FY2020 Public Health Regulations 

July 2019 
 

 

 

 

 

Table of Contents 

Summary......................................................................................................................................... 6 

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

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

2.1 Criteria for Selection of Candidate Regulations ................................................................. 10 

2.2 Relationship with Pathogen Positives and Enforcement Actions....................................... 11 

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

4.0 Relationship Between Candidate regulations and Pathogen Positives and Enforcement 

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

4.1 Salmonella........................................................................................................................... 12 

4.1.1 Salmonella in Intact Chicken....................................................................................... 15 

4.1.2 Salmonella in Intact Turkey......................................................................................... 15 

4.1.3 Salmonella in Ground Beef.......................................................................................... 16 

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

4.1.5 Salmonella in Comminuted Chicken ........................................................................... 19 

4.1.6 Salmonella in Comminuted Turkey............................................................................. 21 

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

4.1.8 Salmonella in Comminuted Pork................................................................................. 23 

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

4.1.10 Salmonella in Ready to Eat (RTE)............................................................................. 25 

4.2 E. Coli ................................................................................................................................. 25 

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

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

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

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

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

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

4.4.3 Campylobacter in Comminuted Chicken..................................................................... 32 

4.4.4 Campylobacter in Comminuted Turkey ...................................................................... 33 

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

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

5.0 List of FY2020 PHRs.............................................................................................................. 40 

6.0 Cut Points for FY2020 PHRs.................................................................................................. 45 

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

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

Appendix A: FY2020 PHR Regulations....................................................................................... 49 

Appendix B: FY2020 Candidate Regulations............................................................................... 51 

Appendix C: Comparison of FY2020 PHR List with FY2019 PHR List..................................... 60 

Appendix D: Methodolgy and Calculation of PHR Cut Points .................................................... 61 

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List of Figures and Tables 

Table S-1 FY2020 PHR Tier 1 Cut Points...................................................................................... 7 

Table S-2 FY2020 PHR Tier 3 Cut Points...................................................................................... 7 

Table S-3 Number of Establishments in Tiers Based Solely on the PHR Criterion....................... 8 

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

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

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

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

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

Table 4-1 Comparison of Noncompliance Rates Three Months before an Intact Turkey 

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

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

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

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

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

Positive with Those for Establishments with No Intact Beef Salmonella Positive ...................... 18 

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

Salmonella Positive with Those for Establishments with No Comminuted Chicken Salmonella 

Positive.........................................................................................................20 

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

Salmonella Positive with Those for Establishments with No Comminuted Turkey Salmonella 

Positive.......................................................................................................................................... 21 

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

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

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

Salmonella Positive with Those for Establishments with No Comminuted Pork Salmonella 

Positive........................................................................................................................................ 223 

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

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

................................................................................................................................................ 24 

Table 4-11 Comparison of Noncompliance Rates Three Months before a Ready to Eat 

Salmonella Positive with those for Establishments with No Ready to Eat Salmonella Positive.. 25 

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

Positive with Those for Establishments with E. coli O157:H7 Positive....................................... 26 

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

Positive with Those for Establishments with No Non-O157 STEC Positive ............................... 27 

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

Positive with Those for Establishments with No Listeria monocytogenes Positive..................... 28 

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

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

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

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

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

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

Turkey Positive with Those for Establishments with No Campylobacter Intact Turkey Positive 32 

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

Campylobacter Positive with Those for Establishments with No Comminuted Chicken 

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

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

Campylobacter Positive with those for Establishments with No Comminuted Turkey 

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

Campylobacter Positive with Those for Establishments with No Chicken Parts Campylobacter 

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

Table 5-3 Regulations Triggered for Inclusion in the FY2020 PHR List by Only a Single Event 

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

Table B-1 FY2020 Candidate Regulations...............................................................51 

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 

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

Positive.......................................................................................................................................... 35 

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

Table 5-1 List of FY2020 PHRs ................................................................................................... 40 

Table 5-2 Events That Triggered Inclusion of a Regulation in the FY2020 PHR list.................. 44 

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

Table 6-1 Mean and Standard Deviation of Quarterly FY2020 PHR Rate .................................. 46 

Table 6-2 FY2020 PHR Tier 1 Cut Points.................................................................................... 46 

Table 6-3 FY2020 PHR Tier 3 Cut Points.................................................................................... 47 

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

Criterion ........................................................................................................................................ 47 

Table 7-1 FY2020 PHR Tier 1 Cut Points.................................................................................... 48 

Table 7-2 FY2020 PHR Tier 3 Cut Points.................................................................................... 48 

Table A-1 List of FY2020 PHRs .................................................................................................. 49 

Table C-1 Regulations from the FY2019 PHR list no longer on the FY2020 PHR list............... 60 

Table C-2 Regulations on the FY2020 PHR list that were not on the FY2019 PHR list ............. 60 

Verifications 3 Months before a Pathogen Positive or Enforcement Action................................ 62 

Figure D-2 Goodness of Fit for Normal Distribution of the Log Transformation........................ 62 

Table D-1 Quarterly PHR Mean, Standard Deviation and Tier Distribution ............................... 63 

Plant Type ..................................................................................................................................... 63 

Table D-3 March 2019 Tier Distribution Based on the PHR Criteria Only ................................. 63 

Table D-4 Distribution of Tier 1 Establishments among Different Product Categories............... 64 

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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, 2019 to September 30, 2020 (FY2020) to prioritize certain 

FY2020 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, 2018 to December 31, 2018 (CY2018) 

verification inspection results and will be implemented in FY2020. 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 FY2020 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 three-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 FY2020 PHRs consists of 49 regulations that have higher rates of 

noncompliance three months before a pathogen positive or enforcement action. This compares 

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

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

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

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

PHREs. 

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

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

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

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with 63 regulations that were identified in the October 1, 2018 to September 30, 2019 (FY2019) 

PHR list. The list of FY2020 PHRs is presented in Appendix A. Forty-five regulations from the 

FY2019 PHR list are included in the FY2020 PHR list. 

The 49 FY2020 PHRs comprise 7 regulations and 42 provisions of regulations. The 42 

provisions fall under 19 different regulations. Thus, the 49 FY2020 PHRs represent 26 

regulations, with the majority of FY2020 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 FY2020 PHR regulations three months before a pathogen 

positive or enforcement action is 7.33 times higher than the average FY2020 PHR 

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

Noncompliance with a single FY2020 PHR does not indicate a loss of process control. The 

aggregate set of PHRs is used to identify establishments that significantly deviate from the threemonth rolling average noncompliance rate for all similar establishments. The aggregate FY2020 

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 FY2020 cut points are computed by determining the mean and standard deviation of the log 

transformed non-zero FY2020 PHR rates for each of the four quarters in CY2018 (the log 

transform of the non-zero FY2020 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 six 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 FY2020 PHR cut points for the non-transformed PHR 

noncompliance data for each of the two establishment operation types. The FY2019 PHR cut 

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

Table S-1 FY2020 PHR Tier 1 Cut Points 

Operation Type FY2020 PHR Cut Points FY2019 PHR Cut Points 

Processing 3.86% 4.40% 

Combination 8.83% 9.40% 

Table S-2 FY2020 PHR Tier 3 Cut Points 

Operation Type FY2020 PHR Cut Points FY2019 PHR Cut Points 

Processing 2.58% 2.90% 

Combination 5.42% 5.64% 

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Table S-3 presents the number of establishments in each tier for from January 1, 2019 to March 

31, 2019, based on the PHR criterion. The period used for calculating the noncompliance rate of 

the PHRs was January 1, 2019 to March 31, 2019. 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 58 12 70 

Tier 2 69 31 100 

Tier 3 4,102 1,008 5,110 

Total 4,229 1,051 5,280 

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 FY2020 PHRs (PHRs that will be used for the time period 

October 1, 2019 to September 30, 2020). 

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 FY2020 PHR list is the same as that used for the 

FY2019 PHR list. For inclusion in the FY2020 PHR list, each candidate 9 CFR regulation was 

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evaluated to determine whether noncompliance with the verified regulation had occurred at a 

more frequent rate in establishments in the three-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 one year of FSIS verification inspection results recorded in PHIS from January 1 to 

December 31, 2018 (CY2018). Candidate regulations related to egg products or Siluriformes 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 

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 FY2020 PHR list is 

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

PHRs. Appendix C describes the differences between the FY2020 PHR list and FY2019 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 list will 

consist of verified 9 CFR regulations with which noncompliance occurs at a more frequent rate 

than in establishments in the three-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: 

• Develop a candidate list of 9 CFR regulations related to verifying HACCP food safety 

process control. 

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

statistically higher in establishments in the three 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 three-month rolling 

average noncompliance rate for all similar establishments. 

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

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

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

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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. A set of four criteria were developed to assist in 

selecting the list of candidate regulations. 

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. If 1) the design of the plan is effective in eliminating food safety 

hazards, and if the establishment executes the plan’s design properly, including 2) maintaining 

sanitary conditions, 3) preventing adulteration, and 4) taking corrective action when appropriate, 

then the resulting product should be safe for the consumer. These four elements of HACCP are 

essential for maintaining an effective process control system and will be 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: 

• Establish and Maintain HACCP plan and Critical Control Points (CCPs) 

• Establish and Maintain Sanitary Conditions 

• Prevent Adulteration 

• Implement Effective Corrective Actions 

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

considered candidate regulations. 

• Establish and Maintain HACCP 

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 

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• 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 three months before the occurrence of a pathogen 

positive during FSIS sampling or enforcement action. The three-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 three 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 

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 one hundred forty-five (145) 9 CFR regulations were 

selected as being indicators of a potential loss of food safety process control. The list of 145 

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 145 candidate regulations in establishments three 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 CY2018. 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 

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the three 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 three 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 1,988 establishments with Salmonella testing data, of which 714 had 

3,304 Salmonella positives and 1,274 did not have Salmonella positives. There were 43,671 

total Salmonella tests performed. 

Table 4-1 presents the 26 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 Test p value of less than 0.05) that the noncompliance rate of the regulation in 

establishments three months prior to a Salmonella positive is higher than the average 

noncompliance rate for establishments with no Salmonella positive for CY2018. 

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Table 4-2 Comparison of Noncompliance Rates Three Months before a Salmonella Positive with Those for Establishments 

with No Salmonella Positive 

Regulation 

Verified 

Description On 

FY2019 

PHR List 

Noncompliance 

Rate in 3 

Months before a 

Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher’s 

Exact p 

Value 

301.2_Adulterated Adulterated Yes 24.64% 2.56% 12.43 7.60E-92 

310.22(c) Disposal of SRM Yes 0.89% 0.26% 3.44 8.31E-10 

310.22(e)(3) 

Evaluate effectiveness of procedures 

for removal, segregation, and 

disposition of SRMs 

Yes 3.41% 0.91% 3.84 

9.55E-11 

310.22(f)(2) 

Use of routine operational sanitation 

procedures on equipment used to cut 

through SRMs 

Yes 0.92% 0.24% 3.85 

3.15E-05 

318.2(a) All products subject to reinspection 

by program employees Yes 0.27% 0.06% 4.12 3.31E-04 

381.65(a) Clean and sanitary practices; 

products not adulterated Yes 2.52% 0.37% 6.94 4.13E-53 

416.1 Operate in a manner to prevent 

insanitary conditions Yes 4.47% 1.18% 3.90 0.00E+00 

416.13(a) Conduct pre-op procedures Yes 5.73% 0.95% 6.33 0.00E+00 

416.13(b) Conduct other procedures listed in 

the plan Yes 0.62% 0.16% 3.81 1.17E-229 

416.13(c) Plant monitors implementation of 

SSOP procedures Yes 7.20% 1.20% 6.40 0.00E+00 

416.14 Evaluate effectiveness of SSOP's & 

maintain plan Yes 1.09% 0.18% 6.03 0.00E+00 

416.15(a) Appropriate corrective actions Yes 7.17% 2.03% 3.73 3.36E-75 

416.15(b) Corrective action, procedures for Yes 10.86% 2.08% 5.74 1.98E-121 

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Regulation 

Verified 

Description On 

FY2019 

PHR List 

Noncompliance 

Rate in 3 

Months before a 

Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher’s 

Exact p 

Value 

416.16(a) Daily records required, responsible 

individual, initialed and dated Yes 0.40% 0.12% 3.30 2.36E-192 

416.3(b) 

Constructed, located & operated in a 

manner that does not deter 

inspection 

Yes 2.91% 0.48% 6.16 

1.94E-61 

416.3(c) Receptacles for storing inedible 

material must identify permitted use Yes 5.99% 0.97% 6.47 4.27E-125 

416.4(a) Food contact surface, cleaning & 

sanitizing as frequency Yes 22.98% 4.30% 6.65 0.00E+00 

416.4(d) 

Product processing, handling, 

storage, loading, unloading, and 

during transportation must be 

protected 

Yes 31.51% 5.75% 7.54 

0.00E+00 

417.2(c)(4) List of procedures & frequency Yes 1.43% 0.30% 4.90 0.00E+00 

417.3(a)(1) Identify and eliminate the cause Yes 12.01% 3.81% 3.45 3.13E-34 

417.3(a)(2) CCP is under control Yes 1.06% 0.32% 3.33 5.79E-35 

417.3(a)(3) Establish measures to prevent 

recurrence 

Yes 21.63% 6.22% 4.16 5.52E-46 

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

affected product Yes 3.84% 0.89% 4.45 3.74E-06 

417.3(b)(3) No adulterated product enters 

commerce 

Yes 0.66% 0.14% 4.64 9.39E-06 

417.3(b)(4) Reassessment Yes 2.68% 0.44% 6.21 2.55E-24 

310.18(a) Carcasses, organs, and other parts 

handled in a sanitary manner Yes 3.57% 0.97% 3.78 3.29E-294 

14 
 

 

 

 

 

 

 

 

 

 

 

 

4.1.1 Salmonella in Intact Chicken 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 202 establishments with Intact Chicken 

Salmonella testing data, of which 150 had 465 Salmonella positives and 52 did not have Salmonella positives. There were 9,054 total 

Intact Chicken Salmonella tests performed. 

Table 4-2 presents the 4 regulations which had more than 30 verifications in a year, an odds ratio of 3.0 or greater, and for which there 

is an 95% probability (as determined by a two-sided Fisher’s Exact p value of less than 0.05) that the noncompliance rate of the 

regulation in establishments three months prior to an Intact Chicken Salmonella positive is higher than the average noncompliance rate 

for establishments with no Intact Chicken Salmonella positive for CY2018. 

Table 4-3 Comparison of Noncompliance Rates Three Months before an Intact Chicken Salmonella Positive with Those for 

Establishments with No Intact Chicken Salmonella Positive 

Regulation 

Verified 

Description On 

FY2019 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher’s 

Exact p 

Value 

417.3(b)(3) No adulterated product enters commerce Yes 1.05% 0.19% 5.58 3.63E-04 

417.3(b)(4) Reassessment Yes 6.12% 1.18% 5.48 2.06E-04 

417.4(a) Adequacy of HACCP in controlling food 

safety hazards 

Yes 8.68% 0.96% 9.77 6.64E-08 

381.76(b)(6)(ii)(D) Ready-to-Cook verification in NPIS No 10.31% 3.44% 3.23 5.93E-05 

4.1.2 Salmonella in Intact Turkey 

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

data, of which 10 had 14 Salmonella positives and 35 did not have Salmonella positives. There were 1,903 total Intact Turkey 

Salmonella tests performed. 

Table 4-3 presents the 3 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 Test p value of less than 0.05) that the noncompliance rate of the 

15 
 

 

 

 

 

 

 

 

 

regulations in establishments three months prior to an Intact Turkey Salmonella positive is higher than the average noncompliance rate 

for establishments with no Intact Turkey Salmonella positive for CY2018. 

Table 4-4 Comparison of Noncompliance Rates Three Months before an Intact Turkey Salmonella Positive with Those for 

Establishments with No Intact Turkey Salmonella Positive 

Regulation 

Verified 

Description On 

FY2019 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher’s 

Exact p 

Value 

381.65(a) Clean and sanitary practices; products not 

adulterated Yes 2.36% 0.42% 5.77 1.99E-02 

417.2(c)(4) List of procedures & frequency Yes 2.28% 0.61% 3.80 2.15E-10 

417.5(a)(3) Records documentation and monitoring of 

CCP's and Critical Limits Yes 0.44% 0.13% 3.43 4.65E-03 

4.1.3 Salmonella in Ground Beef 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 1229 establishments with Salmonella testing 

data, of which 127 had 229 Salmonella positives and 1,102 did not have Salmonella positives. There were 11,124 total Ground Beef 

Salmonella tests performed. 

Table 4-4 presents the 11 regulations 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 three months prior to a Ground Beef Salmonella positive is higher than the average noncompliance rate 

for establishments with no Ground Beef Salmonella positive for CY2018. 

16 
 

 

Table 4-5 Comparison of Noncompliance Rates Three Months before a Ground Beef Salmonella Positive with Those for 

Establishments with No Ground Beef Salmonella Positive 

Regulation 

Verified 

Description On 

FY2019 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher’s 

Exact p 

Value 

301.2_Adulterated Adulterated Yes 18.72% 2.10% 10.72 1.52E-22 

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

segregation, and disposition of SRMs Yes 4.31% 1.19% 3.72 1.00E-04 

310.22(e)(2) Appropriate corrective actions Yes 15.22% 2.48% 7.06 5.35E-04 

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

removal, segregation, and disposition of 

SRMs Yes 5.42% 0.89% 6.42 7.33E-09 

318.1(b) Only inspected and passed poultry 

product to enter official establishment Yes 0.42% 0.01% 67.09 2.48E-03 

416.13(c) Plant monitors implementation of SSOP 

procedures Yes 2.91% 0.88% 3.38 1.60E-189 

416.15(a) Appropriate corrective actions Yes 4.78% 1.56% 3.16 2.36E-07 

416.15(b) Corrective action, procedures for Yes 4.98% 1.56% 3.30 1.88E-03 

416.4(d) Product processing, handling, storage, 

loading, unloading, and during 

transportation must be protected Yes 10.56% 3.63% 3.13 1.14E-73 

417.2(c)(4) List of procedures & frequency Yes 1.34% 0.21% 6.57 4.08E-101 

310.18(a) Carcasses, organs, and other parts 

handled in a sanitary manner Yes 3.06% 0.78% 4.04 6.96E-77 

17 
 

 

 

 

 

 

4.1.4 Salmonella in Intact Beef 

FSIS tests beef trim and beef manufacturing trimmings as a surrogate for testing intact beef. There are 864 establishments with Intact 

Beef Salmonella testing data, of which 71 had 168 Salmonella positives and 793 did not have Salmonella positives. There were 5,935 

total Intact Beef Salmonella tests performed. 

Table 4-5 presents the 13 regulations which had more than 30 verifications in a year, an odds ratio of 3.0 or greater, and for which 

there is an 95% probability, as determined by a two-sided Fisher’s Exact Test p value of less than 0.05) that the noncompliance rate of 

the regulation in establishments three months prior to an Intact Beef Salmonella positive is higher than the average noncompliance 

rate for establishments with no Intact Beef Salmonella positive for CY2018. 

Table 4-6 Comparison of Noncompliance Rates Three Months before an Intact Beef Salmonella Positive with Those for 

Establishments with No Intact Beef Salmonella Positive 

Regulation 

Verified 

Description On 

FY2019 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

Two-Sided 

Fisher’s 

Exact p 

Value 

301.2_Adulterated Adulterated Yes 38.29% 3.57% 16.78 1.16E-88 

310.22(c) Disposal of SRM Yes 1.07% 0.28% 3.79 5.22E-08 

310.22(e)(3) 

Evaluate effectiveness of procedures for 

removal, segregation, and disposition of 

SRMs Yes 4.94% 1.55% 3.29 1.34E-07 

310.22(f)(2) 

Use of routine operational sanitation 

procedures on equipment used to cut 

through SRMs Yes 2.05% 0.24% 8.76 1.98E-10 

416.13(c) 

Plant monitors implementation of SSOP 

procedures Yes 4.88% 1.00% 5.08 0.00E+00 

416.15(a) Appropriate corrective actions Yes 9.15% 1.84% 5.38 3.45E-20 

416.15(b) Corrective action, procedures for Yes 9.90% 1.93% 5.59 2.20E-14 

18 
 

 

 

 

Regulation 

Verified 

Description On 

FY2019 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

Two-Sided 

Fisher’s 

Exact p 

Value 

416.4(d) 

Product processing, handling, storage, 

loading, unloading, and during 

transportation must be protected Yes 13.11% 4.79% 3.00 1.10E-87 

417.2(a)(1) Hazard analysis Yes 4.71% 1.54% 3.16 1.32E-07 

417.2(c)(4) List of procedures & frequency Yes 1.71% 0.24% 7.18 2.46E-116 

417.3(b)(3) No adulterated product enters commerce Yes 2.14% 0.21% 10.54 1.82E-07 

417.3(b)(4) Reassessment Yes 5.92% 0.49% 12.74 1.56E-07 

310.18(a) 

Carcasses, organs, and other parts 

handled in a sanitary manner Yes 4.52% 0.89% 5.29 3.64E-223 

4.1.5 Salmonella in Comminuted Chicken 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 96 establishments with Comminuted Chicken 

Salmonella testing data, of which 80 had 566 Salmonella positives and 16 did not have Salmonella positives. There were 2,028 total 

Comminuted Chicken Salmonella tests performed. 

Table 4-6 presents the 11 regulations 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 three months before an Comminuted Chicken Salmonella positive is higher than the average noncompliance rate for 

establishments with no Comminuted Chicken Salmonella positive for CY2018. 

19 
 

Table 4-7 Comparison of Noncompliance Rates Three Months before a Comminuted Chicken Salmonella Positive with Those 

for Establishments with No Comminuted Chicken Salmonella Positive 

Regulation 

Verified 

Description On 

FY2019 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher’s 

Exact p 

Value 

416.1 Operate in a manner to prevent insanitary 

conditions 

Yes 3.70% 0.91% 4.19 2.43E-12 

416.13(a) Conduct pre-op procedures Yes 5.52% 0.65% 8.97 9.85E-33 

416.13(b) Conduct other procedures listed in the 

plan 

Yes 0.66% 0.10% 6.57 5.00E-10 

416.13(c) Plant monitors implementation of SSOP 

procedures 

Yes 5.01% 1.29% 4.03 1.33E-71 

416.14 Evaluate effectiveness of SSOP's & 

maintain plan 

Yes 1.21% 0.15% 8.47 3.91E-16 

416.15(a) Appropriate corrective actions Yes 12.20% 3.23% 4.17 3.81E-02 

416.3(c) Receptacles for storing inedible material 

must identify permitted use 

Yes 5.07% 0.80% 6.63 1.15E-03 

416.4(a) Food contact surface, cleaning & 

sanitizing as frequency 

Yes 28.35% 3.50% 10.91 1.34E-90 

416.4(d) Product processing, handling, storage, 

loading, unloading, and during 

transportation must be protected 

Yes 32.02% 12.02% 3.45 2.82E-52 

417.2(c)(4) List of procedures & frequency Yes 0.97% 0.31% 3.17 1.43E-06 

417.5(a)(2) Written HACCP plan Yes 0.25% 0.08% 3.28 2.50E-02 

20 
 

 

 

 

 

 

 

 

 

 

 

 

4.1.6 Salmonella in Comminuted Turkey 

There are 63 establishments with Comminuted Turkey Salmonella testing data, of which 43 had 298 Salmonella positives and 20 did 

not have Salmonella positives. There were 1,598 total Comminuted Turkey Salmonella tests performed. 

Table 4-7 presents the 6 regulations which had more than 30 verifications in a year, an odds ratio of 3.0 or greater, and for which there 

is an 95% probability (as determined by a two-sided Fisher’s Exact p value of less than 0.05) that the noncompliance rate of the 

regulation in establishments three months before an Comminuted Turkey Salmonella positive is higher than the average 

noncompliance rate for establishments with no Comminuted Turkey Salmonella positive for CY2018. 

Table 4-8 Comparison of Noncompliance Rates Three Months before a Comminuted Turkey Salmonella Positive with Those 

for Establishments with No Comminuted Turkey Salmonella Positive 

Regulation 

Verified 

Description On 

FY2019 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher’s 

Exact p 

Value 

416.13(a) Conduct pre-op procedures Yes 3.19% 0.89% 3.67 9.85E-33 

416.13(c) Plant monitors implementation of SSOP 

procedures 

Yes 4.80% 1.59% 3.12 1.33E-71 

416.3(b) 

Constructed, located & operated in a 

manner that does not deter inspection Yes 1.75% 0.26% 6.82 2.68E-02 

416.3(c) 

Receptacles for storing inedible material 

must identify permitted use Yes 5.80% 1.66% 3.64 6.13E-04 

416.4(d) 

Product processing, handling, storage, 

loading, unloading, and during 

transportation must be protected Yes 

20.30% 5.09% 4.75 4.53E-48 

417.2(c)(4) List of procedures & frequency Yes 0.71% 0.19% 3.80 1.87E-06 

21 
 

 

 

 

 

 

 

4.1.7 Salmonella in Intact Pork 

There are 126 establishments with Intact Pork Salmonella testing data, of which 41 had 137 Salmonella positives and 85 did not have 

Salmonella positives. There were 1,290 total Intact Pork Salmonella tests performed. 

Table 4-8 presents the 7 regulations which had more than 30 verifications in a year, an odds ratio of 3.0 or greater, and for which there 

is an 95% probability (as determined by a two-sided Fisher’s Exact p value of less than 0.05) that the noncompliance rate of the 

regulation in establishments three months before an Intact Pork Salmonella positive is higher than the average noncompliance rate for 

establishments with no Intact Pork Salmonella positive for CY2018. 

Table 4-9 Comparison of Noncompliance Rates Three Months before an Intact Pork Salmonella Positive with Those for 

Establishments with No Intact Pork Salmonella Positive 

Regulation 

Verified 

Description On 

FY2019 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher’s 

Exact p 

Value 

416.13(c) Plant monitors implementation of SSOP 

procedures 

Yes 6.56% 2.11% 3.25 9.79E-166 

416.15(b) Corrective action, procedures for Yes 13.46% 2.51% 6.03 2.58E-07 

416.16(a) Daily records required, responsible 

individual, initialed and dated 

Yes 0.60% 0.10% 6.25 6.05E-31 

416.3(b) Constructed, located & operated in a 

manner that does not deter inspection 

Yes 3.10% 0.51% 6.27 4.18E-06 

416.3(c) Receptacles for storing inedible material 

must identify permitted use 

Yes 3.42% 0.82% 4.26 3.87E-06 

416.4(d) Product processing, handling, storage, 

loading, unloading, and during 

transportation must be protected 

Yes 25.41% 9.29% 3.33 5.64E-88 

417.3(a)(2) CCP is under control Yes 3.00% 0.43% 7.09 2.12E-04 

22 
 

 

 

 

 

 

 

 

4.1.8 Salmonella in Comminuted Pork 

There are 163 establishments with Comminuted Pork Salmonella testing data, of which 95 had 405 Salmonella positives and 68 did 

not have Salmonella positives. There were 2,793 total Comminuted Pork Salmonella tests performed. 

Table 4-9 presents the 5 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 for which the noncompliance rate of 

the regulation in establishments three months before an Comminuted Pork Salmonella positive is higher than the average 

noncompliance rate for establishments with no Comminuted Pork Salmonella positive for CY2018. 

Table 4-9 Comparison of Noncompliance Rates Three Months before a Comminuted Pork Salmonella Positive with those for 

Establishments with No Comminuted Pork Salmonella Positive 

Regulation 

Verified 

Description On 

FY2019 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher’s 

Exact p 

Value 

416.1 Operate in a manner to prevent insanitary 

conditions 

Yes 3.93% 1.02% 3.96 1.19E-42 

416.13(b) Conduct other procedures listed in the 

plan 

Yes 0.50% 0.13% 3.93 7.33E-18 

416.3(b) Constructed, located & operated in a 

manner that does not deter inspection 

Yes 1.88% 0.55% 3.47 1.58E-03 

416.3(c) Receptacles for storing inedible material 

must identify permitted use 

Yes 4.21% 0.84% 5.16 3.47E-07 

416.4(a) Food contact surface, cleaning & 

sanitizing as frequency 

Yes 15.21% 4.76% 3.59 9.19E-76 

23 
 

 

 

 

 

 

 

4.1.9 Salmonella in Chicken Parts 

There are 449 establishments with Chicken Parts Salmonella testing data, of which 313 had 1022 Salmonella positives and 136 did not 

have Salmonella positives. There were 7,946 total Chicken Parts Salmonella tests performed. 

Table 4-10 presents the 6 regulations which had more than 30 verifications in a year, an odds ratio of 3.0 or greater, and for which 

there is an 95% probability (as determined by a two-sided Fisher’s Exact p value of less than 0.05) that the noncompliance rate of the 

regulation in establishments three months before an Chicken Parts Salmonella positive is higher than the average noncompliance rate 

for establishments with no Chicken Parts Salmonella positive for CY2018. 

Table 4-10 Comparison of Noncompliance Rates Three Months before a Chicken Parts Salmonella Positive with Those for 

Establishments with No Chicken Parts Salmonella Positive 

Regulation 

Verified 

Description On 

FY2019 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher’s 

Exact p 

Value 

381.65(a) Clean and sanitary practices; products 

not adulterated 

Yes 3.50% 1.06% 3.37 4.46E-34 

381.83 Septicemia or toxemia Yes 0.03% 0.01% 3.30 2.59E-02 

416.16(a) Daily records required, responsible 

individual, initialed and dated 

Yes 0.49% 0.15% 3.31 5.35E-47 

416.3(c) Receptacles for storing inedible material 

must identify permitted use 

Yes 8.70% 2.61% 3.56 4.26E-17 

417.3(b)(4) Reassessment Yes 7.85% 0.67% 12.59 7.61E-13 

417.4(a) Adequacy of HACCP in controlling food 

safety hazards 

Yes 6.20% 0.79% 8.33 1.12E-05 

24 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.1.10 Salmonella in Ready to Eat (RTE) 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 2,247 establishments with Salmonella testing 

data, of which 1 had 1 Salmonella positive and 2,246 did not have Salmonella positives. There were 14,457 total RTE Salmonella 

tests performed. 

Table 4-11 presents the 2 regulations which had more than 30 verifications in a year, an odds ratio of 3.0 or greater, and for which 

there is an 95% probability (as determined by a two-sided Fisher’s Exact p value of less than 0.05) that the noncompliance rate of the 

regulation in establishments three months before an RTE Salmonella positive is higher than the average noncompliance rate for 

establishments with no RTE Salmonella positive for CY2018. 

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

Establishments with No Ready to Eat Salmonella Positive 

Regulation 

Verified 

Description On 

FY2019 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher’s 

Exact p 

Value 

430.4(a) Lm, post-lethality exposed RTE Yes 1.05% 0.03% 34.28 2.94E-02 

430.4(c)(2) 

Lm, post-lethality exposed RTE – 

Alternative 3 Yes 1.05% 0.05% 20.60 4.82E-02 

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 1,382 establishments with E. coli 

O157:H7 testing data, of which 13 had 14 E. coli O157:H7 positives and 1369 did not have E. coli O157:H7 positives. There were 

17,048 total E. coli O157:H7 tests performed. 

25 
 

 

Table 4-12 presents the 10 regulations which 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 three 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 CY2018. 

Table 4-12 Comparison of Noncompliance Rates Three Months before an E. coli O157:H7 Positive with Those for 

Establishments with E. coli O157:H7 Positive 

Regulation 

Verified 

Description On 

FY2019 

PHR 

List 

Noncompliance 

Rate in 3 Months 

before a 

Salmonella 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Odds 

Ratio 

TwoSided 

Fisher’s 

Exact p 

Value 

310.22(c) Disposal of SRM Yes 2.36% 0.37% 6.59 1.32E-03 

416.13(a) Conduct pre-op procedures Yes 6.67% 0.87% 8.10 4.21E-15 

416.13(b) 

Conduct other procedures listed in the 

plan 

Yes 0.80% 0.15% 5.41 1.65E-04 

416.13(c) 

Plant monitors implementation of 

SSOP procedures 

Yes 4.51% 1.10% 4.25 5.11E-21 

416.3(b) 

Constructed, located & operated in a 

manner that does not deter inspection 

Yes 5.00% 0.51% 10.25 1.99E-04 

417.2(a)(1) Hazard analysis Yes 6.67% 1.55% 4.54 3.30E-02 

417.2(c)(4) List of procedures & frequency Yes 1.40% 0.29% 4.92 9.58E-07 

417.5(a)(1) Written hazard analysis Yes 0.79% 0.26% 3.08 9.13E-03 

430.4(c)(3) 

Lm, maintain sanitation in postlethality processing environment No 1.06% 0.04% 28.79 3.73E-02 

310.18(a) 

Carcasses, organs, and other parts 

handled in a sanitary manner 

Yes 4.34% 1.31% 3.41 3.57E-11 

26 
 

 

 

 

 

 

 

 

 

 

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 480 establishments with Non-O157 STEC testing data, of which 10 had 21 Non- O157 STEC positives and 470 did not have NonO157 STEC positives. There were 3,726 total Non-O157 STEC tests performed. 

Table 4-13 presents the 2 regulations which had more than 30 verifications in a year, an odds ratio of 3.0 or greater, and for which 

there is an 95% probability (as determined by a two-sided Fisher’s Exact p value of less than 0.05) that the noncompliance rate of the 

regulation in establishments three months before an Non-O157 STEC positive is higher than the average noncompliance rate for 

establishments with no Non-O157 STEC positive for CY2018. 

Table 4-13 Comparison of Noncompliance Rates Three Months before a Non-O157 STEC Positive with Those for 

Establishments with No Non-O157 STEC Positive 

Regulation 

Verified 

Description On 

FY2019 

PHR 

List 

Noncompliance 

Rate in 3 Months 

before a 

Non-O157 STEC 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Non-O157 STEC 

Positive 

Odds 

Ratio 

TwoSided 

Fisher’s 

Exact p 

Value 

310.22(c) Disposal of SRM Yes 3.00% 0.48% 6.35 5.49E-04 

416.4(d) Product processing, handling, 

storage, loading, unloading, and 

during transportation must be 

protected 

Yes 25.00% 7.41% 4.16 2.66E-13 

27 
 

 

 

 

 

 

 

 

 

 

 

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 2,250 establishments with Listeria 

monocytogenes testing data, of which 3 had 3 Listeria monocytogenes positives and 2,247 did not have Listeria monocytogenes 

positives. There were 14,470 total Listeria monocytogenes tests performed. 

Table 4-14 presents the 2 regulations that had more than 30 verifications in a year, an odds ratio of 3.0 or greater, and for which there 

is 95% probability (as determined by a two-sided Fisher’s Exact p value of less than 0.05) that the noncompliance rate of the 

regulation in the three months before a Listeria monocytogenes positive is higher than the noncompliance rate for establishments with 

no Listeria monocytogenes positive for CY2018. 

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

Establishments with No Listeria monocytogenes Positive 

Regulation 

Verified 

Description On 

FY2019 

PHR 

List 

Noncompliance 

Rate in 3 Months 

before a Listeria 

monocytogenes 

Positive 

Noncompliance 

Rate for 

Establishments 

with no Listeria 

monocytogenes 

Positive 

Odds 

Ratio 

TwoSided 

Fisher’s 

Exact p 

Value 

416.4(a) Food contact surface, cleaning & 

sanitizing as frequency 

Yes 14.29% 4.49% 3.54 5.69E-09 

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

decision in hazard analysis 

Yes 0.58% 0.05% 11.73 2.43E-03 

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 590 establishments with Campylobacter 

testing data, of which 325 had 1,315 Campylobacter positives and 265 did not have Campylobacter positives. There were 22,513 total 

Campylobacter tests performed. 

Table 4-15 presents the 18 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 

28 
 

 

 

regulation in the three months before a Campylobacter positive is higher than the noncompliance rate for establishments with no 

Campylobacter positive for CY2018. 

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

Establishments with No Campylobacter Positive 

Regulation 

Verified 

Description On 

FY2019 

PHR 

List 

Noncompliance 

Rate in 3 Months 

before a 

Campylobacter 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

Odds 

Ratio 

Two-Sided 

Fisher’s 

Exact p 

Value 

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

authorized Program employees only 

Yes 11.43% 0.67% 19.23 5.25E-04 

381.71(a) Condemnation on ante mortem 

inspection 

Yes 11.42% 0.20% 64.87 1.66E-20 

416.1 Operate in a manner to prevent 

insanitary conditions 

Yes 5.21% 1.76% 3.06 5.89E-142 

416.13(a) Conduct pre-op procedures Yes 11.37% 1.68% 7.49 0.00E+00 

416.13(b) Conduct other procedures listed in 

the plan 

Yes 0.80% 0.18% 4.52 1.44E-112 

416.13(c) Plant monitors implementation of 

SSOP procedures 

Yes 9.83% 2.00% 5.33 0.00E+00 

416.14 Evaluate effectiveness of SSOP's & 

maintain plan 

Yes 1.48% 0.29% 5.13 2.85E-183 

416.15(b) Corrective action, procedures for Yes 14.44% 4.76% 3.37 1.12E-37 

416.16(a) Daily records required, responsible 

individual, initialed and dated 

Yes 0.46% 0.14% 3.33 2.70E-72 

416.3(b) Constructed, located & operated in a 

manner that does not deter inspection 

Yes 4.71% 1.27% 3.84 1.17E-17 

416.3(c) Receptacles for storing inedible 

material must identify permitted use 

Yes 10.90% 2.11% 5.68 7.19E-56 

29 
 

 

 

 

 

Regulation Description On Noncompliance Noncompliance Odds Two-Sided 

Verified FY2019 

PHR 

List 

Rate in 3 Months 

before a 

Campylobacter 

Positive 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

Ratio Fisher’s 

Exact p 

Value 

416.4(a) Food contact surface, cleaning & 

sanitizing as frequency 

Yes 30.97% 7.31% 5.69 0.00E+00 

416.4(d) Product processing, handling, 

storage, loading, unloading, and 

during transportation must be 

protected 

Yes 45.72% 9.59% 7.94 0.00E+00 

416.6 Only FSIS program employee may 

remove "U.S. Rejected" tag 

Yes 29.36% 5.53% 7.10 5.79E-09 

417.2(c)(4) List of procedures & frequency Yes 1.87% 0.32% 5.94 0.00E+00 

417.3(b)(4) Reassessment Yes 4.30% 0.53% 8.43 2.57E-18 

417.5(f) Official Review Yes 0.25% 0.02% 15.49 1.05E-04 

430.4(c)(3) Lm, maintain sanitation in postlethality processing environment No 0.24% 0.03% 8.09 1.13E-03 

4.4.1 Campylobacter in Intact Chicken 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 202 establishments with Intact Chicken 

Campylobacter testing data, of which 169 had 623 Campylobacter positives and 33 did not have Campylobacter positives. There 

were 9,052 total Intact Chicken Campylobacter tests performed. 

Table 4-16 presents the one regulation 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 three months before a Campylobacter positive is higher than the noncompliance rate for establishments with no 

Campylobacter positive for CY2018. 

30 
 

 

 

 

 

 

Table 4-16 Comparison of Noncompliance Rates Three Months before a Campylobacter Intact Chicken Positive with Those 

for Establishments with No Campylobacter Intact Chicken Positive 

Regulation 

Verified 

Description On 

FY2019 

PHR 

List 

Noncompliance 

Rate in 3 Months 

before a 

Campylobacter 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

Odds 

Ratio 

Two-Sided 

Fisher’s 

Exact p 

Value 

416.1 Operate in a manner to prevent 

insanitary conditions 

Yes 5.94% 1.72% 3.61 1.09E-47 

4.4.2 Campylobacter in Intact Turkey 

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

data, of which 7 had 9 Campylobacter positives and 38 did not have Campylobacter positives. There were 1,899 total Intact Turkey 

Campylobacter tests performed. 

Table 4-17 presents the 3 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 

regulations in the three months before an Intact Turkey Campylobacter positive is higher than the noncompliance rate for 

establishments with no Intact Turkey Campylobacter positive for CY2018. 

31 
 

 

 

 

 

 

 

Table 4-17 Comparison of Noncompliance Rates Three Months before a Campylobacter Intact Turkey Positive with Those for 

Establishments with No Campylobacter Intact Turkey Positive 

Regulation 

Verified 

Description On 

FY2019 

PHR 

List 

Noncompliance 

Rate in 3 Months 

before a 

Campylobacter 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

Odds 

Ratio 

Two-Sided 

Fisher’s 

Exact p 

Value 

381.91(b) Reprocessing of carcasses 

accidentally contaminated with 

digestive tract contents. 

No 3.13% 0.46% 6.96 3.95E-02 

416.1 Operate in a manner to prevent 

insanitary conditions 

Yes 12.42% 2.76% 4.99 2.59E-13 

416.3(b) Constructed, located & operated in a 

manner that does not deter inspection 

Yes 6.00% 1.49% 4.23 4.77E-02 

4.4.3 Campylobacter in Comminuted Chicken 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 96 establishments with Comminuted Chicken 

Campylobacter testing data, of which 38 had 114 Campylobacter positives and 58 did not have Campylobacter positives. There were 

2,022 total Comminuted Chicken Campylobacter tests performed. 

Table 4-18 presents the 2 regulations which had more than 30 verifications in a year, an odds ratio of 3.0 or greater, and for which 

there is an 95% probability (as determined by a two-sided Fisher’s Exact p value of less than 0.05) that the noncompliance rate of the 

regulation in establishments three months before an Comminuted Chicken Campylobacter positive is higher than the average 

noncompliance rate for establishments with no Comminuted Chicken Campylobacter positive for CY2018. 

32 
 

 

 

 

 

 

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

Those for Establishments with No Comminuted Chicken Campylobacter Positive 

Regulation 

Verified 

Description On 

FY2019 

PHR 

List 

Noncompliance 

Rate in 3 Months 

before a 

Campylobacter 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

Odds 

Ratio 

Two-Sided 

Fisher’s 

Exact p 

Value 

381.76(a) Post-mortem inspection, when 

required, extent. 

Yes 7.14% 1.56% 4.86 1.18E-02 

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

Reprocessing 

Yes 0.50% 0.05% 9.62 3.74E-05 

4.4.4 Campylobacter in Comminuted Turkey 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 63 establishments with Comminuted Turkey 

Campylobacter testing data, of which 12 had 30 Campylobacter positives and 51 did not have Campylobacter positives. There were 

1,597 total Comminuted Turkey Campylobacter tests performed. 

Table 4-19 presents the 4 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 

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

noncompliance rate for establishments with no Comminuted Turkey Campylobacter positive for CY2018. 

33 
 

 

 

 

 

 

 

Table 4-19 Comparison of Noncompliance Rates Three Months before a Comminuted Turkey Campylobacter Positive with 

those for Establishments with No Comminuted Turkey Campylobacter Positive 

Regulation 

Verified 

Description On 

FY2019 

PHR 

List 

Noncompliance 

Rate in 3 Months 

before a 

Campylobacter 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

Odds 

Ratio 

Two-Sided 

Fisher’s 

Exact p 

Value 

416.3(c) Receptacles for storing 

inedible material must identify 

permitted use 

Yes 15.09% 2.69% 6.42 1.70E-04 

417.3(b)(3) No adulterated product enters 

commerce 

Yes 1.22% 0.11% 10.84 3.03E-02 

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

Reprocessing 

Yes 5.26% 0.46% 12.09 3.72E-09 

381.76(b)(6)(ii)(B) NPIS reprocessing and salvage No 2.07% 0.22% 9.73 3.46E-04 

4.4.5 Campylobacter in Chicken Parts 

The dataset used in the analysis consists of candidate PHR noncompliance rates for the 449 establishments with Chicken Parts 

Campylobacter testing data, of which 233 had 539 Campylobacter positives and 216 did not have Campylobacter positives. There 

were 7,943 total Chicken Parts Campylobacter tests performed. 

Table 4-20 presents the 13 regulations which had more than 30 verifications in a year, an odds ratio of 3.0 or greater, and for which 

there is an 95% probability (as determined by a two-sided Fisher’s Exact p value of less than 0.05) that the noncompliance rate of the 

regulation in establishments three months before an Chicken Parts Campylobacter positive is higher than the average noncompliance 

rate for establishments with no Chicken Parts Campylobacter positive for CY2018. 

34 
 

 

Table 4-20 Comparison of Noncompliance Rates Three Months before a Chicken Parts Campylobacter Positive with Those for 

Establishments with No Chicken Parts Campylobacter Positive 

Regulation Description On Noncompliance Noncompliance Odds TwoVerified FY2019 Rate in 3 Months Rate for Ratio Sided 

PHR before a Establishments Fisher’s 

List Campylobacter with no Exact p 

Positive Campylobacter Value 

Positive 

381.1_Adulterated NRs review, NRs cite for 

quality (OCP), not being used 

as public health- related 

Yes 2.65% 0.16% 17.36 2.35E-06 

381.65(a) Clean and sanitary practices; 

products not adulterated 

Yes 1.87% 0.52% 3.67 4.34E-19 

381.91(b) Reprocessing of carcasses 

accidentally contaminated with 

digestive tract contents. 

No 2.68% 0.16% 16.84 1.73E-33 

416.13(a) Conduct pre-op procedures Yes 13.13% 2.48% 5.95 0.00E+00 

416.13(b) Conduct other procedures listed 

in the plan 

Yes 0.78% 0.19% 4.06 2.04E-68 

416.13(c) Plant monitors implementation 

of SSOP procedures 

Yes 10.36% 3.31% 3.38 0.00E+00 

416.14 Evaluate effectiveness of 

SSOP's & maintain plan 

Yes 1.59% 0.32% 4.98 3.56E-130 

416.15(a) Appropriate corrective actions Yes 10.08% 3.13% 3.47 6.92E-23 

416.3(c) Receptacles for storing inedible 

material must identify 

permitted use 

Yes 11.52% 2.97% 4.25 2.41E-26 

416.4(d) Product processing, handling, 

storage, loading, unloading, 

and during transportation must 

be protected 

Yes 46.12% 18.82% 3.69 0.00E+00 

35 
 

 

 

 

 

 

Regulation 

Verified 

Description On 

FY2019 

PHR 

List 

Noncompliance 

Rate in 3 Months 

before a 

Campylobacter 

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

Odds 

Ratio 

TwoSided 

Fisher’s 

Exact p 

Value 

416.6 Only FSIS program employee 

may remove "U.S. Rejected" 

tag 

Yes 45.45% 19.18% 3.51 3.29E-03 

417.2(c)(4) List of procedures & frequency Yes 1.91% 0.50% 3.90 2.64E-187 

417.3(b)(4) Reassessment Yes 5.83% 0.80% 7.63 7.78E-10 

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 will be selected from the same list of candidate regulations used to select all other FY2020 

PHRs. The enforcement action list will consist of candidate 9 CFR regulations in which noncompliances occurs at a more frequent 

rate in establishments in the three-month period prior to an NOIE or suspension than in establishments without an NOIE or suspension 

for CY2018. The dataset used in the analysis consists of candidate PHR noncompliance rates for the 5,336 active meat and poultry 

establishments, of which 113 had 122 enforcement actions and 5,223 did not have any enforcement actions. 

36 
 

 

 

 

Table 4-21 presents the 29 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 three months before an enforcement action is higher than the noncompliance rate for establishments with no 

enforcement action for CY2018. 

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

with No Enforcement Action 

Regulation Description On Noncompliance Noncompliance Odds TwoVerified FY2019 Rate in 3 Months Rate for Ratio Sided 

PHR before an Establishments Fisher’s 

List Enforcement with no Exact p 

Action Enforcement Value 

Action 

310.22(c) Disposal of SRM Yes 3.42% 0.38% 9.31 1.16E-03 

310.22(e)(1) Written procedures for 

removal, segregation, and 

disposition of SRMs 

Yes 20.00% 1.66% 14.85 3.27E-07 

310.22(f)(2) Use of routine operational 

sanitation procedures on 

equipment used to cut through 

SRMs 

Yes 9.09% 0.30% 33.55 1.25E-05 

381.65(a) Clean and sanitary practices; 

products not adulterated 

Yes 14.40% 0.84% 19.80 3.73E-31 

416.1 Operate in a manner to 

prevent insanitary conditions 

Yes 5.34% 1.52% 3.65 1.63E-38 

416.13(a) Conduct pre-op procedures Yes 4.87% 1.31% 3.86 1.71E-39 

416.13(b) Conduct other procedures 

listed in the plan 

Yes 1.04% 0.17% 6.03 1.19E-38 

416.13(c) Plant monitors 

implementation of SSOP 

procedures 

Yes 6.54% 1.71% 4.02 3.86E215 

37 
Regulation 

Verified 

Description On 

FY2019 

PHR 

List 

Noncompliance 

Rate in 3 Months 

before an 

Enforcement 

Action 

Noncompliance 

Rate for 

Establishments 

with no 

Enforcement 

Action 

Odds 

Ratio 

TwoSided 

Fisher’s 

Exact p 

Value 

416.14 Evaluate effectiveness of 

SSOP's & maintain plan 

Yes 0.82% 0.24% 3.47 7.44E-15 

416.15(a) Appropriate corrective actions Yes 7.84% 1.95% 4.27 1.76E-14 

416.16(a) Daily records required, 

responsible individual, 

initialed and dated 

Yes 0.60% 0.14% 4.33 9.52E-24 

416.3(b) Constructed, located & 

operated in a manner that 

does not deter inspection 

Yes 3.16% 0.75% 4.34 3.63E-04 

416.3(c) Receptacles for storing 

inedible material must 

identify permitted use 

Yes 6.05% 1.47% 4.31 9.37E-08 

416.4(a) Food contact surface, cleaning 

& sanitizing as frequency 

Yes 25.40% 7.04% 4.50 2.31E-93 

416.4(d) Product processing, handling, 

storage, loading, unloading, 

and during transportation 

must be protected 

Yes 27.33% 8.78% 3.91 1.54E108 

417.2(a)(1) Hazard analysis Yes 4.09% 1.19% 3.54 9.94E-07 

417.2(c)(4) Hazard analysis Yes 1.85% 0.53% 3.54 1.62E-26 

417.3(a)(2) CCP is under control Yes 2.10% 0.46% 4.66 2.25E-08 

417.3(b)(3) No adulterated product enters 

commerce 

Yes 1.37% 0.44% 3.13 1.60E-02 

417.5(a)(1) Written hazard analysis Yes 1.41% 0.28% 5.07 9.80E-31 

417.5(a)(2) Written HACCP plan Yes 0.37% 0.11% 3.29 1.17E-05 

38 
Regulation 

Verified 

Description On 

FY2019 

PHR 

List 

Noncompliance 

Rate in 3 Months 

before an 

Enforcement 

Action 

Noncompliance 

Rate for 

Establishments 

with no 

Enforcement 

Action 

Odds 

Ratio 

TwoSided 

Fisher’s 

Exact p 

Value 

417.5(a)(3) Records documentation and 

monitoring of CCP's and 

Critical Limits 

Yes 0.99% 0.24% 4.14 6.78E-19 

430.4(a) Lm, post-lethality exposed 

RTE 

Yes 0.38% 0.03% 12.10 4.28E-04 

430.4(c)(2) Lm, documentation that 

supports decision in hazard 

analysis 

Yes 1.05% 0.05% 22.67 9.73E-12 

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

post-lethality processing 

environment 

No 1.11% 0.06% 20.33 2.82E-11 

310.18(a) Carcasses, organs, and other 

parts handled in a sanitary 

manner 

Yes 6.25% 1.32% 4.99 1.01E-35 

418.3 Lm, maintain sanitation in 

post-lethality processing 

environment 

Yes 4.35% 0.25% 18.29 6.52E-03 

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

Reprocessing 

Yes 3.61% 0.51% 7.36 2.53E-07 

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

NPIS 

No 18.18% 5.12% 4.12 1.94E-03 

39 
 

 

 

 

 

 

 

5.0 LIST OF FY2020 PHRS 

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

PHRs into a single FY2020 PHR list. Table 5-1 presents the complete list of the 49 FY2020 

PHRs. These 49 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 three 

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 49 FY2020 PHRs are composed of 7 regulations and 42 provisions of regulations. The 42 

provisions fall under 19 different regulations. Thus, the 49 FY2020 PHRs represent 26 

regulations, with the majority of FY2020 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 FY2020 PHRs 

Regulation Verified Description On 

FY2019 

PHR List 

Average 

Odds 

Ratio 

Average 

Two-Sided 

Fisher’s 

Exact p 

Value 

301.2_Adulterated Adulterated Yes 13.31 5.06E-23 

310.22(c) Disposal of SRM Yes 5.90 6.04E-04 

310.22(e)(1) Written procedures for 

removal, segregation, and 

disposition of SRMs 

Yes 9.29 5.03E-05 

310.22(e)(2) Appropriate corrective 

actions 

Yes 7.06 5.35E-04 

310.22(e)(3) Evaluate effectiveness of 

procedures for removal, 

segregation, and 

disposition of SRMs 

Yes 4.52 4.72E-08 

310.22(f)(2) Use of routine operational 

sanitation procedures on 

equipment used to cut 

through SRMs 

Yes 15.38 1.47E-05 

318.1(b) Only inspected and passed 

poultry product to enter 

official establishment 

Yes 67.09 2.48E-03 

318.2(a) All products subject to 

reinspection by program 

employees 

Yes 4.12 3.31E-04 

318.2(d) Removal of U.S. retained 

by authorized Program 

employees only 

Yes 19.23 5.25E-04 

381.1_Adulterated Adulterated Yes 17.36 2.35E-06 

40 
 

 

Regulation Verified Description On 

FY2019 

PHR List 

Average 

Odds 

Ratio 

Average 

Two-Sided 

Fisher’s 

Exact p 

Value 

381.65(a) Clean and sanitary 

practices; products not 

adulterated 

Yes 7.91 3.97E-03 

381.71(a) Condemnation on ante 

mortem inspection 

Yes 64.87 1.66E-20 

381.76(a) Post-mortem inspection, 

when required, extent. 

Yes 4.86 1.18E-02 

381.83 Septicemia or toxemia Yes 3.30 2.59E-02 

381.91(b) Reprocessing of carcasses 

accidentally contaminated 

with digestive tract 

contents. 

No 11.90 1.97E-02 

416.1 Operate in a manner to 

prevent insanitary 

conditions 

Yes 3.91 3.84E-13 

416.13(a) Conduct pre-op procedures Yes 6.34 4.83E-13 

416.13(b) Conduct other procedures 

listed in the plan 

Yes 4.90 2.35E-05 

416.13(c) Plant monitors 

implementation of SSOP 

procedures 

Yes 4.22 6.38E-22 

416.14 Evaluate effectiveness of 

SSOP's & maintain plan 

Yes 5.62 1.57E-15 

416.15(a) Appropriate corrective 

actions 

Yes 4.03 6.35E-03 

416.15(b) Corrective action, 

procedures for 

Yes 4.81 3.76E-04 

416.16(a) Daily records required, 

responsible individual, 

initialed and dated 

Yes 4.10 1.90E-24 

416.3(b) Constructed, located & 

operated in a manner that 

does not deter inspection 

Yes 5.67 9.58E-03 

416.3(c) Receptacles for storing 

inedible material must 

identify permitted use 

Yes 5.04 1.94E-04 

416.4(a) Food contact surface, 

cleaning & sanitizing as 

frequency 

Yes 5.81 1.14E-09 

41 
Regulation Verified Description On 

FY2019 

PHR List 

Average 

Odds 

Ratio 

Average 

Two-Sided 

Fisher’s 

Exact p 

Value 

416.4(d) Product processing, 

handling, storage, loading, 

unloading, and during 

transportation must be 

protected 

Yes 4.49 3.32E-14 

416.6 Only FSIS program 

employee may remove 

"U.S. Rejected" tag 

Yes 5.30 1.65E-03 

417.2(a)(1) Hazard analysis Yes 3.75 1.10E-02 

417.2(c)(4) List of procedures & 

frequency 

Yes 4.77 4.72E-07 

417.3(a)(1) Identify and eliminate the 

cause 

Yes 3.45 3.13E-34 

417.3(a)(2) CCP is under control Yes 5.03 7.07E-05 

417.3(a)(3) Establish measures to 

prevent recurrence 

Yes 4.16 5.52E-46 

417.3(b)(2) Determine the acceptability 

of the affected product 

Yes 4.45 3.74E-06 

417.3(b)(3) No adulterated product 

enters commerce 

Yes 6.95 9.34E-03 

417.3(b)(4) Reassessment Yes 8.85 3.44E-05 

417.4(a) Adequacy of HACCP in 

controlling food safety 

hazards 

Yes 9.05 5.61E-06 

417.5(a)(1) Written hazard analysis Yes 4.07 4.54E-03 

417.5(a)(2) Written HACCP plan Yes 3.28 1.25E-02 

417.5(a)(3) Records documentation 

and monitoring of CCP's 

and Critical Limits 

Yes 3.78 2.32E-03 

417.5(f) Official Review Yes 15.49 1.05E-04 

430.4(a) Lm, post-lethality exposed 

RTE 

Yes 23.19 1.49E-02 

430.4(c)(2) Lm, documentation that 

supports decision in hazard 

analysis 

Yes 18.33 1.69E-02 

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

post-lethality processing 

environment 

No 19.07 1.28E-02 

42 
 

 

 

 

 

Regulation Verified Description On 

FY2019 

PHR List 

Average 

Odds 

Ratio 

Average 

Two-Sided 

Fisher’s 

Exact p 

Value 

310.18(a) Carcasses, organs, and 

other parts handled in a 

sanitary manner 

Yes 4.30 7.14E-12 

418.3 Recall Plans Yes 18.29 6.52E-03 

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

and Reprocessing 

Yes 9.69 1.25E-05 

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

in NPIS 

No 3.68 1.00E-03 

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

salvage 

No 9.73 3.46E-04 

Forty-five of the previous 63 FY2019 PHRs are included in the FY2020 PHRs. There are 18 

regulations on the FY2019 PHR list that are not in the FY2020 PHR list (See Appendix C). Vice 

versa, there are 4 regulations that are on the FY2020 PHR list that were not on the FY2019 PHR 

list. 

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

for inclusion in the FY2020 PHR list. Most regulations were triggered by multiple events. 

Similar to the FY2019 PHR list, enforcement actions triggered the most regulations. 

43 
 

 

 

 

 

Table 5-2 Events That Triggered Inclusion of a Regulation in the FY2020 PHR list 

Product Number of Regulations 

Campylobacter 18 

Comminuted Chicken Campylobacter 2 

Comminuted Chicken Salmonella 11 

Comminuted Pork Salmonella 5 

Comminuted Turkey Campylobacter 4 

Comminuted Turkey Salmonella 6 

Chicken Parts Campylobacter 13 

Chicken Parts Salmonella 6 

Enforcements 29 

Ground Beef Salmonella 11 

Intact Beef Salmonella 13 

Intact Chicken Campylobacter 1 

Intact Chicken Salmonella 4 

Intact Pork Salmonella 7 

Intact Turkey Campylobacter 7 

Intact Turkey Salmonella 3 

Listeria 2 

Non-O157 E.coli 2 

O157 E.coli 10 

RTE Salmonella 2 

Salmonella 26 

There were three regulations triggered by a single type of event. One was from Salmonella in 

one Ground Beef, one was from Campylobacter in Comminuted Chicken, and one was from 

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

inclusion in the FY2020 PHR list by only single pathogen product or enforcement action type. 

44 
 

 

 

 

 

 

 

 

 

 

 

Table 5-3 Regulations Triggered for Inclusion in the FY2020 PHR List by Only a Single 

Event 

Regulation 

Verified Description Event 

318.1(b) Only inspected and passed poultry product to 

enter official establishment 

Ground Beef 

Salmonella 

381.76(a) 

Post-mortem inspection, when required, extent. Comminuted 

Chicken 

Campylobacter 

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

Campylobacter 

6.0 CUT POINTS FOR FY2020 PHRS 

The FY2020 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 FY2020 PHR does not indicate a loss of process control. The 

aggregate set of PHRs is used to identify establishments that significantly deviate from the threemonth 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 FY2020 

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

broad categories of establishment operations: Processing and Combination (Slaughter plus 

Processing). Only establishments with greater than or equal to 20 verifications and at least two 

non-compliances were considered when developing cut points. 

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

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

D). Then to determine a set of annual FY2020 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). 

45 
 

 

 

 

 

 

 

 

 

 

 

 

Table 6-1 Mean and Standard Deviation of Quarterly FY2020 PHR Rate 

Mean of Natural Log 

FY2020 PHR Rate 

Standard Deviation 

FY2020 PHR Rate 

Combination Processing Combination Processing 

Jan-Mar 2018 -4.43 -4.89 0.99 0.82 

Apr-Jun 2018 -4.23 -4.69 0.93 0.75 

July-Sep 2018 -4.41 -4.94 1.01 0.82 

Oct-Dec 2018 -4.44 -4.92 0.97 0.82 

Average -4.38 -4.86 0.97 0.80 

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 example, the upper cut point for the 

log transformed data for Processing establishments is -4.86 + 2*0.80 = -4.86 + 1.60 = -3.26. 

The cut point of the original, non-transformed PHR noncompliance data is the antilog of -3.26 or 

Exp(-3.26) = 3.86%. 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 FY2020 PHR upper and lower cut points for each of the two 

establishment operation types. The FY2019 PHR cut points are included for comparison. (See 

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

the cut points is planned for October 2020. 

Table 6-2 FY2020 PHR Tier 1 Cut Points 

Operation Type FY2020 PHR Cut Points FY2019 PHR Cut Points 

Processing 3.86% 4.40% 

Combination 8.83% 9.40% 

46 
 

 

 

 

 

 

 

 

 

 

 

 

Table 6-3 FY2020 PHR Tier 3 Cut Points 

Operation Type FY2020 PHR Cut Points FY2019 PHR Cut Points 

Processing 2.58% 2.90% 

Combination 5.42% 5.64% 

Table 6-4 presents the number of establishments in each Tier based solely on the FY2020 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 FY2020 

PHRs, 70 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, 2019. 

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

Classification Number of Establishments 

Tier 1 70 

Tier 2 100 

Tier 3 5,110 

Total 5,280 

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 58 12 

Tier 2 69 31 

Tier 3 4,102 1,008 

Total 4,229 1,051 

7.0 CONCLUSION 

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

FY2020 PHR regulations used to prioritize certain FY2020 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 

three 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 FY2020 PHRs has 49 regulations whose individual noncompliance rates are higher in 

establishments three 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-five regulations on the FY2019 PHR list are also on the 

FY2020 PHR list. 

47 
 

 

 

 

 

 

 

 

 

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 FY2020 PHR upper and lower cut points. The FY2019 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 FY2020 PHR Tier 1 Cut Points 

Operation Type FY2020 PHR Cut Points FY2019 PHR Cut Points 

Processing 3.86% 4.40% 

Combination 8.83% 9.40% 

Table 7-2 FY2020 PHR Tier 3 Cut Points 

Operation Type FY2020 PHR Cut Points FY2019 PHR Cut Points 

Processing 2.58% 2.90% 

Combination 5.42% 5.64% 

8.0 REFERENCES 

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

and Slaughter Establishments, Public Health Decision Criteria. 

(http://www.fsis.usda.gov/OPPDE/NACMPI/Sep2010/2010_Public_Health_Decsion_Cri 

teria_Report.pdf) 

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

Public Health Regulations, http://www.fsis.usda.gov/wps/portal/fsis/topics/datacollection-and-reports/fsis-data-analysis-and-reporting/data-reporting/public-healthregulations 

3. Food Safety and Inspection Service (FSIS) 2014, FY2015 Public Health Regulations. 

http://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/fsis-dataanalysis-and-reporting/data-reporting/public-health-regulations 

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

Subcommittee Two, Issue Two: Data Analysis. 

http://www.fsis.usda.gov/wps/wcm/connect/9ee42a72-a1fc-4045-982bb4dfe7e7a43f/NACMPI_Transcript_Subcmt2_011613.pdf?MOD=AJPERES 

48 
 

 

 

 

APPENDIX A: FY2020 PHR REGULATIONS 

Table A-1 presents the list of forty-nine FY2020 Public Health Regulations (PHRs). On average, 

these PHR regulations have noncompliance rates three months prior to a pathogen positive or 

enforcement action that is 7.33 times higher than the PHR noncompliance rates for 

establishments with no pathogen positive or enforcement action. 

Table A-1 List of FY2020 PHRs 

Regulation Description 

301.2_Adulterated Adulterated 

310.22(c) Disposal of SRM 

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

SRMs 

310.22(e)(2) Appropriate corrective actions 

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

disposition of SRMs 

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

to cut through SRMs 

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

establishment 

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

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

381.1_Adulterated Adulterated 

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

381.71(a) Condemnation on ante mortem inspection 

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

381.83 Septicemia or toxemia 

381.91(b) Reprocessing of carcasses accidentally contaminated with digestive 

tract contents. 

416.1 Operate in a manner to prevent insanitary conditions 

416.13(a) Conduct pre-op procedures 

416.13(b) Conduct other procedures listed in the plan 

416.13(c) Plant monitors implementation of SSOP procedures 

416.14 Evaluate effectiveness of SSOP's & maintain plan 

416.15(a) Appropriate corrective actions 

416.15(b) Corrective action, procedures for 

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

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

inspection 

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

49 
Regulation Description 

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

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

417.3(b)(4) Reassessment 

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 

430.4(a) Lm, post-lethality exposed RTE 

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 

418.3 Recall Plans 

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

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

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

50 
 

APPENDIX B: FY2020 CANDIDATE REGULATIONS 

Table B-1 presents the list of 145 candidate regulations. The noncompliance rates in Table B-1 are based on PHIS data for January 1, 

2018 through December 31, 2018. 

Table B-1 FY2020 Candidate regulations 

FY2020 Candidate 

Regulation 

Description FY2019 

PHR 

Mandatory 

Regulation 

Total FSIS 

Verifications 

Total 

NCs1 

NC1 

Rate 

301.2_Adulterated Adulterated Yes No 5777 188 3.15% 

304.3(a) Develop written SSOP No No 593 2 0.34% 

304.3(c) Conduct hazard analysis & develop HACCP 

plan for new product 

No No 821 5 0.61% 

309.2(a) Livestock suspected of being diseased or 

affected with certain conditions; identifying 

suspects 

No No 611 4 0.65% 

309.3 (HIMP ONLY) Dead, dying, disabled or 

diseased and similar livestock. 

No No 241 2 0.82% 

309.4 (HIMP ONLY) Livestock showing symptoms of 

metabolic, toxic, nervous, or diseases 

No No 220 2 0.90% 

309.5 (HIMP ONLY) Swine; disposal because of hog 

cholera 

No No 215 0 0.00% 

309.9 (HIMP ONLY) Swine erysipelas No No 216 0 0.00% 

310.18 Contamination of carcasses, organs, or other 

parts 

Yes No 338 9 2.59% 

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

food 

No No 4139 4 0.10% 

310.22(c) Disposal of SRM Yes Yes 53792 158 0.29% 

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

human exposure to BSE as similar US products 

No No 98 0 0.00% 

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

disposition of SRMs 

Yes No 14491 196 1.33% 

310.22(e)(2) Appropriate corrective actions Yes No 2622 50 1.87% 

51 
 

 

 

FY2020 Candidate 

Regulation 

Description FY2019 

PHR 

Mandatory 

Regulation 

Total FSIS 

Verifications 

Total 

NCs1 

NC1 

Rate 

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

removal, segregation, and disposition of SRMs 

Yes No 8926 142 1.57% 

310.22(e)(4)(i) Maintain daily records Yes No 72199 161 0.22% 

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

on equipment used to cut through SRMs 

Yes No 16447 41 0.25% 

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

the vertebral columns to another federal 

inspected establishment 

No No 1366 2 0.15% 

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

showing proper disposition of vertebral columns 

No No 4294 25 0.58% 

310.25(a) Verification criteria for E. coli testing meat Yes No 28770 241 0.83% 

310.25(b) Pathogen reduction performance standards; 

Salmonella 

No No 123 2 1.60% 

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

HACCP Plan 

No No 33 0 0.00% 

310.3 Carcasses and parts in certain instances to be 

retained. 

No No 2938 222 7.03% 

311.16 (HIMP ONLY) Carcasses so infected that 

consumption of the meat may cause food 

poisoning. 

No No 208 9 4.15% 

311.17 (HIMP ONLY) Necrobacillosis, pyemia, 

septicemia. 

No No 527 3 0.57% 

311.24 (HIMP ONLY) Hogs affected with tapeworm 

cysts. 

No No 200 0 0.00% 

315.2 Carcasses and parts passed for cooking No No 82 0 0.00% 

316.6 Products not to be removed from official 

establishments unless marked in accordance with 

the regulations 

No No 11805 40 0.34% 

317.24(a) Packaging materials composed of poisonous or 

deleterious substances 

Yes No 2840 13 0.46% 

52 
 

FY2020 Candidate 

Regulation 

Description FY2019 

PHR 

Mandatory 

Regulation 

Total FSIS 

Verifications 

Total 

NCs1 

NC1 

Rate 

318.1(b) Only inspected and passed poultry product to 

enter official establishment 

Yes No 98561 13 0.01% 

318.10(b) Products requiring treatment to destroy trichinae No No 2411 3 0.12% 

318.10(c)(1) Destruction of trichinae through heating No No 2338 0 0.00% 

318.10(c)(2) Destruction of trichinae through refrigeration No No 903 1 0.11% 

318.10(c)(3) Destruction of trichinae through curing No No 815 0 0.00% 

318.14(a) Product and ingredients rendered adulterated by 

polluted water shall be condemned 

No No 82 0 0.00% 

318.14(b) Establishment shall be thoroughly cleaned and 

disinfected under FSIS supervision 

No No 542 0 0.00% 

318.14(c) Hermetically sealed contaminated containers 

shall be examined/rehandled under FSIS 

supervision 

No No 124 0 0.00% 

318.16(b) Pesticides chemicals & other residues in 

products not to exceed FD&C Act levels - Meat 

ingredients 

No No 41 0 0.00% 

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

cooked beef 

No No 3067 7 0.23% 

318.17(b) Lethality and Stabilization processes other than 

HACCP for cooked beef 

No No 706 0 0.00% 

318.17(c) Validation of new or altered process schedules 

(for cooked beef) 

No No 34 0 0.00% 

318.2(a) All products subject to reinspection by program 

employees 

Yes No 49324 42 0.09% 

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

employees only 

Yes No 8303 39 0.47% 

318.23(b)(1) Time/Temperature for heat-processing 

combinations of fully-cooked meat patties 

No No 400 2 0.50% 

318.23(b)(3) Heat deviations for meat patties No No 16 1 5.88% 

53 
 

FY2020 Candidate 

Regulation 

Description FY2019 

PHR 

Mandatory 

Regulation 

Total FSIS 

Verifications 

Total 

NCs1 

NC1 

Rate 

318.23(c)(1) Stabilization requirements for meat patties No No 195 1 0.51% 

318.23(c)(2) Stabilization processes for meat patties other 

than HACCP 

No No 10 0 0.00% 

318.23(c)(4) Labeling statement for partially cooked patties No No 118 0 0.00% 

318.23(c)(5) Labeling statement for char-marked patties No No 102 0 0.00% 

318.24 Product prepared using advanced meat/bone 

separation machinery; process control 

No No 2564 20 0.77% 

318.303 Critical factors and the application of the process 

schedule 

No Yes 5071 1 0.02% 

318.308 Deviation in processing No Yes 3212 1 0.03% 

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

containers 

No No 2648 0 0.00% 

318.6(b)(4) Detached spinal cords No No 9612 0 0.00% 

318.6(b)(6) Tonsils No No 12741 0 0.00% 

318.6(b)(8) Intestines as ingredients No No 295 0 0.00% 

319.5(b) Mechanically separated (species) No No 283 0 0.00% 

381.1_Adulterated Adulterated Yes No 5233 25 0.48% 

381.144(a) Packaging materials not to be composed of any 

poisonous or deleterious substance 

No No 2248 1 0.04% 

381.150(a) Lethality and Stabilization requirements for 

cooked poultry 

No No 1620 2 0.12% 

381.150(c) Lethality and Stabilization processes other than 

HACCP for cooked poultry 

No No 185 1 0.54% 

381.150(d) Validation of new or altered process schedules 

by scientifically supportable means (cooked 

poultry) 

No No 3 0 0.00% 

381.151(a) Product and ingredients rendered adulterated by 

polluted water shall be condemned 

No No 67 0 0.00% 

381.22(a) Develop written SSOP No No 269 5 1.82% 

54 
 

FY2020 Candidate 

Regulation 

Description FY2019 

PHR 

Mandatory 

Regulation 

Total FSIS 

Verifications 

Total 

NCs1 

NC1 

Rate 

381.22(b) Conduct hazard analysis & develop and validate 

HACCP plan 

No No 919 3 0.33% 

381.22(c) Conduct hazard analysis & develop HACCP 

plan for new product 

No No 217 2 0.91% 

381.310 Personnel and training No Yes 2360 0 0.00% 

381.311 Recall procedure No Yes 2348 0 0.00% 

381.37(a) Product not produced under supervision of 

program employee 

No No 1932 18 0.92% 

381.65(a) Clean and sanitary practices; products not 

adulterated 

Yes No 57442 546 0.94% 

381.65(e) Zero-tolerance for visible fecal material entering 

chiller 

No No 0 0 0.00% 

381.71(a) Condemnation on ante mortem inspection Yes No 2127 103 4.62% 

381.72(a) Poultry No No 214 0 0.00% 

381.72(b) Ratites No No 2 0 0.00% 

381.76(a) Post-mortem inspection, when required, extent. Yes No 17536 290 1.63% 

381.83 Septicemia or toxemia Yes No 573872 122 0.02% 

381.85 Special Diseases (organisms or toxins dangerous 

to the consumer) 

No No 128 0 0.00% 

381.91(a) Certain contaminated carcasses to be condemned No No 8467 26 0.31% 

381.91(b) Reprocessing of carcasses accidentally 

contaminated with digestive tract contents. 

No No 22309 276 1.22% 

381.94(a) Verification criteria for E. coli testing poultry No No 0 0 0.00% 

416.1 Operate in a manner to prevent insanitary 

conditions 

Yes No 606860 9154 1.49% 

416.12(c) plan identifies procedures for pre-op Yes No 51170 85 0.17% 

416.12(d) plan list frequency for each procedure & 

responsible individual 

Yes No 65329 105 0.16% 

55 
FY2020 Candidate 

Regulation 

Description FY2019 

PHR 

Mandatory 

Regulation 

Total FSIS 

Verifications 

Total 

NCs1 

NC1 

Rate 

416.13 

Implementation of 

SOP’s 

Implementation of SSOP Yes No 5701 16 0.28% 

416.13(a) Conduct pre-op procedures Yes Yes 746132 9444 1.25% 

416.13(b) Conduct other procedures listed in the plan Yes Yes 1873365 3308 0.18% 

416.13(c) Plant monitors implementation of SSOP 

procedures 

Yes Yes 2678666 44076 1.62% 

416.14 Evaluate effectiveness of SSOP's & maintain 

plan 

Yes Yes 1636948 3888 0.24% 

416.15 Corrective 

Actions 

Corrective actions No No 559 3 0.53% 

416.15(a) Appropriate corrective actions Yes Yes 68002 1153 1.67% 

416.15(b) Corrective action, procedures for Yes Yes 46351 1121 2.36% 

416.16(a) Daily records required, responsible individual, 

initialed and dated 

Yes Yes 2926480 4559 0.16% 

416.3(b) Constructed, located & operated in a manner that 

does not deter inspection 

Yes No 80117 595 0.74% 

416.3(c) Receptacles for storing inedible material must 

identify permitted use 

Yes No 68297 979 1.41% 

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

frequency 

Yes No 281260 20025 6.65% 

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

unloading, and during transportation must be 

protected 

Yes No 254980 23045 8.29% 

416.5(c) Employees who appears to have any abnormal 

source of microbial contamination 

No No 34457 17 0.05% 

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

Rejected" tag 

Yes No 2535 124 4.66% 

417.2(a)(1) Hazard analysis Yes Yes 122293 1686 1.36% 

56 
 

FY2020 Candidate 

Regulation 

Description FY2019 

PHR 

Mandatory 

Regulation 

Total FSIS 

Verifications 

Total 

NCs1 

NC1 

Rate 

417.2(c) Contents of HACCP Plan Yes No 28213 94 0.33% 

417.2(c)(4) List of procedures & frequency Yes Yes 1356468 6573 0.48% 

417.3 Corrective 

Actions 

Corrective actions No No 336 0 0.00% 

417.3(a) Corrective action after deviation from CCP No No 266 2 0.75% 

417.3(a)(1) Identify and eliminate the cause Yes No 8389 544 6.09% 

417.3(a)(2) CCP is under control Yes No 127492 717 0.56% 

417.3(a)(3) Establish measures to prevent recurrence Yes No 5136 642 11.11 

% 

417.3(a)(4) No adulterated product enters commerce. Yes No 32212 207 0.64% 

417.3(b)(1) Segregate and hold the affected product Yes No 4238 110 2.53% 

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

product 

Yes No 2944 86 2.84% 

417.3(b)(3) No adulterated product enters commerce Yes No 25665 107 0.42% 

417.3(b)(4) Reassessment Yes Yes 28313 258 0.90% 

417.3(c) Document corrective actions Yes No 6946 249 3.46% 

417.4(a) Adequacy of HACCP in controlling food safety 

hazards 

Yes No 7980 224 2.73% 

417.4(a)(1) Initial validation Yes No 6817 388 5.39% 

417.4(a)(3) Reassessment, at least annually or when 

necessary 

No No 0 0 0.00% 

417.4(b) Reassessment of hazard analysis Yes Yes 31505 118 0.37% 

417.5(a)(1) Written hazard analysis Yes Yes 1381680 4217 0.30% 

417.5(a)(2) Written HACCP plan Yes Yes 1229633 1462 0.12% 

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

and Critical Limits 

Yes Yes 1421504 3851 0.27% 

417.5(f) Official Review Yes No 92050 108 0.12% 

417.6 Inadequate HACCP systems Yes No 364 116 24.17 

% 

57 
FY2020 Candidate 

Regulation 

Description FY2019 

PHR 

Mandatory 

Regulation 

Total FSIS 

Verifications 

Total 

NCs1 

NC1 

Rate 

430.4(a) Lm, post-lethality exposed RTE Yes Yes 308727 130 0.04% 

430.4(b)(1) Lm, post-lethality exposed RTE - Alternative 1 No No 878 6 0.68% 

430.4(b)(2) Lm, post-lethality exposed RTE - Alternative 2 Yes No 14607 93 0.63% 

430.4(b)(3) Lm, post-lethality exposed RTE - Alternative 3 Yes No 24658 312 1.25% 

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

hazard analysis 

Yes Yes 299753 181 0.06% 

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

processing environment 

No Yes 306736 185 0.06% 

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

HACCP plan 

No No 4057 16 0.39% 

430.4(c)(5) Lm, evaluate control measures in Sanitation SOP No No 7178 20 0.28% 

430.4(c)(6) Lm, prerequisite program requirements No No 6013 70 1.15% 

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

sanitary manner 

Yes Yes 306889 3443 1.11% 

310.18(b) Brains, cheek meat, head trimmings from 

animals slaughtered by gunshot 

No No 19926 0 0.00% 

418.2 Notification of adulterated or misbranded 

product in commerce 

No No 1141 107 8.57% 

418.3 Recall Plans Yes No 14770 50 0.34% 

354.242(b) All equipment and utensils clean and sanitary No No 94 2 2.08% 

354.242(h) Tools and equipment used in preparation to be 

kept clean and sanitary 

No No 42 1 2.33% 

354.243(a) No handling or storage of objectionable 

materials 

No No 30 0 0.00% 

381.193(a) Poultry not intended for human food in 

commerce 

No No 409 8 1.92% 

381.65(f) Procedures for controlling visible fecal 

contamination 

No No 1027214 10349 1.00% 

381.65(h) Recordkeeping requirements No No 13545 0 0.00% 

58 
FY2020 Candidate 

Regulation 

Description FY2019 

PHR 

Mandatory 

Regulation 

Total FSIS 

Verifications 

Total 

NCs1 

NC1 

Rate 

381.76(b)(6)(ii)(A) NPIS Sorting, Trimming, and Reprocessing Yes No 48905 355 0.72% 

381.76(b)(6)(ii)(D) Ready-to-Cook verification in NPIS No No 2132 163 7.10% 

381.76(b)(6)(ii)(C) NPIS septicemia/toxemia Yes No 666150 154 0.02% 

381.76(b)(6)(ii)(B) NPIS reprocessing and salvage No No 58959 87 0.15% 

311.14 Abrasions, bruises, abscesses, pus, etc. No No 21071 21 0.10% 

1

NC = Noncompliance 

59 
 

 

 

 

 

APPENDIX C: COMPARISON OF FY2020 PHR LIST WITH FY2019 PHR LIST 

There are 18 regulations from the FY2019 PHR list that no longer appear in the FY2020 PHR 

list. These 18 regulations are shown in Table C-1. 

Table C-1 Regulations from the FY2019 PHR list no longer on the FY2020 PHR list 

List of FY2019 PHRs Description 

310.18 Contamination of carcasses, organs, or other parts 

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

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

317.24(a) 

Packaging materials composed of poisonous or 

deleterious substances 

381.65(e) Zero-tolerance for visible fecal material entering chiller 

416.12(c) plan identifies procedures for pre-op 

416.12(d) 

plan list frequency for each procedure & responsible 

individual 

416.13 Implementation of SOP's Implementation of SSOP 

417.2(c) Contents of HACCP Plan 

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

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

417.3(c) Document corrective actions 

417.4(a)(1) Initial validation 

417.4(b) Reassessment of hazard analysis 

417.6 Inadequate HACCP systems 

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

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

381.76(b)(6)(ii)(C) NPIS septicemia/toxemia 

There are 4 regulations on the FY2020 PHR list that were not on the FY2019 PHR list. These 

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

Table C-2 Regulations on the FY2020 PHR list that were not on the FY2019 PHR list 

List of FY2020 PHRs Description 

381.91(b) 

Reprocessing of carcasses accidentally contaminated 

with digestive tract contents. 

430.4(c)(3) 

Lm, maintain sanitation in post-lethality processing 

environment 

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

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

60 
 

 

 

 

 

 

 

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 three 

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. 

61 
 

2 

10 

8 

c 

a) 

~ 6 a) 

Q_ 

4 

2 

-7.2 -6.6 -6.0 -5. 4 

Curve 

Distribution of lograte 

-4.8 -4.2 -3.6 -3.0 -2.4 -1 .8 -1 .2 -0.6 

lo grat e 

--- Normal(M u=-3.68 Sigma=1 .0738) 

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 0.03731 Pr > D <0.010 

Cramer-von Mises W-Sq 1.55238 Pr > W-Sq <0.005 

Anderson-Darling A-Sq 11.53728 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 

62 
 

 

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 

Number of 

Establishments Mean Standard Deviation 

Tier 

Distribution 

(Number of 

Establishments) 

Q1CY2018 Tier 1 66 

Both 1,065 -4.43 0.99 Tier 2 95 

Processing 4,169 -4.89 0.82 Tier 3 5073 

Q2CY2018 Tier 1 60 

Both 1,064 -4.23 0.93 Tier 2 68 

Processing 4,213 -4.69 0.75 Tier 3 5149 

Q3CY2018 Tier 1 67 

Both 1,056 -4.41 1.01 Tier 2 89 

Processing 4,143 -4.94 0.82 Tier 3 5043 

Q4CY2018 Tier 1 61 

Both 1,069 -4.44 0.97 Tier 2 87 

Processing 4,221 -4.92 0.82 Tier 3 5142 

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 2019 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 -4.38 -4.86 

Standard Deviation 0.97 0.80 

Table D-3 March 2019 Tier Distribution Based on the PHR Criteria Only 

Classification Plants 

Tier 1 70 

Tier 2 100 

Tier 3 5,110 

Total 5,280 

63 
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 202 3.83% 2 2.78% 

Turkey Slaughter 50 0.95% 1 1.39% 

Beef Slaughter 1090 20.65% 4 5.56% 

Pork Slaughter 1031 19.53% 2 2.78% 

Beef Processing 1960 37.13% 11 15.28% 

Chicken Processing 896 16.97% 12 16.67% 

Turkey Processing 346 6.55% 3 4.17% 

Pork Processing 2135 40.44% 14 19.44% 

RTE 0 0.00% 0 0.00% 

Poultry Combination 383 7.26% 4 5.56% 

Total Number of 

Establishments 5279 72 

64