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FY2018 Public Health Regulations 

May 2017 
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Table of Contents

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

1.0 Introduction............................................................................................................................... 9

2.0 Selection of PHRs................................................................................................................... 10

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

2.2 Relationship with Pathogen Positives................................................................................. 11

3.0 Candidate Regulations............................................................................................................ 13

4.0 Relationship Between Candidate regulations and Pathogen Positives................................... 14

4.1 Salmonella........................................................................................................................... 14

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

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

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

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

4.1.5 Salmonella in Comminuted Chicken ........................................................................... 18

4.1.6 Salmonella in Comminuted Turkey............................................................................. 19

4.1.7 Salmonella in Intact Pork............................................................................................. 20

4.1.8 Salmonella in Ground Pork.......................................................................................... 21

4.1.9 Salmonella in Chicken Parts........................................................................................ 21

4.1.10 Salmonella in Ready to Eat........................................................................................ 22

4.2 E. Coli ................................................................................................................................. 23

4.2.1 E. coli O157:H7 ........................................................................................................... 23

4.2.2 Non-O157 STEC.......................................................................................................... 24

4.3 Listeria monocytogenes...................................................................................................... 24

4.4 Campylobacter.................................................................................................................... 25

4.4.1 Campylobacter in Intact Chicken ................................................................................ 26

4.4.2 Campylobacter in Intact Turkey .................................................................................. 27

4.4.3 Campylobacter in Comminuted Chicken..................................................................... 27

4.4.4 Campylobacter in Comminuted Turkey ...................................................................... 28

4.4.5 Campylobacter in Chicken Parts ................................................................................. 29

4.5 Enforcement Actions .......................................................................................................... 30

5.0 List of FY2018 PHRs.............................................................................................................. 32

6.0 Cut Points for FY2018 PHRs.................................................................................................. 39

7.0 Conclusion .............................................................................................................................. 42

8.0 References............................................................................................................................... 43

Appendix A: FY2018 PHR Regulations....................................................................................... 44

Appendix B: Past Use of Public Health regulations..................................................................... 47

Appendix C: FY2018 Candidate regulations................................................................................ 48

Appendix D: Comparison of FY2018 PHR List with FY2017 PHR List .................................... 52
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Appendix E: Use of Public Health Regulations in Scheduling Food Safety Assessments........... 53
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List of Figures and Tables

Figures

Figure 5-1 Odds Ratio for the 2018 PHRs................................................................................ 36

Figure E-1 Log Transformed Non-zero Non-Compliance Rates of PHRs with 20 or More 

Verifications 3 Months before a Pathogen Positive or Enforcement Action........................ 54

Figure E-2 Goodness of Fit for Normal Distribution of the Log Transformation .................... 54

Tables

Table S-1 FY2018 PHR Tier 1 Cut Points.................................................................................. 7

Table S-2 FY2018 PHR Tier 3 Cut Points.................................................................................. 7

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

Table S-4 Distribution of Tier 1 Establishments Among Different Product Categories............ 8

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

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

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

Salmonella Positive with Those for Establishments with No Intact Chicken Salmonella 

Positive.................................................................................................................................. 16

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

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

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

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

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

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

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

Salmonella Positive with Those for Establishments with No Comminuted Chicken 

Salmonella Positive............................................................................................................... 19

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

Salmonella Positive with Those for Establishments with No Comminuted Turkey 

Salmonella Positive............................................................................................................... 20

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

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

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

Positive with those for Establishments with No Ground Pork Salmonella Positive ............ 21

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

Positive with Those for Establishments with No Chicken Parts Salmonella Positive.......... 22

Table 4-11 Comparison of Noncompliance Rates 3 Months before a Ready to Eat Salmonella 

Positive with those for Establishments with No Ready to Eat Salmonella Positive............. 22

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

H7 Positive with Those for Establishments with No E. coli O157

H7 Positive........................................................................................................................ 23

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

with Those for Establishments with No Non-O157 STEC Positive ..................................... 24

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

Positive with Those for Establishments with No Listeria monocytogenes Positive............. 25
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Table 4-15 Comparison of Noncompliance Rates 3 Months before a Campylobacter Positive 

with Those for Establishments with No Campylobacter Positive ........................................ 25

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

Chicken Positive with Those for Establishments with No Campylobacter Intact Chicken 

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

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

Turkey Positive with Those for Establishments with No Campylobacter Intact Turkey 

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

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

Campylobacter Positive with Those for Establishments with No Comminuted Chicken 

Campylobacter Positive ........................................................................................................ 28

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

Campylobacter Positive with those for Establishments with No Comminuted Turkey 

Campylobacter Positive ........................................................................................................ 28

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

Campylobacter Positive with Those for Establishments with No Chicken Parts 

Campylobacter Positive ........................................................................................................ 29

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

with Those for Establishments with No Enforcement Action .............................................. 30

Table 5-1 List of FY2018 PHRs............................................................................................... 32

Table 5-2 Events That Triggered Inclusion of a Regulation in the FY2018 PHR list.............. 36

Table 5-3 Regulations Triggered for Inclusion in the FY2018 PHR List by Only a Single 

Event ..................................................................................................................................... 37

Table 6-3 FY2018 PHR Tier 3 Cut Points................................................................................ 40

Table 6-1 Mean and Standard Deviation of Quarterly FY2018 PHR Rate .............................. 39

Table 6-2 FY2018 PHR Tier 1 Cut Points................................................................................ 40

Table 6-4 Tier Classification of Establishments Based Solely on the PHR Criterion.............. 40

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

Criterion ................................................................................................................................ 41

Table 7-1 FY2018 PHR Tier 1 Cut Points................................................................................ 42

Table 7-2 FY2018 PHR Tier 3 Cut Points................................................................................ 42

Table A-1 List of FY2018 PHRs.............................................................................................. 44

Table C-1 FY2018 Candidate regulations ................................................................................ 48

Table D-1 Regulation from the FY2017 PHR list no longer on the FY2018 PHR list ............ 52

Table E-1 Quarterly PHR Mean, Standard Deviation and Tier Distribution............................ 55

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

by Plant Type ........................................................................................................................ 55

Table E-3 March 2017 Tier Distribution Based on the PHR Criteria Only.............................. 55

Table E-4 Distribution of Tier 1 Establishments Among Different Product Categories.......... 56
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SUMMARY

The purpose of the present report is to update the FY2017 list of Public Health Regulations 

(PHRs) used by the Food Safety and Inspection Service (FSIS) for prioritizing Food Safety 

Assessments (FSAs). The updated list of PHRs is based on CY2016 verification inspection 

results and will be implemented in FY2018. If an establishment is prioritized for an FSA, the 

District Office first performs a Public Health Risk Evaluation (PHRE), as described in FSIS 

Directive 5100.4, to review the operational and compliance history of the establishment to decide 

if an FSA is appropriate.

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 public 

health related provisions of regulations that may be most informative for prioritizing FSAs.

The methodology used in developing the FY2018 PHR list is the same as that used for the 

FY2017 PHR list. For inclusion in the FY2018 PHR list, each candidate 9 CFR regulation in the 

candidate list was evaluated to determine whether noncompliance with the regulation had 

occurred more frequently in establishments in the three month period before Salmonella, E. coli 

O157: H7, Non-O157 STEC, Listeria monocytogenes (Lm), Campylobacter positives or 

enforcement action than in establishments without positives or enforcement actions. The analysis 

was based on one year of FSIS verification inspection results (January 1 –December 31, 2016) 

recorded in PHIS. The term “enforcement action” refers to a public health NOIE or suspension.

The final list of FY2018 PHRs consists of 57 regulations that have higher rates of 

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

with 53 regulations that were identified in the FY2017 PHR list. The list of FY2018 PHRs is

presented in Appendix A. Eighty one percent of the regulations on the FY2017 PHR list are also 

on the FY2018 PHR list.

The 57 FY2018 PHRs are composed of 11 regulations and 46 provisions of regulations. The 46

provisions fall under 22 different regulations. Thus, the 53 FY2018 PHRs represent 33

regulations, with the majority of FY2018 PHRs actually 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 FY2018 PHR regulations three months before a pathogen 

positive or enforcement action is 13.43 times higher than the average FY2018 PHR 

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

The FY2018 PHRs are one of seven public health based decision criteria that will be used in 

prioritizing Public Health Risk Evaluations (PHREs). Noncompliance with a single FY2018

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. The aggregate FY2018 PHR noncompliance rate by 
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establishments is evaluated and compared to cut points that have been set for two broad 

categories of establishment operations: Processing Only, and Slaughter/Processing (Named

Processing, and Combination in the main body of the report).

To compute the set of FY2018 cut points, the mean and standard deviation of the log 

transformed non-zero FY2018 PHR rates for each of the four quarters in CY2016 is computed

(the log transform of the non-zero FY2018 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 non-compliance 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” FSA if they have not had an FSA in the last six months. Tables S-1

and S-2 present the upper and lower FY2018 PHR cut points for the non-transformed PHR noncompliance data for each of the two establishment operation types. The FY2017 PHR cut points 

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

Table S-1 FY2018 PHR Tier 1 Cut Points

Operation Type FY2018 PHR Cut Points FY2017 PHR Cut Points

Processing 4.22% 4.81%

Combination 8.73% 9.46%

Table S-2 FY2018 PHR Tier 3 Cut Points

Operation Type FY2018 PHR Cut Points FY2017 PHR Cut Points

Processing 2.82% 3.16%

Combination 5.38% 5.82%

The cut points are used to determine when FSIS will send “early warning alerts” through PHIS 

or prioritize establishments for a PHRE. The cut points in Table S-1 are the upper cut points. 

When establishments exceed these cut points, based on a monthly evaluation of the prior 90 

days, they will be prioritized for a “for cause” PHRE and an EIAO will make a determination 

whether to conduct an FSA or not. The cut points in Table S-2 are the lower cut points. For 

establishments that fall in between these two cut points, FSIS sends an alert to its in-plant 

inspection personnel to make them aware of the elevated non-compliance at these 

establishments. For establishments that fall below the cut points in Table S-2, no action is taken 

related to the PHR measure.

Table S-3 presents the number of establishments in each Tier for the time period from January 1 

–March 31, 2017, based on the PHR criterion. The number of “for cause” PHREs, for Tier 1 

establishments will be 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 56 13 69

Tier 2 80 29 109
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Classification Processing Combination Total

Tier 3 3,970 994 4,964

Total 4,106 1,036 5,142

Table S-4 presents the distribution of Tier 1 establishments (as determined using only the PHR 

criterion) among different product categories, for the time period from January 1 –March 31, 

2017. 

Table S-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 197 3.83% 6 8.70%

Turkey Slaughter 49 0.95% 1 1.45%

Beef Slaughter 637 12.39% 5 7.25%

Pork Slaughter 596 11.59% 2 2.90%

Beef Processing 1639 31.87% 14 20.29%

Chicken Processing 820 15.95% 17 24.64%

Turkey Processing 317 6.16% 4 5.80%

Pork Processing 1808 35.16% 10 14.49%

RTE 2531 49.22% 37 53.62%

Poultry Combination 396 7.70% 8 11.59%

Total Number of 

Establishments 5142 69

The time period used for calculating the noncompliance rate of the PHRs was January 1 –March 

31, 2017. When establishments have had an FSA in the past six months, Tier 1 establishments 

are not automatically scheduled to receive a PHRE. Instead, the District is notified that such 

establishments have received a Tier 1 classification and it is up to the District to determine if the 

establishment should receive an additional PHRE and possible FSA. 
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1.0 INTRODUCTION

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

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

Safety Assessments (FSAs). 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 an FSA is to review an establishment’s food safety system 

to verify that the establishment is able to produce safe and wholesome meat or poultry products 

in accordance with FSIS statutory and regulatory requirements. If an establishment is prioritized 

for an FSA, the District Office first performs a Public Health Risk Evaluation (PHRE), as 

described in FSIS Directive 5100.4, to review the operational and compliance history of the 

establishment to decide if an FSA is appropriate.

The subset of 9 CFR regulations used to schedule FSAs were initially called W3NR regulations 

to indicate they are the most serious non-compliances. 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 were 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 the present report is to update the list 

of FY2017 PHRs using current verification inspection results from the Public Health Information 

System (PHIS). The updated list is called the FY2018 PHRs.

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 public

health-related provisions of regulations that may be most informative for prioritizing FSAs.

The methodology used in developing the FY2018 PHR list is the same as that used for the 

FY2017 PHR. Specifically, for inclusion in the FY2018 PHR list, each candidate 9 CFR 

regulation was evaluated to determine whether noncompliance with the regulation had occurred 

more frequently 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 actions. The analysis was based 

on one year of FSIS verification inspection results (January 1 –December 31, 2016) recorded in 

PHIS. Candidate regulations related to egg products are not included in the present report. 

The final FY2018 PHR list is presented in Appendix A. Appendix B describes how noncompliance with PHR regulations has been used in the past to prioritize scheduling of FSAs.
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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 those 9 CFR regulations with which noncompliance occurs more frequently 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, to facilitate the analysis and to focus on the most relevant 9 CFR 

regulations, first the list of 9 CFR regulations is narrowed to those regulations 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.

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 for the production of safe, wholesome food. To make the selection process more 

transparent, a set of four criteria were developed to assist in selecting the list of candidate 

regulations.

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

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

establishment’s particular 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 will be 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
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The following are examples of the types of regulations under each criterion that would be 

considered candidate regulations.

 Establish and maintain HACCP

o Failure to maintain adequate HACCP Plan

o Adequacy of HACCP Plan in controlling food safety hazards

o Critical factors specified in the process schedule shall be measured, controlled and 

recorded

o CCPs are under control

 Establish and Maintain Sanitary Conditions

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

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

o Products do not contain foreign material

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

conditions

 Prevent Adulteration

o No adulterated product enters commerce.

o Product and ingredients rendered adulterated by polluted water shall be 

condemned

o Container composed of any poisonous or deleterious substance

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

o Lethality and stabilization requirements for cooked beef

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

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

 Corrective Actions

o Procedures for and selection of appropriate corrective actions

o Document corrective actions

o Identify and eliminate the cause

o Establish measures to prevent recurrence

o Reassess hazard analysis

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

not deter FSIS’ ability to conduct verification inspections will also be included. Inclusion of 9 

CFR regulations in the list of candidate regulations should err on the side of inclusiveness.

2.2 Relationship with Pathogen Positives or 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 an enforcement action. The three month time period is chosen 

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

indicative of establishment operating conditions before a pathogen positive. 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 action than the average noncompliance rate 

in establishments that do not have a Salmonella, E. coli O157:H7, Non-O157 STEC, Lm, 

Campylobacter positive or enforcement action. The current analysis includes the six non-O157 
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STECs (O26, O45, O103, O111, O121, and O145) that FSIS has declared adulterants in beef 

trim.
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3.0 CANDIDATE REGULATIONS

The purpose of this section is to use the above criteria to select a list of candidate regulations. 

The purpose of the candidate list is to narrow the list of all 9 CFR regulations to those related to 

verifying HACCP food safety process control in order to make the analysis of relationship to 

pathogen positives manageable. All regulations in 9 CFR were individually reviewed to 

determine if they satisfied any of the 4 criteria delineated in Section 2.1. A set of one hundred 

forty eight (144) 9 CFR regulations were selected as being indicators of a potential loss of food 

safety process control. The list of 144 candidate regulations that are indicators of a potential loss 

of HACCP food safety process control are presented in Appendix C.
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4.0 RELATIONSHIP BETWEEN CANDIDATE REGULATIONS AND

PATHOGEN POSITIVES OR ENFORCEMENT ACTIONS

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

regulations and Salmonella, E. coli O157:H7, Non-O157 STEC, Listeria monocytogenes, 

Campylobacter positives or enforcement actions during FSIS verification testing. The 

noncompliance rate of each of the 144 candidate regulations in establishments three months 

before 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 in the period January 1, 2016 through December 31, 2016. 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 Exact p value of less than 0.05) that the noncompliance rate 

of the regulation in establishments in the three months before a pathogen positive or enforcement 

action is higher than the noncompliance rate for establishments with no positives or enforcement 

actions are selected as PHRs. The exact sequence of steps used to develop the list of PHRs is 

given in Appendix D.

A few candidate regulations have 30 or less verifications three months before a specific pathogen 

positive or enforcement action. These candidate regulations 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 that 

have more the 30 verifications).

An odds ratio (OR) is one of several statistics useful as an effect-size measure, especially when 

statistical significance of dichotomous data is computed using the Fisher 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 non-compliance 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 noncompliance rate of each of the 144 candidate regulations in establishments three months 

before a Salmonella positive was compared with the average noncompliance rate of 

establishments that received Salmonella FSIS verification testing, but had no Salmonella

positives in the period January 1, 2016 to December 31, 2016. The dataset used in the analysis 

consists of candidate PHR noncompliance rates for the 2,096 establishments with Salmonella 

testing data, of which 793 had 2,978 Salmonella positives and 1,303 did not have Salmonella

positives. There were 39,677 total Salmonella tests performed.

Table 4-1 presents the 19 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 Exact p value of less than 0.05) that the noncompliance rate of the regulation in 
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establishments 3 months before a Salmonella positive is higher than the average noncompliance 

rate for establishments with no Salmonella positive in the period January 1, 2016 to December

31, 2016.

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

Those for Establishments with No Salmonella Positive

Reg 

ID 

Regulation 

Verified 

On 

FY2017 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a Salmonella 

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

TwoSided 

Fisher 

Exact p 

Value

Odds 

Ratio

178 317.24(a) No 6.04% 0.17% 1.12E-08 37.92

207 318.1(b) No 0.10% 0.03% 4.17E-02 3.00

234 318.2(a) Yes 0.47% 0.07% 4.21E-07 6.50

543 381.71(a) Yes 23.05% 7.14% 6.72E-16 3.90

557 381.83 Yes 0.07% 0.01% 5.97E-05 13.25

589 416.13(a) Yes 3.53% 0.77% 0.00E+00 4.74

590 416.13(b) Yes 0.57% 0.18% 5.58E-163 3.15

591 416.13(c) Yes 6.30% 1.28% 0.00E+00 5.19

592 416.14 Yes 1.02% 0.23% 0.00E+00 4.44

594 416.15(a) Yes 5.11% 1.66% 3.10E-50 3.19

595 416.15(b) Yes 8.99% 2.07% 6.07E-91 4.67

630 416.3(b) Yes 2.65% 0.67% 2.40E-43 4.04

631 416.3(c) Yes 4.88% 0.88% 3.36E-98 5.78

633 416.4(a) Yes 20.74% 5.95% 0.00E+00 4.14

636 416.4(d) Yes 27.92% 7.04% 0.00E+00 5.11

649 417.2(c)(4) Yes 1.75% 0.41% 0.00E+00 4.35

717 310.18(a) Yes 3.90% 1.07% 5.73E-275 3.75

1349 381.76(b)(6)(ii)(A) Yes 1.11% 0.09% 2.26E-22 12.21

1444 311.14 No 0.27% 0.03% 2.38E-02 10.30

4.1.1 Salmonella in Intact Chicken

The noncompliance rate of each of the 144 candidate regulations in establishments three months 

before an Intact Chicken Salmonella positive was compared with the average noncompliance rate 

of establishments that received Intact Chicken Salmonella FSIS verification testing, but had no 

Intact Chicken Salmonella positives in the period January 1, 2016 to December 31, 2016. The 

dataset used in the analysis consists of candidate PHR noncompliance rates for the 203

establishments with Intact Chicken Salmonella testing data, of which 129 had 347 Salmonella

positives and 74 did not have Salmonella positives. There were 8,818 total Intact Chicken 

Salmonella tests performed.
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Table 4-2 presents the 10 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 Exact p value of less than 0.05) that the noncompliance rate of the regulation in 

establishments three months before an Intact Chicken Salmonella positive is higher than the 

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

period January 1, 2016 to December 31, 2016.

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

Salmonella Positive with Those for Establishments with No Intact Chicken Salmonella

Positive

Reg 

ID 

Regulation 

Verified 

On 

FY2017 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a Salmonella 

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

TwoSided 

Fisher 

Exact p 

Value

Odds Ratio

543 381.71(a) Yes 42.48% 3.98% 2.61E-106 17.83

557 381.83 Yes 0.14% 0.04% 6.45E-10 3.41

594 416.15(a) Yes 8.81% 3.05% 1.97E-12 3.07

657 417.3(a)(1) Yes 8.23% 1.45% 1.67E-15 6.09

659 417.3(a)(3) Yes 16.84% 2.62% 3.90E-27 7.51

660 417.3(a)(4) Yes 0.93% 0.21% 8.23E-05 4.41

666 417.3(c) No 5.10% 1.24% 7.64E-06 4.30

668 417.4(a) Yes 37.84% 0.24% 4.44E-19 254.13

689 417.5(f) No 0.44% 0.03% 1.11E-03 13.96

1349 381.76(b)(6)(ii)(A) Yes 1.46% 0.43% 2.58E-14 3.39

4.1.2 Salmonella in Intact Turkey

The noncompliance rate of each of the candidate regulations in establishments three months 

before an Intact Turkey Salmonella positive was compared with the average noncompliance rate 

of establishments that received Intact Turkey Salmonella FSIS verification testing, but had no 

Intact Turkey Salmonella positives in the period January 1, 2016 to December 31, 2016. The 

dataset used in the analysis consists of candidate PHR noncompliance rates for the 45

establishments with Salmonella testing data, of which 13 had 16 Salmonella positives and 32 did 

not have Salmonella positives. There were 1,841 total Intact Turkey Salmonella tests performed.

Table 4-3 presents the 1 regulation 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 

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

three months before an Intact Turkey Salmonella positive is higher than the average 

noncompliance rate for establishments with no Intact Turkey Salmonella positive in the period 

January 1, 2016 to December 31, 2016.
17

17

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

Salmonella Positive with Those for Establishments with No Intact Turkey Salmonella 

Positive

Reg 

ID 

Regulation 

Verified 

On 

FY2017 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a Salmonella 

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

TwoSided 

Fisher 

Exact p 

Value

Odds 

Ratio

590 416.13(b) Yes 1.20% 0.37% 2.62E-05 3.24

4.1.3 Salmonella in Ground Beef

The noncompliance rate of each of the candidate regulations in establishments three months 

before a Ground Beef Salmonella positive was compared with the average noncompliance rate of 

establishments that received Ground Beef Salmonella FSIS verification testing, but had no 

Ground Beef Salmonella positives in the period January 1, 2016 to December 31, 2016. The 

dataset used in the analysis consists of candidate PHR noncompliance rates for the 1,202

establishments with Salmonella testing data, of which 123 had 211 Salmonella positives and 

1,079 did not have Salmonella positives. There were 11,426 total Ground Beef Salmonella tests 

performed.

Table 4-4 presents the 5 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 

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

three months before an Ground Beef Salmonella positive is higher than the average 

noncompliance rate for establishments with no Ground Beef Salmonella positive in the period 

January 1, 2016 to December 31, 2016.

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

Positive with Those for Establishments with No Ground Beef Salmonella Positive

Reg 

ID 

Regulation 

Verified

On 

FY2017 

PHR List 

Noncompliance 

Rate in 3 

Months before 

a Salmonella 

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Two-Sided 

Fisher Exact 

p Value

Odds 

Ratio

29 301.2_Adulterated Yes 16.81% 1.54% 3.15E-13 12.88

99 310.22(f)(2) Yes 1.12% 0.11% 1.51E-03 10.24

595 416.15(b) Yes 6.56% 1.70% 1.26E-05 4.06

649 417.2(c)(4) Yes 1.43% 0.39% 1.18E-51 3.75

717 310.18(a) Yes 4.09% 1.31% 1.33E-55 3.21
18

18

4.1.4 Salmonella in Intact Beef

The noncompliance rate of each of the candidate regulations in establishments three months 

before an Intact Beef Salmonella positive was compared with the average noncompliance rate of 

establishments that received Intact Beef Salmonella FSIS verification testing, but had no Intact 

Beef Salmonella positives in the period January 1, 2016 to December 31, 2016. FSIS tests beef 

trim and beef manufacturing trimmings as a surrogate for testing intact beef. There are 855

establishments with Intact Beef Salmonella testing data, of which 82 had 128 Salmonella

positives and 773 did not have Salmonella positives. There were 5,242 total Intact Beef 

Salmonella tests performed.

Table 4-5 presents the 12 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 Exact p value of less than 0.05) that the noncompliance rate of the regulation in 

establishments three months before an Intact Beef Salmonella positive is higher than the average 

noncompliance rate for establishments with no Intact Beef Salmonella positive in the period 

January 1, 2016 to December 31, 2016.

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

Positive with Those for Establishments with No Intact Beef Salmonella Positive

Reg 

ID 

Regulation 

Verified 

On 

FY2017 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a Salmonella 

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Two-Sided 

Fisher Exact 

p Value

Odds 

Ratio

591 416.13(c) Yes 5.21% 1.22% 3.42E-229 4.43

594 416.15(a) Yes 7.41% 1.60% 1.65E-08 4.93

595 416.15(b) Yes 16.81% 1.48% 5.03E-14 13.47

631 416.3(c) Yes 2.22% 0.74% 4.62E-03 3.06

636 416.4(d) Yes 25.92% 5.70% 1.28E-199 5.79

649 417.2(c)(4) Yes 4.06% 0.31% 9.02E-252 13.59

658 417.3(a)(2) Yes 1.82% 0.36% 1.93E-08 5.17

664 417.3(b)(3) Yes 3.39% 0.48% 4.83E-03 7.21

665 417.3(b)(4) Yes 4.59% 0.74% 1.97E-03 6.49

668 417.4(a) Yes 20.59% 4.27% 6.83E-04 5.81

717 310.18(a) Yes 5.82% 1.14% 1.61E-209 5.36

1331 381.65(f) Yes 2.35% 0.32% 3.56E-02 7.58

4.1.5 Salmonella in Comminuted Chicken

The noncompliance rate of each of the candidate regulations in establishments three months 

before a Comminuted Chicken Salmonella positive was compared with the average 

noncompliance rate of establishments that received Comminuted Chicken Salmonella FSIS 

verification testing, but had no Comminuted Chicken Salmonella positives in the period January 
19

19

1, 2016 to December 31, 2016. The dataset used in the analysis consists of candidate PHR 

noncompliance rates for the 104 establishments with Comminuted Chicken Salmonella testing 

data, of which 95 had 427 Salmonella positives and 9 did not have Salmonella positives. There 

were 1,330 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 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 in the 

period January 1, 2016 to December 31, 2016.

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

Salmonella Positive with Those for Establishments with No Comminuted Chicken 

Salmonella Positive

Reg 

ID 

Regulation 

Verified 

On 

FY2017 

PHR 

List 

Noncompliance 

Rate in 3 Months 

before a 

Salmonella 

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Two-Sided 

Fisher 

Exact p 

Value

Odds 

Ratio

582 416.1 Yes 3.87% 0.60% 2.60E-10 6.64

589 416.13(a) Yes 3.62% 0.25% 7.69E-19 14.88

590 416.13(b) Yes 0.33% 0.09% 1.38E-02 3.60

591 416.13(c) Yes 4.50% 0.64% 3.43E-54 7.37

597 416.16(a) Yes 0.28% 0.02% 3.59E-05 14.24

631 416.3(c) Yes 3.92% 0.97% 3.07E-02 4.17

633 416.4(a) Yes 19.75% 3.02% 1.84E-40 7.90

636 416.4(d) Yes 26.03% 2.64% 1.57E-43 12.99

649 417.2(c)(4) Yes 0.99% 0.14% 6.29E-10 7.24

659 417.3(a)(3) Yes 12.29% 0.61% 4.71E-07 22.71

1331 381.65(f) Yes 1.26% 0.11% 1.08E-11 11.93

4.1.6 Salmonella in Comminuted Turkey

The noncompliance rate of each of the candidate regulations in establishments three months 

before a Comminuted Turkey Salmonella positive was compared with the average 

noncompliance rate of establishments that received Comminuted Turkey Salmonella FSIS 

verification testing, but had no Comminuted Turkey Salmonella positives in the period January 

1, 2016 to December 31, 2016. There are 60 establishments with Comminuted Turkey 

Salmonella testing data, of which 40 had 159 Salmonella positives and 20 did not have 

Salmonella positives. There were 978 total Comminuted Turkey Salmonella tests performed.

Table 4-7 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 
20

20

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 in the 

period January 1, 2016 to December 31, 2016.

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

Salmonella Positive with Those for Establishments with No Comminuted Turkey 

Salmonella Positive

Reg ID Regulation 

Verified 

On 

FY2017 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a Salmonella 

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

TwoSided 

Fisher 

Exact p 

Value

Odds 

Ratio

527 381.65(a) Yes 1.92% 0.27% 3.23E-04 7.16

592 416.14 Yes 0.57% 0.11% 1.97E-07 5.17

594 416.15(a) Yes 4.35% 0.19% 4.99E-08 24.26

681 417.5(a)(2) Yes 0.18% 0.02% 3.56E-03 9.74

4.1.7 Salmonella in Intact Pork

The noncompliance rate of each of the candidate regulations in establishments three months 

before an Intact Pork Salmonella positive was compared with the average noncompliance rate of 

establishments that received Intact Pork Salmonella FSIS verification testing, but had no Intact 

Pork Salmonella positives in the period January 1, 2016 to December 31, 2016. There are 244

establishments with Intact Pork Salmonella testing data, of which 93 had 241 Salmonella

positives and 151 did not have Salmonella positives. There were 1430 total Intact Pork 

Salmonella tests performed.

Table 4-8 presents the 11 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 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 in the period 

January 1, 2016 to December 31, 2016.

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

Positive with Those for Establishments with No Intact Pork Salmonella Positive

Reg 

ID 

Regulation 

Verified 

On 

FY2017 

PHR 

List 

Noncompliance 

Rate in 3 

Months before a 

Salmonella 

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Two-Sided 

Fisher 

Exact p 

Value

Odds 

Ratio
21

21

178 317.24(a) No 21.05% 1.32% 5.99E-04 20.00

527 381.65(a) Yes 1.88% 0.14% 1.16E-02 13.47

631 416.3(c) Yes 4.76% 1.18% 2.68E-09 4.19

649 417.2(c)(4) Yes 1.30% 0.30% 4.80E-46 4.31

657 417.3(a)(1) Yes 14.15% 2.78% 2.52E-06 5.77

659 417.3(a)(3) Yes 47.62% 10.33% 1.42E-15 7.89

660 417.3(a)(4) Yes 7.69% 1.57% 1.09E-03 5.22

664 417.3(b)(3) Yes 20.00% 2.07% 6.36E-05 11.85

665 417.3(b)(4) Yes 3.54% 0.81% 5.05E-03 4.49

666 417.3(c) No 13.04% 3.85% 2.05E-02 3.75

717 310.18(a) Yes 3.39% 0.010871502 2.0809E-42 3.19

4.1.8 Salmonella in Ground Pork

The noncompliance rate of each of the candidate regulations in establishments three months 

before a Ground Pork Salmonella positive was compared with the average noncompliance rate of 

establishments that received Ground Pork Salmonella FSIS verification testing, but had no 

Ground Pork Salmonella positives in the period January 1, 2016 to December 31, 2016. There 

are 361 establishments with Ground Pork Salmonella testing data, of which 146 had 342

Salmonella positives and 215 did not have Salmonella positives. There were 1,808 total Ground 

Pork Salmonella tests performed.

There is 1 regulation 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 Exact p 

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

three months before an Ground Pork Salmonella positive is higher than the average 

noncompliance rate for establishments with no Ground Pork Salmonella positive in the period 

January 1, 2016 to December 31, 2016.

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

Salmonella Positive with those for Establishments with No Ground Pork Salmonella

Positive

Reg ID Regulation 

Verified 

On 

FY2017 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a Salmonella 

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

TwoSided 

Fisher 

Exact p 

Value

Odds 

Ratio

152 316.6 Yes 4.55% 0.90% 3.57E-02 5.21

4.1.9 Salmonella in Chicken Parts

The noncompliance rate of each of the candidate regulations in establishments three months 

before a Chicken Parts Salmonella positive was compared with the average noncompliance rate 

of establishments that received Chicken Parts Salmonella FSIS verification testing, but had no 
22

22

Chicken Parts Salmonella positives in the period January 1, 2016 to December 31, 2016. There 

are 418 establishments with Chicken Parts Salmonella testing data, of which 313 had 1,107

Salmonella positives and 105 did not have Salmonella positives. There were 6,804 total Chicken 

Parts Salmonella tests performed.

Table 4-10 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 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 in the 

period January 1, 2016 to December 31, 2016.

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

Salmonella Positive with Those for Establishments with No Chicken Parts Salmonella 

Positive

Reg 

ID 

Regulation 

Verified 

On 

FY2017 

PHR 

List 

Noncompliance 

Rate in 3 Months 

before a 

Salmonella 

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

Two-Sided 

Fisher 

Exact p 

Value

Odds 

Ratio

630 416.3(b) Yes 3.31% 0.95% 3.85E-11 3.57

631 416.3(c) Yes 6.78% 2.12% 2.51E-17 3.35

1349 381.76(b)(6)(ii)(A) Yes 1.40% 0.38% 3.88E-14 3.75

4.1.10 Salmonella in Ready to Eat

The noncompliance rate of each of the candidate regulations in establishments three months 

before an Ready to Eat Salmonella positive was compared with the average noncompliance rate 

of establishments that received Ready to Eat Salmonella FSIS verification testing, but had no 

Ready to Eat Salmonella positives in the period January 1, 2016 to December 31, 2016. The 

dataset used in the analysis consists of candidate PHR noncompliance rates for the 1,933

establishments with Salmonella testing data, of which 10 had 13 Salmonella positives and 1,923

did not have Salmonella positives. There were 12,169 total Ready to Eat Salmonella tests

performed.

There is 1 regulation 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 Exact p 

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

months before an Ready to Eat Salmonella positive is higher than the average noncompliance 

rate for establishments with no Ready to Eat Salmonella positive in the period January 1, 2016 to 

December 31, 2016.

Table 4-11 Comparison of Noncompliance Rates 3 Months before a Ready to Eat 

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

Positive
23

23

Reg ID Regulation 

Verified 

On 

FY2017 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a Salmonella 

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella 

Positive 

TwoSided 

Fisher 

Exact p 

Value

Odds 

Ratio

636 416.4(d) Yes 20.59% 4.97% 1.23E-03 4.96

4.2 E. Coli

4.2.1 E. coli O157:H7

The purpose of this section is to investigate the relationship 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

noncompliance rate of each of the candidate regulations in the three months before an E. coli 

O157:H7 positive was compared with the average noncompliance rate of establishments that 

received FSIS E. coli O157:H7 verification testing, but had no E. coli O157:H7 positives in the 

period January 1, 2016 to December 31, 2016. The dataset used in the analysis consists of 

candidate PHR noncompliance rates for the 1,202 establishments with E. coli O157:H7 testing 

data, of which 13 had 13 E. coli O157:H7 positives and 1,189 did not have E. coli O157:H7 

positives. There were 15,533 total E. coli O157:H7 tests performed.

Table 4-12 presents the 5 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 

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 in the period January 1, 2016 to December 

31, 2016.

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

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

Reg 

ID 

Regulation 

Verified 

On 

FY2017 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a E Coli O157 

Positive

Noncompliance 

Rate for 

Establishments 

with no E Coli 

O157 Positive 

Two-Sided 

Fisher 

Exact p 

Value

Odds 

Ratio

29 301.2_Adulterated Yes 47.06% 2.68% 2.60E-23 32.33

234 318.2(a) Yes 1.18% 0.05% 4.39E-02 25.68

582 416.1 Yes 6.07% 2.02% 4.26E-07 3.14

592 416.14 Yes 0.86% 0.26% 3.32E-03 3.36

681 417.5(a)(2) Yes 0.45% 0.00120144 2.44E-02 3.73
24

24

4.2.2 Non-O157 STEC

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

and non- O157 Shiga toxin-producing E. coli (STEC) positives inMT55 (bench trim) and MT60

(beef or veal trim). FSIS has declared there are six non-O157 STEC adulterants in raw beef trim. 

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

trimmings. The noncompliance rate of each of the candidate regulations in the three months 

before a non- 157 STEC positive was compared with the average noncompliance rate of 

establishments that received FSIS non- O157 STEC verification testing, but had no non-O157

STEC positives in the period January 1, 2016 to December 31, 2016. The dataset used in the 

analysis consists of candidate PHR noncompliance rates for the 350 establishments with nonO157 STEC testing data, of which 23 had 58 non- O157 STEC positives and 327 did not have 

non-O157 STEC positives. There were 3,345 total non-O157 STEC tests performed.

Table 4-13 presents the 9 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 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 in the period January 1, 

2016 to December 31, 2016.

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

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

Reg 

ID 

Regulation 

Verified 

On 

FY2017 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a Non-O157 

STEC Positive

Noncompliance 

Rate for 

Establishments 

with no NonO157 STEC 

Positive 

TwoSided 

Fisher 

Exact p 

Value

Odds 

Ratio

527 381.65(a) Yes 5.26% 0.33% 1.16E-02 16.56

586 416.12(c) Yes 2.56% 0.13% 8.78E-03 19.86

587 416.12(d) Yes 2.56% 0.22% 1.80E-02 11.76

589 416.13(a) Yes 2.82% 0.95% 6.25E-10 3.02

590 416.13(b) Yes 0.90% 0.25% 7.34E-09 3.63

633 416.4(a) Yes 16.22% 5.86% 5.51E-25 3.11

636 416.4(d) Yes 29.98% 9.08% 1.00E-49 4.29

649 417.2(c)(4) Yes 4.69% 0.78% 2.84E-71 6.30

717 310.18(a) Yes 5.13% 1.68% 4.14E-50 3.18

4.3 Listeria monocytogenes

The noncompliance rate of each of the candidate regulations in the three months before a Listeria 

monocytogenes positive was compared with the average noncompliance rate of establishments 

that received FSIS Listeria monocytogenes verification testing, but had no Listeria 

monocytogenes positives in the period January 1, 2016 to December 31, 2016. The dataset used 

in the analysis consists of candidate PHR noncompliance rates for the 1,933 establishments with 
25

25

Listeria monocytogenes testing data, of which 22 had 23 Listeria monocytogenes positives and 

1,911 did not have Listeria monocytogenes positives. There were 12,174 total Listeria 

monocyogenes tests performed.

Table 4-14 presents the 1 regulation that had more than 30 verifications in a year, an odds ratio 

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

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 in the period January 1, 2016 to 

December 31, 2016.

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

Positive with Those for Establishments with No Listeria monocytogenes Positive

Reg 

ID 

Regulation 

Verified 

On 

FY2017 

PHR List 

Noncompliance 

Rate in 3 

Months before 

a Listeria 

monocytogenes 

Positive

Noncompliance 

Rate for 

Establishments 

with no Listeria 

monocytogenes 

Positive 

TwoSided 

Fisher 

Exact p 

Value

Odds 

Ratio

630 416.3(b) Yes 8.51% 0.80% 5.73E-04 11.56

4.4 Campylobacter

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

and Campylobacter positives. The noncompliance rate of each of the candidate regulations in the 

three months before a Campylobacter positive was compared with the average noncompliance 

rate of establishments that received FSIS Campylobacter verification testing, but had no 

Campylobacter positives in the period January 1, 2016 to December 31, 2016. The dataset used 

in the analysis consists of candidate PHR noncompliance rates for the 557 establishments with 

Campylobacter testing data, of which 274 had 826 Campylobacter positives and 283 did not 

have Campylobacter positives. There were 19,051 total Campylobacter tests performed.

Table 4-13 presents the 10 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 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 in the period January 1, 2016 to December 31, 

2016.

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

Positive with Those for Establishments with No Campylobacter Positive
26

26

Reg 

ID 

Regulation 

Verified 

On 

FY2017 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a 

Campylobacter 

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

TwoSided 

Fisher 

Exact p 

Value

Odds 

Ratio

234 318.2(a) Yes 1.28% 0.10% 4.14E-03 12.74

590 416.13(b) Yes 1.08% 0.36% 1.87E-92 3.03

592 416.14 Yes 1.50% 0.37% 1.08E1464.12

631 416.3(c) Yes 6.21% 2.04% 5.80E-27 3.18

641 416.6 No 12.12% 4.11% 1.08E-03 3.22

668 417.4(a) Yes 10.06% 1.91% 4.36E-06 5.74

701 430.4(a) Yes 0.19% 0.03% 3.15E-02 6.78

1348 381.69 No 10.45% 1.79% 1.93E-03 6.42

1349 381.76(b)(6)(ii)(A) Yes 0.81% 0.08% 5.86E-22 10.64

1350 381.76(b)(6)(ii)(D) No 10.39% 0.46% 1.53E-08 25.05

4.4.1 Campylobacter in Intact Chicken

The noncompliance rate of each of the candidate regulations in the three months before an Intact 

Chicken Campylobacter positive was compared with the average noncompliance rate of 

establishments that received FSIS Campylobacter verification testing, but had no Intact Chicken

Campylobacter positives in the period January 1, 2016 to December 31, 2016. The dataset used 

in the analysis consists of candidate PHR noncompliance rates for the 203 establishments with 

Intact Chicken Campylobacter testing data, of which 104 had 223 Campylobacter positives and 

99 did not have Campylobacter positives. There were 8,435 total Intact Chicken Campylobacter

tests performed.

Table 4-16 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 95% probability (as determined by a two-sided 

Fisher 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 in the period January 1, 2016 to December 31, 

2016.
27

27

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

Chicken Positive with Those for Establishments with No Campylobacter Intact Chicken 

Positive

Reg 

ID 

Regulation 

Verified 

On 

FY2017 

PHR 

List 

Noncompliance 

Rate in 3 

Months before a 

Campylobacter 

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

TwoSided 

Fisher 

Exact p 

Value

Odds 

Ratio

107 310.25(a) Yes 2.36% 0.29% 3.33E-02 8.19

681 417.5(a)(2) Yes 0.39% 0.08% 9.89E-19 5.11

4.4.2 Campylobacter in Intact Turkey

The noncompliance rate of each of the candidate regulations in the three months before an Intact 

Turkey Campylobacter positive was compared with the average noncompliance rate of 

establishments that received FSIS Campylobacter verification testing, but had no Intact Turkey

Campylobacter positives in the period January 1, 2016 to December 31, 2016. The dataset used 

in the analysis consists of candidate PHR noncompliance rates for the 45 establishments with 

Campylobacter testing data, of which 10 had 10 Campylobacter positives and 35 did not have 

Campylobacter positives. There were 1,758 total Intact Turkey Campylobacter tests performed.

Table 4-17 presents the 1 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 

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 in the period January 1, 2016 to December 31, 2016.

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

Turkey Positive with Those for Establishments with No Campylobacter Intact Turkey 

Positive

Reg 

ID 

Regulation 

Verified 

On 

FY2017 

PHR List 

Noncompliance 

Rate in 3 

Months before 

a 

Campylobacter 

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

TwoSided 

Fisher 

Exact p 

Value

Odds 

Ratio

1349 381.76(b)(6)(ii)(A) Yes 1.56% 0.36% 3.70E-02 4.36

4.4.3 Campylobacter in Comminuted Chicken

The noncompliance rate of each of the candidate regulations in establishments three months 

before a Comminuted Chicken Campylobacter positive was compared with the average 

noncompliance rate of establishments that received Comminuted Chicken Campylobacter FSIS 

verification testing, but had no Comminuted Chicken Campylobacter positives in the period 
28

28

January 1, 2016 to December 31, 2016. The dataset used in the analysis consists of candidate 

PHR noncompliance rates for the 105 establishments with Comminuted Chicken Campylobacter

testing data, of which 21 had 45 Campylobacter positives and 84 did not have Campylobacter 

positives. There were 1,328 total Comminuted Chicken Campylobacter tests performed.

Table 4-18 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 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 in the period January 1, 2016 to December 31, 2016.

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

Campylobacter Positive with Those for Establishments with No Comminuted Chicken 

Campylobacter Positive

Reg 

ID 

Regulation 

Verified 

On 

FY2017 

PHR List 

Noncompliance 

Rate in 3 

Months before 

a 

Campylobacter 

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

Two-Sided 

Fisher 

Exact p 

Value

Odds 

Ratio

550 381.76(a)* Yes 19.57% 0.77% 2.23E-10 31.29

565 381.91(b) Yes 4.09% 1.09% 4.54E-03 3.87

659 417.3(a)(3) Yes 50.00% 15.81% 5.47E-06 5.33

4.4.4 Campylobacter in Comminuted Turkey

The noncompliance rate of each of the candidate regulations in establishments three months 

before a Comminuted Turkey Campylobacter positive was compared with the average 

noncompliance rate of establishments that received Comminuted Turkey Campylobacter FSIS 

verification testing, but had no Comminuted Turkey Campylobacter positives in the period 

January 1, 2016 to December 31, 2016. The dataset used in the analysis consists of candidate 

PHR noncompliance rates for the 59 establishments with Comminuted Turkey Campylobacter

testing data, of which 6 had 10 Campylobacter positives and 49 did not have Campylobacter 

positives. There were 973 total Comminuted Turkey Campylobacter tests performed.

There is one regulation 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 Exact p 

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

the period January 1, 2016 to December 31, 2016.

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

Campylobacter Positive with those for Establishments with No Comminuted Turkey 

Campylobacter Positive
29

29

Reg ID Regulation 

Verified 

On 

FY2017 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

a 

Campylobacter 

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter 

Positive 

TwoSided 

Fisher 

Exact p 

Value

Odds 

Ratio

681 417.5(a)(2) Yes 0.33% 0.10% 2.73E-02 3.30

4.4.5 Campylobacter in Chicken Parts

The noncompliance rate of each of the candidate regulations in establishments three months 

before a Chicken Parts Campylobacter positive was compared with the average noncompliance 

rate of establishments that received Chicken Parts Campylobacter FSIS verification testing, but 

had no Chicken Parts Campylobacter positives in the period January 1, 2016 to December 31, 

2016. The dataset used in the analysis consists of candidate PHR noncompliance rates for the 

419 establishments with Chicken Parts Campylobacter testing data, of which 209 had 538

Campylobacter positives and 210 did not have Campylobacter positives. There were 6,557 total 

Chicken Parts Campylobacter tests performed.

Table 4-20 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 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 in 

the period January 1, 2016 to December 31, 2016.

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

Campylobacter Positive with Those for Establishments with No Chicken Parts 

Campylobacter Positive

Reg 

ID 

Regulation 

Verified 

On 

FY2017 

PHR 

List 

Noncomplianc

e Rate in 3 

Months before 

a 

Campylobacte

r Positive

Noncomplianc

e Rate for 

Establishment

s with no 

Campylobacte

r Positive 

TwoSided 

Fisher 

Exact p 

Value

Odds 

Ratio

234 318.2(a) Yes 2.11% 0.18% 5.06E-03 12.03

557 381.83 Yes 0.07% 0.02% 2.07E-04 3.37

592 416.14 Yes 1.53% 0.51% 3.21E-78 3.03

668 417.4(a) Yes 6.11% 1.92% 1.14E-02 3.32

1348 381.69 No 11.55% 1.01% 5.74E-04 12.80

1350 381.76(b)(6)(ii)(D

)

No 11.15% 0.65% 1.60E-06 19.21
30

30

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. Food Safety 

Inspection Service (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.

A public-health related NOIE or suspension is one that results 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 FY2018 PHRs. The enforcement action list will consist of 

candidate 9 CFR regulations in which non-compliances occur more frequently in establishments 

in the three month period before a Notice of Intended Enforcement Action (NOIE) or suspension

than in establishments without a NOIE or suspension in the period January 1, 2016 to December 

31, 2016. The dataset used in the analysis consists of candidate PHR noncompliance rates for the 

5,372 active meat and poultry establishments, of which 147 had 167 public health related NOIEs

or suspensions and 5,225 did not have any public health related NOIEs or suspensions.

Table 4-21 presents the 35 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 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 in the period January 1, 2016 to December 31, 2016.

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

with Those for Establishments with No Enforcement Action

Reg 

ID 

Regulation 

Verified 

On 

FY2017 

PHR 

List 

Noncompliance 

Rate in 3 

Months before 

an 

Enforcement 

Action

Noncompliance 

Rate for 

Establishments 

with no 

Enforcement 

Action

Two-Sided 

Fisher 

Exact p 

Value

Odds 

Ratio

78 310.22(c) No 2.59% 0.31% 1.96E-08 8.56

89 310.22(e)(2) No 11.36% 1.85% 1.83E-03 6.79

90 310.22(e)(3) Yes 9.76% 1.37% 2.38E-05 7.80

107 310.25(a) Yes 6.35% 0.76% 3.23E-10 8.89

110 310.3 No 18.18% 5.82% 1.37E-03 3.59

178 317.24(a) No 6.06% 0.42% 4.58E-04 15.35

207 318.1(b) No 0.38% 0.02% 4.37E-03 23.07
31

31

582 416.1 Yes 9.25% 2.29% 2.69E-108 4.35

587 416.12(d) Yes 1.22% 0.18% 1.09E-02 6.82

590 416.13(b) Yes 1.18% 0.20% 4.81E-53 5.99

592 416.14 Yes 1.17% 0.28% 3.52E-33 4.18

594 416.15(a) Yes 9.25% 1.74% 4.32E-12 5.77

595 416.15(b) Yes 7.81% 2.53% 1.10E-06 3.26

597 416.16(a) Yes 0.48% 0.16% 1.01E-16 3.05

630 416.3(b) Yes 4.23% 0.99% 2.31E-07 4.43

631 416.3(c) Yes 9.64% 1.44% 2.04E-20 7.30

633 416.4(a) Yes 20.96% 8.03% 6.55E-84 3.04

636 416.4(d) Yes 27.91% 9.15% 4.30E-136 3.85

641 416.6 No 11.86% 4.00% 4.08E-04 3.23

645 417.2(a)(1) Yes 10.49% 1.49% 2.63E-35 7.70

649 417.2(c)(4) Yes 2.87% 0.61% 1.62E-86 4.85

657 417.3(a)(1) Yes 33.70% 4.65% 1.90E-18 10.42

658 417.3(a)(2) Yes 4.61% 0.39% 2.04E-37 12.16

659 417.3(a)(3) Yes 36.84% 9.50% 1.17E-12 5.55

660 417.3(a)(4) Yes 4.65% 0.70% 5.88E-07 6.88

663 417.3(b)(2) No 42.42% 3.84% 1.62E-11 18.44

664 417.3(b)(3) Yes 2.01% 0.57% 0.0301 3.56

666 417.3(c) No 30.56% 4.64% 5.38E-07 9.04

680 417.5(a)(1) Yes 1.59% 0.31% 9.67E-48 5.14

681 417.5(a)(2) Yes 0.98% 0.12% 2.86E-38 7.98

682 417.5(a)(3) Yes 0.82% 0.26% 8.52E-16 3.12

704 430.4(b)(3) Yes 9.89% 1.18% 1.67E-06 9.17

717 310.18(a) Yes 7.71% 1.26% 4.39E-109 6.56

1174 418.3 No 3.03% 0.41% 0.0319 7.59

1352 381.76(b)(6)(ii)(B) No 7.48% 0.21% 2.11E-10 37.37
32

32

5.0 LIST OF FY2018 PHRS

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

PHRs into a single FY2018 PHR list. Table 5-1 presents the list of 57 FY2018 PHRs. These 57

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 57 FY2018 PHRs are composed of 11 regulations and 46 provisions of regulations. The 46

provisions fall under 22 different regulations. Thus, the 57 FY2018 PHRs represent 33

regulations, with the majority of FY2018 PHRs actually 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 FY2018 PHRs

Reg 

ID 

List of FY2018 

PHRs

Description On 

FY2017 

PHR List 

TwoSided 

Fisher 

Exact p 

Value

Odds 

Ratio

29 301.2_Adulterated Adulterated Yes 3.15E-13 12.88

78 310.22(c) Disposal of SRM No 1.96E-08 8.56

89 310.22(e)(2) Appropriate corrective actions No 1.83E-03 6.79

90 310.22(e)(3)

Evaluate effectiveness of 

procedures for removal, 

segregation, and disposition of 

SRMs Yes 2.38E-05 7.80

99 310.22(f)(2)

Use of routine operational 

sanitation procedures on 

equipment used to cut through 

SRMs Yes 1.51E-03 10.24

107 310.25(a)

Verification criteria for E. coli 

testing meat Yes 3.33E-02 8.19

110 310.3

Carcasses and parts in certain 

instances to be retained. No 1.37E-03 3.59

152 316.6

Products not to be removed 

from official establishments 

unless marked in accordance 

with the regulations Yes 3.57E-02 5.21

178 317.24(a)

Packaging materials composed 

of poisonous or deleterious No 1.12E-08 37.92
33

33

substances

207 318.1(b)

Only inspected and passed 

poultry product to enter official 

establishment No 4.17E-02 3.00

234 318.2(a)

All products subject to 

reinspection by program 

employees Yes 4.21E-07 6.50

406 381.1_Adulterated1 Adulterated Yes

527 381.65(a)

Clean and sanitary practices; 

products not adulterated Yes 3.23E-04 7.16

543 381.71(a)

Condemnation on ante mortem 

inspection Yes 6.72E-16 3.90

550 381.76(a)*

Post-mortem inspection, when 

required, extent. Yes 2.23E-10 31.29

557 381.83 Septicemia or toxemia Yes 5.97E-05 13.25

565 381.91(b)

Reprocessing of carcasses 

accidentally contaminated with 

digestive tract contents. Yes 4.54E-03 3.87

582 416.1

Operate in a manner to prevent 

insanitary conditions Yes 2.60E-10 6.64

586 416.12(c)

plan identifies procedures for 

pre-op Yes 8.78E-03 19.86

587 416.12(d)

plan list frequency for each 

procedure & responsible 

individual Yes 1.80E-02 11.76

589 416.13(a) Conduct pre-op procedures Yes 0.00E+00 4.74

590 416.13(b)

Conduct other procedures listed 

in the plan Yes

5.58E163 3.15

591 416.13(c)

Plant monitors implementation 

of SSOP procedures Yes 0.00E+00 5.19

592 416.14

Evaluate effectiveness of SSOP's 

& maintain plan Yes 0.00E+00 4.44

594 416.15(a) Appropriate corrective actions Yes 3.10E-50 3.19

595 416.15(b)

Corrective action, procedures 

for Yes 6.07E-91 4.67

597 416.16(a)

Daily records required, 

responsible individual, initialed 

and dated Yes 3.59E-05 14.24

630 416.3(b)

Constructed, located & 

operated in a manner that does Yes 2.40E-43 4.04
34

34

not deter inspection

631 416.3(c)

Receptacles for storing inedible 

material must identify 

permitted use Yes 3.36E-98 5.78

633 416.4(a)

Food contact surface, cleaning 

& sanitizing as frequency Yes 0.00E+00 4.14

636 416.4(d)

Product processing, handling, 

storage, loading, unloading, and 

during transportation must be 

protected Yes 0.00E+00 5.11

641 416.6

Only FSIS program employee 

may remove "U.S. Rejected" tag No 1.08E-03 3.22

645 417.2(a)(1) Hazard analysis Yes 2.64E-35 7.70

649 417.2(c)(4) List of procedures & frequency Yes 0.00E+00 4.35

657 417.3(a)(1) Identify and eliminate the cause Yes 1.67E-15 6.09

658 417.3(a)(2) CCP is under control Yes 1.93E-08 5.17

659 417.3(a)(3)

Establish measures to prevent 

recurrence Yes 3.90E-27 7.51

660 417.3(a)(4)

No adulterated product enters 

commerce. Yes 8.23E-05 4.41

663 417.3(b)(2)

Determine the acceptability of 

the affected product No 1.62E-11 18.45

664 417.3(b)(3)

No adulterated product enters 

commerce Yes 4.83E-03 7.21

665 417.3(b)(4) Reassessment Yes 5.05E-03 4.49

666 417.3(c) Document corrective actions No 7.64E-06 4.30

668 417.4(a)

Adequacy of HACCP in 

controlling food safety hazards Yes 4.44E-19 254.13

680 417.5(a)(1) Written hazard analysis Yes 9.67E-48 5.14

681 417.5(a)(2) Written HACCP plan Yes 3.56E-03 9.74

682 417.5(a)(3)

Records documentation and 

monitoring of CCP's and Critical 

Limits Yes 8.52E-16 3.12

689 417.5(f) Official Review No 1.11E-03 13.96

701 430.4(a) Lm, post-lethality exposed RTE Yes 3.15E-02 6.78

704 430.4(b)(3) Alternative 3 Yes 1.67E-06 9.17

717 310.18(a)

Carcasses, organs, and other 

parts handled in a sanitary

manner Yes

5.73E275 3.75
35

35

1174 418.3 Recall Plans No 3.20E-02 7.59

1331 381.65(f)

Procedures for controlling 

visible fecal contamination Yes 3.56E-02 7.58

1348 381.69

Maximum line speed rates 

under the New Poultry 

Inspection System No 1.93E-03 6.42

1349 381.76(b)(6)(ii)(A)

NPIS Sorting, Trimming, and 

Reprocessing Yes 2.26E-22 12.21

1350 381.76(b)(6)(ii)(D)

Ready-to-Cook verification in 

NPIS No 1.53E-08 25.05

1352 381.76(b)(6)(ii)(B) NPIS reprocessing and salvage No 2.11E-10 37.37

1444 311.14

Abrasions, bruises, abscesses, 

pus, etc. No 2.38E-02 10.30

1

381.1 (adulteration in poultry) was not found to be significant from this analysis. However, the 

FY18 update did find 301.2 (adulteration in livestock) to be significant. FSIS has decided to 

include 381.1 on the final FY18 PHR list for consistency between livestock and poultry 

establishments
36

36

Figure 5-1 presents a histogram of the ratios (odds ratios) for each of the 57 PHRs between the 

odds of a non-compliance 3 months before a pathogen positive versus the odds of a noncompliance of the regulations for establishments with no pathogen positive. The average odds 

ratio is 13.43. That is, for a given PHR, the ratio of non-compliances to compliances for that 

regulation in establishments 3 months before a positive pathogen or enforcement action is on 

average 13.43 times higher than the ratio of non-compliances to compliances for that regulation 

in establishments with no pathogen positive or enforcement action.

Figure 5-1 Odds Ratio for the 2018 PHRs

Forty three of the previous 53 FY2017 PHRs are mapped into these 57 FY2018 PHRs. 

Approximately 81% of the FY2017 PHRs are included in the FY2018 PHRs. There are 10

additional regulations that were on the FY2017 PHR list and are not in the FY2018 PHR list (See 

Appendix E).

Table 5-2 lists the number of regulations triggered by different events for inclusion in the 

FY2018 PHR list. Most regulations were triggered by multiple events.

Table 5-2 Events That Triggered Inclusion of a Regulation in the FY2018 PHR list

Product Number of Regulations Percent

Campylobacter 10 6.84%

Campylobacter Intact Chicken 2 1.37%

Campylobacter Intact Turkey 1 0.68%

Campylobacter Chicken Parts 6 4.10%

Campylobacter Comminuted 

Chicken 3 2.05%

0

5

10

15

20

25

4 5 10 20 30 40 50 60 70 80 90 100 Higher

Frequency

Frequency
37

37

Product Number of Regulations Percent

Campylobacter Comminuted 

Turkey 1 0.68%

Enforcement Actions 35 23.97%

NonO157 STEC 5 3.42%

O157 4 2.74%

Listeria 1 0.68%

Salmonella 19 13.01%

Salmonella Ground Beef 5 3.42%

Salmonella Comminuted Chicken 11 7.53%

Salmonella Comminuted Turkey 4 2.74%

Salmonella Intact Beef 12 8.21%

Salmonella Intact Chicken 10 6.84%

Salmonella Intact Turkey 1 0.68%

Salmonella RTE 1 0.68%

Salmonella Intact Pork 11 7.53%

Salmonella Ground Pork 1 0.68%

Salmonella Chicken Parts 3 2.05%

Total 146 100.00%

There were nineteen regulations triggered by a single type of event. Eleven were from 

enforcement actions, two were from Campylobacter Comminuted Chicken, and one each were 

from Non O157 STEC All Products, Salmonella, Salmonella Ground Beef, Salmonella Ground 

Pork, Campylobacter, and Salmonella Intact Chicken. Table 5-3 presents the regulations 

triggered for inclusion in the FY2018 PHR list by only single event type.

Table 5-3 Regulations Triggered for Inclusion in the FY2018 PHR List by Only a Single 

Event

Reg ID Regulations from a Single Event Event

78 310.22(c) Enforcements

89 310.22(e)(2) Enforcements

90 310.22(e)(3) Enforcements

99 310.22(f)(2) Salmonella Ground Beef

110 310.3 Enforcements

152 316.6 Salmonella Ground Pork

550 381.76(a)*

Campylobacter Comminuted

Chicken

565 381.91(b)

Campylobacter Comminuted 

Chicken

586 416.12(c) NonO157

645 417.2(a)(1) Enforcements

663 417.3(b)(2) Enforcements

680 417.5(a)(1) Enforcements
38

38

Reg ID Regulations from a Single Event Event

682 417.5(a)(3) Enforcements

689 417.5(f) Salmonella Intact Chicken

701 430.4(a) Campylobacter

704 430.4(b)(3) Enforcements

1174 418.3 Enforcements

1352 381.76(b)(6)(ii)(B) Enforcements

1444 311.14 Salmonella

After the analysis was complete, one regulation was added to the PHR list for administrative 

reasons. Reg 381.1 (adulteration in poultry) was not found to be significant in the FY18 analysis. 

However, the FY18 update did find 301.2 (adulteration in livestock) to be significant. FSIS has 

decided to include 381.1 on the final FY18 PHR list for consistency between livestock and 

poultry establishments
39

39

6.0 CUT POINTS FOR FY2018 PHRS

The FY2018 PHRs are one of seven public health based decision criteria that are used in 

prioritizing Food Safety Assessments (FSAs). 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 FY2018 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. 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 of the PHR regulations

in a 90 day period together into a single aggregate ratio. The aggregate FY2018 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).

The aggregate non-zero PHR non-compliance rates are approximately log normally distributed. 

That means that the natural logarithm of the non-zero PHR non-compliance rates are 

approximately normally distributed. Only establishments with greater than or equal to 20 

verifications and at least two non-compliances were considered when developing cut points.

To determine a set of annual FY2018 cut points, the mean and standard deviation of the natural 

log transformed non-zero FY2018 PHR rate (for establishments having more than 20 

verifications in the past 90 days and at least two non-compliances) for each of four quarters and 

each of the two types of establishment operation is computed (the log transform of the non-zero 

FY2018 PHR rates is taken to obtain an approximately normal distribution, see Appendix F). 

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 non-compliance rates). 

The standard deviations are positive.

Table 6-1 Mean and Standard Deviation of Quarterly FY2018 PHR Rate

Mean of Natural Log

FY2018 PHR Rate

Standard Deviation

FY2018 PHR Rate

Mean Combination Processing Combination Processing

Jan-Mar 2016 -4.43 -4.83 1.06 0.82

Apr-Jun 2016 -4.25 -4.59 0.88 0.79

July-Sep 2016 -4.36 -4.77 0.98 0.83

Oct-Dec 2016 -4.41 -4.85 1.06 0.84

Average -4.38 -4.78 0.97 0.81

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 FSA. For example, the upper cut point for the log 
40

40

transformed data for Processing establishments is -4.78 + 2*0.81 = —4.78 + 1.61 = -3.17. 

(Rounding shows the standard deviation in 6-1 as 0.81, but it is closer to 0.806) The cut point of 

the original, non-transformed PHR non-compliance data is the antilog of -3.17 or Exp(-3.17) = 

4.22%. Tables 6-2 and 6-3 present the FY2018 PHR upper and lower cut points for each of the 

two establishment operation types. The FY2017 PHR cut points are included for comparison. 

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

the cut points is planned for October 2018.

Table 6-2 FY2018 PHR Tier 1 Cut Points

Operation Type FY2018 PHR Cut Points FY2017 PHR Cut Points

Processing 4.22% 4.89%

Combination 8.73% 9.70%

Table 6- 3 FY2018 PHR Tier 3 Cut Points

Operation Type FY2018 PHR Cut Points FY2017 PHR Cut Points

Processing 2.82% 3.23%

Combination 5.38% 5.97%

Table 6-4 presents the number of establishments in each Tier based solely on the FY2018 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. The other six decision criteria used in determining 

establishment Tiers were not used. Based solely on noncompliance rate with FY2018 PHRs, 69

establishments are in Tier 1 and candidates to receive for cause FSAs. These establishments are 

scheduled for a PHRE. Table 6-3 is based on regulatory non-compliances for the period January 

1 –March 31, 2017.

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

Classification Number of Establishments 

Tier 1 69

Tier 2 109

Tier 3 4,964

Total 5,142

Table 6-5 presents the number of establishments in each Tier based establishment operation type 

and only the PHR criterion. The other six decision criteria used in determining an

establishment’s Tier classification were not used. For example for processing establishments, 

based solely on non-compliances with the FY2018 PHRs, 56 processing establishments are Tier 

1 and are candidates to receive for cause FSAs. In total, 69 establishments are in Tier 1 based 

solely on non-compliances with the FY2018 PHRs. Table 6-4 is based on regulatory noncompliances during January 1 –March 31, 2017.
41

41

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

PHR Criterion

Classification Processing Combination

Tier 1 56 13

Tier 2 80 29

Tier 3 3,970 994

Total 4,106 1,036

In using the decision tree methodology and the seven decision criteria to schedule Food Safety 

Assessments (FSA), a new FSA is not automatically scheduled if the establishment has received 

an FSA in the past six months. Instead, the District is notified that the establishment has received 

a Tier 1 classification and it is up to the District to determine if the establishment should receive 

an additional PHRE and possible FSA. The number of Tier 1 establishments that are eligible for 

FSAs is approximately the same as in recent years.
42

42

7.0 CONCLUSION

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

FY2018 PHR regulations used to prioritize certain FY2018 FSIS inspection activities.

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

higher in establishments three months before a Salmonella, E. coli O157:H7, Non-O157

STEC, Lm, Campylobacter positive or enforcement action than in establishments without 

positives or enforcement actions.

The list of FY2018 PHRs has 57 regulations whose individual noncompliance rates are higher in 

establishments three months before Salmonella, E. coli O157:H7, Non-O157 STEC, Lm,

Campylobacter positives or enforcement action than in establishments without positives or 

enforcement actions. About eighty one percent of the regulations on the FY2017 PHR list are 

also on the FY2018 PHR list.

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

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

establishments are 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 Public Health Risk 

Evaluation (PHRE), described in FSIS Directive 5100.4.

Tables 7-1 and 7-2 present the FY2018 PHR upper and lower cut points (the upper cut points are 

equal to antilog of the mean plus two times the standard deviation of the log transformed nonzero PHR rate for similar establishments). The FY2017 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 FY2018 PHR Tier 1 Cut Points

Operation Type FY2018 PHR Cut Points FY2017 PHR Cut Points

Processing 4.22% 4.81%

Combination 8.73% 9.46%

Table 7- 2 FY2018 PHR Tier 3 Cut Points

Operation Type FY2018 PHR Cut Points FY2017 PHR Cut Points

Processing 2.82% 3.16%

Combination 5.38% 5.82%
43

43

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
44

44

APPENDIX A: FY2018 PHR REGULATIONS

Table A-1 presents the list of fifty seven FY2018 Public Health Regulations (PHRs). On average,

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

enforcement action 13.43 times higher than the PHR noncompliance rates for establishments 

with no pathogen positive or enforcement action.

Table A-1 List of FY2018 PHRs

Reg 

ID 

List of FY2018 

PHRs

Description

29 301.2_Adulterated Adulterated

78 310.22(c) Disposal of SRM

89 310.22(e)(2) Appropriate corrective actions

90 310.22(e)(3)

Evaluate effectiveness of procedures for 

removal, segregation, and disposition of 

SRMs

99 310.22(f)(2)

Use of routine operational sanitation 

procedures on equipment used to cut 

through SRMs

107 310.25(a) Verification criteria for E. coli testing meat

110 310.3

Carcasses and parts in certain instances to 

be retained.

152 316.6

Products not to be removed from official 

establishments unless marked in 

accordance with the regulations

178 317.24(a)

Packaging materials composed of 

poisonous or deleterious substances

207 318.1(b)

Only inspected and passed poultry product 

to enter official establishment

234 318.2(a)

All products subject to reinspection by 

program employees

406 381.1_Adulterated1 Adulterated

527 381.65(a)

Clean and sanitary practices; products not 

adulterated

543 381.71(a) Condemnation on ante mortem inspection

550 381.76(a)*

Post-mortem inspection, when required, 

extent.
45

45

557 381.83 Septicemia or toxemia

565 381.91(b)

Reprocessing of carcasses accidentally 

contaminated with digestive tract 

contents.

582 416.1

Operate in a manner to prevent insanitary 

conditions

586 416.12(c) plan identifies procedures for pre-op

587 416.12(d)

plan list frequency for each procedure & 

responsible individual

589 416.13(a) Conduct pre-op procedures

590 416.13(b) Conduct other procedures listed in the plan

591 416.13(c)

Plant monitors implementation of SSOP 

procedures

592 416.14

Evaluate effectiveness of SSOP's & 

maintain plan

594 416.15(a) Appropriate corrective actions

595 416.15(b) Corrective action, procedures for

597 416.16(a)

Daily records required, responsible 

individual, initialed and dated

630 416.3(b)

Constructed, located & operated in a 

manner that does not deter inspection

631 416.3(c)

Receptacles for storing inedible material 

must identify permitted use

633 416.4(a)

Food contact surface, cleaning & sanitizing 

as frequency

636 416.4(d)

Product processing, handling, storage, 

loading, unloading, and during 

transportation must be protected

641 416.6

Only FSIS program employee may remove 

"U.S. Rejected" tag

645 417.2(a)(1) Hazard analysis

649 417.2(c)(4) List of procedures & frequency

657 417.3(a)(1) Identify and eliminate the cause

658 417.3(a)(2) CCP is under control

659 417.3(a)(3) Establish measures to prevent recurrence

660 417.3(a)(4) No adulterated product enters commerce.

663 417.3(b)(2)

Determine the acceptability of the affected 

product

664 417.3(b)(3) No adulterated product enters commerce

665 417.3(b)(4) Reassessment
46

46

666 417.3(c) Document corrective actions

668 417.4(a)

Adequacy of HACCP in controlling food 

safety hazards

680 417.5(a)(1) Written hazard analysis

681 417.5(a)(2) Written HACCP plan

682 417.5(a)(3)

Records documentation and monitoring of 

CCP's and Critical Limits

689 417.5(f) Official Review

701 430.4(a) Lm, post-lethality exposed RTE

704 430.4(b)(3) Alternative 3

717 310.18(a)

Carcasses, organs, and other parts handled 

in a sanitary manner

1174 418.3 Recall Plans

1331 381.65(f)

Procedures for controlling visible fecal 

contamination

1348 381.69

Maximum line speed rates under the New 

Poultry Inspection System

1349 381.76(b)(6)(ii)(A) NPIS Sorting, Trimming, and Reprocessing

1350 381.76(b)(6)(ii)(D) Ready-to-Cook verification in NPIS

1352 381.76(b)(6)(ii)(B) NPIS reprocessing and salvage

1444 311.14 Abrasions, bruises, abscesses, pus, etc.

1

381.1 (adulteration in poultry) was not found to be significant from this analysis. However, the 

FY18 update did find 301.2 (adulteration in livestock) to be significant. FSIS has decided to 

include 381.1 on the final FY18 PHR list for consistency between livestock and poultry 

establishments
47

47

APPENDIX B: PAST USE OF PUBLIC HEALTH REGULATIONS

The purpose of this Appendix is to explain how the list of Public Health regulations had been

used to prioritize scheduling for Food Safety Assessments (FSAs).

If a pattern of public health related non-compliances occurs, it indicates an establishment’s food 

safety system may not be in control and may not be able to prevent adulterated product from 

entering commerce. The list of FY2018 PHRs is presented in Appendix A.

The PHR noncompliance rate is calculated by the following formula using the most recent three 

months of establishment noncompliance data:

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

Slaughter/Processing Combination):

 For establishments with a PHR rate that is less than the lower cut point for all 

establishments with the same establishment type, they would not receive any early 

warnings or prioritized PHREs based on this criterion. These establishments are 

performing better on average than their peers with respect to compliance with FSIS 

regulations. These establishments would still be eligible for a routine PHRE or could be 

prioritized based on other public health criteria as explained in FSIS Directive 5100.4.

 For establishments with a PHR rate between the lower and upper cut points for all 

establishments with the same establishment type, the in-plant inspection personnel would 

receive an “early warning” alert through PHIS.

 Establishments with a PHR rate greater than the upper cut point for establishments with 

the same establishment type that have not had a FSA in the last six months would be 

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

 Number of PHR Non-compliances

PHR NC Rate = 

Total Number of PHR Inspection Verifications
48

48

APPENDIX C: FY2018 CANDIDATE REGULATIONS

Table C-1 presents the list of 144 candidate regulations. The noncompliance rates in Table C-1 

are based on PHIS data for January 1, 2016 through December 31, 2016.

Table C-1 FY2018 Candidate regulations

Reg 

ID

FY2018 Candidate 

Regulation

FY2017 

PHR

Mandatory 

Regulation

Total FSIS 

Verifications

Total 

NCs1

NC1

Rate

29 301.2_Adulterated Yes No 9496 258 2.65%

43 304.3(a) No No 1045 11 1.04%

45 304.3(c) No No 1177 8 0.68%

53 309.2(a) No No 976 5 0.51%

54 309.3 No No 210 1 0.47%

55 309.4 No No 188 2 1.05%

56 309.5 No No 137 - 0.00%

57 309.9 No No 129 - 0.00%

69 310.18 No No 382 5 1.29%

77 310.22(b) No No 6013 16 0.27%

78 310.22(c) No Yes 54571 183 0.33%

84 310.22(d)(2) No No 67 - 0.00%

88 310.22(e)(1) Yes No 15148 176 1.15%

89 310.22(e)(2) No No 4816 52 1.07%

90 310.22(e)(3) Yes No 10023 123 1.21%

92 310.22(e)(4)(i) Yes No 92628 251 0.27%

99 310.22(f)(2) Yes No 19114 34 0.18%

101 310.22(g)(1) No No 2121 3 0.14%

104 310.22(g)(4) No No 4805 15 0.31%

107 310.25(a) Yes No 29319 274 0.93%

108 310.25(b) No No 206 4 1.90%

109 310.25(b)(3)(ii) No No 371 1 0.27%

110 310.3 No No 3662 204 5.28%

114 311.16 No No 171 10 5.52%

115 311.17 No No 416 2 0.48%

116 311.24 No No 96 - 0.00%

138 315.2 No No 83 - 0.00%

152 316.6 Yes No 11805 66 0.56%

178 317.24(a) No No 4165 16 0.38%

207 318.1(b) No No 93248 16 0.02%

215 318.10(b) No No 2412 11 0.45%

217 318.10(c)(1) No No 2669 2 0.07%

218 318.10(c)(2) No No 721 1 0.14%

219 318.10(c)(3) No No 414 1 0.24%

221 318.14(a) No No 86 - 0.00%
49

49

222 318.14(b) No No 906- 0.00%

223 318.14(c) No No 401 2.44%

226 318.16(b) No No 537- 0.00%

228 318.17(a)(1)(2) Yes No 34148 0.23%

229 318.17(b) No No 7961 0.13%

230 318.17(c) No No 35- 0.00%

234 318.2(a) Yes No 49100 61 0.12%

235 318.2(d) No No 8482 42 0.49%

239 318.23(b)(1) No No 3724 1.06%

241 318.23(b)(3) No No 172 10.53%

242 318.23(c)(1) No No 1631 0.61%

243 318.23(c)(2) No No 14- 0.00%

245 318.23(c)(4) No No 35- 0.00%

246 318.23(c)(5) No No 14- 0.00%

247 318.24 No No 2483 14 0.56%

251 318.303 No Yes 81448 0.10%

256 318.308 No Yes 50465 0.10%

268 318.6(b)(1) No No 2865- 0.00%

273 318.6(b)(4) No No 9376- 0.00%

274 318.6(b)(6) No No 12576- 0.00%

275 318.6(b)(8) No No 4841 0.21%

329 319.5(b) No No 168- 0.00%

406 381.1_Adulterated Yes No 5694 66 1.15%

450 381.144(a) No No 2583- 0.00%

457 381.150(a) Yes No 18166 0.33%

459 381.150(c) No No 77- 0.00%

460 381.150(d) No No61 14.29%

462 381.151(a) No No 47- 0.00%

490 381.22(a) No No 4111 0.24%

491 381.22(b) No No 12166 0.49%

492 381.22(c) No No 3122 0.64%

503 381.310 No Yes 47321 0.02%

504 381.311 No Yes 4623- 0.00%

506 381.37(a) No No 2195 13 0.59%

527 381.65(a) Yes No 80801 900 1.10%

543 381.71(a) Yes No 3302 290 8.07%

545 381.72(a) No No 156- 0.00%

546 381.72(b) No No2- 0.00%

550 381.76(a)* Yes No 22860 375 1.61%

557 381.83 Yes No 241150 135 0.06%

559 381.85 No No 55- 0.00%

564 381.91(a) Yes No 11756 25 0.21%
50

50

565 381.91(b) Yes No 29063 319 1.09%

572 381.94(b) No No1- 0.00%

582 416.1 Yes Yes 640587 14974 2.28%

586 416.12(c) Yes No 48339 95 0.20%

587 416.12(d) Yes No 65328 127 0.19%

588 416.13 Implementation of 

SOP's

No No 6246 15 0.24%

589 416.13(a) Yes Yes 733754 6878 0.93%

590 416.13(b) Yes Yes 1778040 3834 0.22%

591 416.13(c) Yes Yes 2575764 42929 1.64%

592 416.14 Yes Yes 1582629 4485 0.28%

593 416.15 Corrective 

Actions

Yes No 7053 0.42%

594 416.15(a) Yes Yes 68218 1136 1.64%

595 416.15(b) Yes Yes 44141 1050 2.32%

597 416.16(a) Yes Yes 2808139 4951 0.18%

630 416.3(b) Yes No 78738 724 0.91%

631 416.3(c) Yes No 72856 1022 1.38%

633 416.4(a) Yes No 298538 24990 7.72%

636 416.4(d) Yes No 270721 26265 8.84%

640 416.5(c) Yes No 42547 27 0.06%

641 416.6 No No 3826 165 4.13%

645 417.2(a)(1) Yes Yes 126657 2271 1.76%

648 417.2(c) Yes No 35830 117 0.33%

649 417.2(c)(4) Yes Yes 1332897 8216 0.61%

655 417.3 Corrective actions No No 4452 0.45%

656 417.3(a) No No 14912 0.13%

657 417.3(a)(1) Yes No 11647 645 5.25%

658 417.3(a)(2) Yes No 141592 643 0.45%

659 417.3(a)(3) Yes No 6765 726 9.69%

660 417.3(a)(4) Yes No 30777 245 0.79%

662 417.3(b)(1) No No 3562 138 3.73%

663 417.3(b)(2) No No 2976 118 3.81%

664 417.3(b)(3) Yes No 22660 120 0.53%

665 417.3(b)(4) Yes Yes 27877 237 0.84%

666 417.3(c) No No 5909 335 5.37%

668 417.4(a) Yes No 6657 298 4.28%

669 417.4(a)(1) Yes No 4773 513 9.70%

675 417.4(b) Yes Yes 31176 103 0.33%

680 417.5(a)(1) Yes Yes 1343138 4443 0.33%

681 417.5(a)(2) Yes Yes 1195495 1706 0.14%

682 417.5(a)(3) Yes Yes 1399871 4197 0.30%
51

51

689 417.5(f) No No 87567 125 0.14%

690 417.6 No No 436 137 23.91%

701 430.4(a) Yes Yes 294085 183 0.06%

702 430.4(b)(1) No No 1082 7 0.64%

703 430.4(b)(2) No No 13620 122 0.89%

704 430.4(b)(3) Yes No 27780 398 1.41%

705 430.4(c)(2) No Yes 284757 209 0.07%

706 430.4(c)(3) No Yes 295652 168 0.06%

707 430.4(c)(4) No No 2971 12 0.40%

708 430.4(c)(5) No No 6561 27 0.41%

709 430.4(c)(6) No No 6150 97 1.55%

717 310.18(a) Yes Yes 312597 3866 1.22%

718 310.18(b) No No 20015 4 0.02%

1173 418.2 No No 1424 100 6.56%

1174 418.3 No No 15018 70 0.46%

1241 354.242(b) No No 165 2 1.20%

1247 354.242(h) No No 112 2 1.75%

1250 354.243(a) No No 84 - 0.00%

1292 381.193(a) No No 233 14 5.67%

1331 381.65(f) Yes No 742919 9203 1.22%

1346 381.65(h) No No 12378 1 0.01%

1348 381.69 No No 472 15 3.08%

1349 381.76(b)(6)(ii)(A) Yes No 36976 266 0.71%

1350 381.76(b)(6)(ii)(D) No No 1549 113 6.80%

1351 381.76(b)(6)(ii)(C) No No 312454 124 0.04%

1352 381.76(b)(6)(ii)(B) No No 29962 72 0.24%

1444 311.14 No No 10265 7 0.07%

1. NC = Noncompliance
52

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APPENDIX D: COMPARISON OF FY2018 PHR LIST WITH FY2017 PHR 

LIST

There are eleven regulations from the FY2017 PHR list that no longer appear in the FY2018

PHR list. These eleven regulations are shown in Table D-1.

Table D-1 Regulation from the FY2017 PHR list no longer on the FY2018 PHR list

Reg

ID

List of FY2016 PHRs Description

88 310.22(e)(1)

Written procedures for removal, segregation, and 

disposition of SRMs

92 310.22(e)(4)(i) Maintain daily records

228 318.17(a)(1)(2)

Lethality and Stabilization requirements for cooked 

beef

457

381.150(a)

Lethality and Stabilization requirements for cooked 

poultry

530 381.65(e)* Zero-tolerance for visible fecal matter entering chiller

564 381.91(a) Certain contaminated carcasses to be condemned

593 416.15 Corrective Actions Corrective Actions

640

416.5(c)

Employees who appear to have any abnormal source 

of microbial contamination

648 417.2(c) Contents of HACCP Plan

669 417.4(a)(1) Initial validation

675 417.4(b) Reassessment of hazard analysis
53

53

APPENDIX E: USE OF PUBLIC HEALTH REGULATIONS IN 

SCHEDULING FOOD SAFETY ASSESSMENTS

The purpose of this Appendix is to explain how the 57 PHRs are used as one component of the 

overall decision tree methodology used to schedule FSAs.

The PHR noncompliance rate is calculated by the following formula using the most recent three 

months of establishment verification inspection data:

PHR Noncompliance Rate =

Number of PHR Noncompliances

Total Number of PHR Inspection Proceures

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 non-compliance rates are approximately log normally distributed. 

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

approximately normally distributed. Figure E-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 non-compliances are considered.
54

54

Figure E-1 Log Transformed Non-zero Non-Compliance 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 E-2, indicate near-normality. 

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

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 non-compliance 

data). Table E-1 shows the number of plants, mean and standard deviation for each plant type as 

well as the Tier distribution (based only on PHR non-compliances) using the quarterly cut points. 
55

55

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

Number of 

Establishments Mean Standard Deviation

Tier 

Distribution 

(Number of 

Establishments)

Q1CY2016 Tier 1 77

Both 1,035 -4.43 1.01 Tier 2 97

Processing 4,036 -4.84 0.82 Tier 3 4,897

Q2CY2016 Tier 1 66

Both 1,049 -4.27 0.88 Tier 2 69

Processing 4,047 -4.61 0.74 Tier 3 4,961

Q3CY2016 Tier 1 61

Both 1,046 -4.39 0.98 Tier 2 117

Processing 4,055 -4.81 0.83 Tier 3 4,923

Q4CY2016 Tier 1 65

Both 1,043 -4.42 1.01 Tier 2 100

Processing 4,064 -4.86 0.84 Tier 3 4,942

Table E-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 E-1. Table E-3 

shows the Tier distribution (based only on PHR non-compliances) using the cut points in Table 

E-2. Table E-4 shows how many Tier 1 establishments in March 2017 are within certain product 

categories.

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

Rates by Plant Type

Combination Processing

Mean -4.38 -4.78

Standard Deviation 0.97 0.81

Table E-3 March 2017 Tier Distribution Based on the PHR Criteria Only

Classification Plants

Tier 1 69

Tier 2 109

Tier 3 4,964

Total 5,142
56

56

Table E-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 197 3.83% 6 8.70%

Turkey Slaughter 49 0.95% 1 1.45%

Beef Slaughter 637 12.39% 5 7.25%

Pork Slaughter 596 11.59% 2 2.90%

Beef Processing 1639 31.87% 14 20.29%

Chicken Processing 820 15.95% 17 24.64%

Turkey Processing 317 6.16% 4 5.80%

Pork Processing 1808 35.16% 10 14.49%

RTE 2531 49.22% 37 53.62%

Poultry Combination 396 7.70% 8 11.59%

Total Number of 

Establishments 5142 69