FY2019 Public Health Regulations 

May 2018 
 

 

 

 

Table of Contents 

Summary......................................................................................................................................... 5 

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

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

2.1 Criteria for Selection of Candidate Regulations ................................................................... 9 

2.2 Relationship with Pathogen Positives................................................................................. 10 

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

4.0 Relationship Between Candidate regulations and Pathogen Positives ................................... 11 

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

4.1.1 Salmonella in Intact Chicken....................................................................................... 13 

4.1.2 Salmonella in Intact Turkey......................................................................................... 14 

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

4.1.4 Salmonella in Intact Beef............................................................................................. 16 

4.1.5 Salmonella in Comminuted Chicken ........................................................................... 17 

4.1.6 Salmonella in Comminuted Turkey............................................................................. 17 

4.1.7 Salmonella in Intact Pork............................................................................................. 18 

4.1.8 Salmonella in Ground Pork.......................................................................................... 19 

4.1.9 Salmonella in Chicken Parts ........................................................................................ 20 

4.1.10 Salmonella in Ready to Eat........................................................................................ 21 

4.2 E. Coli ................................................................................................................................. 22 

4.2.1 E. coli O157:H7 ........................................................................................................... 22 

4.2.2 Non-O157 STEC.......................................................................................................... 22 

4.3 Listeria monocytognes ........................................................................................................ 23 

4.4 Campylobacter.................................................................................................................... 23 

4.4.1 Campylobacter in Intact Chicken ................................................................................ 24 

4.4.2 Campylobacter in Intact Turkey .................................................................................. 25 

4.4.3 Campylobacter in Comminuted Chicken..................................................................... 26 

4.4.4 Campylobacter in Comminuted Turkey ...................................................................... 26 

4.4.5 Campylobacter in Chicken Parts ................................................................................. 27 

4.5 Enforcement Actions .......................................................................................................... 28 

5.0 List of FY2019 PHRs.............................................................................................................. 30 

6.0 Cut Points for FY2019 PHRs.................................................................................................. 36 

7.0 Conclusion .............................................................................................................................. 39 

8.0 References............................................................................................................................... 40 

Appendix A: FY2019 PHR Regulations....................................................................................... 41 

Appendix B: Past Use of Public Health regulations ..................................................................... 44 

Appendix C: FY2019 Candidate regulations................................................................................ 45 

Appendix D: Comparison of FY2019 PHR List with FY2018 PHR List .................................... 49 

Appendix E: Use of Public Health Regulations in Scheduling Food Safety Assessments........... 50 

2 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

List of Figures and Tables 

Table S-1 FY2019 PHR Tier 1 Cut Points...................................................................................... 6 

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

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

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

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

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

Salmonella Positive with Those for Establishments with No Comminuted Chicken Salmonella 

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

Salmonella Positive with Those for Establishments with No Comminuted Turkey Salmonella 

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

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

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

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

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

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

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

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

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

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

Campylobacter Positive with Those for Establishments with No Comminuted Chicken 

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

Campylobacter Positive with those for Establishments with No Comminuted Turkey 

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

Campylobacter Positive with Those for Establishments with No Chicken Parts Campylobacter 

Table S-2 FY2019 PHR Tier 3 Cut Points...................................................................................... 6 

Table S-3 Number of Establishments in Tiers Based Solely on the PHR Criterion....................... 6 

Table S-4 Distribution of Tier 1 Establishments Among Different Product Categories ................ 7 

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

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

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

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

Positive.......................................................................................................................................... 17 

Positive.......................................................................................................................................... 18 

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

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

Positive with those for Establishments with No Ready to Eat Salmonella Positive..................... 21 

with Those for Establishments with No Non-O157 STEC Positive............................................. 23 

Positive with Those for Establishments with No Listeria monocytognes Positive....................... 23 

with Those for Establishments with No Campylobacter Positive ................................................ 24 

....................................................................................................................................................... 25 

Turkey Positive with Those for Establishments with No Campylobacter Intact Turkey Positive 25 

Campylobacter Positive ................................................................................................................ 26 

Campylobacter Positive ................................................................................................................ 27 

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

3 
 

 

 

 

 

 

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

Those for Establishments with No Enforcement Action .............................................................. 28 

Table 5-3 Regulations Triggered for Inclusion in the FY2019 PHR List by Only a Single Event 

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

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

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

Table 5-1 List of FY2019 PHRs ................................................................................................... 30 

Figure 5-1 Odds Ratio for the 2019 PHRs.................................................................................... 34 

Table 5-2 Events That Triggered Inclusion of a Regulation in the FY2019 PHR list.................. 35 

....................................................................................................................................................... 36 

Table 6-1 Mean and Standard Deviation of Quarterly FY2019 PHR Rate .................................. 37 

Table 6-2 FY2019 PHR Tier 1 Cut Points.................................................................................... 37 

Table 6-3 FY2019 PHR Tier 3 Cut Points.................................................................................... 38 

Table 6-4 Tier Classification of Establishments Based Solely on the PHR Criterion.................. 38 

Criterion ........................................................................................................................................ 38 

Table 7-1 FY2019 PHR Tier 1 Cut Points.................................................................................... 39 

Table 7-2 FY2019 PHR Tier 3 Cut Points.................................................................................... 39 

Table A-1 List of FY2019 PHRs .................................................................................................. 41 

Table D-1 Regulation from the FY2018 PHR list no longer on the FY2019 PHR list ................ 49 

Verifications 3 Months before a Pathogen Positive or Enforcement Action................................ 51 

Figure E-2 Goodness of Fit for Normal Distribution of the Log Transformation........................ 51 

Table E-1 Quarterly PHR Mean, Standard Deviation and Tier Distribution................................ 52 

Plant Type ..................................................................................................................................... 52 

Table E-3 March 2018 Tier Distribution Based on the PHR Criteria Only.................................. 52 

Table E-4 Distribution of Tier 1 Establishments Among Different Product Categories.............. 53 

4 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SUMMARY 

The purpose of the present report is to update the FY2018 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 CY2017 verification inspection 

results and will be implemented in FY2019. 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 health 

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

The methodology used in developing the FY2019 PHR list is the same as that used for the 

FY2018 PHR list. For inclusion in the FY2019 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 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, 

2017) recorded in PHIS. The term “enforcement action” refers to a public health NOIE or 

suspension. 

The final list of FY2019 PHRs consists of 63 regulations that have higher rates of 

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

with 57 regulations that were identified in the FY2018 PHR list. The list of FY2019 PHRs is 

presented in Appendix A. Seventy eight percent of the regulations on the FY2018 PHR list are 

also on the FY2019 PHR list. 

The 63 FY2019 PHRs are composed of 10 regulations and 53 provisions of regulations. The 53 

provisions fall under 18 different regulations. Thus, the 63 FY2019 PHRs represent 28 

regulations, with the majority of FY2019 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 FY2019 PHR regulations three months before a pathogen 

positive or enforcement action is 9.57 times higher than the average FY2019 PHR 

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

The FY2019 PHRs are one of seven public health based decision criteria that will be used in 

prioritizing Food Safety Assessments (FSAs). Noncompliance with a single FY2019 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 FY2019 PHR noncompliance rate by 

5 
 

 

 

 

 

 

 

 

 

 

 

 

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 FY2019 cut points, the mean and standard deviation of the log 

transformed non-zero FY2019 PHR rates for each of the four quarters in CY2017 is computed 

(the log transform of the non-zero FY2019 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 FY2019 PHR cut points for the non-transformed PHR noncompliance data for each of the two establishment operation types. The FY2018 PHR cut points 

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

Table S-1 FY2019 PHR Tier 1 Cut Points 

Operation Type FY2019 PHR Cut Points FY2018 PHR Cut Points 

Processing 4.40% 4.22% 

Combination 9.40% 8.73% 

Table S-2 FY2019 PHR Tier 3 Cut Points 

Operation Type FY2019 PHR Cut Points FY2018 PHR Cut Points 

Processing 2.90% 2.82% 

Combination 5.64% 5.38% 

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

–March 31, 2018, based on the PHR criterion. The number of “for cause” FSAs, 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 53 10 63 

Tier 2 49 19 68 

Tier 3 4,066 1,036 5,102 

Total 4,168 1,065 5,233 

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, 

2018. 

6 
 

 

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 201 3.84% 5 7.94% 

Turkey Slaughter 54 1.03% 1 1.59% 

Beef Slaughter 652 12.46% 1 1.59% 

Pork Slaughter 610 11.66% 2 3.17% 

Beef Processing 1646 31.45% 14 22.22% 

Chicken Processing 805 15.38% 14 22.22% 

Turkey Processing 310 5.92% 3 4.76% 

Pork Processing 1812 34.63% 13 20.63% 

RTE 2550 48.73% 38 60.32% 

Poultry Combination 390 7.45% 8 12.70% 

Total Number of 

Establishments 5233 63 

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. The time period used for 

calculating the noncompliance rate of the PHRs was January 1 –March 31, 2018. 

7 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

1.0 INTRODUCTION 

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

methodology and a set of seven public health based decision criteria for use in prioritizing 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 FY2018 PHRs using current verification inspection results from the Public Health Information 

System (PHIS). The updated list is called the FY2019 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 FY2019 PHR list is the same as that used for the 

FY2018 PHR. Specifically, for inclusion in the FY2019 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, 2017) recorded in 

PHIS. Candidate regulations related to egg products or siluriformes are not included in the 

present report. 

The final FY2019 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. 

8 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 

9 
 

 

 

 

 

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

considered candidate regulations. 

• Establish and maintain HACCP 

o Failure to maintain adequate HACCP Plan 

o Adequacy of HACCP Plan in controlling food safety hazards 

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

recorded 

o CCPs are under control 

• Establish and Maintain Sanitary Conditions 

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

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

o Products do not contain foreign material 

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

conditions 

• Prevent Adulteration 

o No adulterated product enters commerce. 

o Product and ingredients rendered adulterated by polluted water shall be 

condemned 

o Container composed of any poisonous or deleterious substance 

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

o Lethality and stabilization requirements for cooked beef 

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

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

• Corrective Actions 

o Procedures for and selection of appropriate corrective actions 

o Document corrective actions 

o Identify and eliminate the cause 

o Establish measures to prevent recurrence 

o Reassess hazard analysis 

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

not deter FSIS’ ability to conduct verification inspections 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

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. 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 actions than the average noncompliance rate in establishments that do 

not have a Salmonella, E. coli O157:H7, Non-O157 STEC, Lm, Campylobacter positive or 

enforcement action. The current analysis includes the six non-O157 STECs (O26, O45, O103, 

10 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

O111, O121, and O145) that FSIS has declared adulterants in non-intact raw beef products and 

product components. 

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 (148) 9 CFR regulations were selected as being indicators of a potential loss of food 

safety process control. The list of 148 candidate regulations that are indicators of a potential loss 

of HACCP food safety process control are presented in Appendix C. 

4.0 RELATIONSHIP BETWEEN CANDIDATE REGULATIONS AND 

PATHOGEN POSITIVES 

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, 2017 through December 31, 2017. 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 is higher than 

the noncompliance rate for establishments with no positives are selected as PHRs. 

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. 

11 
 

 

 

 

 

 

 

 

 

 

 

 

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, 2017 to December 31, 2017. The dataset used in the analysis 

consists of candidate PHR noncompliance rates for the 2,132 establishments with Salmonella 

testing data, of which 797 had 3,313 Salmonella positives and 1,335 did not have Salmonella 

positives. There were 42,122 total Salmonella tests performed. 

Table 4-1 presents the 36 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 3 months before a Salmonella positive is higher than the average noncompliance 

rate for establishments with no Salmonella positive in the period January 1, 2017 to December 

31, 2017. 

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 

FY2018 

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 

29 301.2_Adulterated Yes 9.32% 2.88% 6.19E-15 3.47 

69 310.18 No 3.86% 1.23% 8.76E-06 3.22 

78 310.22(c) Yes 0.76% 0.20% 1.71E-07 3.83 

88 310.22(e)(1) No 3.04% 0.88% 4.88E-08 3.53 

90 310.22(e)(3) Yes 2.38% 0.68% 1.94E-05 3.58 

178 317.24(a) Yes 5.23% 0.21% 4.00E-06 25.86 

234 318.2(a) Yes 0.48% 0.10% 2.17E-06 4.56 

406 381.1_Adulterated Yes 2.91% 0.55% 3.71E-03 5.46 

527 381.65(a) Yes 2.25% 0.50% 5.40E-34 4.59 

543 381.71(a) Yes 13.35% 0.71% 1.89E-07 21.42 

582 416.1 Yes 5.97% 1.28% 0.00E+00 4.88 

586 416.12(c) Yes 0.41% 0.10% 2.49E-05 4.07 

588 

416.13 

Implementation of 

SOP's 

No 0.46% 0.03% 4.39E-02 13.86 

589 416.13(a) Yes 4.50% 0.53% 0.00E+00 8.88 

590 416.13(b) Yes 0.69% 0.13% 0.00E+00 5.13 

591 416.13(c) Yes 8.05% 1.05% 0.00E+00 8.27 

592 416.14 Yes 1.31% 0.17% 0.00E+00 7.79 

594 416.15(a) Yes 7.80% 1.96% 6.38E-101 4.24 

12 
 

 

 

 

 

Reg 

ID 

Regulation 

Verified 

On 

FY2018 

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 

595 416.15(b) Yes 10.95% 2.15% 4.25E-126 5.59 

597 416.16(a) Yes 0.43% 0.12% 6.34E-235 3.53 

630 416.3(b) Yes 3.43% 0.51% 2.70E-78 6.90 

631 416.3(c) Yes 5.50% 0.87% 8.09E-128 6.60 

633 416.4(a) Yes 28.85% 4.48% 0.00E+00 8.65 

636 416.4(d) Yes 34.64% 4.83% 0.00E+00 10.45 

641 416.6 Yes 8.89% 2.06% 6.29E-09 4.64 

648 417.2(c) No 0.52% 0.17% 1.37E-04 3.10 

649 417.2(c)(4) Yes 1.63% 0.28% 0.00E+00 5.82 

657 417.3(a)(1) Yes 8.60% 1.58% 5.25E-111 5.85 

659 417.3(a)(3) Yes 11.70% 1.99% 2.21E-135 6.54 

662 417.3(b)(1) No 1.91% 0.53% 4.61E-10 3.65 

663 417.3(b)(2) Yes 1.64% 0.41% 6.44E-09 4.01 

665 417.3(b)(4) Yes 1.70% 0.48% 4.71E-16 3.62 

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, 2017 to December 31, 2017. The 

dataset used in the analysis consists of candidate PHR noncompliance rates for the 205 

establishments with Intact Chicken Salmonella testing data, of which 159 had 514 Salmonella 

positives and 46 did not have Salmonella positives. There were 9,126 total Intact Chicken 

Salmonella tests performed. 

Table 4-2 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 Chicken Salmonella positive is higher than the 

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

period January 1, 2017 to December 31, 2017. 

13 
 

 

 

 

 

 

 

 

 

 

 

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 

FY2018 

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 20.32% 1.07% 1.16E-31 23.67 

557 381.83 Yes 0.11% 0.02% 3.67E-13 4.77 

590 416.13(b) Yes 1.35% 0.32% 2.01E-52 4.23 

592 416.14 Yes 2.47% 0.73% 2.03E-66 3.46 

594 416.15(a) Yes 18.52% 4.47% 2.36E-38 4.86 

657 417.3(a)(1) Yes 9.75% 1.04% 9.59E-19 10.33 

659 417.3(a)(3) Yes 12.73% 2.53% 9.97E-18 5.62 

664 417.3(b)(3) Yes 0.57% 0.12% 4.32E-03 4.87 

669 417.4(a)(1) No 14.58% 2.50% 8.88E-05 6.66 

717 310.18(a) Yes 2.58% 0.43% 7.85E-04 6.08 

1351 381.76(b)(6)(ii)(C) No 0.09% 0.02% 6.48E-12 4.42 

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, 2017 to December 31, 2017. The 

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

establishments with Salmonella testing data, of which 12 had 16 Salmonella positives and 33 did 

not have Salmonella positives. There were 1,904 total Intact Turkey Salmonella tests performed. 

Table 4-3 presents the 2 regulations which had more than 30 verifications in a year, an odds ratio 

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

Exact p value of less than 0.05) that the noncompliance rate of the regulations 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, 2017 to December 31, 2017. 

14 
 

 

 

 

 

 

 

 

 

 

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 

FY2018 

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 

649 417.2(c)(4) Yes 2.34% 0.71% 5.66E-13 3.35 

682 417.5(a)(3) Yes 0.79% 0.25% 5.08E-05 3.21 

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, 2017 to December 31, 2017. The 

dataset used in the analysis consists of candidate PHR noncompliance rates for the 1,250 

establishments with Salmonella testing data, of which 117 had 166 Salmonella positives and 

1,133 did not have Salmonella positives. There were 11,182 total Ground Beef Salmonella tests 

performed. 

Table 4-4 presents the 6 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, 2017 to December 31, 2017. 

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 

FY2018 

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 

90 310.22(e)(3) Yes 4.94% 1.31% 2.45E-02 3.91 

594 416.15(a) Yes 5.77% 1.44% 8.19E-05 4.20 

648 417.2(c) No 7.79% 0.26% 1.67E-07 32.44 

657 417.3(a)(1) Yes 5.88% 1.54% 1.33E-05 4.01 

662 417.3(b)(1) No 4.81% 0.47% 2.05E-06 10.62 

663 417.3(b)(2) Yes 3.66% 0.42% 6.83E-05 9.04 

15 
 

 

 

 

 

 

 

 

 

 

 

 

 

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, 2017 to December 31, 2017. FSIS tests beef 

trim and beef manufacturing trimmings as a surrogate for testing intact beef. There are 911 

establishments with Intact Beef Salmonella testing data, of which 68 had 109 Salmonella 

positives and 843 did not have Salmonella positives. There were 5,188 total Intact Beef 

Salmonella tests performed. 

Table 4-5 presents the 15 regulations which had more than 30 verifications in a year, an odds 

ratio of 3.0 or greater, and for which there is 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, 2017 to December 31, 2017. 

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 

FY2018 

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 19.76% 2.60% 9.50E-28 9.24 

69 310.18 3.70% 1.22% 1.01E-02 3.11 

78 310.22(c) Yes 1.55% 0.21% 2.41E-12 7.39 

88 310.22(e)(1) 7.09% 1.00% 1.72E-13 7.53 

89 310.22(e)(2) Yes 12.50% 4.09% 1.94E-02 3.35 

90 310.22(e)(3) Yes 9.24% 0.64% 2.36E-13 15.81 

99 310.22(f)(2) Yes 0.53% 0.09% 2.51E-02 5.75 

588 416.13 

Implementation of 

SOP's 

0.78% 0.03% 1.62E-02 24.63 

589 416.13(a) Yes 2.11% 0.55% 1.93E-24 3.89 

590 416.13(b) Yes 0.50% 0.16% 1.19E-10 3.06 

591 416.13(c) Yes 5.04% 1.09% 3.38E-244 4.83 

630 416.3(b) Yes 2.26% 0.45% 9.87E-03 5.12 

636 416.4(d) Yes 17.58% 4.71% 3.97E-107 4.31 

649 417.2(c)(4) Yes 2.30% 0.28% 2.61E-114 8.47 

717 310.18(a) Yes 4.16% 0.95% 5.55E-128 4.54 

16 
 

 

 

 

 

 

 

 

 

 

 

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 

1, 2017 to December 31, 2017. The dataset used in the analysis consists of candidate PHR 

noncompliance rates for the 105 establishments with Comminuted Chicken Salmonella testing 

data, of which 83 had 513 Salmonella positives and 22 did not have Salmonella positives. There 

were 1,665 total Comminuted Chicken Salmonella tests performed. 

Table 4-6 presents the 12 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, 2017 to December 31, 2017. 

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 

FY2018 

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 

527 381.65(a) Yes 2.03% 0.09% 1.56E-07 23.05 

550 381.76(a)* Yes 6.66% 0.56% 4.72E-09 12.72 

591 416.13(c) Yes 5.89% 1.75% 3.34E-107 3.50 

594 416.15(a) Yes 11.38% 2.21% 2.38E-04 5.69 

595 416.15(b) Yes 16.44% 1.53% 9.74E-08 12.69 

630 416.3(b) Yes 3.44% 1.08% 4.15E-02 3.27 

633 416.4(a) Yes 29.97% 7.68% 7.61E-97 5.14 

636 416.4(d) Yes 31.63% 13.04% 4.20E-52 3.09 

657 417.3(a)(1) Yes 14.53% 1.44% 1.31E-12 11.65 

658 417.3(a)(2) Yes 1.80% 0.25% 4.46E-14 7.47 

659 417.3(a)(3) Yes 19.12% 0.74% 3.47E-20 31.92 

664 417.3(b)(3) Yes 0.56% 0.14% 1.36E-02 4.00 

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 

17 
 

 

 

 

 

 

 

 

 

 

 

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

1, 2017 to December 31, 2017. There are 56 establishments with Comminuted Turkey 

Salmonella testing data, of which 37 had 184 Salmonella positives and 19 did not have 

Salmonella positives. There were 1208 total Comminuted Turkey Salmonella tests performed. 

Table 4-7 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 Comminuted Turkey Salmonella positive is higher than 

the average noncompliance rate for establishments with no Comminuted Turkey Salmonella 

positive in the period January 1, 2017 to December 31, 2017. 

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 

FY2018 

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 

589 416.13(a) Yes 1.81% 0.44% 5.85E-08 4.22 

592 416.14 Yes 0.93% 0.22% 3.53E-09 4.30 

594 416.15(a) Yes 6.38% 1.47% 1.57E-05 4.57 

595 416.15(b) Yes 12.67% 0.28% 2.51E-16 51.06 

597 416.16(a) Yes 0.42% 0.09% 2.70E-09 4.60 

645 417.2(a)(1) Yes 3.35% 1.06% 3.37E-03 3.22 

649 417.2(c)(4) Yes 1.64% 0.43% 6.58E-17 3.84 

657 417.3(a)(1) Yes 23.08% 2.47% 5.07E-07 11.85 

658 417.3(a)(2) Yes 2.51% 0.54% 9.81E-04 4.72 

659 417.3(a)(3) Yes 35.02% 1.18% 7.34E-14 45.27 

717 310.18(a) Yes 3.78% 1.12% 2.26E-02 3.48 

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, 2017 to December 31, 2017. There are 262 

establishments with Intact Pork Salmonella testing data, of which 86 had 192 Salmonella 

positives and 176 did not have Salmonella positives. There were 1389 total Intact Pork 

Salmonella tests performed. 

18 
 

 

 

 

 

 

 

 

 

Table 4-8 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 Intact Pork Salmonella positive is higher than the average noncompliance 

rate for establishments with no Intact Pork Salmonella positive in the period January 1, 2017 to 

December 31, 2017. 

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 

FY2018 

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 6.03% 1.37% 9.90E-61 4.62 

592 416.14 Yes 0.64% 0.19% 3.93E-12 3.45 

630 416.3(b) Yes 4.22% 0.32% 2.65E-12 13.58 

631 416.3(c) Yes 5.30% 0.81% 5.11E-12 6.88 

649 417.2(c)(4) Yes 1.30% 0.36% 2.03E-27 3.65 

657 417.3(a)(1) Yes 19.35% 0.87% 7.92E-07 27.24 

659 417.3(a)(3) Yes 59.49% 1.56% 2.35E-45 92.98 

660 417.3(a)(4) Yes 23.40% 0.32% 5.73E-15 95.64 

666 417.3(c) Yes 29.55% 1.67% 5.40E-11 24.74 

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, 2017 to December 31, 2017. There 

are 341 establishments with Ground Pork Salmonella testing data, of which 161 had 456 

Salmonella positives and 180 did not have Salmonella positives. There were 2,537 total Ground 

Pork Salmonella tests performed. 

There are 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 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, 2017 to December 31, 2017. 

19 
 

 

 

 

 

 

 

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 

FY2018 

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) Yes 16.67% 1.64% 7.42E-03 12.00 

631 416.3(c) Yes 3.52% 1.02% 1.55E-07 3.55 

665 417.3(b)(4) Yes 3.27% 0.63% 2.38E-03 5.32 

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 

Chicken Parts Salmonella positives in the period January 1, 2017 to December 31, 2017. There 

are 432 establishments with Chicken Parts Salmonella testing data, of which 315 had 1,153 

Salmonella positives and 117 did not have Salmonella positives. There were 7,742 total Chicken 

Parts Salmonella tests performed. 

Table 4-10 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 Chicken Parts Salmonella positive is higher than the 

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

period January 1, 2017 to December 31, 2017. 

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 

FY2018 

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 

557 381.83 Yes 0.08% 0.00% 6.96E-14 19.88 

582 416.1 Yes 6.47% 1.76% 2.50E-131 3.87 

589 416.13(a) Yes 6.52% 2.01% 1.68E-122 3.39 

591 416.13(c) Yes 10.04% 2.94% 0.00E+00 3.68 

592 416.14 Yes 1.61% 0.54% 1.51E-69 3.03 

633 416.4(a) Yes 34.48% 14.74% 4.03E-281 3.05 

20 
 

 

 

 

 

 

 

 

 

 

 

Reg 

ID 

Regulation 

Verified 

On 

FY2018 

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 

657 417.3(a)(1) Yes 4.71% 1.51% 5.05E-06 3.22 

659 417.3(a)(3) Yes 5.86% 0.41% 2.51E-14 15.03 

665 417.3(b)(4) Yes 2.22% 0.46% 2.54E-04 4.87 

1351 381.76(b)(6)(ii)(C) No 0.06% 0.00% 4.51E-12 17.33 

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, 2017 to December 31, 2017. The 

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

1837establishments with Salmonella testing data, of which 1 had 1 Salmonella positives and 

1,836 did not have Salmonella positives. There were 12,318 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, 2017 to 

December 31, 2017. 

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 

Reg ID Regulation 

Verified 

On 

FY2018 

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 

591 416.13(c) Yes 8.65% 1.05% 1.73E-06 8.94 

21 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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, 2017 to December 31, 2017. The dataset used in the analysis consists of 

candidate PHR noncompliance rates for the 1177 establishments with E. coli O157:H7 testing 

data, of which 16 had 16 E. coli O157:H7 positives and 1,161 did not have E. coli O157:H7 

positives. There were 14725 total E. coli O157:H7 tests performed. 

There were no 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, 2017 to December 31, 

2017. 

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 in MT55 (bench trim) and MT60 

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

beef products and product components. On June 4, 2012, FSIS began testing for these six nonO157 STECs in beef manufacturing trimmings. The noncompliance rate of each of the candidate 

regulations in the three months before a non-O157 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, 2017 to December 31, 

2017. The dataset used in the analysis consists of candidate PHR noncompliance rates for the 

373 establishments with non-O157 STEC testing data, of which 15 had 31 non- O157 STEC 

positives and 358 did not have non-O157 STEC positives. There were 3,105 total non-O157 

STEC tests performed. 

Table 4-12 presents the 2 regulations which had more than 30 verifications in a year, an odds 

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

Fisher 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, 

2017 to December 31, 2017. 

22 
 

 

 

 

 

 

 

 

 

 

 

 

 

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

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

Reg 

ID 

Regulation 

Verified 

On 

FY2018 

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 

78 310.22(c) Yes 1.37% 0.44% 1.62E-02 3.11 

88 310.22(e)(1) No 7.69% 2.16% 7.63E-03 3.77 

4.3 Listeria monocytognes 

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, 2017 to December 31, 2017. The dataset used 

in the analysis consists of candidate PHR noncompliance rates for the 1837 establishments with 

Listeria monocytogenes testing data, of which 19 had 20 Listeria monocytogenes positives and 

1818 did not have Listeria monocytogenes positives. There were 12,319 total Listeria 

monocyogenes tests performed. 

Table 4-13 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, 2017 to 

December 31, 2017. 

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

Positive with Those for Establishments with No Listeria monocytognes Positive 

Reg 

ID 

Regulation 

Verified 

On 

FY2018 

PHR List 

Noncompliance 

Rate in 3 

Months before 

a Listeria 

monocytognes 

Positive 

Noncompliance 

Rate for 

Establishments 

with no Listeria 

monocytognes 

Positive 

TwoSided 

Fisher 

Exact p 

Value 

Odds 

Ratio 

717 310.18(a) Yes 3.06% 0.83% 4.89E-02 3.78 

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 

23 
 

 

 

 

 

 

 

 

 

 

 

 

Campylobacter positives in the period January 1, 2017 to December 31, 2017. The dataset used 

in the analysis consists of candidate PHR noncompliance rates for the 577 establishments with 

Campylobacter testing data, of which 206 had 479 Campylobacter positives and 371 did not 

have Campylobacter positives. There were 21,229 total Campylobacter tests performed. 

Table 4-14 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 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, 2017 to December 31, 

2017. 

Table 4-94 Comparison of Noncompliance Rates 3 Months before a Campylobacter 

Positive with Those for Establishments with No Campylobacter Positive 

Reg 

ID 

Regulation 

Verified 

On 

FY2018 

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 4.55% 0.30% 1.01E-06 15.84 

668 417.4(a) Yes 19.92% 3.19% 4.83E-18 7.55 

669 417.4(a)(1) No 19.23% 6.53% 1.58E-04 3.41 

689 417.5(f) Yes 0.39% 0.12% 6.02E-03 3.27 

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, 2017 to December 31, 2017. The dataset used 

in the analysis consists of candidate PHR noncompliance rates for the 204 establishments with 

Intact Chicken Campylobacter testing data, of which 96 had 187 Campylobacter positives and 

108 did not have Campylobacter positives. There were 8978 total Intact Chicken Campylobacter 

tests performed. 

Table 4-15 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, 2017 to December 31, 

2017. 

24 
 

 

 

 

 

 

 

 

 

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

Chicken Positive with Those for Establishments with No Campylobacter Intact Chicken 

Positive 

Reg 

ID 

Regulation 

Verified 

On 

FY2018 

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 

668 417.4(a) Yes 46.36% 1.86% 3.50E-39 45.70 

669 417.4(a)(1) No 34.29% 8.67% 2.49E-04 5.50 

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, 2017 to December 31, 2017. The dataset used 

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

Campylobacter testing data, of which 4 had 4 Campylobacter positives and 41 did not have 

Campylobacter positives. There were 1852 total Intact Turkey Campylobacter tests performed. 

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

Fisher Exact p value of less than 0.05) that the noncompliance rate of the regulations 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, 2017 to December 31, 

2017. 

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

Turkey Positive with Those for Establishments with No Campylobacter Intact Turkey 

Positive 

Reg 

ID 

Regulation 

Verified 

On 

FY2018 

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 

591 416.13(c) Yes 13.66% 4.60% 2.08E-16 3.28 

594 416.15(a) Yes 11.36% 3.80% 2.94E-02 3.25 

597 416.16(a) Yes 1.43% 0.29% 8.72E-04 4.91 

649 417.2(c)(4) Yes 4.29% 1.11% 6.63E-07 3.98 

25 
 

 

 

 

 

 

 

 

 

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 

January 1, 2017 to December 31, 2017. The dataset used in the analysis consists of candidate 

PHR noncompliance rates for the 105 establishments with Comminuted Chicken Campylobacter 

testing data, of which 22 had 60 Campylobacter positives and 83 did not have Campylobacter 

positives. There were 1,651 total Comminuted Chicken Campylobacter tests performed. 

Table 4-17 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 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, 2017 to December 31, 2017. 

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

Campylobacter Positive with Those for Establishments with No Comminuted Chicken 

Campylobacter Positive 

Reg 

ID 

Regulation 

Verified 

On 

FY2018 

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 8.42% 2.61% 6.81E-03 3.43 

657 417.3(a)(1) Yes 21.57% 1.28% 8.19E-39 21.24 

658 417.3(a)(2) Yes 1.99% 0.28% 8.33E-17 7.14 

659 417.3(a)(3) Yes 27.72% 4.82% 8.78E-26 7.57 

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, 2017 to December 31, 2017. The dataset used in the analysis consists of candidate 

PHR noncompliance rates for the 56 establishments with Comminuted Turkey Campylobacter 

testing data, of which 4 had 6 Campylobacter positives and 52 did not have Campylobacter 

positives. There were 1201 total Comminuted Turkey Campylobacter tests performed. 

There are three 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 regulations in establishments three 

months before an Comminuted Turkey Campylobacter positive is higher than the average 

26 
 

 

 

 

noncompliance rate for establishments with no Comminuted Turkey Campylobacter positive in 

the period January 1, 2017 to December 31, 2017. 

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

Campylobacter Positive with those for Establishments with No Comminuted Turkey 

Campylobacter Positive 

Reg ID Regulation 

Verified 

On 

FY2018 

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 

594 416.15(a) Yes 10.00% 2.77% 2.76E-02 3.90 

636 416.4(d) Yes 36.25% 15.42% 6.20E-06 3.12 

689 417.5(f) Yes 1.24% 0.17% 4.98E-02 7.54 

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, 2017 to December 31, 

2017. The dataset used in the analysis consists of candidate PHR noncompliance rates for the 

432 establishments with Chicken Parts Campylobacter testing data, of which 129 had 222 

Campylobacter positives and 303 did not have Campylobacter positives. There were 7547 total 

Chicken Parts Campylobacter tests performed. 

Table 4-19 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 Campylobacter positive is higher than the 

average noncompliance rate for establishments with no Chicken Parts Campylobacter positive in 

the period January 1, 2017 to December 31, 2017. 

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

Campylobacter Positive with Those for Establishments with No Chicken Parts 

Campylobacter Positive 

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 

207 318.1(b) Yes 0.29% 0.03% 1.65E-02 8.87 

234 318.2(a) Yes 9.78% 0.23% 3.56E-09 46.05 

717 310.18(a) Yes 7.65% 1.01% 2.28E-02 8.12 

27 
 

 

 

 

 

 

 

 

 

 

 

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 FY2019 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, 2017 to December 

31, 2017. The dataset used in the analysis consists of candidate PHR noncompliance rates for the 

5,492 active meat and poultry establishments, of which 129 had 222 public health related NOIEs 

or suspensions and 5,354 did not have any public health related NOIEs or suspensions. 

Table 4-20 presents the 38 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, 2017 to December 31, 2017. 

Table 4-20 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 

88 310.22(e)(1) No 11.11% 1.70% 1.05E-03 7.22 

92 310.22(e)(4)(i) No 2.97% 0.15% 1.03E-06 20.16 

107 310.25(a) Yes 3.57% 0.60% 6.38E-04 6.17 

234 318.2(a) Yes 1.12% 0.11% 1.92E-02 9.92 

235 318.2(d) No 2.94% 0.55% 2.18E-02 5.44 

530 381.65(e)* No 4.94% 1.27% 2.16E-02 4.03 

587 416.12(d) Yes 0.90% 0.20% 2.93E-02 4.64 

28 
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 

589 416.13(a) Yes 3.10% 0.97% 2.92E-27 3.26 

590 416.13(b) Yes 1.24% 0.19% 9.53E-55 6.59 

592 416.14 Yes 0.96% 0.26% 1.20E-21 3.72 

594 416.15(a) Yes 7.73% 1.90% 8.42E-10 4.33 

595 416.15(b) Yes 10.19% 2.88% 4.37E-07 3.83 

597 416.16(a) Yes 0.60% 0.14% 4.31E-27 4.16 

630 416.3(b) Yes 2.65% 0.86% 1.99E-03 3.13 

645 417.2(a)(1) Yes 11.99% 1.41% 1.58E-39 9.54 

649 417.2(c)(4) Yes 1.94% 0.64% 7.48E-27 3.09 

657 417.3(a)(1) Yes 21.03% 2.77% 1.14E-25 9.35 

658 417.3(a)(2) Yes 1.88% 0.52% 5.51E-07 3.66 

659 417.3(a)(3) Yes 23.61% 3.87% 6.62E-25 7.68 

660 417.3(a)(4) Yes 3.94% 0.46% 2.77E-09 8.96 

662 417.3(b)(1) No 9.76% 0.86% 7.75E-07 12.46 

663 417.3(b)(2) Yes 8.97% 0.70% 1.81E-06 14.01 

664 417.3(b)(3) Yes 3.78% 0.32% 3.40E-06 12.28 

665 417.3(b)(4) Yes 6.44% 0.56% 2.72E-10 12.30 

666 417.3(c) Yes 12.50% 1.80% 2.42E-08 7.79 

668 417.4(a) Yes 56.25% 3.69% 1.09E-25 33.54 

669 417.4(a)(1) No 51.43% 8.05% 3.64E-11 12.10 

675 417.4(b) No 1.59% 0.25% 4.01E-02 6.57 

680 417.5(a)(1) Yes 2.10% 0.32% 7.53E-71 6.74 

681 417.5(a)(2) Yes 0.84% 0.12% 2.23E-26 6.94 

682 417.5(a)(3) Yes 1.15% 0.25% 7.59E-31 4.75 

689 417.5(f) Yes 0.67% 0.12% 1.76E-02 5.68 

701 430.4(a) Yes 0.40% 0.03% 1.80E-05 11.95 

703 430.4(b)(2) No 4.76% 0.62% 5.90E-04 8.05 

704 430.4(b)(3) Yes 3.54% 0.95% 9.19E-04 3.83 

705 430.4(c)(2) No 0.21% 0.04% 1.86E-02 5.55 

1174 418.3 Yes 5.41% 0.56% 9.43E-04 10.15 

1349 381.76(b)(6)(ii)(A) Yes 3.33% 0.51% 3.83E-02 6.72 

29 
 

 

 

 

 

 

 

 

 

5.0 LIST OF FY2019 PHRS 

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

PHRs into a single FY2019 PHR list. Table 5-1 presents the list of 63 FY2019 PHRs. These 63 

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 63 FY2019 PHRs are composed of 10 regulations and 53 provisions of regulations. The 53 

provisions fall under 18 different regulations. Thus, the 63 FY2019 PHRs represent 28 

regulations, with the majority of FY2019 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 FY2019 PHRs 

Reg 

ID 

List of FY2019 

PHRs Description 

On 

FY2018 

PHR List 

Average 

TwoSided 

Fisher 

Exact p 

Value 

Average 

Odds 

Ratio 

29 301.2_Adulterated Adulterated Yes 3.10E-15 6.35 

69 310.18 Contamination of carcasses, 

organs, or other parts 

No 5.03E-03 3.16 

78 310.22(c) Disposal of SRM Yes 5.41E-03 4.78 

88 310.22(e)(1) Written procedures for removal, 

segregation, and disposition of 

SRMs 

No 2.17E-03 5.51 

89 310.22(e)(2) Appropriate corrective actions Yes 1.94E-02 3.35 

90 310.22(e)(3) Evaluate effectiveness of 

procedures for removal, 

segregation, and disposition of 

SRMs 

Yes 8.16E-03 7.76 

92 310.22(e)(4)(i) Maintain daily records No 1.03E-06 20.16 

99 310.22(f)(2) Use of routine operational 

sanitation procedures on 

equipment used to cut through 

SRMs 

Yes 2.51E-02 5.75 

107 310.25(a) Verification criteria for E. coli 

testing meat 

Yes 6.38E-04 6.17 

178 317.24(a) Packaging materials composed 

of poisonous or deleterious 

substances 

Yes 3.71E-03 18.93 

30 
Reg 

ID 

List of FY2019 

PHRs Description 

On 

FY2018 

PHR List 

Average 

TwoSided 

Fisher 

Exact p 

Value 

Average 

Odds 

Ratio 

207 318.1(b) Only inspected and passed 

poultry product to enter official 

establishment 

Yes 1.65E-02 8.87 

234 318.2(a) All products subject to 

reinspection by program 

employees 

Yes 4.79E-03 19.09 

235 318.2(d) Removal of U.S. retained by 

authorized Program employees 

only 

No 2.18E-02 5.44 

406 381.1_Adulterated Adulterated Yes 3.71E-03 5.46 

527 381.65(a) Clean and sanitary practices; 

products not adulterated 

Yes 7.82E-08 13.82 

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

material entering chiller 

No 2.16E-02 4.03 

543 381.71(a) Condemnation on ante mortem 

inspection 

Yes 9.44E-08 22.55 

550 381.76(a)* Post-mortem inspection, when 

required, extent. 

Yes 3.40E-03 8.07 

557 381.83 Septicemia or toxemia Yes 2.19E-13 12.32 

582 416.1 Operate in a manner to prevent 

insanitary conditions 

Yes 3.30E-61 4.46 

586 416.12(c) plan identifies procedures for 

pre-op 

Yes 2.49E-05 4.07 

587 416.12(d) plan list frequency for each 

procedure & responsible 

individual 

Yes 2.93E-02 4.64 

588 416.13 

Implementation of 

SOP's 

Implementation of SSOP No 3.01E-02 19.25 

589 416.13(a) Conduct pre-op procedures Yes 1.17E-08 4.73 

590 416.13(b) Conduct other procedures listed 

in the plan 

Yes 2.97E-11 4.75 

591 416.13(c) Plant monitors implementation 

of SSOP procedures 

Yes 2.88E-07 5.42 

592 416.14 Evaluate effectiveness of 

SSOP's & maintain plan 

Yes 5.90E-10 4.29 

594 416.15(a) Appropriate corrective actions Yes 7.17E-03 4.38 

31 
Reg 

ID 

List of FY2019 

PHRs Description 

On 

FY2018 

PHR List 

Average 

TwoSided 

Fisher 

Exact p 

Value 

Average 

Odds 

Ratio 

595 416.15(b) Corrective action, procedures 

for 

Yes 1.34E-07 18.29 

597 416.16(a) Daily records required, 

responsible individual, initialed 

and dated 

Yes 2.18E-04 4.30 

630 416.3(b) Constructed, located & 

operated in a manner that does 

not deter inspection 

Yes 1.07E-02 6.40 

631 416.3(c) Receptacles for storing inedible 

material must identify permitted 

use 

Yes 5.16E-08 5.68 

633 416.4(a) Food contact surface, cleaning 

& sanitizing as frequency 

Yes 2.54E-97 5.61 

636 416.4(d) Product processing, handling, 

storage, loading, unloading, and 

during transportation must be 

protected 

Yes 1.55E-06 5.24 

641 416.6 Only FSIS program employee 

may remove "U.S. Rejected" 

tag 

Yes 6.29E-09 4.64 

645 417.2(a)(1) Hazard analysis Yes 1.68E-03 6.38 

648 417.2(c) Contents of HACCP Plan No 6.88E-05 17.77 

649 417.2(c)(4) List of procedures & frequency Yes 9.48E-08 4.60 

657 417.3(a)(1) Identify and eliminate the cause Yes 2.18E-06 11.64 

658 417.3(a)(2) CCP is under control Yes 2.45E-04 5.75 

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

recurrence 

Yes 1.23E-14 26.58 

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

commerce. 

Yes 1.38E-09 52.30 

662 417.3(b)(1) Segregate and hold the affected 

product 

No 9.43E-07 8.91 

663 417.3(b)(2) Determine the acceptability of 

the affected product 

Yes 2.34E-05 9.02 

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

commerce 

Yes 5.97E-03 7.05 

665 417.3(b)(4) Reassessment Yes 6.59E-04 6.52 

666 417.3(c) Document corrective actions Yes 1.21E-08 16.26 

32 
Reg 

ID 

List of FY2019 

PHRs Description 

On 

FY2018 

PHR List 

Average 

TwoSided 

Fisher 

Exact p 

Value 

Average 

Odds 

Ratio 

668 417.4(a) Adequacy of HACCP in 

controlling food safety hazards 

Yes 1.21E-18 23.51 

669 417.4(a)(1) Initial validation No 1.24E-04 6.91 

675 417.4(b) Reassessment of hazard 

analysis 

No 4.01E-02 6.57 

680 417.5(a)(1) Written hazard analysis Yes 7.53E-71 6.74 

681 417.5(a)(2) Written HACCP plan Yes 2.23E-26 6.94 

682 417.5(a)(3) Records documentation and 

monitoring of CCP's and 

Critical Limits 

Yes 2.54E-05 3.98 

689 417.5(f) Official Review Yes 2.45E-02 5.50 

690 417.6 Inadequate HACCP systems No 1.51E-19 12.85 

701 430.4(a) Lm, post-lethality exposed RTE Yes 1.80E-05 11.95 

703 430.4(b)(2) Alternative 2 No 5.90E-04 8.05 

704 430.4(b)(3) Alternative 3 Yes 9.19E-04 3.83 

705 430.4(c)(2) Alternative 3 No 1.86E-02 5.55 

717 310.18(a) Carcasses, organs, and other 

parts handled in a sanitary 

manner 

Yes 1.59E-02 4.90 

1174 418.3 Recall Plans Yes 9.43E-04 10.15 

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

Reprocessing 

Yes 1.92E-02 10.05 

1351 381.76(b)(6)(ii)(C) NPIS septicemia/toxemia No 5.50E-12 10.88 

33 
 

25 

20 

15 

10 

 Frequency 

5 

0 

4 5 10 20 Higher 

Figure 5-1 presents a histogram of the ratios (odds ratios) for each of the 63 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 9.57. 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 9.57 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 2019 PHRs 

Forty nine of the previous 57 FY2018 PHRs are mapped into these 63 FY2019 PHRs. 

Approximately 86% of the FY2018 PHRs are included in the FY2019 PHRs. There are 8 

additional regulations that were on the FY2018 PHR list and are not in the FY2019 PHR list (See 

Appendix E). 

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

FY2019 PHR list. Most regulations were triggered by multiple events. 

34 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Table 5-2 Events That Triggered Inclusion of a Regulation in the FY2019 PHR list 

Product Number of Regulations Percent 

Campylobacter 4 2.26% 

Chicken Parts Campylobacter 3 1.69% 

Chicken Parts Salmonella 10 5.65% 

Enforcements 38 21.47% 

Ground Beef Salmonella 6 3.39% 

Ground Chicken Campylobacter 4 2.26% 

Ground Chicken Salmonella 12 6.78% 

Ground Pork Salmonella 3 1.69% 

Ground Turkey Campylobacter 3 1.69% 

Ground Turkey Salmonella 11 6.21% 

Intact Beef Salmonella 15 8.47% 

Intact Chicken Campylobacter 2 1.13% 

Intact Chicken Salmonella 11 6.21% 

Intact Pork Salmonella 9 5.08% 

Intact Turkey Campylobacter 4 2.26% 

Intact Turkey Salmonella 2 1.13% 

Listeria 1 0.56% 

Non-O157 Ecoli 2 1.13% 

RTE Salmonella 1 0.56% 

Salmonella 36 20.34% 

Grand Total 177 100.00% 

There were twenty regulations triggered by a single type of event. Thirteen were from 

enforcement actions, four were from Salmonella, two were from Salmonella in Intact Beef and 

one was from Campylobacter in Chicken Parts. Table 5-3 presents the regulations triggered for 

inclusion in the FY2019 PHR list by only single event type. 

35 
 

 

 

 

 

 

Table 5-3 Regulations Triggered for Inclusion in the FY2019 PHR List by Only a Single 

Event 

Reg ID Regulations from a Single Event Event 

89 310.22(e)(2) Intact Beef Salmonella 

92 310.22(e)(4)(i) Enforcements 

99 310.22(f)(2) Intact Beef Salmonella 

107 310.25(a) Enforcements 

207 318.1(b) Chicken Parts Campylobacter 

235 318.2(d) Enforcements 

406 381.1_Adulterated Salmonella 

530 381.65(e)* Enforcements 

586 416.12(c) Salmonella 

587 416.12(d) Enforcements 

641 416.6 Salmonella 

675 417.4(b) Enforcements 

680 417.5(a)(1) Enforcements 

681 417.5(a)(2) Enforcements 

690 417.6 Salmonella 

701 430.4(a) Enforcements 

703 430.4(b)(2) Enforcements 

704 430.4(b)(3) Enforcements 

705 430.4(c)(2) Enforcements 

1174 418.3 Enforcements 

6.0 CUT POINTS FOR FY2019 PHRS 

The FY2019 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 FY2019 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 FY2019 PHR 

36 
 

 

 

 

 

 

 

 

 

 

 

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 FY2019 cut points, the mean and standard deviation of the natural 

log transformed non-zero FY2019 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 

FY2019 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 FY2019 PHR Rate 

Mean of Natural Log 

FY2019 PHR Rate 

Standard Deviation 

FY2019 PHR Rate 

Combination Processing Combination Processing 

Jan-Mar 2017 -4.47 -4.84 1.03 0.85 

Apr-Jun 2017 -4.29 -4.61 1.01 0.79 

July-Sep 2017 -4.40 -4.88 1.03 0.87 

Oct-Dec 2017 -4.47 -4.86 1.02 0.84 

Average -4.41 -4.80 1.02 0.84 

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 

transformed data for Processing establishments is -4.80 + 2*0.84 = -4.80 + 1.67 = -3.12. 

(Rounding shows the standard deviation in 6-1 as 0.84, but it is closer to 0.837) The cut point of 

the original, non-transformed PHR non-compliance data is the antilog of -3.12 or Exp(-3.12) = 

4.40%. Tables 6-2 and 6-3 present the FY2019 PHR upper and lower cut points for each of the 

two establishment operation types. The FY2018 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 2019. 

Table 6-2 FY2019 PHR Tier 1 Cut Points 

Operation Type FY2019 PHR Cut Points FY2018 PHR Cut Points 

Processing 4.40% 4.22% 

Combination 9.40% 8.73% 

37 
 

 

 

 

 

 

 

Table 6-3 FY2019 PHR Tier 3 Cut Points 

Operation Type FY2019 PHR Cut Points FY2018 PHR Cut Points 

Processing 2.90% 2.82% 

Combination 5.64% 5.38% 

Table 6-4 presents the number of establishments in each Tier based solely on the FY2019 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 FY2019 PHRs, 63 

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, 2018. 

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

Classification Number of Establishments 

Tier 1 63 

Tier 2 68 

Tier 3 5,102 

Total 5,233 

Table 6-5 presents the number of establishments in each Tier based on 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 FY2019 PHRs, 53 processing establishments are Tier 

1 and are candidates to receive for cause FSAs. In total, 63 establishments are in Tier 1 based 

solely on non-compliances with the FY2019 PHRs. Table 6-4 is based on regulatory noncompliances during January 1 –March 31, 2018. 

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

PHR Criterion 

Classification Processing Combination 

Tier 1 53 10 

Tier 2 49 19 

Tier 3 4,066 1,036 

Total 4,168 1,065 

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. 

38 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

7.0 CONCLUSION 

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

FY2019 PHR regulations used to prioritize certain FY2019 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 FY2019 PHRs has 63 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 seventy eight percent of the regulations on the FY2018 PHR list are 

also on the FY2019 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 FY2019 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 FY2018 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 FY2019 PHR Tier 1 Cut Points 

Operation Type FY2019 PHR Cut Points FY2018 PHR Cut Points 

Processing 4.40% 4.22% 

Combination 9.40% 8.73% 

Table 7-2 FY2019 PHR Tier 3 Cut Points 

Operation Type FY2019 PHR Cut Points FY2018 PHR Cut Points 

Processing 2.90% 2.82% 

Combination 5.64% 5.38% 

39 
 

 

 

 

 

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 

40 
 

 

 

 

 

 

 

 

 

 

 

 

APPENDIX A: FY2019 PHR REGULATIONS 

Table A-1 presents the list of sixty three FY2019 Public Health Regulations (PHRs). On average, 

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

enforcement action 9.57 times higher than the PHR noncompliance rates for establishments with 

no pathogen positive or enforcement action. 

Table A-1 List of FY2019 PHRs 

Reg 

ID 

List of FY2019 

PHRs Description 

29 301.2_Adulterated Adulterated 

69 310.18 Contamination of carcasses, organs, or 

other parts 

78 310.22(c) Disposal of SRM 

88 310.22(e)(1) Written procedures for removal, 

segregation, and disposition of SRMs 

89 310.22(e)(2) Appropriate corrective actions 

90 310.22(e)(3) 

Evaluate effectiveness of procedures for 

removal, segregation, and disposition of 

SRMs 

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

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 

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 

235 318.2(d) Removal of U.S. retained by authorized 

Program employees only 

406 381.1_Adulterated Adulterated 

527 381.65(a) Clean and sanitary practices; products not 

adulterated 

530 381.65(e)* Zero-tolerance for visible fecal material 

entering chiller 

543 381.71(a) Condemnation on ante mortem inspection 

550 381.76(a)* Post-mortem inspection, when required, 

extent. 

557 381.83 Septicemia or toxemia 

41 
 

 

 

 

 

 

 

 

 

 

Reg 

ID 

List of FY2019 

PHRs Description 

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 

588 

416.13 

Implementation of 

SOP's 

Implementation of SSOP 

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 

648 417.2(c) Contents of HACCP Plan 

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. 

662 417.3(b)(1) Segregate and hold the affected product 

663 417.3(b)(2) Determine the acceptability of the affected 

product 

42 
 

 

Reg 

ID 

List of FY2019 

PHRs Description 

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

665 417.3(b)(4) Reassessment 

666 417.3(c) Document corrective actions 

668 417.4(a) Adequacy of HACCP in controlling food 

safety hazards 

669 417.4(a)(1) Initial validation 

675 417.4(b) Reassessment of hazard analysis 

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 

690 417.6 Inadequate HACCP systems 

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

703 430.4(b)(2) Alternative 2 

704 430.4(b)(3) Alternative 3 

705 430.4(c)(2) Alternative 3 

717 310.18(a) Carcasses, organs, and other parts handled 

in a sanitary manner 

1174 418.3 Recall Plans 

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

1351 381.76(b)(6)(ii)(C) NPIS septicemia/toxemia 

43 
 

 

 

 

 

 

 

 

 

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 FY2019 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: 

Number of PHR Non-compliances 

PHR NC Rate = 

Total Number of PHR Inspection Verifications 

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

Slaughter/Processing Combination): 

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

establishments with the same establishment type would continue to receive routine 

inspection procedures and routine FSAs every four years. These establishments are 

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

regulations. 

• Establishments with a PHR rate between the lower and upper cut points for all 

establishments with the same establishment type would continue to receive routine 

inspection procedures and, in addition, be prioritized for routine FSAs. 

• 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 

continue to receive routine inspection procedures plus a PHRE to determine if a for cause 

FSA is appropriate. 

44 
 

APPENDIX C: FY2019 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, 2017 through December 31, 2017. 

Table C-1 FY2019 Candidate regulations 

Reg 

ID 

FY2019 Candidate 

Regulation 

FY2018 

PHR 

Mandatory 

Regulation 

Total FSIS 

Verifications 

Total 

NCs1 

NC1 

Rate 

29 301.2_Adulterated Yes No 8231 215 2.55% 

43 304.3(a) No No 867 7 0.80% 

45 304.3(c) No No 1062 9 0.84% 

53 309.2(a) No No 881 0 0.00% 

54 309.3 No No 331 2 0.60% 

55 309.4 No No 255 0 0.00% 

56 309.5 No No 240 0 0.00% 

57 309.9 No No 233 0 0.00% 

69 310.18 No Yes 5535 82 1.46% 

77 310.22(b) No No 5538 7 0.13% 

78 310.22(c) Yes Yes 56616 157 0.28% 

84 310.22(d)(2) No No 92 0 0.00% 

88 310.22(e)(1) No No 15345 214 1.38% 

89 310.22(e)(2) Yes No 3502 58 1.63% 

90 310.22(e)(3) Yes No 9437 132 1.38% 

92 310.22(e)(4)(i) No No 87789 218 0.25% 

99 310.22(f)(2) Yes No 18612 24 0.13% 

101 310.22(g)(1) No No 1674 4 0.24% 

104 310.22(g)(4) No No 4292 15 0.35% 

107 310.25(a) Yes No 29535 248 0.83% 

108 310.25(b) No No 161 4 2.42% 

109 310.25(b)(3)(ii) No No 134 1 0.74% 

110 310.3 Yes No 3651 252 6.46% 

114 311.16 No No 243 9 3.57% 

115 311.17 No No 571 7 1.21% 

116 311.24 No No 186 0 0.00% 

138 315.2 No No 68 0 0.00% 

152 316.6 Yes No 12816 59 0.46% 

178 317.24(a) Yes No 2723 20 0.73% 

207 318.1(b) Yes No 95580 19 0.02% 

215 318.10(b) No No 2378 10 0.42% 

217 318.10(c)(1) No No 2445 3 0.12% 

218 318.10(c)(2) No No 760 1 0.13% 

219 318.10(c)(3) No No 490 2 0.41% 

45 
Reg 

ID 

FY2019 Candidate 

Regulation 

FY2018 

PHR 

Mandatory 

Regulation 

Total FSIS 

Verifications 

Total 

NCs1 

NC1 

Rate 

221 318.14(a) No No 110 2 1.79% 

222 318.14(b) No No 621 0 0.00% 

223 318.14(c) No No 83 0 0.00% 

226 318.16(b) No No 289 0 0.00% 

228 318.17(a)(1)(2) No No 3402 6 0.18% 

229 318.17(b) No No 666 1 0.15% 

230 318.17(c) No No 22 0 0.00% 

234 318.2(a) Yes No 48140 53 0.11% 

235 318.2(d) No No 8569 46 0.53% 

239 318.23(b)(1) No No 501 3 0.60% 

241 318.23(b)(3) No No 30 1 3.23% 

242 318.23(c)(1) No No 230 2 0.86% 

243 318.23(c)(2) No No 19 0 0.00% 

245 318.23(c)(4) No No 55 0 0.00% 

246 318.23(c)(5) No No 53 0 0.00% 

247 318.24 No No 2701 10 0.37% 

251 318.303 No Yes 8073 3 0.04% 

256 318.308 No Yes 5146 3 0.06% 

268 318.6(b)(1) No No 3036 0 0.00% 

273 318.6(b)(4) No No 9401 1 0.01% 

274 318.6(b)(6) No No 12931 1 0.01% 

275 318.6(b)(8) No No 433 1 0.23% 

329 319.5(b) No No 322 0 0.00% 

406 381.1_Adulterated Yes No 4518 68 1.48% 

450 381.144(a) No No 2331 0 0.00% 

457 381.150(a) No No 1759 8 0.45% 

459 381.150(c) No No 129 0 0.00% 

460 381.150(d) No No 7 0 0.00% 

462 381.151(a) No No 77 0 0.00% 

490 381.22(a) No No 362 1 0.28% 

491 381.22(b) No No 1028 12 1.15% 

492 381.22(c) No No 263 2 0.75% 

503 381.310 No Yes 4642 1 0.02% 

504 381.311 No Yes 4597 0 0.00% 

506 381.37(a) No No 1931 18 0.92% 

527 381.65(a) Yes No 65238 633 0.96% 

530 381.65(e)* No Yes 7326 97 1.31% 

543 381.71(a) Yes No 2331 223 8.73% 

545 381.72(a) No No 252 0 0.00% 

546 381.72(b) No No 11 0 0.00% 

46 
Reg 

ID 

FY2019 Candidate 

Regulation 

FY2018 

PHR 

Mandatory 

Regulation 

Total FSIS 

Verifications 

Total 

NCs1 

NC1 

Rate 

550 381.76(a)* Yes No 20245 338 1.64% 

557 381.83 Yes No 389952 185 0.05% 

559 381.85 No No 139 0 0.00% 

564 381.91(a) No No 9435 23 0.24% 

565 381.91(b) Yes No 25335 303 1.18% 

571 381.94(a)* No No 52 1 1.89% 

582 416.1 Yes Yes 642693 11512 1.76% 

586 416.12(c) Yes No 53920 85 0.16% 

587 416.12(d) Yes No 68469 137 0.20% 

588 416.13 Implementation of 

SOP's 

No No 6281 7 0.11% 

589 416.13(a) Yes Yes 748815 6871 0.91% 

590 416.13(b) Yes Yes 1847746 3506 0.19% 

591 416.13(c) Yes Yes 2652621 44877 1.66% 

592 416.14 Yes Yes 1627582 4082 0.25% 

593 416.15 Corrective 

Actions 

No No 677 3 0.44% 

594 416.15(a) Yes Yes 74738 1200 1.58% 

595 416.15(b) Yes Yes 48293 1211 2.45% 

597 416.16(a) Yes Yes 2892951 4693 0.16% 

630 416.3(b) Yes No 80068 662 0.82% 

631 416.3(c) Yes No 72299 987 1.35% 

633 416.4(a) Yes No 292553 24889 7.84% 

636 416.4(d) Yes No 271364 25979 8.74% 

640 416.5(c) No No 40780 24 0.06% 

641 416.6 Yes No 3432 123 3.46% 

645 417.2(a)(1) Yes Yes 125410 1995 1.57% 

648 417.2(c) No No 33990 115 0.34% 

649 417.2(c)(4) Yes Yes 1358531 7933 0.58% 

655 417.3 Corrective actions No No 451 1 0.22% 

656 417.3(a) No No 536 1 0.19% 

657 417.3(a)(1) Yes Yes 27138 827 2.96% 

658 417.3(a)(2) Yes Yes 163105 814 0.50% 

659 417.3(a)(3) Yes Yes 23098 947 3.94% 

660 417.3(a)(4) Yes Yes 50229 236 0.47% 

662 417.3(b)(1) No Yes 17547 151 0.85% 

663 417.3(b)(2) Yes Yes 16366 112 0.68% 

664 417.3(b)(3) Yes Yes 39611 121 0.30% 

665 417.3(b)(4) Yes Yes 43276 257 0.59% 

666 417.3(c) Yes Yes 16058 293 1.79% 

47 
 

Reg 

ID 

FY2019 Candidate 

Regulation 

FY2018 

PHR 

Mandatory 

Regulation 

Total FSIS 

Verifications 

Total 

NCs1 

NC1 

Rate 

668 417.4(a) Yes No 6980 296 4.07% 

669 417.4(a)(1) No No 6424 596 8.49% 

674 417.4(a)(3) No No 7 0 0.00% 

675 417.4(b) No Yes 32241 93 0.29% 

680 417.5(a)(1) Yes Yes 1371552 4681 0.34% 

681 417.5(a)(2) Yes Yes 1222781 1729 0.14% 

682 417.5(a)(3) Yes Yes 1428606 4162 0.29% 

689 417.5(f) Yes No 91067 125 0.14% 

690 417.6 No No 331 136 29.12% 

701 430.4(a) Yes Yes 303822 160 0.05% 

702 430.4(b)(1) No No 989 5 0.50% 

703 430.4(b)(2) No No 15530 114 0.73% 

704 430.4(b)(3) Yes No 29120 392 1.33% 

705 430.4(c)(2) No Yes 293596 157 0.05% 

706 430.4(c)(3) No Yes 303338 187 0.06% 

707 430.4(c)(4) No No 3332 22 0.66% 

708 430.4(c)(5) No No 7167 22 0.31% 

709 430.4(c)(6) No No 6275 80 1.26% 

717 310.18(a) Yes Yes 313208 3808 1.20% 

718 310.18(b) No No 20793 1 0.00% 

1173 418.2 No No 1414 127 8.24% 

1174 418.3 Yes No 14857 87 0.58% 

1241 354.242(b) No No 101 0 0.00% 

1247 354.242(h) No No 58 0 0.00% 

1250 354.243(a) No No 42 0 0.00% 

1292 381.193(a) No No 256 9 3.40% 

1331 381.65(f) Yes No 878764 10158 1.14% 

1346 381.65(h) No No 12642 0 0.00% 

1349 381.76(b)(6)(ii)(A) Yes No 50333 280 0.55% 

1350 381.76(b)(6)(ii)(D) Yes No 1777 118 6.23% 

1351 381.76(b)(6)(ii)(C) No No 481064 199 0.04% 

1352 381.76(b)(6)(ii)(B) Yes No 50243 101 0.20% 

1444 311.14 Yes No 18601 15 0.08% 

1. NC = Noncompliance 

48 
 

 

 

APPENDIX D: COMPARISON OF FY2019 PHR LIST WITH FY2018 PHR 

LIST 

There are eight regulations from the FY2018 PHR list that no longer appear in the FY2019 PHR 

list. These eight regulations are shown in Table D-1. 

Table D-1 Regulation from the FY2018 PHR list no longer on the FY2019 PHR list 

Reg 

ID 

List of FY2018 PHRs Description 

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 

565 381.91(b) 

Reprocessing of carcasses accidentally contaminated 

with digestive tract contents. 

1331 381.65(f) Procedures for controlling visible fecal contamination 

1348 381.69 

Maximum line speed rates under the New Poultry 

Inspection System 

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. 

49 
 

 

 

 

 

 

 

APPENDIX E: USE OF PUBLIC HEALTH REGULATIONS IN 

SCHEDULING FOOD SAFETY ASSESSMENTS 

The purpose of this Appendix is to explain how the 63 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: 

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

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

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

plant type is determined from the type of HACCP Inspection Task Codes performed at each 

establishment. If an establishment has only 03A through 03I codes, it is classified as a 

Processing Only establishment. If an establishment has a combination of 03A through 03J codes 

it is classified as a Slaughter/Processing establishment. 

The aggregate non-zero PHR 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. 

50 
 

 

Q) 

u 

:;; 

[l_ 

Distribution of lo grate 

-735 -6.75 -6. 15 -5.55 -4 .95 -435 -3.75 -3. 15 -2.55 -1 .95 -135 -0.75 

lograt e 

Curve --- Normal(M u=- 3.63 Sigma=1 .0912) 

c 

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 

Goodness-of-Fit Tests for Normal Distribution 

Test Statistic p Value 

Kolmogorov-Smirnov D 0.05368 Pr > D <0.010 

Cramer-von Mises W-Sq 3.13714 Pr > W-Sq <0.005 

Anderson-Darling A-Sq 18.5995 Pr > A-Sq <0.005 

The final list of log-transformed cut points is derived from the average of the mean and standard 

deviation of the log transformed non-zero PHR rate from four quarters of PHR data. (The antilog 

of these cut points is taken to obtain the cut points of the non-transformed PHR 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. 

51 
Table E-1 Quarterly PHR Mean, Standard Deviation and Tier Distribution 

Number of 

Establishments Mean Standard Deviation 

Tier 

Distribution 

(Number of 

Establishments) 

Q1CY2017 Tier 1 68 

Both 1,036 -4.47 1.03 Tier 2 122 

Processing 4,104 -4.84 0.85 Tier 3 4,950 

Q2CY2017 Tier 1 57 

Both 1,055 -4.29 1.01 Tier 2 76 

Processing 4,106 -4.61 0.79 Tier 3 5,028 

Q3CY2017 Tier 1 69 

Both 1,079 -4.40 1.03 Tier 2 108 

Processing 4,140 -4.88 0.87 Tier 3 5,042 

Q4CY2017 Tier 1 65 

Both 1,076 -4.47 1.02 Tier 2 95 

Processing 4,172 -4.86 0.84 Tier 3 5,088 

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 2018 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 -4.41 -4.80 

Standard Deviation 1.02 0.84 

Table E-3 March 2018 Tier Distribution Based on the PHR Criteria Only 

Classification Plants 

Tier 1 63 

Tier 2 68 

Tier 3 5,102 

Total 5,233 

52 
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 201 3.84% 5 7.94% 

Turkey Slaughter 54 1.03% 1 1.59% 

Beef Slaughter 652 12.46% 1 1.59% 

Pork Slaughter 610 11.66% 2 3.17% 

Beef Processing 1646 31.45% 14 22.22% 

Chicken Processing 805 15.38% 14 22.22% 

Turkey Processing 310 5.92% 3 4.76% 

Pork Processing 1812 34.63% 13 20.63% 

RTE 2550 48.73% 38 60.32% 

Poultry Combination 390 7.45% 8 12.70% 

Total Number of 

Establishments 5233 63 

53