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FY2017 Public Health Regulations

June 2016
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Table of Contents

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

1.0 Introduction............................................................................................................................. 10

2.0 Selection of PHRs................................................................................................................... 12

2.1 Criteria for Selection of Candidate Regulations................................................................. 12

2.2 Relationship with Pathogen Positives................................................................................. 13

3.0 Candidate Regulations............................................................................................................ 15

4.0 Relationship Between Candidate regulations and Pathogen Positives................................... 16

4.1 Salmonella........................................................................................................................... 17

4.1.1 Salmonella in Intact Chicken....................................................................................... 18

4.1.2 Salmonella in Intact Turkey......................................................................................... 19

4.1.3 Salmonella in Ground Beef.......................................................................................... 19

4.1.4 Salmonella in Intact Beef............................................................................................. 20

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

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

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

4.1.8 Salmonella in Ground Pork.......................................................................................... 23

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

4.1.10 Salmonella in Ready to Eat........................................................................................ 25

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

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

4.2.2 Non-O157 STEC.......................................................................................................... 26

4.3 Listeria monocytogenes...................................................................................................... 27

4.4 Campylobacter.................................................................................................................... 27

4.4.1 Campylobacter in Intact Chicken ................................................................................ 28

4.4.2 Campylobacter in Intact Turkey .................................................................................. 29

4.4.3 Campylobacter in Comminuted Chicken..................................................................... 30

4.4.4 Campylobacter in Comminuted Turkey ...................................................................... 30

4.4.5 Campylobacter in Chicken Parts ................................................................................. 31

4.5 Enforcement Actions .......................................................................................................... 31

5.0 List of FY2017 PHRs.............................................................................................................. 34

6.0 Cut Points for FY2017 PHRs.................................................................................................. 41

7.0 Conclusion .............................................................................................................................. 44

8.0 References............................................................................................................................... 45

Appendix A: FY2017 PHR Regulations....................................................................................... 46

Appendix B: Past Use of Public Health regulations..................................................................... 48

Appendix C: FY2017 Candidate regulations................................................................................ 49

Appendix D: Steps Used to Develop PHR List ............................................................................ 54
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Appendix E: Comparison of FY2017 PHR List with FY2016 PHR List..................................... 55

Appendix F: Use of Public Health Regulations in Scheduling Food Safety Assessments........... 58

F-1 Calculating the Cut Points.................................................................................................. 58

F-2 Scheduling FSAs Using Seven Criteria.............................................................................. 63
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List of Figures and Tables

Figure 4-1 Number of Verifications of Candidate Regulations 3 Months before a Pathogen 

Positive or Enforcement Action.................................................................................................... 16

Figure 5-1 Odds Ratio for 54 PHRs.............................................................................................. 39

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

Verifications 3 Months before a Pathogen Positive or Enforcement Action for Processing 

Establishments.............................................................................................................................. 59

Figure F-2 Regulatory Non-Compliance Rate of PHRs with 20 or More Verifications 3 Months 

before a Pathogen Positive or Enforcement Action for Both (Slaughter and Processing) 

Establishments.............................................................................................................................. 59

Figure F-3 Q-Q Plot of the Log Transformed Non-Zero Non-Compliance Rates of PHRs with 20 

or More Verifications 3 Months before a Pathogen Positive or Enforcement Action for 

Processing Establishments............................................................................................................ 60

Figure F-4 Q-Q Plot of the Log Transformed Non-Zero Non-Compliance Rates of PHRs with 20 

or More Verifications 3 Months before a Pathogen Positive or Enforcement Action for Both 

(Slaughter and Processing) Establishments.................................................................................. 61

Table S-1 Regulatory Categories of FY2017 PHRs....................................................................... 7

Table S-2 FY2017 PHR Tier 1 Cut Points...................................................................................... 8

Table S-3 FY2017 PHR Tier 2 Cut Points...................................................................................... 8

Table S-4 Number of Establishments in Tiers Based on all Seven Decision Criteria.................... 8

Table S-5 Distribution of Tier 1 Establishments Among Different Product Categories................ 9

Table S-6 Number of Establishments in Each Tier without an FSA in Past Six Months Based on 

the all Seven Decision Criteria Level ............................................................................................. 9

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

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

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................. 18

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 .................. 19

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 ................... 20

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 ...................... 20

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.......................................................................................................................................... 22

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

Salmonella Positive with Those for Establishments with No Comminuted Turkey Salmonella

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

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 ...................... 23

Table 4-9 Comparison of Noncompliance Rates 3 Months before a Chicken Parts Salmonella

Positive with Those for Establishments with No Chicken Parts Salmonella Positive.................. 24
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Table 4-10 Comparison of Noncompliance Rates 3 Months before an E. coli O157:H7 Positive 

with Those for Establishments with No E. coli O157:H7 Positive............................................... 25

Table 4-11 Comparison of Noncompliance Rates 3 Months before a Non-O157 STEC Positive 

with Those for Establishments with No Non-O157 STEC Positive............................................. 26

Table 4-12 Comparison of Noncompliance Rates 3 Months before a Listeria monocytogenes

Positive with Those for Establishments with No Listeria monocytogenes Positive..................... 27

Table 4-13 Comparison of Noncompliance Rates 3 Months before a Campylobacter Positive 

with Those for Establishments with No Campylobacter Positive ................................................ 28

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

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

....................................................................................................................................................... 29

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

Turkey Positive with Those for Establishments with No Campylobacter Intact Turkey Positive29

Table 4-16 Comparison of Noncompliance Rates 3 Months before a Comminuted Chicken 

Campylobacter Positive with Those for Establishments with No Comminuted Chicken 

Campylobacter Positive................................................................................................................ 30

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

Campylobacter Positive with Those for Establishments with No Chicken Parts Campylobacter

Positive.......................................................................................................................................... 31

Table 4-18 Comparison of Noncompliance Rates 3 Months before an Enforcement Action with 

Those for Establishments with No Enforcement Action .............................................................. 32

Table 5-1 List of FY2017 PHRs................................................................................................... 34

Table 5-2 Events That Triggered Inclusion of a Regulation in the FY2017 PHR list.................. 39

Table 6-1 Mean and Standard Deviation of Quarterly FY2017 PHR Rate .................................. 41

Table 6-2 FY2017 PHR Tier 1 Cut Points.................................................................................... 42

Table 6- 3 FY2017 PHR Tier 2 Cut Points................................................................................... 42

Table 6-4 Tier Classification of Establishments Based Solely on the PHR Criterion.................. 42

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

Criterion ........................................................................................................................................ 43

Table 6-6 Tier Classification of Establishments Based on the all Seven Decision Criteria ......... 43

Table 6-7 Tier Classification of Establishments without an FSA in Past Six Months Based on the 

all Seven Decision Criteria ........................................................................................................... 43

Table 7- 1 FY2017 PHR Tier 1 Cut Points................................................................................... 44

Table 7- 2 FY2017 PHR Tier 2 Cut Points................................................................................... 44

Table A-1 List of FY2017 PHRs.................................................................................................. 46

Table C-1 FY2017 Candidate Regulations................................................................................... 49

Table C-2 New Candidate Regulations Added............................................................................. 53

Table E-1 Comparison of FY2017 Public Health Regulations with FY2016 PHR List .............. 55

Table E-2 Regulation from the FY2016 PHR list no longer on the FY2017 PHR list................. 57

Table F-1 Quarterly PHR Mean, Standard Deviation and Tier Distribution................................ 62

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

Plant Type ..................................................................................................................................... 62

Table F-3 March 2016 Tier Distribution Based on the PHR Criteria Only.................................. 62

Table F-4 FSA Scheduling for March 2016 Using All Seven Decision Criteria.......................... 63

Table F-5 Distribution of Tier 1 Establishments among Different Plant Types........................... 63

Table F-6 Distribution of Tier 1 Establishments Among Different Product Categories.............. 64
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SUMMARY

The purpose of the present report is to update the FY2016 list of Public Health Regulations 

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

Assessments (FSAs). The FY2016 list of PHRs was based on 2014 FSIS verification inspection 

results and used for FSA scheduling in FY2016. The updated list of PHRs is based on 2015 

verification inspection results and will be implemented in FY2017. The updated list is called 

FY2017 PHRs. 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 list of 

PHRs contains both regulations and specific provisions of regulations. 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 FY2017 PHR list is the same as that used for the 

FY2016 PHR list. As in FY2016, a new approach is employed to develop the cut points between 

Tier 1, Tier 2, and Tier 3 establishments. Rather than apply the means and standard deviations 

directly to the aggregate PHR non-compliance rates, the non-zero, aggregate PHR noncompliances are first log transformed to obtain an approximately normal distribution. The cut 

points are then the mean plus 1.5 standard deviations and the mean plus 2.0 standard deviations 

of the log-transformed normal distribution. The antilog is then taken to obtain the cut points of 

the non-transformed PHR non-compliance data.

Regulations that have higher noncompliance rates in establishments three months before a public 

health related Notice of Intended Enforcement (NOIE) or suspension than in establishments 

without a public health related NOIE or suspension are included in the derivation of the FY2017 

PHRs. A public health related NOIE or suspension is one that results from a Sanitation Standard 

Operating Procedure (Sanitation SOP), HACCP, or Sanitation Performance Standards (SPS)

violation. There were 161 public health related NOIE or suspensions issued in CY2015. The 

public health related NOIE and suspensions are simply referred to as enforcement actions in the 

rest of the report. The enforcement action list of possible PHR regulations was selected from the 

same list of 149 candidate regulations used to select the other FY2017 PHRs.

For inclusion in the FY2017 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 action than in 

establishments without positives or enforcement actions. The analysis was based on one year of 

FSIS verification inspection results (January 1 –December 31, 2015) recorded in PHIS.

The final list of FY2017 PHRs consists of 54 regulations that have higher rates of 

noncompliance three months before a pathogen positive or enforcement action. This compares 
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with 54 regulations that were identified in the FY2016 PHR list. The list of FY2017 PHRs is

presented in Appendix A. Seventy six percent of the regulations on the FY2016 PHR list are also 

on the FY2017 PHR list.

The 54 FY2017 PHRs are composed of 7 regulations and 47 provisions of regulations. The 47

provisions fall under 22 different regulations. Thus, the 54 FY2017 PHRs represent 29

regulations, with the majority of FY2017 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 FY2017 PHR regulations three months before a pathogen 

positive or enforcement action is 6.4 times higher than the average FY2017 PHR noncompliance 

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

The FY2017 PHRs fall into one of 5 broad regulatory categories (see Table S-1). PHRs may fall 

into more than one category.

Table S-1 Regulatory Categories of FY2017 PHRs

FY2017 PHR Category Percent of 

FY2016 PHRs

Percent of 

FY2017 PHRs

Prevent insanitary conditions and ensure product is not 

adulterated (Sanitation SOP/SPS) 53.7% 44.4%

Perform initial hazard analysis, develop HACCP plan and 

verify adequacy of HACCP plans (HACCP) 24.1% 31.5%

Maintain adequate records 9.3% 7.4%

Monitor Critical Control Points and critical limits 3.7% 7.4%

Identify corrective actions and prevent recurrence 9.3% 9.3%

Total 100.0% 100.0%

The FY2017 PHRs are one of seven public health based decision criteria that will be used in 

prioritizing Food Safety Assessments (FSAs). Noncompliance with a single FY2017 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 FY2017 PHR noncompliance rate by 

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 FY2017 cut points, the mean and standard deviation of the log 

transformed non-zero FY2017 PHR rates for each of the four quarters in CY2015 is computed

(the log transform of the non-zero FY2017 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 
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considered for a PHRE if they have not had an FSA in the last six months. Tables S-2 and S-3

present the Tier 1 and Tier 2 FY2017 PHR cut points for the non-transformed PHR noncompliance data for each of the two establishment operation types. Anything below the Tier 2 

cut points would be in Tier 3. The FY2016 PHR cut points are included for comparison. (See 

Section 6 and Appendix F for more details.)

Table S-2 FY2017 PHR Tier 1 Cut Points

Operation Type FY2017 PHR Cut Points FY2016 PHR Cut Points

Processing 4.81% 4.80%

Combination 9.46% 9.25%

Table S-3 FY2017 PHR Tier 2 Cut Points

Operation Type FY2017 PHR Cut Points FY2016 PHR Cut Points

Processing 3.16% 2.97%

Combination 5.82% 5.32%

Table S-4 presents the number of establishments in each Tier based on all seven decision criteria, 

including the PHR criterion. The time period used for calculating the noncompliance rate of the 

PHRs was January 1 –March 31, 2016.

Table S-4 Number of Establishments in Tiers Based on all Seven Decision Criteria

Classification Processing Combination Total

Tier 1 83 18 101

Tier 2 191 147 338

Tier 3 3,793 870 4,663

Total 4,067 1,035 5,102

Table S-5 presents the distribution of Tier 1 establishments (as determined using only the PHR 

criterion) among different product categories. The percentage of all plants and Tier 1 plants adds 

up to more than 100% since a plant may produce more than one product. There is no statistically 

significant difference between the percentage of establishments producing a given product 

category and the percentage of establishments in Tier 1 for that product category except for 

Ground Beef, Pork Slaughter, Ground Pork and RTE.

The product type “Poultry Combination” was included to determine if establishments that 

slaughter poultry only or slaughter and process poultry might receive a higher percentage of Tier 

1 classifications. Analysis indicates that they do not; there is not a statistically significant 

difference between the percentage of establishments in the Poultry Combination product

category and the percentage of establishments in Tier 1 for that product category.
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Table S-5 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

Statistical 

Difference

Chicken Slaughter 193 3.81% 4 6.67% No

Turkey Slaughter 46 0.91% - 0.00% No

Beef Slaughter 639 12.60% 7 11.67% No

Pork Slaughter 596 11.75% 1 1.67% Yes

Ground Beef 1,622 31.99% 9 15.00% Yes

Ground Chicken 808 15.93% 9 15.00% No

Ground Turkey 315 6.21% 2 3.33% No

Ground Pork 1,799 35.48% 9 15.00% Yes

RTE 2,030 40.03% 33 55.00% Yes

Poultry Combination 390 7.69% 5 8.33% No

Total Number of 

Establishments 5,071 60

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. Table S-6 presents the 

number of establishments in each Tier based on all seven decision criteria that have not had an 

FSA in the past six months. The time period used for calculating the noncompliance rate of the 

PHRs was January 1 –March 31, 2016. Seventy two establishments would receive a PHRE after 

removing establishments that have had an FSA in the past six months.

Table S-6 Number of Establishments in Each Tier without an FSA in Past Six Months 

Based on the all Seven Decision Criteria Level

Classification Processing Combination Total

Tier 1 58 14 72

Tier 2 155 110 265

Tier 3 3,240 713 3,953

Total 3,453 837 4,290
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1.0 INTRODUCTION

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

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

Safety Assessments (FSAs). The decision criteria include factors such as pathogen testing 

results, recalls, outbreaks, regulatory findings, and a record of noncompliance with certain 9 

CFR regulations. These criteria are described in detail in FSIS' Public Health Decision Criteria

Report (FSIS 2010). The purpose of an FSA is to review an establishment’s food safety system 

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

in accordance with FSIS statutory and regulatory requirements.

In May, 2015, FSIS issued Directive 5100.4, “Enforcement, Investigations and Analysis Officer 

(EIAO) Public Health Risk Evaluation (PHRE) Methodology” and revised Directive 5100.1, 

“Enforcement, Investigations, and Analysis Officer (EIAO) Comprehensive Food Safety 

Assessment Methodology - Revision 4”. Directive 5100.4 introduced a Public Health Risk 

Evaluation (PHRE) that EIAOs would conduct based on a set of public health decision criteria. 

These criteria include the original criteria from 2008 and additional criteria that FSIS has 

identified. The PHRE is an assessment by an EIAO of available data on an establishment, 

including non-compliances, testing data and enforcement actions. Based on this assessment, the 

EIAO will make a determination whether to conduct an FSA, proceed directly to an enforcement 

action, or take no action. The public health decision criteria now inform the PHRE assessment 

which in turn determines if an FSA is needed.

The subset of 9 CFR regulations used to schedule FSAs was 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 was called Public Health Regulations (PHRs). In January, 2013, FSIS 

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

plans to implement the PHRs. NACMPI endorsed the use of PHRs, and suggested that the PHR 

list be updated annually (NACMPI 2013). The list of FY2014 PHRs was published in July 2013 

(FSIS 2013). The list of FY2015 PHRs was published in July 2014 (FSIS 2014). The list of 

FY2016 PHRs was published in July 2015 (FSIS 2015). The purpose of the present report is to 

update the list of FY2016 PHRs using current verification inspection results from the Public 

Health Information System (PHIS). The updated list is called FY2017 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 list of 

PHRs contains both regulations and specific provisions of regulations. 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 FY2017 PHR list is the same as that used for the 

FY2016 PHR. Specifically, for inclusion in the FY2017 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:
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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, 2015) recorded in 

PHIS.

FSIS has been collecting Campylobacter samples on young chicken carcasses since July 2011. In 

addition, FSIS began testing beef trim for the six non-O157 Shiga toxin-producing Escherichia 

coli (STEC) (O26, O45, O103, O111, O121, and O145) that FSIS declared adulterants in nonintact raw beef products and product components in June 2012. In March 2015, FSIS began testing 

for Salmonella and Campylobacter on raw chicken parts. In May 2015, FSIS began testing for 

Salmonella in both intact and ground pork products. The Campylobacter, the six non-O157

STEC data, the Salmonella on raw chicken parts, and the Salmonella in pork products data will 

be added to the pathogens used to update the list of PHRs. The report does not address possible 

health impacts from allergens or residues. The final FY2017 PHR list is presented in Appendix 

A. Appendix B describes how non-compliance with PHR regulations has been used in the past to 

prioritize scheduling of FSAs.
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2.0 SELECTION OF PHRS

The purpose of this section is to outline the process for selection of PHRs. The PHR list will 

consist of those 9 CFR regulations with which noncompliance occurs more frequently in

establishments in the three month period before Salmonella, E. coli O157:H7, Non-O157 STEC, 

Lm, Campylobacter positives or enforcement actions than in establishments without positives or 

enforcement actions. However, to facilitate the analysis and to focus on the most relevant 9 CFR 

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

verifying HACCP food safety process control.

Thus, the selection of PHRs is a two-step process:

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

process control.

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

statistically higher in establishments in the three months before a Salmonella, E. coli 

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

establishments without positives or enforcement actions.

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

of PHRs is used to identify establishments that significantly deviate from the three month rolling 

average noncompliance rate for all similar establishments.

2.1 Criteria for Selection of Candidate Regulations

The purpose of the list of candidate regulations is to identify a subset of 9 CFR regulations that 

are more directly related to a possible loss of process control. Process control refers to

procedures designed by an establishment to provide control of operating conditions that are 

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

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

regulations.

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

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

establishment’s particular operation. If 1) the design of the plan is effective in eliminating food 

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

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

appropriate, then the resulting product should be safe for the consumer. These four elements of 

HACCP are essential for maintaining an effective process control system and will be used as the 

criteria for selecting the list of candidate regulations.

Regulations will be selected for the candidate list if noncompliance with the regulation provides 

evidence that establishments are NOT satisfying one of the four criteria:

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

• Establish and Maintain Sanitary Conditions

• Prevent Adulteration

• Implement Effective Corrective Actions
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The following are examples of the types of regulations under each criterion that would be 

considered candidate regulations.

• Establish and maintain HACCP

o Failure to maintain adequate HACCP Plan

o Adequacy of HACCP Plan in controlling food safety hazards

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

recorded

o CCPs are under control

• Establish and Maintain Sanitary Conditions

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

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

o Products do not contain foreign material

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

conditions

• Prevent Adulteration

o No adulterated product enters commerce.

o Product and ingredients rendered adulterated by polluted water shall be 

condemned

o Container composed of any poisonous or deleterious substance

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

o Lethality and stabilization requirements for cooked beef

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

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

• Corrective Actions

o Procedures for and selection of appropriate corrective actions

o Document corrective actions

o Identify and eliminate the cause

o Establish measures to prevent recurrence

o Reassess hazard analysis

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

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

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

In the second step of the process, the final list of public health regulations will consist of that 

subset of candidate regulations that are associated with higher noncompliance rates in 

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

or Campylobacter positive or enforcement actions than in establishments without pathogen 

positives or enforcement actions. These regulations will be called PHRs and are considered to be 

indicators of potential public health impact.

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 
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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, 

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

product components.
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3.0 CANDIDATE REGULATIONS

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

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

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

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

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

forty nine (149) 9 CFR regulations were selected as being indicators of a potential loss of food 

safety process control. The list of 149 candidate regulations that are indicators of a potential loss 

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

The FY2017 list of candidate regulations is the same as the FY2016 list of candidate regulations 

except for the addition of 14 regulations. Nine (9) of these regulations are new regulations in 

PHIS related to the New Poultry Inspection System (NPIS) and fecal contamination. Four (4) of 

the regulations are propositions of a regulation in the FY2016 candidate list, and thus offer more 

specificity than in FY2016. A complete list of the 14 additional FY2017 candidate regulations is 

presented in Appendix C.
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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 149 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, 2015 through December 31, 2015. 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. The exact 

sequence of steps used to develop the list of PHRs is given in Appendix D.

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

positive or enforcement action. These candidate regulations are excluded from consideration for 

that specific pathogen or enforcement action since the noncompliance rate associated with these 

regulations is highly uncertain (the candidate regulation is still considered for pathogens where 

the regulations has more the 30 verifications). For candidate regulations with more than 30 

verifications, the average number of verifications of candidate regulations 3 months before a 

pathogen positive or verification for candidate regulations with more than 30 verifications is 

11,479.

Figure 4-1 presents a histogram of the number of verifications of candidate regulations 3 months 

before a pathogen positive or enforcement action. Only pathogen positives or enforcement 

actions with greater than 30 verifications were considered in constructing the figure.

Figure 4-1 Number of Verifications of Candidate Regulations 3 Months before a Pathogen 

Positive or Enforcement Action

0

50

100

150

200

250

300

350

50 100 500 1000 2000 3000 4000 5000 6000 7000 8000 9000 10000 More

Frequency

Bin
17

17

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 is calculated as the number of events divided by the number of non-events. An odds 

ratio is calculated by dividing the odds of a test group (in our case, the odds of receiving a noncompliance of a candidate regulation for establishments with a pathogen positive or enforcement 

action) by the odds in the control group (in our case, the odds of receiving a non-compliance of a 

candidate regulation for establishments without a pathogen positive or enforcement action).

There is no definitive rule for determining a meaningful odds ratio size. In this report, an odds 

ratio size of 3.0 is taken as the threshold for a meaningful odds ratio size.

4.1 Salmonella

The noncompliance rate of each of the 149 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, 2015 to December 31, 2015. The dataset used in the analysis 

consists of candidate PHR noncompliance rates for the 2,082 establishments with Salmonella 

testing data, of which 715 had 2,672 Salmonella positives and 1,367 did not have Salmonella

positives. There were 31,883 total Salmonella tests performed.

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

rate for establishments with no Salmonella positive in the period January 1, 2015 to December

31, 2015.

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 

FY2016 

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

99 310.22(f)(2) Yes 0.39% 0.11% 2.24E-02 3.45

527 381.65(a) Yes 1.94% 0.59% 1.39E-38 3.31

543 381.71(a) Yes 13.20% 1.10% 6.60E-20 13.72

589 416.13(a) No 3.74% 0.78% 0.00E+00 4.97

590 416.13(b) No 0.58% 0.16% 5.65E-193 3.67

591 416.13(c) No 5.67% 1.34% 0.00E+00 4.44

592 416.14 Yes 0.71% 0.23% 4.55E-172 3.18

594 416.15(a) Yes 5.87% 2.03% 9.86E-61 3.00

595 416.15(b) Yes 13.82% 2.55% 1.56E-192 6.14
18

18

Reg 

ID

Regulation 

Verified

On 

FY2016 

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

597 416.16(a) Yes 0.43% 0.14% 8.31E-177 3.08

630 416.3(b) Yes 4.48% 0.88% 1.01E-84 5.32

631 416.3(c) Yes 5.20% 0.98% 2.37E-115 5.53

633 416.4(a) Yes 19.86% 6.15% 0.00E+00 3.78

636 416.4(d) Yes 23.02% 6.61% 0.00E+00 4.22

649 417.2(c)(4) Yes 1.66% 0.38% 0.00E+00 4.40

4.1.1 Salmonella in Intact Chicken

The noncompliance rate of each of the 149 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, 2015 to December 31, 2015. The 

dataset used in the analysis consists of candidate PHR noncompliance rates for the 201 

establishments with Intact Chicken Salmonella testing data, of which 71 had 151 Salmonella

positives and 130 did not have Salmonella positives. There were 6,572 total Intact Chicken 

Salmonella tests performed.

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

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

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, 2015 to December 31, 2015.

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 

FY2016 

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

406 381.1_Adulterated Yes 4.03% 0.78% 1.60E-03 5.33

1349 381.76(b)(6)(ii)(A) No 2.49% 0.25% 8.64E-06 10.27

664 417.3(b)(3) Yes 1.95% 0.53% 5.34E-04 3.74

682 417.5(a)(3) Yes 0.42% 0.13% 5.87E-15 3.35
19

19

4.1.2 Salmonella in Intact Turkey

The noncompliance rate of each of the 149 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, 2015 to December 31, 2015. The 

dataset used in the analysis consists of candidate PHR noncompliance rates for the 46 

establishments with Salmonella testing data, of which 14 had 17 Salmonella positives and 32 did 

not have Salmonella positives. There were 1,422 total Intact Turkey Salmonella tests performed.

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

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

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

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

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

January 1, 2015 to December 31, 2015.

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 

FY2016 

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

1331 381.65(f) No 2.97% 0.97% 7.58E-12 3.12

590 416.13(b) No 4.03% 0.61% 3.52E-24 6.89

597 416.16(a) Yes 1.17% 0.36% 1.53E-05 3.26

4.1.3 Salmonella in Ground Beef

The noncompliance rate of each of the 149 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, 2015 to December 31, 2015. The 

dataset used in the analysis consists of candidate PHR noncompliance rates for the 1,244

establishments with Salmonella testing data, of which 138 had 212 Salmonella positives and 

1,106 did not have Salmonella positives. There were 11,585 total Ground Beef Salmonella tests 

performed.

Table 4-4 presents the 3 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 
20

20

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

January 1, 2015 to December 31, 2015.

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 

FY2016 

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

587 416.12(d) Yes 1.92% 0.18% 5.78E-05 10.86

594 416.15(a) Yes 7.16% 1.62% 8.61E-09 4.68

649 417.2(c)(4) Yes 1.24% 0.29% 9.78E-49 4.32

4.1.4 Salmonella in Intact Beef

The noncompliance rate of each of the 149 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, 2015 to December 31, 2015. FSIS tests beef 

trim and beef manufacturing trimmings as a surrogate for testing intact beef. There are 942 

establishments with Intact Beef Salmonella testing data, of which 75 had 127 Salmonella

positives and 867 did not have Salmonella positives. There were 4,565 total Intact Beef 

Salmonella tests performed.

Table 4-5 presents the 20 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, 2015 to December 31, 2015.

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 

FY2016 

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

717 310.18(a) Yes 4.14% 1.02% 2.11E-117 4.19

99 310.22(f)(2) Yes 0.64% 0.14% 9.19E-03 4.72

152 316.6 No 2.44% 0.49% 3.26E-02 5.09

234 318.2(a) Yes 1.06% 0.07% 8.87E-05 14.75
21

21

Reg 

ID

Regulation 

Verified

On 

FY2016 

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

586 416.12(c) Yes 1.52% 0.17% 6.74E-03 9.23

590 416.13(b) No 0.48% 0.15% 1.90E-11 3.25

591 416.13(c) No 4.80% 1.05% 1.47E-237 4.76

592 416.14 Yes 0.68% 0.23% 1.30E-13 3.01

594 416.15(a) Yes 8.97% 1.65% 4.31E-09 5.87

595 416.15(b) Yes 11.72% 1.72% 1.70E-08 7.57

597 416.16(a) Yes 0.41% 0.13% 1.57E-13 3.07

630 416.3(b) Yes 5.24% 0.70% 2.37E-07 7.81

631 416.3(c) Yes 4.35% 0.86% 2.41E-05 5.24

636 416.4(d) Yes 15.99% 4.92% 2.03E-87 3.68

640 416.5(c) No 4.21% 0.05% 1.63E-06 91.09

645 417.2(a)(1) No 10.67% 2.65% 7.70E-14 4.39

649 417.2(c)(4) Yes 2.95% 0.34% 4.65E-145 8.83

657 417.3(a)(1) Yes 11.84% 2.89% 5.57E-09 4.50

658 417.3(a)(2) Yes 1.16% 0.37% 4.17E-05 3.14

659 417.3(a)(3) Yes 15.20% 5.11% 3.76E-07 3.33

4.1.5 Salmonella in Comminuted Chicken

The noncompliance rate of each of the 149 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, 2015 to December 31, 2015. The dataset used in the analysis consists of candidate PHR 

noncompliance rates for the 141 establishments with Comminuted Chicken Salmonella testing 

data, of which 125 had 954 Salmonella positives and 16 did not have Salmonella positives. There 

were 1,896 total Comminuted Chicken Salmonella tests performed.

Table 4-6 presents the 5 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, 2015 to December 31, 2015.
22

22

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 

FY2016 

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

1331 381.65(f) No 1.14% 0.31% 9.59E-07 3.78

594 416.15(a) Yes 8.72% 2.19% 2.26E-05 4.27

630 416.3(b) Yes 11.35% 1.72% 6.93E-11 7.32

631 416.3(c) Yes 6.99% 1.49% 1.04E-07 4.98

649 417.2(c)(4) Yes 1.40% 0.30% 5.64E-27 4.74

4.1.6 Salmonella in Comminuted Turkey

The noncompliance rate of each of the 149 candidate regulations in establishments three months 

before a Comminuted Turkey Salmonella positive was compared with the average 

noncompliance rate of establishments that received Comminuted Turkey Salmonella FSIS

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

1, 2015 to December 31, 2015. There are 59 establishments with Comminuted Turkey 

Salmonella testing data, of which 42 had 211 Salmonella positives and 17 did not have 

Salmonella positives. There were 1,173 total Comminuted Turkey Salmonella tests performed.

Table 4-7 presents the 6 regulations which had more than 30 verifications in a year, an odds ratio 

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

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, 2015 to December 31, 2015.

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 

FY2016 

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) No 1.65% 0.45% 1.96E-07 3.73

590 416.13(b) No 0.63% 0.10% 1.25E-09 6.14

594 416.15(a) Yes 4.50% 0.49% 1.38E-07 9.48

595 416.15(b) Yes 6.47% 0.15% 9.28E-14 47.46
23

23

Reg 

ID

Regulation 

Verified

On 

FY2016 

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

597 416.16(a) Yes 0.39% 0.09% 1.12E-07 4.27

636 416.4(d) Yes 13.71% 4.45% 1.92E-25 3.41

4.1.7 Salmonella in Intact Pork

The noncompliance rate of each of the 149 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, 2015 to December 31, 2015. There are 172

establishments with Intact Pork Salmonella testing data, of which 33 had 55 Salmonella positives 

and 139 did not have Salmonella positives. There were 411 total Intact Pork Salmonella tests 

performed.

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

rate for establishments with no Intact Pork Salmonella positive in the period January 1, 2015 to 

December 31, 2015.

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 

FY2016 

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 8.66% 2.34% 1.31E-35 3.96

591 416.13(c) No 6.55% 2.07% 4.33E-80 3.32

631 416.3(c) Yes 4.62% 0.68% 2.90E-06 7.10

4.1.8 Salmonella in Ground Pork

The noncompliance rate of each of the 149 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, 2015 to December 31, 2015. There 

are 296 establishments with Ground Pork Salmonella testing data, of which 87 had 145
24

24

Salmonella positives and 209 did not have Salmonella positives. There were 789 total Ground 

Pork Salmonella tests performed.

There are no 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, 2015 to December 31, 2015. 

4.1.9 Salmonella in Chicken Parts

The noncompliance rate of each of the 149 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, 2015 to December 31, 2015. There 

are 406 establishments with Chicken Parts Salmonella testing data, of which 287 had 800 

Salmonella positives and 119 did not have Salmonella positives. There were 3,470 total Chicken 

Parts Salmonella tests performed.

Table 4-9 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 Chicken Parts Salmonella positive is higher than the average 

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

January 1, 2015 to December 31, 2015. 

Table 4-9 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 

FY2016 

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

234 318.2(a) Yes 1.26% 0.08% 1.59E-02 15.24

527 381.65(a) Yes 3.14% 0.84% 1.20E-52 3.83

543 381.71(a) Yes 13.63% 2.04% 1.73E-15 7.57

557 381.83 No 0.03% 0.00% 2.12E-02 6.83

564 381.91(a) Yes 0.73% 0.10% 1.90E-05 7.42

565 381.91(b) Yes 1.47% 0.42% 1.64E-10 3.53

631 416.3(c) Yes 6.26% 1.87% 3.19E-18 3.50

658 417.3(a)(2) Yes 0.59% 0.17% 5.03E-08 3.46

668 417.4(a) Yes 11.26% 2.02% 3.25E-05 6.16
25

25

4.1.10 Salmonella in Ready to Eat

The noncompliance rate of each of the 149 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, 2015 to December 31, 2015. The 

dataset used in the analysis consists of candidate PHR noncompliance rates for the 2,007

establishments with Salmonella testing data, of which 6 had 6 Salmonella positives and 2,001 did 

not have Salmonella positives. There were 11,990 total Ready to Eat Salmonella tests performed.

There are no 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 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, 2015 to 

December 31, 2015.

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 149 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, 2015 to December 31, 2015. The dataset used in the analysis consists of 

candidate PHR noncompliance rates for the 1,281 establishments with E. coli O157:H7 testing 

data, of which 11 had 11 E. coli O157:H7 positives and 1,270 did not have E. coli O157:H7 

positives. There were 15,454 total E. coli O157:H7 tests performed.

Table 4-10 presents the 4 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, 2015 to December 

31, 2015.

Table 4-10 Comparison of Noncompliance Rates 3 Months before an E. coli O157:H7 

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

Reg 

ID

Regulation 

Verified

On 

FY2016 

PHR 

List

Noncompliance 

Rate in 3 

Months before 

a E. coli O157 

Positive

Noncompliance 

Rate for 

Establishments 

with no E. coli

O157 Positive

TwoSided 

Fisher 

Exact p 

Value

Odds 

Ratio

99 310.22(f)(2) Yes 2.78% 0.20% 1.10E-02 13.94

582 416.1 Yes 8.16% 2.26% 7.28E-13 3.84
26

26

Reg 

ID

Regulation 

Verified

On 

FY2016 

PHR 

List

Noncompliance 

Rate in 3 

Months before 

a E. coli O157 

Positive

Noncompliance 

Rate for 

Establishments 

with no E. coli

O157 Positive

TwoSided 

Fisher 

Exact p 

Value

Odds 

Ratio

636 416.4(d) Yes 19.44% 5.15% 1.31E-13 4.45

682 417.5(a)(3) Yes 1.13% 0.27% 8.37E-05 4.29

4.2.2 Non-O157 STEC

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

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

(beef or veal trim). FSIS has declared there are six non-O157 STEC adulterants in raw 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 149 

candidate regulations in the three months before a non- 157 STEC positive was compared with 

the average noncompliance rate of establishments that received FSIS non- O157 STEC

verification testing, but had no non-O157 STEC positives in the period January 1, 2015 to 

December 31, 2015. The dataset used in the analysis consists of candidate PHR noncompliance 

rates for the 367 establishments with non-O157 STEC testing data, of which 23 had 59 nonO157 STEC positives and 344 did not have non-O157 STEC positives. There were 3,034 total 

non-O157 STEC tests performed.

Table 4-11 presents the 7 regulations which had more than 30 verifications in a year, an odds 

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

Fisher 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, 

2015 to December 31, 2015.

Table 4-11 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 

FY2016 

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

29 301.2_Adulterated Yes 56.76% 2.30% 4.97E-24 55.79

586 416.12(c) Yes 1.60% 0.11% 3.49E-03 14.79

587 416.12(d) Yes 1.68% 0.13% 4.33E-03 12.84

631 416.3(c) Yes 3.42% 0.95% 2.83E-02 3.71

633 416.4(a) Yes 18.67% 6.60% 4.36E-24 3.25

636 416.4(d) Yes 21.98% 8.35% 3.79E-22 3.09

660 417.3(a)(4) Yes 2.29% 0.58% 1.47E-02 4.05
27

27

4.3 Listeria monocytogenes

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

and Listeria monocytogenes positives. The noncompliance rate of each of the 149 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, 2015 to 

December 31, 2015. The dataset used in the analysis consists of candidate PHR noncompliance 

rates for the 2,008 establishments with Listeria monocytogenes testing data, of which 43 had 46 

Listeria monocytogenes positives and 1,965 did not have Listeria monocytogenes positives.

There were 11,963 total Listeria monocytogenes tests performed.

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

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

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, 2015 to 

December 31, 2015.

Table 4-12 Comparison of Noncompliance Rates 3 Months before a Listeria monocytogenes 

Positive with Those for Establishments with No Listeria monocytogenes Positive

Reg 

ID

Regulation 

Verified

On 

FY2016 

PHR List

Noncompliance 

Rate in 3 

Months before 

a Listeria

monocytogenes

Positive

Noncompliance 

Rate for 

Establishments 

with no Listeria

monocytogenes

Positive

Two-Sided 

Fisher 

Exact p 

Value

Odds 

Ratio

631 416.3(c) Yes 8.33% 1.39% 1.37E-02 6.47

701 430.4(a) Yes 0.37% 0.04% 1.14E-03 9.24

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 149 candidate regulations

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

noncompliance rate of establishments that received FSIS Campylobacter verification testing, but 

had no Campylobacter positives in the period January 1, 2015 to December 31, 2015. The 

dataset used in the analysis consists of candidate PHR noncompliance rates for the 567 

establishments with Campylobacter testing data, of which 264 had 854 Campylobacter positives 

and 303 did not have Campylobacter positives. There were 13,805 total Campylobacter tests 

performed.

Table 4-13 presents the 7 regulations which had more than 30 verifications in a year, an odds 

ratio of 3.0 or greater, and for which there is 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
28

28

months before a Campylobacter positive is higher than the noncompliance rate for 

establishments with no Campylobacter positive in the period January 1, 2015 to December 31, 

2015.

Table 4-13 Comparison of Noncompliance Rates 3 Months before a Campylobacter Positive 

with Those for Establishments with No Campylobacter Positive

Reg 

ID

Regulation 

Verified

On 

FY2016 

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

234 318.2(a) Yes 2.91% 0.08% 4.67E-06 37.17

457 381.150(a) No 8.06% 0.46% 2.34E-04 19.04

630 416.3(b) Yes 4.79% 1.43% 4.17E-24 3.46

668 417.4(a) Yes 11.28% 3.09% 3.36E-05 3.98

669 417.4(a)(1) No 7.32% 1.94% 1.70E-02 4.00

675 417.4(b) Yes 1.31% 0.40% 3.33E-03 3.34

701 430.4(a) Yes 0.22% 0.03% 2.36E-02 7.00

4.4.1 Campylobacter in Intact Chicken

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

and Campylobacter positives. The noncompliance rate of each of the 149 candidate regulations

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

noncompliance rate of establishments that received FSIS Campylobacter verification testing, but 

had no Campylobacter positives in the period January 1, 2015 to December 31, 2015. The 

dataset used in the analysis consists of candidate PHR noncompliance rates for the 201 

establishments with Intact Chicken Campylobacter testing data, of which 66 had 164 

Campylobacter positives and 135 did not have Campylobacter positives. There were 6,129 total 

Intact Chicken Campylobacter tests performed.

Table 4-14 presents the 3 regulations which had more than 30 verifications in a year, an odds 

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

Fisher 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, 2015 to December 31, 

2015.
29

29

Table 4-14 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 

FY2016 

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

1349 381.76(b)(6)(ii)(A) No 14.04% 0.49% 2.00E-09 33.36

648 417.2(c) Yes 1.15% 0.27% 2.33E-02 4.38

682 417.5(a)(3) Yes 0.80% 0.13% 1.51E-44 6.31

4.4.2 Campylobacter in Intact Turkey

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

and Campylobacter positives. The noncompliance rate of each of the 149 candidate regulations

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

noncompliance rate of establishments that received FSIS Campylobacter verification testing, but 

had no Campylobacter positives in the period January 1, 2015 to December 31, 2015. The 

dataset used in the analysis consists of candidate PHR noncompliance rates for the 46 

establishments with Campylobacter testing data, of which 13 had 21 Campylobacter positives 

and 33 did not have Campylobacter positives. There were 1,323 total Intact Turkey 

Campylobacter tests performed.

Table 4-15 presents the 1 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, 2015 to December 31, 

2015.

Table 4-15 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 

FY2016 

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

681 417.5(a)(2) Yes 0.34% 0.11% 3.87E-02 3.03
30

30

4.4.3 Campylobacter in Comminuted Chicken

The noncompliance rate of each of the 149 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, 2015 to December 31, 2015. The dataset used in the analysis consists of candidate 

PHR noncompliance rates for the 141 establishments with Comminuted Chicken Campylobacter

testing data, of which 40 had 161 Campylobacter positives and 101 did not have Campylobacter 

positives. There were 1,894 total Comminuted Chicken Campylobacter tests performed.

Table 4-16 presents the 7 regulations which had more than 30 verifications in a year, an odds 

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

Fisher 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, 2015 to December 31, 2015.

Table 4-16 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 

FY2016 

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 2.99% 0.42% 3.20E-08 7.25

565 381.91(b) Yes 2.11% 0.63% 1.75E-03 3.43

594 416.15(a) Yes 9.79% 3.20% 2.64E-12 3.29

630 416.3(b) Yes 17.39% 3.90% 1.52E-19 5.19

648 417.2(c) Yes 1.31% 0.22% 4.70E-03 6.08

659 417.3(a)(3) Yes 34.17% 3.84% 9.80E-27 13.01

675 417.4(b) Yes 2.69% 0.55% 4.68E-03 5.05

4.4.4 Campylobacter in Comminuted Turkey

The noncompliance rate of each of the 149 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, 2015 to December 31, 2015. The dataset used in the analysis consists of candidate 

PHR noncompliance rates for the 59 establishments with Comminuted Turkey Campylobacter

testing data, of which 4 had 5 Campylobacter positives and 55 did not have Campylobacter 

positives. There were 1,171 total Comminuted Turkey Campylobacter tests performed.
31

31

There are no 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 Campylobacter positive is higher than the average 

noncompliance rate for establishments with no Comminuted Turkey Campylobacter positive in 

the period January 1, 2015 to December 31, 2015.

4.4.5 Campylobacter in Chicken Parts

The noncompliance rate of each of the 149 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, 2015 to December 31, 

2015. The dataset used in the analysis consists of candidate PHR noncompliance rates for the 

405 establishments with Chicken Parts Campylobacter testing data, of which 207 had 503

Campylobacter positives and 198 did not have Campylobacter positives. There were 3,288 total 

Chicken Parts Campylobacter tests performed.

Table 4-17 presents the 3 regulations which had more than 30 verifications in a year, an odds 

ratio of 3.0 or greater, and for which there is 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, 2015 to December 31, 2015.

Table 4-17 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 

FY2016 

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

234 318.2(a) Yes 1.53% 0.12% 3.06E-02 12.45

669 417.4(a)(1) No 11.90% 2.88% 2.25E-02 4.55

675 417.4(b) Yes 0.99% 0.25% 2.67E-02 3.98

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 
32

32

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 149 candidate 

regulations used to select all other FY2017 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, 2015 to December 

31, 2015. The dataset used in the analysis consists of candidate PHR noncompliance rates for the 

5,337 active meat and poultry establishments, of which 138 had 161 public health related NOIEs

or suspensions and 5,199 did not have any public health related NOIEs or suspensions.

Table 4-18 presents the 24 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, 2015 to December 31, 2015.

Table 4-18 Comparison of Noncompliance Rates 3 Months before an Enforcement Action 

with Those for Establishments with No Enforcement Action

Reg 

ID

Regulation 

Verified

On 

FY2016 

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) Yes 5.91% 1.71% 5.17E-04 3.62

90 310.22(e)(3) Yes 4.46% 1.28% 1.68E-02 3.61

92 310.22(e)(4)(i) Yes 1.11% 0.19% 3.32E-04 5.76

107 310.25(a) Yes 3.83% 0.69% 2.14E-05 5.77

228 318.17(a)(1)(2) No 2.90% 0.32% 2.52E-02 9.43

530 381.65(e)* Yes 4.59% 1.04% 1.16E-18 4.56

1331 381.65(f) No 5.49% 1.28% 2.62E-23 4.49

587 416.12(d) Yes 1.25% 0.23% 7.26E-03 5.47

593

416.15 

Corrective 

Actions No 6.45% 0.54% 3.15E-02 12.69

594 416.15(a) Yes 7.37% 2.13% 7.13E-05 3.65

597 416.16(a) Yes 0.57% 0.16% 2.20E-20 3.46

630 416.3(b) Yes 4.63% 1.11% 2.31E-05 4.30

631 416.3(c) Yes 4.73% 1.50% 2.03E-04 3.26
33

33

Reg 

ID

Regulation 

Verified

On 

FY2016 

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

645 417.2(a)(1) No 12.32% 2.08% 4.62E-35 6.60

649 417.2(c)(4) Yes 2.15% 0.68% 4.49E-32 3.19

657 417.3(a)(1) Yes 27.85% 2.33% 9.45E-18 16.17

659 417.3(a)(3) Yes 25.61% 3.15% 1.08E-13 10.58

664 417.3(b)(3) Yes 7.14% 0.76% 4.28E-03 10.00

665 417.3(b)(4) Yes 9.40% 0.83% 6.42E-09 12.46

680 417.5(a)(1) Yes 1.81% 0.33% 1.80E-52 5.62

681 417.5(a)(2) Yes 0.90% 0.13% 3.44E-29 6.81

682 417.5(a)(3) Yes 1.75% 0.29% 1.63E-62 6.21

701 430.4(a) Yes 0.33% 0.05% 4.17E-04 6.59

704 430.4(b)(3) Yes 5.92% 1.33% 2.45E-04 4.66
34

34

5.0 LIST OF FY2017 PHRS

Since many establishments produce multiple products and were included in multiple analyses in Chapter 4, a consolidated list of 

regulations applied to all establishments was selected to combine the above lists of pathogen-specific and enforcement PHRs into a 

single FY2017 PHR list. Table 5-1 presents the list of 54 FY2017 PHRs. These 53 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 54 FY2017 PHRs are composed of 7 regulations and 47 provisions of regulations. The 47 provisions fall under 22 different 

regulations. Thus, the 54 FY2017 PHRs represent 29 regulations, with the majority of FY2017 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 FY2017 PHRs

Reg 

ID

List of FY2017 

PHRs

Description On 

FY2016 

PHR 

List

NC Rate 

in 3 

Months 

before a 

Pathogen 

Positive

NC Rate for 

Establishments 

with no 

Pathogen 

Positive

Two-Sided 

Fisher 

Exact p 

Value

Odds 

Ratio

29 301.2_Adulterated Adulterated Yes 56.76% 2.30% 4.97E-24 55.790

717 310.18(a)

Carcasses, organs, and other parts 

handled in a sanitary manner Yes 4.14% 1.02% 2.11E-117 4.189

88 310.22(e)(1)

Written procedures for removal, 

segregation, and disposition of SRMs Yes 5.91% 1.71% 5.17E-04 3.62

90 310.22(e)(3)

Evaluate effectiveness of procedures 

for removal, segregation, and 

disposition of SRMs Yes 4.46% 1.28% 1.68E-02 3.61

92 310.22(e)(4)(i) Maintain daily records Yes 1.11% 0.19% 3.32E-04 5.758

99 310.22(f)(2)

Use of routine operational sanitation 

procedures on equipment used to cut 

through SRMs Yes 0.64% 0.14% 9.19E-03 4.716
35

35

Reg 

ID

List of FY2017 

PHRs

Description On 

FY2016 

PHR 

List

NC Rate 

in 3 

Months 

before a 

Pathogen 

Positive

NC Rate for 

Establishments 

with no 

Pathogen 

Positive

Two-Sided 

Fisher 

Exact p 

Value

Odds 

Ratio

107 310.25(a)

Verification criteria for E. coli testing 

meat Yes 3.83% 0.69% 2.14E-05 5.765

152 316.6

Products not to be removed from 

official establishments unless marked 

in accordance with the regulations No 2.44% 0.49% 3.26E-02 5.086

228 318.17(a)(1)(2)

Lethality and Stabilization 

requirements for cooked beef No 2.90% 0.32% 2.52E-02 9.433

234 318.2(a)

All products subject to reinspection by 

program employees Yes 2.91% 0.08% 4.67E-06 37.170

406 381.1_Adulterated Adulterated Yes 4.03% 0.78% 1.60E-03 5.328

457 381.150(a)

Lethality and Stabilization 

requirements for cooked poultry No 8.06% 0.46% 2.34E-04 19.035

527 381.65(a)

Clean and sanitary practices; products 

not adulterated Yes 3.14% 0.84% 1.20E-52 3.83

530 381.65(e)*

Zero-tolerance for visible fecal material 

entering chiller Yes 4.59% 1.04% 1.16E-18 4.563

1331 381.65(f)

Procedures for controlling visible fecal 

contamination No 5.49% 1.28% 2.62E-23 4.485

543 381.71(a)

Condemnation on ante mortem 

inspection Yes 13.20% 1.10% 6.60E-20 13.719

550 381.76(a)*

Post-mortem inspection, when 

required, extent. Yes 2.99% 0.42% 3.20E-08 7.251

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

NPIS Sorting, Trimming, and 

Reprocessing No 14.04% 0.49% 2.00E-09 33.358

557 381.83 (HIMP ONLY) Septicemia or toxemia No 0.03% 0.00% 2.12E-02 6.833
36

36

Reg 

ID

List of FY2017 

PHRs

Description On 

FY2016 

PHR 

List

NC Rate 

in 3 

Months 

before a 

Pathogen 

Positive

NC Rate for 

Establishments 

with no 

Pathogen 

Positive

Two-Sided 

Fisher 

Exact p 

Value

Odds 

Ratio

564 381.91(a)

Certain contaminated carcasses to be 

condemned Yes 0.73% 0.10% 1.90E-05 7.421

565 381.91(b)

Reprocessing of carcasses accidentally 

contaminated with digestive tract 

contents. Yes 1.47% 0.42% 1.64E-10 3.53

582 416.1

Operate in a manner to prevent 

insanitary conditions Yes 8.66% 2.34% 1.31E-35 3.96

586 416.12(c) plan identifies procedures for pre-op Yes 1.60% 0.11% 3.49E-03 14.792

587 416.12(d)

plan list frequency for each procedure 

& responsible individual Yes 1.92% 0.18% 5.78E-05 10.860

589 416.13(a) conduct pre-op procedures No 3.74% 0.78% 0.00E+00 4.969

590 416.13(b)

conduct other procedures listed in the 

plan No 0.58% 0.16% 5.62E-193 3.67

591 416.13(c)

plant monitors implementation of 

SSOP procedures No 5.67% 1.34% 0.00E+00 4.441

592 416.14

Evaluate effectiveness of SSOP's & 

maintain plan Yes 0.71% 0.23% 4.55E-172 3.18

593

416.15 Corrective 

Actions

Corrective Actions

No 6.45% 0.54% 3.15E-02 12.690

594 416.15(a) Appropriate corrective actions Yes 5.87% 2.03% 9.86E-61 3.00

595 416.15(b) Corrective action, procedures for Yes 13.82% 2.55% 1.56E-192 6.135

597 416.16(a)

daily records required, responsible 

individual, initialed and dated Yes 0.43% 0.14% 8.30E-177 3.08

630 416.3(b)

Constructed, located & operated in a 

manner that does not deter inspection Yes 4.48% 0.88% 1.01E-84 5.318
37

37

Reg 

ID

List of FY2017 

PHRs

Description On 

FY2016 

PHR 

List

NC Rate 

in 3 

Months 

before a 

Pathogen 

Positive

NC Rate for 

Establishments 

with no 

Pathogen 

Positive

Two-Sided 

Fisher 

Exact p 

Value

Odds 

Ratio

631 416.3(c)

Receptacles for storing inedible 

material must identify permitted use Yes 5.20% 0.98% 2.37E-115 5.529

633 416.4(a)

Food contact surface, cleaning & 

sanitizing as frequency Yes 19.86% 6.15% 0.00E+00 3.78

636 416.4(d)

Product processing, handling, storage, 

loading, unloading, and during 

transportation must be protected Yes 23.02% 6.61% 0.00E+00 4.222

640 416.5(c)

Employees who appears to have any 

abnormal source of microbial 

contamination No 4.21% 0.05% 1.63E-06 91.092

645 417.2(a)(1) Hazard analysis No 12.32% 2.08% 4.62E-35 6.604

648 417.2(c) Contents of HACCP Plan Yes 1.31% 0.22% 4.70E-03 6.075

649 417.2(c)(4) List of procedures & frequency Yes 1.66% 0.38% 0.00E+00 4.398

657 417.3(a)(1) Identify and eliminate the cause Yes 27.85% 2.33% 9.45E-18 16.165

658 417.3(a)(2) CCP is under control Yes 0.59% 0.17% 5.03E-08 3.46

659 417.3(a)(3)

Establish measures to prevent 

recurrence Yes 34.17% 3.84% 9.80E-27 13.013

660 417.3(a)(4)

No adulterated product enters 

commerce. Yes 2.29% 0.58% 1.47E-02 4.053

664 417.3(b)(3)

No adulterated product enters 

commerce Yes 1.95% 0.53% 5.34E-04 3.74

665 417.3(b)(4) Reassessment Yes 9.40% 0.83% 6.42E-09 12.464

668 417.4(a)

Adequacy of HACCP in controlling 

food safety hazards Yes 11.26% 2.02% 3.25E-05 6.162

669 417.4(a)(1) Initial validation No 7.32% 1.94% 1.70E-02 4.00
38

38

Reg 

ID

List of FY2017 

PHRs

Description On 

FY2016 

PHR 

List

NC Rate 

in 3 

Months 

before a 

Pathogen 

Positive

NC Rate for 

Establishments 

with no 

Pathogen 

Positive

Two-Sided 

Fisher 

Exact p 

Value

Odds 

Ratio

675 417.4(b) Reassessment of hazard analysis Yes 1.31% 0.40% 3.33E-03 3.34

680 417.5(a)(1) Written hazard analysis Yes 1.81% 0.33% 1.80E-52 5.618

681 417.5(a)(2) Written HACCP plan Yes 0.90% 0.13% 3.44E-29 6.814

682 417.5(a)(3)

Records documentation and monitoring 

of CCP's and Critical Limits Yes 1.75% 0.29% 1.63E-62 6.206

701 430.4(a) Lm, post-lethality exposed RTE Yes 0.33% 0.05% 4.17E-04 6.588

704 430.4(b)(3) Alternative 3 Yes 5.92% 1.33% 2.45E-04 4.663
39

39

Figure 5-1 presents a histogram of the ratios (odds ratios) for each of the 54 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 9.97. 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 9.97 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 54 PHRs

Forty one of the previous 54 FY2016 PHRs are mapped into these 54 FY2017 PHRs. 

Approximately 76% of the FY2016 PHRs are included in the FY2017 PHRs. There are 13 

additional regulations that were on the FY2016 PHR list and are not in the FY2017 PHR list (See 

Appendix E).

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

FY2017 PHR list. Most regulations were triggered by multiple events.

Table 5-2 Events That Triggered Inclusion of a Regulation in the FY2017 PHR list

Product Number of Regulations Percent

Campylobacter 7 5.56%

Campylobacter Ground Chicken 7 5.56%

Campylobacter Ground Turkey 0 0.00%

Campylobacter Intact Chicken 3 2.38%

Campylobacter Intact Turkey 1 0.79%

Campylobacter Chicken Parts 3 2.38%

Enforcement Actions 24 19.05%

NonO157 STEC 7 5.56%

0

5

10

15

20

3 4 5 10 20 30 40 50 60 70 80 90

Frequency

Bin

Odds Ratio for 54 PHRs
40

40

Product Number of Regulations Percent

O157 4 3.17%

Listeria 2 1.59%

Salmonella 15 11.90%

Salmonella Ground Beef 3 2.38%

Salmonella Ground Chicken 5 3.97%

Salmonella Ground Turkey 6 4.76%

Salmonella Intact Beef 20 15.87%

Salmonella Intact Chicken 4 3.17%

Salmonella Intact Turkey 3 2.38%

Salmonella RTE 0 0.00%

Salmonella Intact Pork 3 2.38%

Salmonella Ground Pork 0 0.00%

Salmonella Chicken Parts 9 7.14%

Total 126 100.00%
41

41

6.0 CUT POINTS FOR FY2017 PHRS

The FY2017 PHRs are one of the original criteria from 2008 and additional criteria that FSIS has 

identified that are used in prioritizing Public Health Risk Evaluation (PHRE). These decision 

criteria are described in detail in FSIS' Directive 5100.4, “Enforcement, Investigations and 

Analysis Officer (EIAO) Public Health Risk Evaluation (PHRE) Methodology” (FSIS 2015). 

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 FY2017 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 FY2017 PHR 

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

categories of establishment operations: Processing and Combination (Slaughter plus Processing).

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

That means that the natural logarithm of the non-zero PHR non-compliance rate is 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 FY2017 cut points, the mean and standard deviation of the natural 

log transformed non-zero FY2017 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 

FY2017 PHR rates is taken to obtain an approximately normal distribution, see Appendix F). 

These results are given in Table 6-1. 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 FY2017 PHR Rate

Mean of Natural

Log FY2017 PHR Rate

Standard Deviation

of FY2017 PHR Rate

Mean Combination Processing Combination Processing

Jan-Mar 2015 -4.37 -4.74 0.95 0.85

Apr-Jun 2015 -4.15 -4.52 0.90 0.78

July-Sep 2015 -4.30 -4.77 1.03 0.87

Oct-Dec 2015 -4.39 -4.81 1.01 0.85

Average -4.30 -4.71 0.97 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 
42

42

noncompliance rates higher than the upper cut point for similar establishments are classified as 

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

transformed data for Processing establishments is -4.71 + 2*0.84 = -4.71 + 1.67 = --3.03. The cut 

point of the original, non-transformed PHR non-compliance data is the antilog of -3.03 or Exp(-

3.03) = 4.81%. Tables 6-2 and 6-3 present the FY2017 PHR Tier 1 and Tier 2 cut points for each 

of the two establishment operation types. Anything below the Tier 2 cut points would be in Tier 

3. The FY2016 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 2017.

Table 6-2 FY2017 PHR Tier 1 Cut Points

Operation Type FY2017 PHR Cut Points FY2016 PHR Cut Points

Processing 4.81% 4.80%

Combination 9.46% 9.25%

Table 6- 3 FY2017 PHR Tier 2 Cut Points

Operation Type FY2017 PHR Cut Points FY2016 PHR Cut Points

Processing 3.16% 2.97%

Combination 5.82% 5.32%

Table 6-4 presents the number of establishments in each Tier based solely on the FY2017 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 FY2017 PHRs, 60

establishments are in Tier 1 and candidates to receive PHREs. Table 6-3 is based on regulatory 

non-compliances for the period January 1 –March 31, 2016.

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

Classification Number of Establishments

Tier 1 60

Tier 2 75

Tier 3 4,936

Total 5,071

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

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

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

based solely on non-compliances with the FY2017 PHRs, 47 processing establishments are Tier 

1 and are candidates to receive PHREs. In total, 60 establishments are in Tier 1 based solely on 

non-compliances with the FY2017 PHRs. Table 6-4 is based on regulatory non-compliances 

during January 1 –March 31, 2016
43

43

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

PHR Criterion

Classification Processing Combination

Tier 1 47 13

Tier 2 52 23

Tier 3 3,937 999

Total 4,036 1,035

Table 6-6 presents the number of establishments in each Tier based on all seven decision criteria, 

including the PHR criterion. The time period used for calculating the noncompliance rate of the 

PHRs was January 1 –March 31, 2016

Table 6-6 Tier Classification of Establishments Based on the all Seven Decision Criteria

Classification Processing Combination Total

Tier 1 83 18 101

Tier 2 191 147 338

Tier 3 3,793 870 4,663

Total 4,067 1,035 5,102

In using the decision tree methodology and the seven decision criteria to schedule PHREs, 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. Table 6-7 presents the number of establishments without an FSA in the past 

six months in each Tier based on all seven decision criteria. The time period used for calculating 

the noncompliance rate of the PHRs was January 1 –March 31, 2016. Seventy two

establishments are candidate to receive a PHRE based on this data. The district may schedule 

additional PHREs at additional establishments based on other considerations. “For cause” 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.

Table 6-7 Tier Classification of Establishments without an FSA in Past Six Months Based 

on the all Seven Decision Criteria

Classification Processing Combination Total

Tier 1 58 14 72

Tier 2 155 110 265

Tier 3 3,240 713 3,953

Total 3,453 837 4,290
44

44

7.0 CONCLUSION

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

FY2017 PHR regulations used to prioritize certain Fy2017 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 FY2017 PHRs has 54 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 six percent of the regulations on the FY2016 PHR list are 

also on the FY2017 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 PHRE. 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 FY2017 PHR Tier 1 and Tier 2 cut points (the upper cut points 

are equal to antilog of the mean plus two times the standard deviation of the log transformed 

non-zero PHR rate for similar establishments). Anything that falls below the Tier 2 cut point 

would be in Tier 3. The FY2016 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 FY2017 PHR Tier 1 Cut Points

Operation Type FY2017 PHR Cut Points FY2016 PHR Cut Points

Processing 4.81% 4.80%

Combination 9.46% 9.25%

Table 7- 2 FY2017 PHR Tier 2 Cut Points

Operation Type FY2017 PHR Cut Points FY2016 PHR Cut Points

Processing 3.16% 2.97%

Combination 5.82% 5.32%
45

45

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/wps/wcm/connect/fcaeabab-b89e-4bd4-b990-

c697f34a797f/2010_Public_Health_Decsion_Criteria_Report.pdf?MOD=AJPERES

)

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/data-collection-and-reports/fsisdata-analysis-and-reporting/data-reporting/public-health-regulations

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

Regulations. http://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-andreports/fsis-data-analysis-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

5. Food Safety and Inspection Service (FSIS) 2015, Directive 5100.4, Enforcement, 

Investigations and Analysis Officer (EIAO) Public Health Risk Evaluation (PHRE) 

Methodology. http://www.fsis.usda.gov/wps/wcm/connect/6c30c8b0-ab6a-4a3cbd87-fbce9bd71001/5100.4.pdf?MOD=AJPERES
46

46

APPENDIX A: FY2017 PHR REGULATIONS

Table A-1 presents the list of fifty four FY2017 Public Health Regulations (PHRs). On average,

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

enforcement action 6.4 times higher than the PHR noncompliance rates for establishments with 

no pathogen positive or enforcement action.

Table A-1 List of FY2017 PHRs

Reg 

ID

List of FY2017 

PHRs

Description

29 301.2_Adulterated Adulterated

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

88 310.22(e)(1)

Written procedures for removal, segregation, and disposition of 

SRMs

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

152 316.6

Products not to be removed from official establishments unless 

marked in accordance with the regulations

228 318.17(a)(1)(2) Lethality and Stabilization requirements for cooked beef

234 318.2(a) All products subject to reinspection by program employees

406 381.1_Adulterated Adulterated

457 381.150(a) Lethality and Stabilization requirements for cooked poultry

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

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

1331 381.65(f) Procedures for controlling visible fecal contamination

543 381.71(a) Condemnation on ante mortem inspection

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

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

557 381.83 (HIMP ONLY) Septicemia or toxemia

564 381.91(a) Certain contaminated carcasses to be condemned

565 381.91(b)

Reprocessing of carcasses accidentally contaminated with 

digestive tract contents.

582 416.1 Operate in a manner to prevent insanitary conditions

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

587 416.12(d) plan list frequency for each procedure & responsible individual

589 416.13(a) conduct pre-op procedures

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

591 416.13(c) plant monitors implementation of SSOP procedures

592 416.14 Evaluate effectiveness of SSOP's & maintain plan
47

47

Reg 

ID

List of FY2017 

PHRs

Description

593

416.15 Corrective 

Actions

Corrective Actions

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

640 416.5(c)

Employees who appears to have any abnormal source of 

microbial contamination

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.

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

665 417.3(b)(4) Reassessment

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

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

704 430.4(b)(3) Alternative 3
48

48

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 FY2017 PHRs is presented in Appendix A. The list of FY2016 

PHRs is presented in FSIS (2014). 

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

months of establishment noncompliance data: 

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

Slaughter/Processing Combination):

• 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 PHREs.

• 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. 

 Number of PHR Non-compliances

PHR NC Rate = 

 Total Number of PHR Inspection Verifications
49

49

APPENDIX C: FY2017 CANDIDATE REGULATIONS

Table C-1 presents the list of 149 candidate regulations. The noncompliance rates in Table C-1 

are based on PHIS data for January 1, 2015 through December 31, 2015.

Table C-1 FY2017 Candidate Regulations

Reg 

ID

FY2017 Candidate 

Regulation

FY2016 

PHR

Mandatory 

Regulation

Total FSIS 

Verifications Total NCs1 NC1 Rate

29 301.2_Adulterated Yes No 10,650 237 2.23%

43 304.3(a) No No 1,113 5 0.45%

45 304.3(c) No No 1,298 18 1.39%

53 309.2(a) No No 1,145 10 0.87%

54 309.3 No No 158 1 0.63%

55 309.4 No No 129 - 0.00%

56 309.5 No No 7 - 0.00%

57 309.9 No No 11 - 0.00%

69 310.18 Yes No 480 9 1.88%

77 310.22(b) No No 6,684 21 0.31%

78 310.22(c) Yes Yes 56,316 161 0.29%

84 310.22(d)(2) No No 178 - 0.00%

88 310.22(e)(1) Yes No 13,869 188 1.36%

89 310.22(e)(2) No No 8,793 48 0.55%

90 310.22(e)(3) Yes No 9,007 97 1.08%

92 310.22(e)(4)(i) Yes No 101,722 305 0.30%

99 310.22(f)(2) Yes No 19,542 28 0.14%

101 310.22(g)(1) No No 2,624 6 0.23%

104 310.22(g)(4) No No 4,478 16 0.36%

107 310.25(a) Yes No 30,197 290 0.96%

108 310.25(b) No No 268 1 0.37%

109 310.25(b)(3)(ii) No No 357 1 0.28%

110 310.3 No No 4,164 173 4.15%

114 311.16 No No 126 14 11.11%

115 311.17 No No 139 - 0.00%

116 311.24 No No 9 - 0.00%

138 315.2 No No 128 - 0.00%

152 316.6 No No 11,401 71 0.62%

178 317.24(a) No No 4,779 11 0.23%

207 318.1(b) No No 93,593 15 0.02%

215 318.10(b) Yes No 3,099 11 0.35%

217 318.10(c)(1) No No 3,406 6 0.18%

218 318.10(c)(2) No No 739 1 0.14%

219 318.10(c)(3) No No 545 3 0.55%

221 318.14(a) No No 350 - 0.00%
50

50

Reg 

ID

FY2017 Candidate 

Regulation

FY2016 

PHR

Mandatory 

Regulation

Total FSIS 

Verifications Total NCs1 NC1 Rate

222 318.14(b) No No 919 - 0.00%

223 318.14(c) No No 37 - 0.00%

226 318.16(b) No No 392 1 0.26%

228 318.17(a)(1)(2) No No 3,999 16 0.40%

229 318.17(b) No No 970 1 0.10%

230 318.17(c) No No 37 - 0.00%

234 318.2(a) Yes No 53,702 101 0.19%

235 318.2(d) No No 9,679 45 0.46%

239 318.23(b)(1) No No 377 10 2.65%

241 318.23(b)(3) No No 23 3 13.04%

242 318.23(c)(1) No No 95 2 2.11%

243 318.23(c)(2) No No 19 1 5.26%

245 318.23(c)(4) No No 40 - 0.00%

246 318.23(c)(5) No No 19 - 0.00%

247 318.24 No No 2,128 11 0.52%

251 318.303 No Yes 7,991 10 0.13%

256 318.308 No Yes 4,790 4 0.08%

268 318.6(b)(1) No No 3,548 1 0.03%

273 318.6(b)(4) No No 9,780 - 0.00%

274 318.6(b)(6) No No 13,707 2 0.01%

275 318.6(b)(8) No No 534 - 0.00%

329 319.5(b) No No 78 - 0.00%

406 381.1_Adulterated Yes No 11,522 136 1.18%

450 381.144(a) No No 2,046 3 0.15%

457 381.150(a) No No 2,167 18 0.83%

459 381.150(c) No No 89 2 2.25%

460 381.150(d) No No 7 2 28.57%

462 381.151(a) No No 43 - 0.00%

490 381.22(a) No No 422 - 0.00%

491 381.22(b) No No 1,485 6 0.40%

492 381.22(c) No No 320 3 0.94%

503 381.310 No Yes 5,033 - 0.00%

504 381.311 No Yes 4,860 - 0.00%

506 381.37(a) No No 2,251 17 0.76%

527 381.65(a) Yes No 89,697 1,204 1.34%

530 381.65(e)* Yes Yes 228,381 2,491 1.09%

543 381.71(a) Yes No 4,135 297 7.18%

545 381.72(a) No No 202 - 0.00%

546 381.72(b) No No 3 - 0.00%

550 381.76(a)* Yes No 24,242 526 2.17%
51

51

Reg 

ID

FY2017 Candidate 

Regulation

FY2016 

PHR

Mandatory 

Regulation

Total FSIS 

Verifications Total NCs1 NC1 Rate

557 381.83 No No 196,857 64 0.03%

559 381.85 No No 163 - 0.00%

564 381.91(a) Yes No 16,101 44 0.27%

565 381.91(b) Yes No 32,530 344 1.06%

571 381.94(a)* Yes No 1,566 8 0.51%

572 381.94(b) No No 345 2 0.58%

573 381.94(b)(3)(ii) No No 13 - 0.00%

582 416.1 Yes Yes 655,740 19,009 2.90%

586 416.12(c) Yes No 47,789 101 0.21%

587 416.12(d) Yes No 62,535 155 0.25%

588

416.13 Implementation 

of SOP's Yes No 7,819 29 0.37%

589 416.13(a) No Yes 744,222 7,119 0.96%

590 416.13(b) No Yes 1,766,074 4,044 0.23%

591 416.13(c) No Yes 2,619,909 41,042 1.57%

592 416.14 Yes Yes 1,584,124 4,385 0.28%

593

416.15 Corrective 

Actions No No 668 4 0.60%

594 416.15(a) Yes No 56,504 1,213 2.15%

595 416.15(b) Yes No 38,809 1,240 3.20%

597 416.16(a) Yes Yes 2,818,201 4,965 0.18%

630 416.3(b) Yes No 75,232 745 0.99%

631 416.3(c) Yes No 72,079 1,011 1.40%

633 416.4(a) Yes No 317,368 24,105 7.60%

636 416.4(d) Yes No 300,089 25,046 8.35%

640 416.5(c) No No 37,490 22 0.06%

641 416.6 No No 2,964 176 5.94%

645 417.2(a)(1) No No 107,849 2,430 2.25%

648 417.2(c) Yes No 34,568 136 0.39%

649 417.2(c)(4) Yes Yes 1,380,050 8,436 0.61%

655 417.3 Corrective actions No No 446 1 0.22%

656 417.3(a) No No 1,553 3 0.19%

657 417.3(a)(1) Yes No 28,069 688 2.45%

658 417.3(a)(2) Yes No 149,843 740 0.49%

659 417.3(a)(3) Yes No 23,796 784 3.29%

660 417.3(a)(4) Yes No 43,298 423 0.98%

662 417.3(b)(1) Yes No 4,588 149 3.25%

663 417.3(b)(2) Yes No 4,025 134 3.33%

664 417.3(b)(3) Yes No 18,183 133 0.73%

665 417.3(b)(4) Yes Yes 27,372 232 0.85%
52

52

Reg 

ID

FY2017 Candidate 

Regulation

FY2016 

PHR

Mandatory 

Regulation

Total FSIS 

Verifications Total NCs1 NC1 Rate

666 417.3(c) Yes No 5,514 322 5.84%

668 417.4(a) Yes No 6,725 280 4.16%

669 417.4(a)(1) No No 4,425 130 2.94%

675 417.4(b) Yes Yes 30,040 118 0.39%

680 417.5(a)(1) Yes Yes 1,321,191 4,493 0.34%

681 417.5(a)(2) Yes Yes 1,194,926 1,853 0.16%

682 417.5(a)(3) Yes Yes 1,431,597 4,667 0.33%

689 417.5(f) Yes No 88,157 146 0.17%

690 417.6 No No 553 127 22.97%

701 430.4(a) Yes Yes 293,714 193 0.07%

702 430.4(b)(1) No No 1,529 7 0.46%

703 430.4(b)(2) Yes No 12,992 127 0.98%

704 430.4(b)(3) Yes No 26,476 388 1.47%

705 430.4(c)(2) Yes Yes 282,447 224 0.08%

706 430.4(c)(3) Yes Yes 296,209 171 0.06%

707 430.4(c)(4) No No 2,794 20 0.72%

708 430.4(c)(5) No No 6,066 31 0.51%

709 430.4(c)(6) No No 6,700 110 1.64%

717 310.18(a) Yes Yes 312,671 3,194 1.02%

718 310.18(b) No No 21,050 4 0.02%

1241 354.242(b) No No 122 1 0.82%

1247 354.242(h) No No 80 - 0.00%

1250 354.243(a) No No 63 1 1.59%

1292 381.193(a) Yes No 126 9 7.14%

1331 381.65(f) No No 484,633 6,221 1.28%

1346 381.65(h) No No 3,514 - 0.00%

1348 381.69 No No 309 5 1.62%

1349 381.76(b)(6)(ii)(A) No No 6,319 31 0.49%

1350 381.76(b)(6)(ii)(D) No No 367 42 11.44%

1351 381.76(b)(6)(ii)(C) No No 68,370 23 0.03%

1352 381.76(b)(6)(ii)(B) No No 566 14 2.47%

1. NC = Noncompliance

Table C-2 shows the 14 new regulations that were added to the candidate list for the FY2017 

analysis.
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Table C-2 New Candidate Regulations Added

Reg 

ID 

Regulation Description

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

645 417.2(a)(1) Hazard analysis

1344 381.65(f) Procedures for controlling visible fecal contamination

1345 381.65(g) Procedures for controlling contamination throughout the slaughter 

and dressing operation

1346 381.65(h) Recordkeeping requirements

1347 381.66(b) Chilling performance standards, except for ratites

1348 381.69 Maximum line speed rates under the New Poultry Inspection System

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

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

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

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

1444 311.14 Abrasions, bruises, abscesses, pus, etc.
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APPENDIX D: STEPS USED TO DEVELOP PHR LIST

The following steps are used to determine the list of PHRs:

1. Obtain the PHIS noncompliance data for the period October 1, 2014 to December 31, 

2015.

2. Develop the list of establishments with at least one Salmonella positive in the four month 

period January 1, 2015 to December 31, 2015.

3. For each candidate regulation and each establishment on the list in step 2 above, 

determine the number of compliant and noncompliant inspection findings three months 

before the occurrence of a Salmonella positive.

4. For each candidate regulation, sum the number of compliant and noncompliant 

verification inspections three months before the occurrence of a Salmonella positive 

across all establishments and all Salmonella positives. The result is the total number of 

compliant and noncompliant verification inspections for a given candidate regulation.

5. Repeat the above process for E. coli O157:H7, Non- O157 STEC, Lm, Campylobacter

and enforcement actions. 

6. Remove any regulations that have 30 or less total inspections in the three months before 

a positive or for establishments without any positives.

7. For each candidate regulation, determine if the noncompliance rate three months before 

the occurrence of a Salmonella positive is statistically higher (as measured by a twosided Fisher Exact p ≤ 0.05) than the noncompliance rate for establishments without any 

Salmonella positives.

8. For each candidate regulation, determine if the odds ratio is 3.0 or greater.

9. The final list of FY2017 PHRs is the combination of the lists for Salmonella, E. coli

O157:H7, Non- O157 STEC, Lm, Campylobacter and enforcement actions determined 

through the above steps.
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APPENDIX E: COMPARISON OF FY2017 PHR LIST WITH FY2016 PHR 

LIST

Table E-1 presents a comparison of the FY2017 PHR list with the FY2016 PHR list (See FSIS 

(2014) for the FY2016 PHR list). Seventy six percent of the regulations on the FY2016 PHR list 

are also on the FY2017 PHR.

Table E-1 Comparison of FY2017 Public Health Regulations with FY2016 PHR List

RegID List of FY2017 

PHRs

Description On 

FY2016 

PHR 

List

29 301.2_Adulterated Adulterated Yes

717 310.18(a)

Carcasses, organs, and other parts handled in a 

sanitary manner Yes

88 310.22(e)(1)

Written procedures for removal, segregation, and 

disposition of SRMs Yes

90 310.22(e)(3)

Evaluate effectiveness of procedures for removal, 

segregation,and disposition of SRMs Yes

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

99 310.22(f)(2)

Use of routine operational sanitation procedures on 

equipment used to cut through SRMs Yes

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

152 316.6

Products not to be removed from official 

establishments unless marked in accordance with the 

regulations No

228 318.17(a)(1)(2)

Lethality and Stabilization requirements for cooked 

beef No

234 318.2(a)

All products subject to reinspection by program 

employees Yes

406 381.1_Adulterated Adulterated Yes

457 381.150(a)

Lethality and Stabilization requirements for cooked 

poultry No

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

530 381.65(e)*

Zero-tolerance for visible fecal material entering 

chiller Yes

1331 381.65(f) Procedures for controlling visible fecal contamination No

543 381.71(a) Condemnation on ante mortem inspection Yes

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

1349 381.76(b)(6)(ii)(A) NPIS Sorting, Trimming, and Reprocessing No

557 381.83 (HIMP ONLY) Septicemia or toxemia No

564 381.91(a) Certain contaminated carcasses to be condemned Yes
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RegID List of FY2017 

PHRs

Description On 

FY2016 

PHR 

List

565 381.91(b)

Reprocessing of carcasses accidentally contaminated 

with digestive tract contents. Yes

582 416.1 Operate in a manner to prevent insanitary conditions Yes

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

587 416.12(d)

plan list frequency for each procedure & responsible 

individual Yes

589 416.13(a) conduct pre-op procedures No

590 416.13(b) conduct other procedures listed in the plan No

591 416.13(c) plant monitors implementation of SSOP procedures No

592 416.14 Evaluate effectiveness of SSOP's & maintain plan Yes

593

416.15 Corrective 

Actions

Corrective Actions

No

594 416.15(a) Appropriate corrective actions Yes

595 416.15(b) Corrective action, procedures for Yes

597 416.16(a)

daily records required, responsible individual, initialed 

and dated Yes

630 416.3(b)

Constructed, located & operated in a manner that does 

not deter inspection Yes

631 416.3(c)

Receptacles for storing inedible material must identify 

permitted use Yes

633 416.4(a)

Food contact surface, cleaning & sanitizing as 

frequency Yes

636 416.4(d)

Product processing, handling, storage, loading, 

unloading, and during transportation must be protected Yes

640 416.5(c)

Employees who appears to have any abnormal source 

of microbial contamination No

645 417.2(a)(1) Hazard analysis No

648 417.2(c) Contents of HACCP Plan Yes

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

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

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

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

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

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

665 417.3(b)(4) Reassessment Yes

668 417.4(a)

Adequacy of HACCP in controlling food safety 

hazards Yes

669 417.4(a)(1) Initial validation No

675 417.4(b) Reassessment of hazard analysis Yes
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RegID List of FY2017 

PHRs

Description On 

FY2016 

PHR 

List

680 417.5(a)(1) Written hazard analysis Yes

681 417.5(a)(2) Written HACCP plan Yes

682 417.5(a)(3)

Records documentation and monitoring of CCP's and 

Critical Limits Yes

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

704 430.4(b)(3) Alternative 3 Yes

There are thirteen regulations from the FY2016 PHR list that no longer appear in the FY2017 

PHR list. These thirteen regulations are shown in Table E-2.

Table E-2 Regulation from the FY2016 PHR list no longer on the FY2017 PHR list

Reg 

ID

List of FY2016 PHRs Description

69 310.18 Contamination of carcasses, organs, or other parts

78 310.22(c) Disposal of SRM

215 318.10(b) Products requiring treatment to destroy trichinae

571 381.94(a)* Verification criteria for E. coli testing poultry

588 416.13 Implementation of SOP's Implementation of SSOP

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

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

666 417.3(c) Document corrective actions

689 417.5(f) Official Review

703 430.4(b)(2) Alternative 2

705 430.4(c)(2) Lm, documentation that supports decision in hazard 

analysis

706 430.4(c)(3) Lm, maintain sanitation in post-lethality processing 

environment

1292 381.193(a) Poultry not intended for human food in commerce
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APPENDIX F: USE OF PUBLIC HEALTH REGULATIONS IN 

SCHEDULING FOOD SAFETY ASSESSMENTS

The purpose of this Appendix is to explain how the 54 PHRs are used as one component of the 

overall decision tree methodology used to schedule FSAs.

F-1 Calculating the Cut Points

This section discusses the derivation of the cut-points for the PHR noncompliance criteria.

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

months of establishment verification inspection data:

PPPPPP NNNNNNNNNNNNNNNNNNNNNNNNNN RR = NNNNNNNNNNNN oo PPPPPP NNNNNNNNNNNNNNNNNNNNNNNNNNNN

TT NNNNNNNNNNNN oo PPPPPP II PP

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 F-1 and Figure F-2 present histograms for 

processing and combination 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.
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Figure F-1 Log Transformed Non-zero Non-Compliance Rates of PHRs with 20 or More 

Verifications 3 Months before a Pathogen Positive or Enforcement Action for Processing 

Establishments

Figure F-2 Regulatory Non-Compliance Rate of PHRs with 20 or More Verifications 3 

Months before a Pathogen Positive or Enforcement Action for Both (Slaughter and 

Processing) Establishments
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60

These distributions are approximately normally distributed. The Shapiro-Wilk test for normality 

W statistics for the two distributions are 0.988 and 0.993, respectively, which indicates nearnormality (The test statistic W takes values between 0 and 1, with values close to 1 indicating 

near-normality).

A visual test for near-normality is the Q-Q plot where the quantiles of a dataset are plotted 

against the quantiles that would be expected from a normal distribution. If the two set of points

come from a population with the same distribution, the points should fall approximately along a 

450 line.

Figure F-3 Q-Q Plot of the Log Transformed Non-Zero Non-Compliance Rates of PHRs 

with 20 or More Verifications 3 Months before a Pathogen Positive or Enforcement Action 

for Processing Establishments
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Figure F-4 Q-Q Plot of the Log Transformed Non-Zero Non-Compliance Rates of PHRs 

with 20 or More Verifications 3 Months before a Pathogen Positive or Enforcement Action 

for Both (Slaughter and Processing) Establishments

For each of the two plant types, the mean and standard deviation of the log transformed non-zero 

PHR noncompliance rates (hereafter called the PHR rate) are calculated separately for all 

establishments with 20 or more PHR verification inspections and at least two non-compliances.

For each of the two plant types, there are two cut points for the log-transformed data: one is two 

times the standard deviation plus the mean of the log transformed non-zero PHR rate and the 

other is one and a half times the standard deviation plus the mean of the log transformed nonzero PHR rate.

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 F-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. 

Across the four quarters, there is an average of 68 Tier 1 establishments per month based solely 

on the PHR criteria. The subset of the 72 establishments that have not had an FSA in the past 6 

months will receive a PHRE.
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Table F-1 Quarterly PHR Mean, Standard Deviation and Tier Distribution

Number of 

Establishments Mean Standard Deviation

Tier Distribution 

(Number of 

Establishments)

Q1CY2015 Tier 1 77

Both 1,030 -4.37 0.95 Tier 2 105

Processing 3,994 -4.74 0.85 Tier 3 4,842

Q2CY2015 Tier 1 57

Both 1,038 -4.15 0.90 Tier 2 81

Processing 4,041 -4.52 0.78 Tier 3 4,941

Q3CY2015 Tier 1 66

Both 1,038 -4.30 1.03 Tier 2 101

Processing 4,024 -4.77 0.87 Tier 3 4,895

Q4CY2015 Tier 1 73

Both 1,039 -4.39 1.01 Tier 2 106

Processing 4,032 -4.81 0.85 Tier 3 4,892

Table F-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 F-1. Table F-3 

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

F-2. There are 60 PHREs in the March 2016 ranking based on PHRs only.

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

Rates by Plant Type

Combination Processing

Mean -4.30 -4.71

Standard Deviation 0.97 0.84

Table F-3 March 2016 Tier Distribution Based on the PHR Criteria Only

Classification Plants

Tier 1 60

Tier 2 75

Tier 3 4,936

Total 5,071
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F-2 Scheduling FSAs Using Seven Criteria

Table F-4 presents the Tier distribution of establishments when using all seven decision criteria, 

including the FY2017 PHR regulations and the cut points defined from Table F-2. The table is 

derived from data for the three month period January 1 –March 31, 2016. The second column 

represents the number of establishments in each of the Tier categories. When scheduling FSAs, 

establishments that have had an FSA in the past six months are not automatically scheduled for 

another FSA. 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 FSA. The third column in Table F-4 represents to number of establishments in each of 

the Tier 1 categories when establishments with an FSA in the past six months are removed.

Table F-4 FSA Scheduling for March 2016 Using All Seven Decision Criteria

Number Plants in Each Tier 

Using all 7 Decision Criteria

Number Plants in Each Tier 

without FSA in Past 6 Months

Tier 1 101 72

Tier 2 338 265

Tier 3 4,663 3,953

Total 5,102 4,290

Table F-5 presents the distribution of Tier 1 establishments among different establishment types. 

There is no statistically significant difference between the percentage of Tier 1 processing and 

combination establishments with their representation among all establishments.

Table F-5 Distribution of Tier 1 Establishments among Different Plant Types

Plant Type Number 

Plants

Percent 

Plants

Number 

Tier 1 

Plants

Percent Tier 1 

Plants

Statistical 

Difference with 

Representation 

Among All Plants

Processing 4,067 79.71% 83 82.18% No

Combination 1,035 20.29% 18 17.82% No

Totals 5,102 100.00% 92 100.00%

Table F-6 presents the distribution of Tier 1 establishments (as determined using only the PHR 

criteria) among different product categories. There is not a statistically significant difference 

between the percentage of establishments producing a given product category and the percentage 

of establishments in Tier 1 for that product category except for Ground Beef, Pork Slaughter, 

Ground Pork and RTE.

The product type “Poultry Combination” was included since it was suspected that establishments 

that slaughter only or slaughter and process poultry may receive a higher percentage of Tier 1 

classifications. The analysis indicates that there is not a statistically significant difference

between the percentage of establishments classified as Poultry Combination and the percentage 

of establishments in Tier 1 for that product category
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Table F-6 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

Statistical 

Difference

Chicken Slaughter 193 3.81% 4 6.67% No

Turkey Slaughter 46 0.91% - 0.00% No

Beef Slaughter 639 12.60% 7 11.67% No

Pork Slaughter 596 11.75% 1 1.67% Yes

Ground Beef 1,622 31.99% 9 15.00% Yes

Ground Chicken 808 15.93% 9 15.00% No

Ground Turkey 315 6.21% 2 3.33% No

Ground Pork 1,799 35.48% 9 15.00% Yes

RTE 2,030 40.03% 33 55.00% Yes

Poultry Combination 390 7.69% 5 8.33% No

Total Number of 

Establishments 5,071 60