 9 

Campylobacter Ground Chicken 4 

Campylobacter Ground Turkey 5 

Campylobacter Intact Chicken 4 

Campylobacter Intact Turkey 1 

Enforcements 34 

Listeria 4 

Non-O157 E. coli 2 

O157 E. coli 5 

Salmonella 31 

Salmonella Chicken Parts 10 

Salmonella Ground Beef 7 

Salmonella Ground Chicken 13 

Salmonella Ground Pork 4 

Salmonella Ground Turkey 4 

Salmonella Intact Beef 28 

Salmonella Intact Chicken 2 

Salmonella Intact Pork 7 

Salmonella Intact Turkey 1 

Salmonella Siluriformes 1 

There were 10 regulations triggered by a single type of event: Four were from Enforcement 

Actions, two were from Salmonella, two were from Salmonella in Chicken Parts, one was from 

Salmonella in Intact Beef, and one was from Campylobacter in Comminuted Turkey. Table 5-3 

presents the regulations triggered for inclusion in the FY2021 PHR list by only single pathogen 

product or enforcement action type. 

53 
 

 

 

 

 

 

 

 

 

Table 5-3 Regulations Triggered for Inclusion in the FY2021 PHR List by Only a Single 

Event 

Regulation 

Verified Description Event 

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

310.25(a) Verification criteria for E. coli 

testing meat Enforcements 

416.12(c) Plan identifies procedures for 

pre-op 

Enforcements 

417.3(b)(1) Segregate and hold the 

affected product Salmonella Chicken Parts 

417.3(c) Document corrective actions Salmonella Chicken Parts 

417.6 Inadequate HACCP systems Salmonella 

430.4(a) Lm, post-lethality exposed 

RTE Salmonella Intact Beef 

430.4(b)(3) Lm, post-lethality exposed 

RTE - Alternative 3 Enforcements 

430.4(c)(3) Lm, maintain sanitation in 

post-lethality processing 

environment 

Campylobacter Ground 

Turkey 

418.2 Notification of adulterated or 

misbranded product in 

commerce 

Salmonella 

6.0 CUT POINTS FOR FY2021 PHRS 

The FY2021 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 FY2021 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 

90-day period together into a single aggregate ratio. The aggregate FY2021 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 

54 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

D). Then to determine a set of annual FY2021 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 FY2021 PHR Rate 

Mean of Natural Log 

FY2021 PHR Rate 

Standard Deviation 

FY2021 PHR Rate 

Processing Combination Processing Combination 

Jan-Mar 2019 -4.96 -4.48 0.82 1.05 

Apr-Jun 2019 -4.72 -4.26 0.75 0.95 

July-Sept 2019 -4.92 -4.42 0.83 1.10 

Oct-Dec 2019 -4.98 -4.43 0.82 1.06 

Average -4.90 -4.40 0.80 1.04 

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 

Tier 1 and are candidates to receive a for cause PHRE. For example4, the upper cut point for the 

log transformed data for Combination establishments is -4.40 + 2*1.04 = -4.40 + 2.08 = -2.32. 

The cut point of the original, non-transformed PHR noncompliance data is the antilog of -2.32 or 

Exp(-2.32) = 9.84%. Establishments that are below the Tier 1 threshold but meet or exceed the 

lower Tier 3 threshold will be notified by inspection personnel of an elevated level of noncompliance. 

The PHR cut points are defined as follows for each of the two plant types (Processing, and 

Slaughter/Processing Combination): 

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

establishments with the same establishment type would continue to receive routine 

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

peers with respect to compliance with the PHR regulations. 

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

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

continue to receive routine inspection procedures and be alerted through inspection 

personnel of elevated PHR noncompliance levels. 

• 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 six months receive a 

PHRE to determine if a for-cause FSA is appropriate. 

Tables 6-2 and 6-3 present the FY2021 PHR upper and lower cut points for each of the two 

establishment operation types. The FY2020 PHR cut points are included for comparison. (See 

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

55 
 

 

 

 

 

 

 

 

 

 

Appendix D for more details). The cut points are determined once a year. The next update to the 

cut points is planned for October 2020. 

Table 6-2 FY2021 PHR Tier 1 Cut Points 

Operation Type FY2021 PHR Cut 

Points 

FY2020 PHR Cut 

Points 

FY2019 PHR Cut 

Points 

Processing 3.73% 3.86% 4.40% 

Combination 9.84% 8.83% 9.40% 

Table 6-3 FY2021 PHR Tier 3 Cut Points 

Operation Type FY2021 PHR Cut 

Points 

FY2020 PHR Cut 

Points 

FY2019 PHR Cut 

Points 

Processing 2.50% 2.58% 2.90% 

Combination 5.85% 5.42% 5.64% 

Table 6-4 presents the number of establishments in each Tier based solely on the FY2021 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 Tier 1 but only have one 

noncompliance are moved to Tier 2. Based solely on the noncompliance rate for the FY2021 

PHRs, 59 establishments are in Tier 1 and candidates to receive for cause PHREs. Table 6-4 is 

based on regulatory noncompliances for the period January 1-March 31, 2020. 

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

Classification Number of Establishments 

Tier 1 59 

Tier 2 92 

Tier 3 5,160 

Total 5,311 

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

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

PHR Criterion 

Classification Processing Combination 

Tier 1 51 8 

Tier 2 62 30 

Tier 3 4,148 1,012 

Total 4,261 1,050 

7.0 CONCLUSION 

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

FY2021 PHR regulations used to prioritize certain FY2021 FSIS inspection activities. This 

process involves 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 

56 
 

 

 

 

 

 

 

 

 

 

 

 

 

months prior to a pathogen positive or enforcement action, and using this subset to determine cut 

points to determine which establishments should be flagged for a PHRE or an alert throughout 

the year. 

The list of FY2021 PHRs has 56 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-three regulations on the FY2020 PHR list are also on the 

FY2021 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, described in FSIS Directive 5100.4. 

Tables 7-1 and 7-2 present the FY2021 PHR upper and lower cut points. The FY2020 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 FY2021 PHR Tier 1 Cut Points 

Operation Type FY2021 PHR Cut 

Points 

FY2020 PHR Cut 

Points 

Processing 3.73% 3.86% 

Combination 9.84% 8.83% 

Table 7-2 FY2021 PHR Tier 3 Cut Points 

Operation Type FY2021 PHR Cut 

Points 

FY2020 PHR Cut 

Points 

Processing 2.50% 2.58% 

Combination 5.85% 5.42% 

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) 2019, FY2020 Public Health Regulations. 

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

Subcommittee Two, Issue Two: Data Analysis. 

57 
 

 

 

 

 

 

APPENDIX A: FY2021 PHR REGULATIONS 

Table A-1 presents the list of 56 FY2021 Public Health Regulations (PHRs). On average, these 

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

action that is 9.92 times higher than the PHR noncompliance rates for establishments with no 

pathogen positive or enforcement action. 

Table A-1 List of FY2021 PHRs 

Regulation Description 

301.2 Adulterated Adulterated 

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

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. 

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

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

only 

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

381.71(a) Condemnation on ante mortem inspection 

381.91(b) Reprocessing of carcasses accidentally contaminated with 

digestive tract contents. 

416.1 Operate in a manner to prevent insanitary conditions 

416.12(c) Plan identifies procedures for pre-op 

416.13(a) Conduct pre-op procedures 

416.13(b) Conduct other procedures listed in the plan 

416.13(c) Plant monitors implementation of SSOP procedures 

416.14 Evaluate effectiveness of SSOP's & maintain plan 

416.15(a) Appropriate corrective actions 

416.15(b) Corrective action, procedures for 

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

dated 

58 
 

 

Regulation Description 

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

deter inspection 

416.3(c) Receptacles for storing inedible material must identify 

permitted use 

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

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

and during transportation must be protected 

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

tag 

417.2(a)(1) Hazard analysis 

417.2(c) Contents of HACCP Plan 

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

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

417.3(a)(2) CCP is under control 

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

417.3(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 

417.5(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 

417.6 Inadequate HACCP systems 

430.4(a) Lm, post-lethality exposed RTE 

430.4(b)(3) Lm, post-lethality exposed RTE - Alternative 3 

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

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

environment 

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

manner 

418.2 Notification of adulterated or misbranded product in 

commerce 

381.65(g) Procedures for controlling contamination throughout the 

slaughter and dressing operation 

59 
Regulation Description 

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

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

311.14 Abrasions, bruises, abscesses, pus, etc. 

60 
 

 

 

 

APPENDIX B: FY2021 CANDIDATE REGULATIONS 

Table B-1 presents the list of candidate regulations. The noncompliance rates in Table B-1 are based on PHIS data for January 1, 

2019, through December 31, 2019. 

Table B-1 FY2021 Candidate Regulations 

FY2021 Candidate 

Regulation 

Description FY2020 

PHR 

Mandatory 

Regulation 

Total FSIS 

Verifications 

Total NCs1 NC1 Rate 

301.2_Adulterated Adulterated Yes No 6058 208 3.32% 

304.3(a) Develop written SSOP No No 628 2 0.32% 

304.3(c) Conduct hazard analysis & 

develop HACCP plan for new 

product 

No No 1468 7 0.47% 

309.2(a) Livestock suspected of being 

diseased or affected with certain 

conditions; identifying suspects 

No No 579 13 2.20% 

309.3 (HIMP ONLY) Dead, dying, 

disabled or diseased and similar 

livestock. 

No No 214 0 0.00% 

309.4 (HIMP ONLY) Livestock 

showing symptoms of metabolic, 

toxic, nervous, or diseases 

No No 223 3 1.33% 

309.5 (HIMP ONLY) Swine; disposal 

because of hog cholera 

No No 203 0 0.00% 

309.9 (HIMP ONLY) Swine erysipelas No No 207 0 0.00% 

310.18 Contamination of carcasses, 

organs, or other parts 

No No 435 5 1.14% 

310.22(b) Inedible and prohibited SRM for 

use as human food 

No No 4217 11 0.26% 

310.22(c) Disposal of SRM Yes Yes 54500 204 0.37% 

310.22(d)(2) Exports have equivalent level of 

protection from human exposure 

to BSE as similar US products 

No No 123 0 0.00% 

61 
 

 

FY2021 Candidate 

Regulation 

Description FY2020 

PHR 

Mandatory 

Regulation 

Total FSIS 

Verifications 

Total NCs1 NC1 Rate 

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

segregation, and disposition of 

SRMs 

Yes No 15877 267 1.65% 

310.22(e)(2) Appropriate corrective actions Yes No 3619 53 1.44% 

310.22(e)(3) Evaluate effectiveness of 

procedures for removal, 

segregation, and disposition of 

SRMs 

Yes No 9778 154 1.55% 

310.22(e)(4)(i) Maintain daily records No No 77402 210 0.27% 

310.22(f)(2) Use of routine operational 

sanitation procedures on 

equipment used to cut through 

SRMs 

Yes No 15988 37 0.23% 

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

carcasses with the vertebral 

columns to another federal 

inspected establishment 

No No 1255 6 0.48% 

310.22(g)(4) Maintain records of official 

establishment showing proper 

disposition of vertebral columns 

No No 4232 14 0.33% 

310.25(a) Verification criteria for E. coli 

testing meat 

No No 29229 255 0.86% 

310.25(b) Pathogen reduction performance 

standards; Salmonella 

No No 216 0 0.00% 

310.25(b)(3)(ii) PR livestock - Failure to maintain 

adequate HACCP Plan 

No No 58 1 1.69% 

310.3 Carcasses and parts in certain 

instances to be retained. 

No No 3012 233 7.18% 

62 
 

 

FY2021 Candidate 

Regulation 

Description FY2020 

PHR 

Mandatory 

Regulation 

Total FSIS 

Verifications 

Total NCs1 NC1 Rate 

311.16 (HIMP ONLY) Carcasses so 

infected that consumption of the 

meat may cause food poisoning. 

No No 202 6 2.88% 

311.17 (HIMP ONLY) Necrobacillosis, 

pyemia, septicemia. 

No No 519 1 0.19% 

311.24 (HIMP ONLY) Hogs affected 

with tapeworm cysts. 

No No 201 0 0.00% 

315.2 Carcasses and parts passed for 

cooking 

No No 87 0 0.00% 

316.6 Products not to be removed from 

official establishments unless 

marked in accordance with the 

regulations 

No No 12733 48 0.38% 

317.24(a) Packaging materials composed of 

poisonous or deleterious 

substances 

No No 2996 14 0.47% 

318.1(b) Only inspected and passed 

poultry product to enter official 

establishment 

Yes No 101717 13 0.01% 

318.14(a) Product and ingredients rendered 

adulterated by polluted water 

shall be condemned 

No No 401 0 0.00% 

318.14(b) Establishment shall be 

thoroughly cleaned and 

disinfected under FSIS 

supervision 

No No 844 1 0.12% 

318.14(c) Hermetically sealed 

contaminated containers shall be 

examined/rehandled under FSIS 

supervision 

No No 192 0 0.00% 

63 
 

 

FY2021 Candidate 

Regulation 

Description FY2020 

PHR 

Mandatory 

Regulation 

Total FSIS 

Verifications 

Total NCs1 NC1 Rate 

318.16(b) Pesticides chemicals & other 

residues in products not to 

exceed FD&C Act levels - Meat 

ingredients 

No No 364 1 0.27% 

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

requirements for cooked beef 

No No 2670 1 0.04% 

318.17(b) Lethality and Stabilization 

processes other than HACCP for 

cooked beef 

No No 678 0 0.00% 

318.17(c) Validation of new or altered 

process schedules (for cooked 

beef) 

No No 39 0 0.00% 

318.2(a) All products subject to 

reinspection by program 

employees 

Yes No 50128 59 0.12% 

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

authorized Program employees 

only 

Yes No 9015 46 0.51% 

318.23(b)(1) Time/Temperature for heatprocessing combinations of fully 

cooked meat patties 

No No 436 2 0.46% 

318.23(b)(3) Heat deviations for meat patties No No 32 1 3.03% 

318.23(c)(1) Stabilization requirements for 

meat patties 

No No 389 0 0.00% 

318.23(c)(2) Stabilization processes for meat 

patties other than HACCP 

No No 24 0 0.00% 

318.23(c)(4) Labeling statement for partially 

cooked patties 

No No 331 0 0.00% 

318.23(c)(5) Labeling statement for charmarked patties No No 164 0 0.00% 

64 
 

FY2021 Candidate 

Regulation 

Description FY2020 

PHR 

Mandatory 

Regulation 

Total FSIS 

Verifications 

Total NCs1 NC1 Rate 

318.24 Product prepared using advanced 

meat/bone separation machinery; 

process control 

No No 2558 16 0.62% 

318.6(b)(1) Requirements for use of casings, 

used as containers 

No No 2030 1 0.05% 

318.6(b)(4) Detached spinal cords No No 9998 0 0.00% 

318.6(b)(6) Tonsils No No 12555 2 0.02% 

318.6(b)(8) Intestines as ingredients No No 306 0 0.00% 

319.5(b) Mechanically separated (beef) -

prohibited for use in human food 

No No 269 0 0.00% 

381.1_Adulterated Adulterated Yes No 3785 22 0.58% 

381.144(a) Packaging materials not to be 

composed of any poisonous or 

deleterious substance 

No No 2546 1 0.04% 

381.150(a) Lethality and Stabilization 

requirements for cooked poultry 

No No 1631 3 0.18% 

381.150(c) Lethality and Stabilization 

processes other than HACCP for 

cooked poultry 

No No 63 0 0.00% 

381.150(d) Validation of new or altered 

process schedules by 

scientifically supportable means 

(cooked poultry) 

No No 4 0 0.00% 

381.151(a) Product and ingredients rendered 

adulterated by polluted water 

shall be condemned 

No No 167 0 0.00% 

381.22(a) Develop written SSOP No No 258 1 0.39% 

381.22(b) Conduct hazard analysis & 

develop and validate HACCP 

plan 

No No 1249 1 0.08% 

65 
 

FY2021 Candidate 

Regulation 

Description FY2020 

PHR 

Mandatory 

Regulation 

Total FSIS 

Verifications 

Total NCs1 NC1 Rate 

381.22(c) Conduct hazard analysis & 

develop HACCP plan for new 

product 

No No 402 1 0.25% 

381.37(a) Product not produced under 

supervision of program employee 

No No 2000 12 0.60% 

381.65(a) Clean and sanitary practices; 

products not adulterated 

Yes No 44145 342 0.77% 

381.71(a) Condemnation on ante mortem 

inspection 

Yes No 1972 81 3.95% 

381.72(a) Poultry No No 148 0 0.00% 

381.72(b) Ratites No No 2 0 0.00% 

381.76(a)* Post-mortem inspection, when 

required, extent. 

Yes No 8286 145 1.72% 

381.83 Septicemia or toxemia Yes No 884160 125 0.01% 

381.85 Special Diseases (organisms or 

toxins dangerous to the 

consumer) 

No No 64 0 0.00% 

381.91(a) Certain contaminated carcasses 

to be condemned 

No No 5974 4 0.07% 

381.91(b) Reprocessing of carcasses 

accidentally contaminated with 

digestive tract contents. 

Yes No 15201 199 1.29% 

416.1 Operate in a manner to prevent 

insanitary conditions 

Yes Yes 608967 7774 1.26% 

416.12(c) Plan identifies procedures for 

pre-op 

No No 48387 83 0.17% 

416.12(d) Plan list frequency for each 

procedure & responsible 

individual 

No No 65813 91 0.14% 

416.13(a) Conduct pre-op procedures Yes Yes 741929 13387 1.77% 

66 
 

 

 

FY2021 Candidate 

Regulation 

Description FY2020 

PHR 

Mandatory 

Regulation 

Total FSIS 

Verifications 

Total NCs1 NC1 Rate 

416.13(b) Conduct other procedures listed 

in the plan 

Yes Yes 1897363 3575 0.19% 

416.13(c) Plant monitors implementation of 

SSOP procedures 

Yes Yes 2695599 43501 1.59% 

416.14 Evaluate effectiveness of SSOP's 

& maintain plan 

Yes Yes 1658091 4044 0.24% 

416.15(a) Appropriate corrective actions Yes Yes 64913 1009 1.53% 

416.15(b) Corrective action, procedures for Yes Yes 41108 1037 2.46% 

416.16(a) daily records required, 

responsible individual, initialed 

and dated 

Yes Yes 2942578 4564 0.15% 

416.3(b) Constructed, located & operated 

in a manner that does not deter 

inspection 

Yes No 80261 606 0.75% 

416.3(c) Receptacles for storing inedible 

material must identify permitted 

use 

Yes No 68919 936 1.34% 

416.4(a) Food contact surface, cleaning & 

sanitizing as frequency 

Yes No 274664 16735 5.74% 

416.4(d) Product processing, handling, 

storage, loading, unloading, and 

during transportation must be 

protected 

Yes No 250748 21063 7.75% 

416.5(c) Employees who appears to have 

any abnormal source of microbial 

contamination 

No No 32164 17 0.05% 

416.6 Only FSIS program employee 

may remove "U.S. Rejected" tag 

Yes No 2304 113 4.68% 

417.2(a)(1) Hazard analysis Yes Yes 126162 1714 1.34% 

417.2(c) Contents of HACCP Plan No No 29248 88 0.30% 

67 
FY2021 Candidate 

Regulation 

Description FY2020 

PHR 

Mandatory 

Regulation 

Total FSIS 

Verifications 

Total NCs1 NC1 Rate 

417.2(c)(4) List of procedures & frequency Yes Yes 1352938 6125 0.45% 

417.3(a) Corrective action after deviation 

from CCP 

No No 285 2 0.70% 

417.3(a)(1) Identify and eliminate the cause Yes No 8520 488 5.42% 

417.3(a)(2) CCP is under control Yes No 127741 657 0.51% 

417.3(a)(3) Establish measures to prevent 

recurrence 

Yes No 5200 596 10.28% 

417.3(a)(4) No adulterated product enters 

commerce 

No No 30265 181 0.59% 

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

product 

No No 3509 90 2.50% 

417.3(b)(2) Determine the acceptability of 

the affected product 

Yes No 2292 96 4.02% 

417.3(b)(3) No adulterated product enters 

commerce 

Yes No 21758 97 0.44% 

417.3(b)(4) Reassessment Yes Yes 28163 184 0.65% 

417.3(c) Document corrective actions No No 4679 213 4.35% 

417.4(a) Adequacy of HACCP in 

controlling food safety hazards 

Yes No 8228 234 2.77% 

417.4(a)(1) Initial validation No No 6097 402 6.19% 

417.4(b) Reassessment of hazard analysis No Yes 30599 90 0.29% 

417.5(a)(1) Written hazard analysis Yes Yes 1398408 3967 0.28% 

417.5(a)(2) Written HACCP plan Yes Yes 1244575 1316 0.11% 

417.5(a)(3) Records documentation and 

monitoring of CCP's and Critical 

Limits 

Yes Yes 1424289 3973 0.28% 

417.5(f) Official Review Yes No 90784 106 0.12% 

417.6 Inadequate HACCP systems No No 388 89 18.66% 

430.4(a) Lm, post-lethality exposed RTE Yes Yes 308853 117 0.04% 

68 
FY2021 Candidate 

Regulation 

Description FY2020 

PHR 

Mandatory 

Regulation 

Total FSIS 

Verifications 

Total NCs1 NC1 Rate 

430.4(b)(1) Lm, post-lethality exposed RTE -

Alternative 1 

No No 784 6 0.76% 

430.4(b)(2) Lm, post-lethality exposed RTE -

Alternative 2 

No No 13994 76 0.54% 

430.4(b)(3) Lm, post-lethality exposed RTE -

Alternative 3 

No No 22203 298 1.32% 

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

decision in hazard analysis 

Yes Yes 300217 170 0.06% 

430.4(c)(3) Lm, maintain sanitation in postlethality processing environment Yes Yes 305736 163 0.05% 

430.4(c)(4) Lm, validate and verify control 

measures in HACCP plan 

No No 3525 12 0.34% 

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

Sanitation SOP 

No No 6176 22 0.35% 

430.4(c)(6) Lm, prerequisite program 

requirements 

No No 5584 51 0.91% 

310.18(a) Carcasses, organs, and other parts 

handled in a sanitary manner 

Yes Yes 319299 4280 1.32% 

310.18(b) Brains, cheek meat, head 

trimmings from animals 

slaughtered by gunshot 

No No 20890 1 0.00% 

418.2 Notification of adulterated or 

misbranded product in commerce 

No No 1443 109 7.02% 

418.3 Recall Plans Yes No 20510 79 0.38% 

354.242(b) All equipment and utensils clean 

and sanitary 

No No 72 1 1.37% 

354.242(h) Tools and equipment used in 

preparation to be kept clean and 

sanitary 

No No 24 0 0.00% 

69 
 

FY2021 Candidate 

Regulation 

Description FY2020 

PHR 

Mandatory 

Regulation 

Total FSIS 

Verifications 

Total NCs1 NC1 Rate 

354.243(a) No handling or storage of 

objectionable materials 

No No 17 0 0.00% 

381.193(a) Poultry not intended for human 

food in commerce 

No No 245 6 2.39% 

381.65(f) Procedures for controlling visible 

fecal contamination 

No No 1285450 11150 0.86% 

381.65(g) Procedures for controlling 

contamination throughout the 

slaughter and dressing operation 

No No 130728 1208 0.92% 

381.76(a) Post-mortem inspection, when 

required, extent 

No No 6109 117 1.88% 

381.94(a) Verification criteria for E. coli 

testing ratites 

No No 1172 9 0.76% 

381.65(h) Recordkeeping requirements No No 11201 0 0.00% 

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

Reprocessing 

Yes No 56665 384 0.67% 

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

NPIS 

Yes No 3110 225 6.75% 

381.76(b)(6)(ii)(C) NPIS septicemia/toxemia No No 1007485 126 0.01% 

381.76(b)(6)(ii)(B) NPIS reprocessing and salvage Yes No 80615 112 0.14% 

311.14 Abrasions, bruises, abscesses, 

pus, etc. 

No No 24510 21 0.09% 

1

NC = Noncompliance 

70 
 

 

 

 

 

APPENDIX C: COMPARISON OF FY2021 PHR LIST WITH FY2020 PHR LIST 

There are six regulations from the FY2020 PHR list that no longer appear in the FY2021 PHR 

list. These are shown in Table C-1. 

Table C-1 Regulations from the FY2020 PHR list no longer on the FY2021 PHR list 

List of FY2020 PHRs Description 

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

official establishment 

381.1_Adulterated Adulterated 

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

381.83 Septicemia or toxemia 

418.3 Recall Plans 

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

* The asterisk is part of the regulation name. 

There are 13 regulations on the FY2021 PHR list that were not on the FY2020 PHR list. These 

regulations, shown in Table C-2, were candidate regulations analyzed in both years. 

Table C-2 Regulations on the FY2021 PHR list that were not on the FY2020 PHR list 

List of FY2021 PHRs Description 

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

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

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

310.3 Carcasses and parts in certain instances to be retained. 

416.12(c) Plan identifies procedures for pre-op 

417.2(c) Contents of HACCP Plan 

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

417.3(c) Document corrective actions 

417.6 Inadequate HACCP systems 

430.4(b)(3) Lm, post-lethality exposed RTE -Alternative 3 

418.2 Notification of adulterated or misbranded product in 

commerce 

381.65(g) Procedures for controlling contamination throughout the 

slaughter and dressing operation 

311.14 Abrasions, bruises, abscesses, pus, etc. 

71 
 

 

 

 

 

 

 

 

 

 

APPENDIX D: METHODOLGY 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: 

NNNNNNNNNNNN NNoo PPPPPP NNNNNNNNNNNNNNNNNNNNNNNNNNNN PPPPPP NNNNNNNNNNNNNNNNNNNNNNNNNN PPNNRRNN = TTNNRRNNNN NNNNNNNNNNNN NNoo PPPPPP IINNNNNNNNNNRRNNNNNN PPNNNNNNNNNNNNNNNN

Establishments are categorized into one of two plant types (Processing Only and 

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. 

72 
 

 

 

0 

1= 

Q) 

~ 7.5 Q) 

Q_ 

5.0 

-7.05 -6.4 5 -5.85 

Curve 

-5.25 

Distribution of Log 

-4.65 -4.05 

Log 

-3. 45 -2.85 

--- Normal(Mu=-4.797 Sigma=0.9165) 

-2.25 -1. 65 

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 within SAS, 

shown in Figure D-2, indicate near-normality. 

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

Goodness-of-Fit Tests for Normal Distribution 

Test Statistic p Value 

Kolmogorov-Smirnov D 0.04215 Pr > D <0.010 

Cramer-von Mises W-Sq 1.26553 Pr > W-Sq <0.005 

Anderson-Darling A-Sq 7.81831 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 Tier distribution (based only on PHR noncompliances) using the quarterly cut points. 

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

73 
 

Number of 

Establishments Mean Standard Deviation 

Tier 

Distribution 

(Number of 

Establishments) 

Q1CY2019 Tier 1 75 

Both 1,051 -4.48 1.05 Tier 2 100 

Processing 4,229 -4.96 0.82 Tier 3 5,105 

Q2CY2019 Tier 1 54 

Both 1,060 -4.26 0.95 Tier 2 77 

Processing 4,231 -4.72 0.75 Tier 3 5,160 

Q3CY2019 Tier 1 73 

Both 1,061 -4.42 1.10 Tier 2 85 

Processing 4,230 -4.92 0.83 Tier 3 5,133 

Q4CY2019 Tier 1 63 

Both 1,063 -4.43 1.06 Tier 2 96 

Processing 4,235 -4.98 0.82 Tier 3 5,139 

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 Tier distribution (based only on PHR noncompliances) using the cut points in Table 

D-2. Table D-4 shows how many Tier 1 establishments in March 2020 are within certain product 

categories. 

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

Rates by Plant Type 

Combination Processing 

Mean -4.40 -4.90 

Standard Deviation 1.04 0.80 

Table D-3 March 2020 Tier Distribution Based on the PHR Criteria Only 

Classification Plants 

Tier 1 61 

Tier 2 103 

Tier 3 5,147 

Total 5,311 

74 
Table D-4 Distribution of Tier 1 Establishments among Different Product Categories 

Product Type 

Number Plants 

Producing 

Product Type 

Percent of all 

Plants 

Number 

Tier 1 

Plants 

Percent Tier 

1 Plants 

Chicken Slaughter 196 3.69% 3 4.84% 

Turkey Slaughter 44 0.83% 2 3.23% 

Beef Slaughter 1104 20.79% 7 11.29% 

Pork Slaughter 1020 19.21% 3 4.84% 

Beef Processing 0 0.00% 0 0.00% 

Chicken Processing 2015 37.94% 12 19.35% 

Turkey Processing 932 17.55% 14 22.58% 

Pork Processing 336 6.33% 5 8.06% 

Siluriformes 

Processing 

26 0..49% 0 0.00% 

RTE 2168 40.82% 13 20.97% 

Poultry Combination 0 0.00% 0 0.00% 

Total Number of 

Establishments 5311 62 

75