1 

FY2016 Public Health Regulations

June 8, 2014

1 
2 

Table of Contents 

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

1.0 Introduction ............................................................................................................................. 11

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

4.1.4 Salmonella in Intact Beef ............................................................................................. 21

4.1.5 Salmonella in Comminuted Chicken ........................................................................... 22

4.1.6 Salmonella in Comminuted Turkey ............................................................................. 23

4.1.7 Salmonella in Ready to Eat .......................................................................................... 24

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

4.5 Enforcement Actions .......................................................................................................... 32

5.0 List of FY2016 PHRs.............................................................................................................. 35

6.0 Cut Points for FY2016 PHRs .................................................................................................. 42

7.0 Conclusion .............................................................................................................................. 45

8.0 References ............................................................................................................................... 46

Appendix A: FY2016 PHR Regulations ....................................................................................... 47

Appendix B: Past Use of Public Health regulations ..................................................................... 49

Appendix C: FY2016 Candidate regulations ................................................................................ 50

Appendix D: Steps Used to Develop PHR List ............................................................................ 54

Appendix E: Comparison of FY2016 PHR List with FY2015 PHR List ..................................... 55

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

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

2 
3 

F-2 Scheduling FSAs Using Seven Criteria.............................................................................. 62

3 
4 

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 Cohen Effect Sizes for 54 PHRs ................................................................................ 40

Figure F- 1 Log Transformed Non-zero Non-Compliance Rates of PHRs with 40 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 40 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 40 

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 40 

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

(Slaughter and Processing) Establishments .................................................................................. 60

Table S- 1 Regulatory Categories of FY2016 PHRs ...................................................................... 7

Table S- 2 Events That Triggered Inclusion of a Regulation in the FY2016 PHR list................... 7

Table S- 3 FY2016 PHR Upper Cut Points .................................................................................... 8

Table S- 4 Number of Establishments in Tiers Based on all Seven Decision Criteria ................... 9

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 ........................................................................................... 10

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

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

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 ................... 21

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

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

Table 4- 8 Comparison of Noncompliance Rates 3 Months before a Ready to Eat Salmonella

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

Table 4- 9 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

4 
5 

Table 4- 10 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- 11 Comparison of Noncompliance Rates 3 Months before a Campylobacter Positive 

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

Table 4- 12 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- 13 Comparison of Noncompliance Rates 3 Months before a Campylobacter Intact 

Turkey Positive with Those for Establishments with No Campylobacter Intact Turkey Positive 30

Table 4- 14 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- 15 Comparison of Noncompliance Rates 3 Months before a Comminuted Turkey 

Campylobacter Positive with Those for Establishments with No Comminuted Turkey 

Campylobacter Positive ................................................................................................................ 31

Table 4- 16 Comparison of Noncompliance Rates 3 Months before an Enforcement Action with 

Those for Establishments with No Enforcement Action .............................................................. 33

Table 5- 1 List of FY2016 PHRs .................................................................................................. 35

Table 5- 2 Events That Triggered Inclusion of a Regulation in the FY2016 PHR list ................. 40

Table 5- 3 Regulations Triggered for Inclusion in the FY2016 PHR List by Only a Single Event

....................................................................................................................................................... 41

Table 6- 1 Mean and Standard Deviation of Quarterly FY2016 PHR Rate ................................. 42

Table 6- 2 FY2016 PHR Tier 1 Cut Points ................................................................................... 43

Table 6- 3 Tier Classification of Establishments Based Solely on the PHR Criterion ................. 43

Table 6- 4 Tier Classification of Establishments Based on Operation Type and Only the PHR 

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

Table 6- 5 Tier Classification of Establishments Based on the all Seven Decision Criteria ........ 44

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

all Seven Decision Criteria ........................................................................................................... 44

Table 7- 1 FY2016 PHR Upper Cut Points .................................................................................. 45

Table A-1 List of FY2016 PHRs .................................................................................................. 47

Table C- 1 FY2016 Candidate regulations ................................................................................... 50

Table E- 1 Comparison of FY2016 Public Health Regulations with FY2015 PHR List ............. 55

Table E- 2 Regulation from the FY2015 PHR list no longer on the FY2016 PHR list ................ 57

Table F- 1 Quarterly PHR Mean, Standard Deviation and Tier Distribution ............................... 61

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

Plant Type ..................................................................................................................................... 61

Table F- 3 February 2015 Tier Distribution Based on the PHR Criteria Only ............................. 62

Table F- 4 FSA Scheduling for February 2015 Using All Seven Decision Criteria..................... 62

Table F- 5 Distribution of Tier 1 Establishments among Different Plant Types .......................... 62

Table F- 6 Distribution of Tier 1 Establishments Among Different Product Categories ............. 63

5 
6 

SUMMARY 

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

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

Assessments (FSAs). The current list of PHRs was based on 2013 FSIS verification inspection 

results and used for FSA scheduling in FY2015. The updated list of PHRs is based on 2014 

verification inspection results and will be implemented in FY2016. The updated list is called 

FY2016 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 health related

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

The methodology used in developing the FY2016 PHR list is the same as that used for the 

FY2015 PHR list. 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 non-compliances 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. 

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 FY2016 

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 166 public health related NOIE or suspensions issued in CY2014. 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 regulations was selected from the same list of 

134 candidate regulations used to select the other FY2016 PHRs.

For inclusion in the FY2016 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, 2014) recorded in PHIS.

The final list of FY2016 PHRs consists of 54 regulations that have higher rates of 

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

with 48 regulations that were identified in the FY2015 PHR list. The list of FY2016 PHRs is

presented in Appendix A. Eighty five percent of regulations on the FY2015 PHR list are also on 

the FY2016 PHR list.

6 
7 

The 54 FY2016 PHRs are composed of 6 regulations and 48 provisions of regulations. The 48 

provisions fall under 21 different regulations. Thus, the 54 FY2016 PHRs represent 27 

regulations, with the majority of FY2016 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 FY2016 PHR regulations three months before a pathogen 

positive or enforcement action is 5.4 times higher than the average FY2016 PHR noncompliance 

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

The FY2016 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 FY2016 PHRs

FY2016 PHR Category Percent of 

FY2015 PHRs

Percent of 

FY2016 PHRs

Prevent insanitary conditions and ensure product is not 

adulterated (Sanitation SOP/SPS) 45.8% 53.7%

Perform initial hazard analysis, develop HACCP plan and 

verify adequacy of HACCP plans (HACCP) 29.2% 24.1%

Maintain adequate records 8.3% 9.3%

Monitor Critical Control Points and critical limits 6.3% 3.7%

Identify corrective actions and prevent recurrence 10.4% 9.3%

Total 100% 100.0%

Table S-2 lists the number of regulations triggered by each type of event for inclusion in the 

FY2015 PHR list. A regulation may be triggered by multiple events. There were fourteen 

regulations triggered by a single type of event.

Table S- 2 Events That Triggered Inclusion of a Regulation in the FY2016 PHR list

Type of Event

Number of FY2015 

PHR Regulations

Number of FY2016 

PHR Regulations Percent

Campylobacter All Products 15 16 7.84%

Campylobacter Comminuted

Chicken

0

12 5.88%

Campylobacter Comminuted

Turkey

0

7 3.43%

Campylobacter Intact Chicken 12 13 6.37%

Campylobacter Intact Turkey 5 4 1.96%

Enforcement Actions 38 40 19.61%

NonO157 STEC All Products 12 8 3.92%

O157 All Products 10 5 2.45%

Salmonella All Products 22 30 14.71%

7 
8 

Type of Event

Number of FY2015 

PHR Regulations

Number of FY2016 

PHR Regulations Percent

Salmonella Ground Beef 10 15 7.35%

Salmonella Comminuted

Chicken

2

7 3.43%

Salmonella Comminuted Turkey 1 8 3.92%

Salmonella Intact Beef 0 15 7.35%

Salmonella Intact Chicken 14 16 7.84%

Salmonella Intact Turkey 8 6 2.94%

Salmonella RTE 1 2 0.98%

Total 155 204 100.00%

The FY2016 PHRs are one of seven public health based decision criteria that will be used in 

prioritizing Food Safety Assessments (FSAs). Noncompliance with a single FY2016 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 FY2016 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 FY2016 cut points, the mean and standard deviation of the log 

transformed non-zero FY2016 PHR rates for each of the four quarters in CY2014 is computed 

(the log transform of the non-zero FY2016 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 receive a 

“for cause” FSA if they have not had an FSA in the last six months. Table S-3 presents the 

FY2016 PHR cut points for the non-transformed PHR non-compliance data for each of the two 

establishment operation types. The FY2015 PHR cut points are included for comparison. (See 

Section 6 and Appendix F for more details.) 

Table S- 3 FY2016 PHR Upper Cut Points

Operation Type FY2016 PHR Cut Points FY2015 PHR Cut Points

Processing 4.80% 6.55%

Combination 9.25% 9.37%

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 December 1, 2014 – February 28, 2015.

8 
9 

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

Classification Processing Combination Total

Tier 1 63 7 70

Tier 2 88 26 114

Tier 3 3,849 1,000 4,849

Total 4,000 1,033 5,033

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

criterion) among different product categories. There is 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 for Beef Slaughter, Pork Slaughter and 

Ground Pork. 

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. 

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 197 3.93% 2 3.57% No

Turkey Slaughter 51 1.02% - 0.00% No

Beef Slaughter 621 12.37% 2 3.57% Yes

Pork Slaughter 589 11.74% - 0.00% Yes

Ground Beef 1,597 31.82% 12 21.43% No

Comminuted Chicken 803 16.00% 10 17.86% No

Comminuted Turkey 313 6.24% 3 5.36% No

Ground Pork 1,721 34.29% 11 19.64% Yes

RTE 2,495 49.71% 31 55.36% No

Poultry Combination 395 7.87% 4 7.14% No

Total Number of 

Establishments 5,019 56

When establishments have had an FSA in the past six months, Tier 1 establishments are not 

automatically scheduled to receive a for cause 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. 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 

December 1, 2014 – February 28, 2015. Sixty establishments would receive a “for cause” FSA 

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

9 
10

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 53 7 60

Tier 2 74 22 96

Tier 3 3,691 954 4,645

Total 3,818 983 4,801

10
11

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 subset of 9 CFR regulations used to schedule FSAs was 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 purpose of the 

present report is to update the list of FY2015 PHRs using current verification inspection results 

from the Public Health Information System (PHIS). The updated list is called FY2016 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 FY2016 PHR list is the same as that used for the 

FY2015 PHR. Specifically, for inclusion in the FY2015 PHR list, each candidate 9 CFR 

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

more frequently in establishments in the three month period before Salmonella, E. coli O157: 

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

actions than in establishments without positives or enforcement actions. The analysis was based 

on one year of FSIS verification inspection results (January 1 –December 31, 2014) recorded in 

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

has developed a proposed list of candidate regulations for egg products and may include egg 

products in the next update of the PHR list.

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. The Campylobacter and the six 

non-O157 STEC 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 FY2016 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. 

11
12

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

12
13

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 

13
14

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. 

14
15

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 three (143) 9 CFR regulations were selected as being indicators of a potential loss of food 

safety process control. These 143 regulations map to 134 regulations in PHIS. Some of the 143 

map directly to regulations in PHIS and others are verified under higher order regulations in 

PHIS. For example, 381.1(i)-381.1(iv) (all of which are on the original W3NR list) are verified 

under 381.1. The list of 134 candidate regulations that are indicators of a potential loss of 

HACCP food safety process control are presented in Appendix C. 

15
16

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 134 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, 2014 through December 31, 2014. Those with more than 30 

verifications in a year, an effect size of 0.5 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 that 

have 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 4,395. 

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

16
17

An effect size is the difference between the means of two groups divided by their combined 

(pooled) standard deviation. Effect size indicates how many pooled standard deviations there are 

between the means of the two groups; for example, an effect size of 0.75 indicates that the mean 

of one group is three quarters of a standard deviation from the mean of the other group. In 

general an effect size of 0.2 is considered small; an effect size of 0.5 is considered medium and 

above 0.8 is large. However, there is no definitive rule for determining a meaningful effect size. 

In this report, an effect size of 0.5 is taken as the threshold for a meaningful separation between 

two means. 

4.1 Salmonella 

The noncompliance rate of each of the 134 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, 2014 to December 31, 2014. The dataset used in the analysis 

consists of candidate PHR noncompliance rates for the 1,550 establishments with Salmonella 

testing data, of which 393 had 2,880 Salmonella positives and 1,157 did not have Salmonella

positives. There were 32,350 total Salmonella tests performed.

Table 4-1 presents the 31 regulations which had more than 30 verifications in a year, an effect 

size of 0.5 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, 2014 to December

31, 2014. 

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

with Those for Establishments with No Salmonella Positive 

Regulation 

Verified

On 

FY2015 

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

Cohen 

Effect 

Size

310.18 Yes 3.33% 1.38% 8.78E-19 0.90

310.18(a) No 3.76% 0.67% 3.29E-182 5.25

310.22(c) No 0.54% 0.26% 5.40E-03 1.27

310.22(e)(1) No 4.91% 0.97% 1.03E-12 0.72

318.10(b) No 3.95% 0.64% 3.12E-02 0.59

381.1_Adulterated Yes 7.19% 2.01% 1.65E-49 2.74

381.193(a) No 15.47% 2.50% 3.50E-02 2.67

381.65(f)

1 Yes 1.34% 1.28% 9.02E-03 43.02

381.71(a) No 29.01% 1.97% 1.69E-182 1.42

381.83 No 0.08% 0.02% 4.16E-12 72.09

381.91(a) No 2.01% 0.27% 3.26E-21 1.42

17
18

Regulation 

Verified

On 

FY2015 

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

Cohen 

Effect 

Size

381.94(a)* Yes 0.35% 0.07% 2.87E-03 6.82

416.1 Yes 12.03% 5.02% 0.00E+00 11.60

416.14 Yes 0.96% 0.43% 2.73E-135 15.50

416.15(a) Yes 4.88% 3.10% 7.52E-12 6.03

416.15(b) Yes 8.50% 4.26% 7.63E-32 6.08

416.16(a) Yes 0.56% 0.21% 2.48E-187 20.44

416.3(b) Yes 3.87% 0.83% 3.97E-63 2.73

416.3(c) Yes 3.02% 1.24% 1.07E-31 4.38

416.4(a) Yes 21.08% 9.27% 0.00E+00 7.98

416.4(d) Yes 24.21% 9.95% 0.00E+00 8.10

417.2(c)(4) Yes 2.00% 0.96% 0.00E+00 17.83

417.3(a)(3) Yes 15.05% 1.68% 1.86E-280 0.74

417.3(a)(4) Yes 1.30% 0.96% 1.90E-03 0.86

417.3(b)(1) Yes 6.84% 2.94% 8.86E-07 2.25

417.3(b)(4) Yes 3.79% 1.56% 1.11E-08 1.61

417.4(b) Yes 0.75% 0.41% 4.51E-02 1.52

417.5(a)(1) Yes 0.49% 0.38% 4.58E-11 14.43

417.5(a)(3) Yes 0.48% 0.29% 2.55E-41 17.91

430.4(b)(2) Yes 3.99% 0.83% 2.73E-08 3.09

430.4(c)(3) Yes 0.15% 0.07% 4.84E-03 8.81

1 In December 2014, FSIS retired regulation 381.65(e)* and replaced it with regulation 

381.65(f). Non-compliances with 381.65(e)* were used in the current analysis to determine that 

381.65(e)*satisfied the PHR conditions. However, the regulations 381.65(f) is listed above as the 

PHR since that regulation name will be used in the future. The “*” on regulations 381.65(e)* and 

381.94(a)* is part of the regulation name. Regulation 381.83 was not included in the final list of 

PHRs since it is restricted to HIMP establishments only. 

4.1.1 Salmonella in Intact Chicken

The noncompliance rate of each of the 134 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, 2014 to December 31, 2014. The 

dataset used in the analysis consists of candidate PHR noncompliance rates for the 182 

establishments with Intact Chicken Salmonella testing data, of which 83 had 320 Salmonella

positives and 99 did not have Salmonella positives. There were 8,799 total Intact Chicken 

Salmonella tests performed.

18
19

Table 4-2 presents the 16 regulations which had more than 30 verifications in a year, an effect 

size of 0.5 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, 2014 to December 31, 2014. 

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 

Regulation Verified On FY2015 

PHR List

Noncomplia

nce Rate in 3 

Months 

before a 

Salmonella

Positive

Noncomplia

nce Rate for 

Establishme

nts with no 

Salmonella

Positive

TwoSided 

Fisher 

Exact p 

Value

Cohen 

Effect 

Size

381.71(a) No 16.15% 3.19% 2.40E-21 2.30

381.91(a) No 0.92% 0.28% 6.30E-03 5.12

381.94(a)* Yes 0.69% 0.05% 5.91E-06 5.92

417.3(a)(1) Yes 12.17% 1.28% 1.26E-23 7.66

417.3(a)(3) Yes 17.21% 1.48% 2.03E-37 7.55

417.3(a)(4) Yes 3.64% 1.05% 8.71E-09 8.41

417.3(b)(1) Yes 13.33% 2.21% 3.92E-08 2.43

417.3(b)(2) Yes 9.55% 1.17% 5.01E-09 2.97

417.3(b)(3) Yes 4.10% 1.01% 5.43E-06 3.93

417.3(b)(4) Yes 6.94% 2.98% 1.42E-02 1.21

417.3(c) Yes 16.41% 8.46% 8.82E-03 2.49

417.5(a)(1) Yes 0.78% 0.40% 1.88E-09 25.53

417.5(a)(2) Yes 0.29% 0.11% 9.59E-07 25.54

417.5(a)(3) Yes 0.44% 0.26% 3.71E-07 21.16

430.4(c)(2) Yes 2.17% 0.00% 1.07E-05 5.93

430.4(c)(3) Yes 2.30% 0.07% 2.09E-05 8.52

4.1.2 Salmonella in Intact Turkey

The noncompliance rate of each of the 134 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, 2014 to December 31, 2014. The 

dataset used in the analysis consists of candidate PHR noncompliance rates for the 40 

establishments with Salmonella testing data, of which 17 had 32 Salmonella positives and 23 did 

not have Salmonella positives. . There were 1,912 total Intact Turkey Salmonella tests 

performed.

19
20

Table 4-3 presents the 6 regulations which had more than 30 verifications in a year, an effect size 

of 0.5 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, 2014 to December 31, 2014. 

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 

Regulation 

Verified

On 

FY2015 

PHR List

Noncompliance 

Rate in 3 

Months before 

a Salmonella

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella

Positive

TwoSided 

Fisher 

Exact p 

Value

Cohen 

Effect 

Size

381.65(a) Yes 2.50% 0.59% 1.26E-05 7.60

381.65(f) Yes 1.32% 0.73% 2.22E-06 31.47

381.91(a) No 1.14% 0.07% 3.45E-02 4.34

381.91(b) Yes 2.25% 0.72% 1.55E-02 5.76

381.94(a)* Yes 2.25% 0.22% 1.35E-03 5.18

416.1 Yes 14.26% 7.18% 1.95E-14 10.33

4.1.3 Salmonella in Ground Beef

The noncompliance rate of each of the 134 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, 2014 to December 31, 2014. The 

dataset used in the analysis consists of candidate PHR noncompliance rates for the 1,179 

establishments with Salmonella testing data, of which 136 had 274 Salmonella positives and 

1,043 did not have Salmonella positives. There were 15,020 total Ground Beef Salmonella tests 

performed.

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

size of 0.5 or greater, and for which there is an 95% probability (as determined by a two-sided 

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

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

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

period January 1, 2014 to December 31, 2014. 

20
21

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

Salmonella Positive with Those for Establishments with No Ground Beef Salmonella

Positive

Regulation Verified On 

FY2015 

PHR 

List

Noncompliance 

Rate in 3 Months 

before a 

Salmonella

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella

Positive

TwoSided 

Fisher 

Exact p 

Value

Cohen 

Effect 

Size

310.18 Yes 3.57% 0.86% 6.03E-28 5.28

310.18(a) No 5.06% 0.58% 2.39E-173 5.42

310.22(c) No 0.51% 0.20% 1.41E-02 1.82

310.22(e)(1) No 5.25% 0.92% 1.25E-08 0.71

416.1 Yes 3.89% 2.90% 6.76E-07 4.68

416.15(a) Yes 10.44% 1.56% 8.99E-21 1.24

416.15(b) Yes 4.66% 1.84% 1.21E-03 1.03

416.4(a) Yes 7.15% 4.62% 1.29E-10 2.84

416.4(d) Yes 11.24% 4.00% 5.68E-75 1.90

417.2(c)(4) Yes 1.98% 0.16% 9.92E-231 5.53

417.3(a)(2) Yes 3.17% 0.24% 2.76E-23 2.57

417.3(b)(1) Yes 7.95% 2.14% 1.39E-03 1.10

417.3(b)(2) Yes 6.71% 2.38% 1.63E-02 1.06

417.3(b)(4) Yes 5.73% 0.95% 2.59E-06 0.54

417.5(a)(1) Yes 0.47% 0.36% 1.62E-02 6.44

4.1.4 Salmonella in Intact Beef

The noncompliance rate of each of the 134 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, 2014 to December 31, 2014. FSIS tests beef 

trim and beef manufacturing trimmings as a surrogate for testing intact beef. There are 354 

establishments with Intact Beef Salmonella testing data, of which 52 had 78 Salmonella positives 

and 302 did not have Salmonella positives. There were 1,952 total Intact Beef Salmonella tests 

performed. 

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

size of 0.5 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, 2014 to December 31, 2014. 

21
22

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 

Regulation 

Verified

On FY2015 

PHR List

Noncompliance 

Rate in 3 

Months before 

a Salmonella

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella

Positive

TwoSided 

Fisher 

Exact p 

Value

Cohen 

Effect 

Size

310.18 Yes 5.21% 1.69% 9.44E-06 11.40

310.18(a) No 3.44% 0.86% 1.98E-68 1.00

310.22(c) No 1.00% 0.31% 1.34E-03 6.45

310.22(e)(1) No 6.45% 0.98% 9.82E-07 2.70

416.1 Yes 6.73% 3.46% 8.41E-23 4.15

416.13 

Implementation of 

SOP's No 0.99% 0.21% 2.38E-02 0.76

416.14 Yes 0.59% 0.33% 1.35E-03 7.54

416.3(c) Yes 2.99% 1.12% 1.53E-02 2.18

416.4(a) Yes 9.67% 7.29% 8.71E-05 0.77

416.4(d) Yes 16.55% 6.47% 7.09E-51 1.32

417.2(c)(4) Yes 1.63% 0.47% 6.06E-29 8.52

417.3(a)(1) Yes 7.09% 2.05% 2.58E-03 1.09

417.3(a)(2) Yes 0.72% 0.27% 6.33E-03 2.54

417.3(a)(4) Yes 1.52% 0.23% 1.94E-02 2.06

417.5(f) Yes 1.43% 0.13% 1.87E-03 1.64

4.1.5 Salmonella in Comminuted Chicken

The noncompliance rate of each of the 134 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, 2014 to December 31, 2014. The dataset used in the analysis consists of candidate PHR 

noncompliance rates for the 117 establishments with Comminuted Chicken Salmonella testing 

data, of which 104 had 1,834 Salmonella positives and 13 did not have Salmonella positives. 

There were 3,082 total Comminuted Chicken Salmonella tests performed.

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

of 0.5 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, 2014 to December 31, 2014. 

22
23

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

Salmonella Positive with Those for Establishments with No Comminuted Chicken 

Salmonella Positive 

Regulation 

Verified

On 

FY2015 

PHR 

List

Noncompliance 

Rate in 3 

Months before 

a Salmonella

Positive 

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella

Positive

TwoSided 

Fisher 

Exact p 

Value

Cohen 

Effect Size

416.1 Yes 13.56% 3.82% 1.08E-37 32.57

416.14 Yes 1.13% 0.29% 7.91E-10 43.51

416.16(a) Yes 0.66% 0.17% 6.39E-10 58.78

416.4(a) Yes 23.27% 5.18% 1.27E-49 20.39

416.4(d) Yes 26.33% 5.32% 4.69E-52 20.67

417.2(c)(4) Yes 2.07% 0.30% 1.61E-25 50.41

417.5(a)(3) Yes 0.56% 0.28% 8.24E-3 47.05

4.1.6 Salmonella in Comminuted Turkey

The noncompliance rate of each of the 134 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, 2014 to December 31, 2014. There are 58 establishments with Comminuted Turkey 

Salmonella testing data, of which 43 had 342 Salmonella positives and 15 did not have 

Salmonella positives. There were 1,582 total Comminuted Turkey Salmonella tests performed.

Table 4-7 presents the 8 regulations which had more than 30 verifications in a year, an effect size 

of 0.5 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, 2014 to December 31, 2014. 

23
24

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

Salmonella Positive with Those for Establishments with No Comminuted Turkey 

Salmonella Positive

Regulation 

Verified

On 

FY2015 

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

Cohen 

Effect Size

416.1 Yes 6.97% 2.27% 2.60E-20 15.67

416.16(a) Yes 0.39% 0.04% 1.83E-11 27.66

416.3(b) Yes 3.44% 0.27% 1.69E-04 1.56

416.3(c) Yes 2.93% 0.97% 1.81E-02 3.26

416.4(a) Yes 17.50% 4.92% 1.12E-42 3.56

416.4(d) Yes 22.63% 5.02% 2.82E-63 4.27

417.2(c)(4) Yes 1.48% 0.21% 1.76E-18 28.77

417.5(a)(1) Yes 0.63% 0.29% 1.37E-03 23.98

4.1.7 Salmonella in Ready to Eat

The noncompliance rate of each of the 134 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, 2014 to December 31, 2014. The 

dataset used in the analysis consists of candidate PHR noncompliance rates for the 2,077 

establishments with Salmonella testing data, of which 5 had 5 Salmonella positives and 2,072 did 

not have Salmonella positives. There were 12,203 total Ready to Eat Salmonella tests performed.

Table 4-8 presents the 2 regulations which had more than 30 verifications in a year, an effect size 

of 0.5 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, 2014 to December 31, 2014. 

24
25

Table 4- 8 Comparison of Noncompliance Rates 3 Months before a Ready to Eat 

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

Positive

Regulation 

Verified

On 

FY2015 

PHR List

Noncompliance 

Rate in 3 

Months before a 

Salmonella

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Salmonella

Positive

TwoSided 

Fisher 

Exact p 

Value

Cohen 

Effect 

Size

430.4(a) Yes 1.92% 0.05% 2.84E-02 14.62

430.4(c)(2) Yes 3.92% 0.07% 5.63E-04 13.83

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 134 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, 2014 to December 31, 2014. The dataset used in the analysis consists of 

candidate PHR noncompliance rates for the 1,319 establishments with E. coli O157:H7 testing 

data, of which 17 had 17 E. coli O157:H7 positives and 1,302 did not have E. coli O157:H7 

positives. There were 16,094 total E. coli O157:H7 tests performed. 

Table 4-9 presents the 5 regulations which had more than 30 verifications in a year, an effect size 

of 0.5 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, 2014 to December 31, 

2014. 

Table 4- 9 Comparison of Noncompliance Rates 3 Months before an E. coli O157:H7 

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

Regulation Verified On 

FY2015 

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

Cohen 

Effect 

Size

310.18(a) No 2.66% 1.08% 1.86E-04 8.57

416.1 Yes 11.20% 3.13% 8.14E-19 10.57

416.4(d) Yes 12.04% 5.30% 1.67E-05 5.12

417.2(c)(4) Yes 0.73% 0.29% 1.53E-02 17.18

25
26

Regulation Verified On 

FY2015 

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

Cohen 

Effect 

Size

417.5(a)(3) Yes 0.68% 0.28% 1.47E-02 20.16

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 134 

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, 2014 to 

December 31, 2014. The dataset used in the analysis consists of candidate PHR noncompliance 

rates for the 342 establishments with non-O157 STEC testing data, of which 12 had 19 nonO157 STEC positives and 330 did not have non-O157 STEC positives. There were 2,665 total 

non-O157 STEC tests performed.

Table 4-10 presents the 8 regulations which had more than 30 verifications in a year, an effect 

size of 0.5 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, 

2014 to December 31, 2014. 

Table 4- 10 Comparison of Noncompliance Rates 3 Months before a Non-O157 STEC 

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

Regulation Verified On 

FY2015 

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

Cohen 

Effect Size

310.18 Yes 12.55% 1.86% 1.43E-29 9.21

310.22(c) No 1.32% 0.23% 6.19E-03 7.04

310.22(e)(1) No 16.22% 1.22% 6.98E-06 3.10

310.22(e)(3) No 5.88% 0.77% 3.00E-02 2.62

310.22(f)(2) Yes 3.05% 0.17% 1.19E-04 4.57

416.14 Yes 0.94% 0.40% 1.34E-02 18.38

416.4(d) Yes 15.87% 8.56% 1.01E-03 6.75

417.5(a)(1) Yes 0.80% 0.39% 4.74E-02 17.78

26
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 134 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, 2014 to 

December 31, 2014. The dataset used in the analysis consists of candidate PHR noncompliance 

rates for the 2,085 establishments with Listeria monocytogenes testing data, of which 40 had 43 

Listeria monocytogenes positives and 2,045 did not have Listeria monocytogenes positives. 

There were 12,713 total Listeria monocyogenes tests performed.

There are no regulations that had more than 30 verifications in a year, an effect size of 0.5 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, 2014 to December 31, 2014. 

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 134 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, 2014 to December 31, 2014. The 

dataset used in the analysis consists of candidate PHR noncompliance rates for the 331 

establishments with Campylobacter testing data, of which 129 had 903 Campylobacter positives 

and 202 did not have Campylobacter positives. There were 15,372 total Campylobacter tests 

performed.

Table 4-11 presents the 17 regulations which had more than 30 verifications in a year, an effect 

size of 0.5 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, 2014 to December 31, 

2014. 

27
28

Table 4- 11 Comparison of Noncompliance Rates 3 Months before a Campylobacter Positive 

with Those for Establishments with No Campylobacter Positive 

Regulation 

Verified

On 

FY201

5 PHR 

List

Noncompliance 

Rate in 3 

Months before 

a 

Campylobacter

Positive

Noncompliance 

Rate for 

Establishments 

with no 

Campylobacter

Positive

TwoSided 

Fisher 

Exact p 

Value

Cohen 

Effect 

Size

318.2(a) No 2.22% 0.08% 3.80E-03 1.65

381.1_Adulterated Yes 7.81% 1.68% 1.51E-32 3.72

381.65(a) Yes 1.97% 1.50% 2.99E-05 1.60

381.65(f) Yes 1.22% 1.16% 1.93E-02 8.31

381.71(a) No 14.86% 2.52% 2.37E-36 1.87

381.83 No 0.07% 0.02% 5.69E-09 22.26

381.91(a) No 1.03% 0.20% 7.23E-08 0.61

416.14 Yes 1.02% 0.88% 2.58E-03 4.87

417.3(a)(1) Yes 5.30% 1.20% 6.38E-20 4.94

417.3(a)(2) Yes 0.68% 0.53% 4.03E-02 7.09

417.3(a)(3) Yes 11.15% 1.42% 1.93E-63 4.63

417.3(a)(4) Yes 1.79% 0.92% 4.81E-05 4.71

417.4(a) Yes 22.86% 1.51% 5.70E-13 2.99

417.5(a)(1) Yes 0.55% 0.44% 1.39E-03 1.57

417.5(a)(3) Yes 0.37% 0.30% 1.03E-02 1.37

430.4(b)(2) Yes 7.41% 1.19% 6.57E-04 1.78

430.4(c)(3) Yes 0.33% 0.02% 8.16E-04 2.72

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 134 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, 2014 to December 31, 2014. The 

dataset used in the analysis consists of candidate PHR noncompliance rates for the 182 

establishments with Intact Chicken Campylobacter testing data, of which 70 had 522 

Campylobacter positives and 112 did not have Campylobacter positives. There were 8,804 total 

Intact Chicken Campylobacter tests performed 

Table 4-12 presents the 13 regulations which had more than 30 verifications in a year, an effect 

size of 0.5 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, 2014 to December 31, 

2014. 

28
29

Table 4- 12 Comparison of Noncompliance Rates 3 Months before a Campylobacter Intact 

Chicken Positive with Those for Establishments with No Campylobacter Intact Chicken 

Positive

Regulation 

Verified

On FY2015 

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

Cohen 

Effect 

Size

381.65(f) Yes 1.40% 1.24% 2.14E-04 50.40

381.94(a)* Yes 0.68% 0.06% 6.38E-07 1.02

416.16(a) Yes 0.69% 0.54% 1.72E-04 4.51

417.2(c) Yes 2.24% 0.34% 6.02E-08 3.02

417.3(a)(1) Yes 13.12% 1.11% 9.88E-27 7.28

417.3(a)(2) Yes 1.25% 0.48% 1.04E-09 13.47

417.3(a)(3) Yes 16.67% 1.36% 1.03E-33 6.93

417.3(a)(4) Yes 4.11% 0.88% 2.12E-12 7.89

417.3(b)(2) Yes 5.11% 1.21% 2.17E-04 1.65

417.3(c) Yes 26.32% 5.43% 8.60E-10 2.93

417.5(a)(1) Yes 0.69% 0.42% 1.02E-07 10.34

417.5(a)(2) Yes 0.21% 0.14% 8.20E-03 12.00

417.5(a)(3) Yes 0.66% 0.21% 8.02E-38 11.37

 

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 134 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, 2014 to December 31, 2014. The 

dataset used in the analysis consists of candidate PHR noncompliance rates for the 40 

establishments with Campylobacter testing data, of which 12 had 38 Campylobacter positives 

and 28 did not have Campylobacter positives. There were 1,911 total Intact Turkey 

Campylobacter tests performed.

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

size of 0.5 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, 2014 to December 31, 

2014. 

29
30

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

Turkey Positive with Those for Establishments with No Campylobacter Intact Turkey 

Positive

Regulation 

Verified

On 

FY2015 

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

Cohen 

Effect 

Size

416.3(b) Yes 9.23% 0.76% 5.46E-05 5.29

416.4(d) Yes 30.37% 18.40% 3.73E-07 10.28

417.3(a)(2) Yes 0.98% 0.40% 4.79E-02 5.87

417.3(a)(4) Yes 6.67% 0.75% 7.29E-03 6.13

4.4.3 Campylobacter in Comminuted Chicken

The noncompliance rate of each of the 134 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, 2014 to December 31, 2014. The dataset used in the analysis consists of candidate 

PHR noncompliance rates for the 118 establishments with Comminuted Chicken Campylobacter

testing data, of which 53 had 333 Campylobacter positives and 65 did not have Campylobacter 

positives. There were 3,081 total Comminuted Chicken Campylobacter tests performed.

Table 4-14 presents the 12 regulations which had more than 30 verifications in a year, an effect 

size of 0.5 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, 2014 to December 31, 2014. 

Table 4- 14 Comparison of Noncompliance Rates 3 Months before a Comminuted Chicken 

Campylobacter Positive with Those for Establishments with No Comminuted Chicken 

Campylobacter Positive 

Regulation 

Verified

On FY2015 

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

Cohen 

Effect 

Size

381.65(a) Yes 2.45% 0.46% 8.73E-17 6.23

381.71(a) No 28.11% 1.61% 4.05E-07 1.55

381.76(a)* No 3.60% 0.41% 3.67E-20 32.78

381.91(b) Yes 2.23% 0.00% 3.31E-03 3.89

30
31

Regulation 

Verified

On FY2015 

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

Cohen 

Effect 

Size

416.1 Yes 12.36% 10.16% 1.07E-08 13.51

416.14 Yes 1.07% 0.28% 1.15E-29 15.48

416.15(a) Yes 4.28% 1.44% 1.48E-06 4.61

416.3(b) Yes 6.10% 2.40% 2.97E-04 0.86

416.4(a) Yes 20.73% 16.44% 3.52E-10 9.59

416.4(d) Yes 23.69% 18.18% 3.17E-15 7.23

417.2(c)(4) Yes 1.53% 0.53% 1.74E-43 28.50

430.4(b)(3) Yes 3.30% 0.44% 2.00E-02 1.56

4.4.4 Campylobacter in Comminuted Turkey

The noncompliance rate of each of the 134 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, 2014 to December 31, 2014. The dataset used in the analysis consists of candidate 

PHR noncompliance rates for the 58 establishments with Comminuted Turkey Campylobacter

testing data, of which 7 had 10 Campylobacter positives and 51 did not have Campylobacter 

positives. There were 1,576 total Comminuted Turkey Campylobacter tests performed.

Table 4-15 presents the 7 regulations which had more than 30 verifications in a year, an effect 

size of 0.5 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, 2014 to December 31, 2014. 

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

Campylobacter Positive with Those for Establishments with No Comminuted Turkey 

Campylobacter Positive 

Regulation 

Verified

On FY2015 

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

Cohen 

Effect 

Size

381.65(f) Yes 2.77% 0.64% 1.30E-21 39.58

381.91(b) Yes 7.32% 0.91% 2.83E-04 8.81

416.3(c) Yes 7.69% 1.85% 3.96E-02 4.80

416.4(a) Yes 31.43% 11.77% 1.12E-07 11.21

31
32

Regulation 

Verified

On FY2015 

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

Cohen 

Effect 

Size

416.4(d) Yes 47.56% 12.52% 1.97E-14 12.08

417.2(c)(4) Yes 4.28% 0.78% 6.26E-29 13.52

417.5(a)(1) Yes 2.36% 0.41% 1.11E-10 21.24

4.5 Enforcement Actions

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

and public health related enforcement actions at meat and poultry establishments. Food Safety 

Inspection Service (FSIS) enforcement actions, as defined in the Rules of Practice (9 CFR 

500.1), include regulatory control actions, withholding actions, and suspensions. A regulatory 

control action is taken by FSIS inspectors when immediate correction of a deficiency is required. 

Plant management does not have to be notified in advance. When a deficiency does not pose an 

imminent threat to public health, a Notice of Intended Enforcement (NOIE) is issued to a plant 

indicating that FSIS is considering withholding the marks of inspection or suspending the 

assignment of inspectors if not corrected. The plant is requested to provide immediate corrective 

action and to specify preventive measures to prevent recurrence. FSIS determines further action 

based on the response provided. 

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

Operating Procedure (SSOP), HACCP, or Sanitation Performance Standards (SPS) violation. 

The enforcement action list of regulations will be selected from the same list of 134 candidate 

regulations used to select all other FY2016 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, 2014 to December 

31, 2014. The dataset used in the analysis consists of candidate PHR noncompliance rates for the 

5,297 active meat and poultry establishments, of which 155 had 166 public health related NOIEs 

or suspensions and 5,142 did not have any public health related NOIEs or suspensions. 

Table 4-16 presents the 40 regulations which had more than 30 verifications in a year, an effect 

size of 0.5 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, 2014 to December 31, 2014. 

32
33

Table 4- 16 Comparison of Noncompliance Rates 3 Months before an Enforcement Action 

with Those for Establishments with No Enforcement Action

Regulation Verified On 

FY2015 

PHR 

List

Noncompliance 

Rate in 3 

Months before a 

NOIE/ 

Suspension

Noncompliance 

Rate for 

Establishments 

with no NOIE/ 

Suspension

Two-Sided 

Fisher 

Exact p 

Value

Cohen 

Effect 

Size

301.2_Adulterated Yes 17.43% 2.17% 6.81E-12 2.14

310.18 Yes 7.63% 1.41% 1.39E-36 5.37

310.18(a) No 2.97% 0.93% 1.57E-13 7.24

310.22(c) No 1.89% 0.22% 5.96E-08 3.11

310.22(e)(1) No 10.23% 1.08% 7.60E-07 2.32

310.22(e)(4)(i) Yes 1.92% 0.14% 4.63E-10 3.06

310.25(a) Yes 2.73% 0.64% 8.16E-04 5.29

318.2(a) No 1.22% 0.23% 2.15E-02 2.57

381.65(a) Yes 5.88% 1.40% 2.29E-06 4.04

381.65(f) Yes 1.88% 1.26% 1.60E-04 36.21

381.71(a) No 48.48% 5.53% 5.66E-12 1.83

381.91(b) Yes 5.68% 0.95% 1.71E-03 6.16

416.1 Yes 11.26% 4.42% 5.55E-77 9.51

416.12(c) No 6.36% 0.28% 7.88E-12 2.22

416.12(d) No 2.33% 0.33% 2.54E-04 2.03

416.14 Yes 0.98% 0.31% 5.52E-20 18.57

416.15(a) Yes 8.73% 2.08% 6.80E-09 2.83

416.15(b) Yes 15.36% 2.71% 7.95E-19 2.42

416.16(a) Yes 0.51% 0.17% 5.41E-17 26.87

416.3(b) Yes 2.15% 1.03% 3.21E-02 1.76

416.3(c) Yes 2.42% 1.32% 3.56E-02 1.90

416.4(a) Yes 12.15% 7.86% 7.59E-12 5.37

416.4(d) Yes 17.25% 8.42% 4.44E-39 5.30

417.2(c) Yes 2.29% 0.58% 1.01E-02 1.75

417.2(c)(4) Yes 1.40% 0.73% 2.65E-12 9.10

417.3(a)(1) Yes 35.24% 2.45% 3.90E-32 1.36

417.3(a)(2) Yes 2.34% 0.63% 1.75E-07 2.24

417.3(a)(3) Yes 28.57% 3.16% 7.38E-18 1.27

417.3(a)(4) Yes 4.17% 1.19% 1.32E-03 1.58

417.3(b)(1) Yes 19.35% 5.37% 5.93E-03 0.99

417.3(b)(3) Yes 3.79% 1.03% 1.31E-02 1.31

417.3(b)(4) Yes 14.29% 1.27% 5.26E-11 0.99

417.5(a)(1) Yes 2.20% 0.36% 1.21E-80 13.29

417.5(a)(2) Yes 1.08% 0.15% 9.27E-42 11.94

417.5(a)(3) Yes 1.37% 0.32% 5.70E-42 13.58

33
34

Regulation Verified On 

FY2015 

PHR 

List

Noncompliance 

Rate in 3 

Months before a 

NOIE/ 

Suspension

Noncompliance 

Rate for 

Establishments 

with no NOIE/ 

Suspension

Two-Sided 

Fisher 

Exact p 

Value

Cohen 

Effect 

Size

430.4(a) Yes 0.66% 0.06% 2.58E-09 9.73

430.4(b)(2) Yes 3.95% 1.05% 4.80E-02 1.59

430.4(b)(3) Yes 10.95% 1.14% 1.08E-10 2.84

430.4(c)(2) Yes 0.39% 0.07% 3.11E-04 9.22

430.4(c)(3) Yes 0.45% 0.04% 4.61E-07 9.15

34
35

5.0 LIST OF FY2016 PHRS

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

PHRs into a single FY2016 PHR list. Table 5-1 presents the list of 54 FY2016 PHRs. These 54 

PHRs were selected since they were verified more than 30 times in a year, had an effect size of 

0.5 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 FY2016 PHRs are composed of 6 regulations and 48 provisions of regulations. The 48 

provisions fall under 21 different regulations. Thus, the 54 FY2016 PHRs represent 27 

regulations, with the majority of FY2016 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 FY2016 PHRs

List of FY2016 

PHRs

Description On List 

of 

FY2015 

PHRs

NC Rate 

in 3 

Months 

before a 

Pathogen 

Positive

NC Rate 

for Plants 

with no 

Pathogen 

Positive 

TwoSided 

Fisher 

Exact p 

Value

Cohen 

Effect 

Size

310.18

Contamination of 

carcasses, organs, or 

other parts Yes 7.63% 1.41% 1.39E-36 5.37

416.1

Operate in a manner 

to prevent insanitary 

conditions Yes 12.03% 5.02% 0.00E+00 11.60

416.14

Evaluate 

effectiveness of 

SSOP's & maintain 

plan Yes 0.96% 0.43% 2.73E-135 15.50

301.2_Adulterated Adulterated Yes 17.43% 2.17% 6.81E-12 2.14

310.18(a)

Carcasses, organs, 

and other parts 

handled in a sanitary 

manner No 3.76% 0.67% 3.29E-182 5.25

310.22(c) Disposal of SRM No 1.89% 0.22% 5.96E-08 3.11

310.22(e)(1)

Written procedures 

for removal, 

segregation, and 

disposition of SRMs No 4.91% 0.97% 1.03E-12 0.72

35
36

List of FY2016 

PHRs

Description On List 

of 

FY2015 

PHRs

NC Rate 

in 3 

Months 

before a 

Pathogen 

Positive

NC Rate 

for Plants 

with no 

Pathogen 

Positive 

TwoSided 

Fisher 

Exact p 

Value

Cohen 

Effect 

Size

310.22(e)(3)

Evaluate 

effectiveness of 

procedures for 

removal, segregation 

and disposition of 

SRMs No 5.88% 0.77% 3.00E-02 2.62

310.22(e)(4)(i)

Maintain daily 

records Yes 1.92% 0.14% 4.63E-10 3.06

310.22(f)(2)

Use of routine 

operational 

sanitation 

procedures on 

equipment used to 

cut through SRMs Yes 3.05% 0.17% 1.19E-04 4.57

310.25(a)

Verification criteria 

for E. coli testing 

meat Yes 2.73% 0.64% 8.16E-04 5.29

318.10(b)

Products requiring 

treatment to destroy 

trichinae No 3.95% 0.64% 3.12E-02 0.59

318.2(a) All products subject 

to reinspection by 

program employees No 2.22% 0.08% 3.80E-03 1.65

381.1_Adulterated Adulterated Yes 7.19% 2.01% 1.65E-49 2.74

381.193(a)

Poultry not intended 

for human food in 

commerce No 15.47% 2.50% 3.50E-02 2.67

381.65(a)

Clean and sanitary 

practices; products 

not adulterated Yes 2.45% 0.46% 8.73E-17 6.23

381.65(f)

Zero-tolerance for 

visible fecal material 

entering chiller Yes 2.77% 0.64% 1.30E-21 39.58

381.71(a)

Condemnation on 

ante mortem 

inspection No 29.01% 1.97% 1.69E-182 1.42

381.76(a)*

Post-mortem 

inspection, when 

required, extent. No 3.60% 0.41% 3.67E-20 32.78

36
37

List of FY2016 

PHRs

Description On List 

of 

FY2015 

PHRs

NC Rate 

in 3 

Months 

before a 

Pathogen 

Positive

NC Rate 

for Plants 

with no 

Pathogen 

Positive 

TwoSided 

Fisher 

Exact p 

Value

Cohen 

Effect 

Size

381.91(a)

Certain 

contaminated 

carcasses to be 

condemned No 2.01% 0.27% 3.26E-21 1.42

381.91(b)

Reprocessing of 

carcasses 

accidentally 

contaminated with 

digestive tract 

contents. Yes 7.32% 0.91% 2.83E-04 8.81

381.94(a)*

Verification criteria 

for E. coli testing 

poultry Yes 0.68% 0.06% 6.38E-07 1.02

416.12(c)

plan identifies 

procedures for preop No 6.36% 0.28% 7.88E-12 2.22

416.12(d)

plan list frequency 

for each procedure 

& responsible 

individual No 2.33% 0.33% 2.54E-04 2.03

416.13 

Implementation of 

SOP's

Implementation of 

SSOP

No 0.99% 0.21% 2.38E-02 0.76

416.15(a)

Appropriate 

corrective actions Yes 10.44% 1.56% 8.99E-21 1.24

416.15(b)

Corrective action, 

procedures for Yes 8.50% 4.26% 7.63E-32 6.08

416.16(a)

daily records 

required, responsible 

individual, initialed 

and dated Yes 0.56% 0.21% 2.48E-187 20.44

416.3(b)

Constructed, located 

& operated in a 

manner that does not 

deter inspection Yes 3.87% 0.83% 3.97E-63 2.73

37
38

List of FY2016 

PHRs

Description On List 

of 

FY2015 

PHRs

NC Rate 

in 3 

Months 

before a 

Pathogen 

Positive

NC Rate 

for Plants 

with no 

Pathogen 

Positive 

TwoSided 

Fisher 

Exact p 

Value

Cohen 

Effect 

Size

416.3(c)

Receptacles for 

storing inedible 

material must 

identify permitted 

use Yes 3.02% 1.24% 1.07E-31 4.38

416.4(a)

Food contact 

surface, cleaning & 

sanitizing as 

frequency Yes 21.08% 9.27% 0.00E+00 7.98

416.4(d)

Product processing, 

handling, storage, 

loading, unloading, 

and during 

transportation must 

be protected Yes 24.21% 9.95% 0.00E+00 8.10

417.2(c)

Contents of HACCP 

Plan Yes 2.24% 0.34% 6.02E-08 3.02

417.2(c)(4)

List of procedures & 

frequency Yes 2.00% 0.96% 0.00E+00 17.83

417.3(a)(1)

Identify and 

eliminate the cause Yes 35.24% 2.45% 3.90E-32 1.36

417.3(a)(2) CCP is under control Yes 3.17% 0.24% 2.76E-23 2.57

417.3(a)(3)

Establish measures 

to prevent 

recurrence Yes 15.05% 1.68% 1.86E-280 0.74

417.3(a)(4)

No adulterated 

product enters 

commerce. Yes 4.11% 0.88% 2.12E-12 7.89

417.3(b)(1)

Segregate and hold 

the affected product Yes 13.33% 2.21% 3.92E-08 2.43

417.3(b)(2)

Determine the 

acceptability of the 

affected product Yes 9.55% 1.17% 5.01E-09 2.97

417.3(b)(3)

No adulterated 

product enters 

commerce Yes 4.10% 1.01% 5.43E-06 3.93

417.3(b)(4) Reassessment Yes 14.29% 1.27% 5.26E-11 0.99

417.3(c)

Document corrective 

actions Yes 26.32% 5.43% 8.60E-10 2.93

38
39

List of FY2016 

PHRs

Description On List 

of 

FY2015 

PHRs

NC Rate 

in 3 

Months 

before a 

Pathogen 

Positive

NC Rate 

for Plants 

with no 

Pathogen 

Positive 

TwoSided 

Fisher 

Exact p 

Value

Cohen 

Effect 

Size

417.4(a) Adequacy of 

HACCP in 

controlling food 

safety hazards Yes 22.86% 1.51% 5.70E-13 2.99

417.4(b)

Reassessment of 

hazard analysis Yes 0.75% 0.41% 4.51E-02 1.52

417.5(a)(1)

Written hazard 

analysis Yes 2.20% 0.36% 1.21E-80 13.29

417.5(a)(2)

Written HACCP 

plan Yes 1.08% 0.15% 9.27E-42 11.94

417.5(a)(3)

Records 

documentation and 

monitoring of CCP's 

and Critical Limits Yes 1.37% 0.32% 5.70E-42 13.58

417.5(f) Official Review Yes 1.43% 0.13% 1.87E-03 1.64

430.4(a)

Lm, post-lethality 

exposed RTE Yes 0.66% 0.06% 2.58E-09 9.73

430.4(b)(2) Alternative 2 Yes 3.99% 0.83% 2.73E-08 3.09

430.4(b)(3) Alternative 3 Yes 10.95% 1.14% 1.08E-10 2.84

430.4(c)(2)

Lm, documentation 

that supports 

decision in hazard 

analysis Yes 2.17% 0.00% 1.07E-05 5.93

430.4(c)(3)

Lm, maintain 

sanitation in postlethality processing 

environment Yes 0.45% 0.04% 4.61E-07 9.15

Figure 5-1 presents a histogram for the 54 PHRs of the Cohen effect sizes for difference between 

the non-compliance rate 3 months before a pathogen positive and the non-compliance rate of 

establishments with no pathogen positive. The average effect size is 6.2. 

39
40

Figure 5- 1 Cohen Effect Sizes for 54 PHRs

Forty one of the previous 48 FY2015 PHRs are mapped into these 54 FY2016 PHRs. Thus, 

approximately 85% of the FY2015 PHRs are included in the FY2016 PHRs. There are 13 

additional regulations that are not in the previous PHR list (See Appendix E). 

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

FY2016 PHR list. Most regulations were triggered by multiple events.

Table 5- 2 Events That Triggered Inclusion of a Regulation in the FY2016 PHR list 

Type of Event Number of Regulations Percent

Campylobacter 16 7.84%

Campylobacter Comminuted

Chicken 12 5.88%

Campylobacter Comminuted

Turkey 7 3.43%

Campylobacter Intact Chicken 13 6.37%

Campylobacter Intact Turkey 4 1.96%

Enforcement Actions 40 19.61%

NonO157 STEC 8 3.92%

O157 5 2.45%

Salmonella 30 14.71%

Salmonella Ground Beef 15 7.35%

Salmonella Comminuted Chicken 7 3.43%

Salmonella Comminuted Turkey 8 3.92%

Salmonella Intact Beef 15 7.35%

Salmonella Intact Chicken 16 7.84%

Salmonella Intact Turkey 6 2.94%

Salmonella RTE 2 0.98%

Total 204 100.00%

0

2

4

6

8

10

12

14

0 1 2 3 4 5 10 15 20 25 30 35 More

Frequency

Bin

Cohen Effect Size for 54 PHR

40
41

There were fourteen regulations triggered by a single type of event. Five were from enforcement 

actions, three were from Salmonella All Products, two were from NonO157 STEC All Products, 

two were from Salmonella Intact Beef and one each were from Campylobacter All Products and 

Campylobacter Comminuted Chicken. Table 5-3 presents the regulations triggered for inclusion 

in the FY2016 PHR list by only single event type. 

Table 5- 3 Regulations Triggered for Inclusion in the FY2016 PHR List by Only a Single 

Event

Regulations Triggered by Single Event Event

301.2_Adulterated Enforcements

310.22(e)(3) NonO157

310.22(e)(4)(i) Enforcements

310.22(f)(2) NonO157

310.25(a) Enforcements

318.10(b) Salmonella

381.193(a) Salmonella

381.76(a)* Campylobacter Comminuted Chicken

416.12(c) Enforcements

416.12(d) Enforcements

416.13 Implementation of SOP's Salmonella Intact Beef

417.4(a) Campylobacter

417.4(b) Salmonella

417.5(f) Salmonella Intact Beef

41
42

6.0 CUT POINTS FOR FY2016 PHRS

The FY2016 PHRs are one of seven public health based decision criteria that are used in 

prioritizing Food Safety Assessments (FSAs). These seven decision criteria are described in 

detail in FSIS' Public Health Decision Criteria Report (FSIS 2010). The decision criteria are 

intended for use in identifying establishments that may pose a greater risk to public health than 

other establishments and thus warrant certain prioritized inspection activities by FSIS inspection 

program personnel. 

Noncompliance with a single FY2016 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 FY2016 PHR 

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

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

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

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

approximately normally distributed. Only establishments with greater than or equal to 40 

verifications and at least one non-compliance were considered when developing cut points. 

To determine a set of annual FY2016 cut points, the mean and standard deviation of the natural 

log transformed non-zero FY2016 PHR rate (for establishments having more than 40 

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

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

FY2016 PHR rates is taken to obtain an approximately normal distribution). These results are 

given in Table 6-1. Notice that the means are negative since they are the means of the natural log 

of number between zero and one (the non-zero PHR non-compliance rates). The standard 

deviations are positive. 

Table 6- 1 Mean and Standard Deviation of Quarterly FY2016 PHR Rate 

Mean of Natural

Log FY2016 PHR Rate

Standard Deviation

of FY2016 PHR Rate

Mean Combination Processing Combination Processing

Jan-Mar 2014 -4.55 -4.92 1.11 0.98

Apr-Jun 2014 -4.54 -4.92 1.11 0.98

July-Sep 2014 -4.63 -4.94 1.11 0.96

Oct-Dec 2014 -4.66 -5.05 1.09 0.92

Average -4.60 -4.96 1.11 0.96

The mean and standard deviation are averaged over the four quarters and the annual upper cut 

point is defined as the mean plus two standard deviations. Establishments that have PHR 

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

42
43

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

transformed data for Processing establishments is -4.96 + 2*0.96 = -4.96 + 1.92 = -3.04. The cut 

point of the original, non-transformed PHR non-compliance data is the antilog of -3.04 or Exp (-

3.04) = 4.80%. Table 6-2 presents the FY2016 PHR upper cut points for each of the two 

establishment operation types. The FY2015 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 2016. 

Table 6- 2 FY2016 PHR Tier 1 Cut Points

Operation Type FY2016 PHR Cut Points FY2015 PHR Cut Points

Processing 4.80% 6.55%

Combination 9.25% 9.37%

Table 6-3 presents the number of establishments in each Tier based solely on the FY2016 PHR 

criterion and the cut points in Table 6-2. When applying the cut points to establishments with 

less than 40 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 FY2016 PHRs, 56 

establishments are in Tier 1 and candidates to receive for cause FSAs. Table 6-3 is based on 

regulatory non-compliances for the period December 1, 2014 – February 28, 2015. 

Table 6- 3 Tier Classification of Establishments Based Solely on the PHR Criterion

Classification Number of Establishments

Tier 1 56

Tier 2 115

Tier 3 4,848

Total 5,019

Table 6-4 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 FY2016 PHRs, 49 processing establishments are Tier 

1 and are candidates to receive for cause FSAs. Table 6-4 is based on regulatory noncompliances during December1, 2014 – February 28, 2015. 

Table 6- 4 Tier Classification of Establishments Based on Operation Type and Only the 

PHR Criterion

Classification Processing Combination

Tier 1 49 7

Tier 2 88 27

Tier 3 3,849 999

Total 3,986 1,033

43
44

Table 6-5 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 December 1, 2014 – February 28, 2015.

Table 6- 5 Tier Classification of Establishments Based on the all Seven Decision Criteria

Classification Processing Combination Total

Tier 1 63 7 70

Tier 2 88 26 114

Tier 3 3,849 1,000 4,849

Total 4,000 1,033 5,033

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

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

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

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

an additional FSA. Table 6-6 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 December 1, 2014 – February 28, 2015. Sixty

establishments would receive a “for cause” FSA based on this data. The district may schedule 

additional for cause FSAs at additional establishments based on other considerations.

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

on the all Seven Decision Criteria

Classification Processing Combination Total

Tier 1 53 7 60

Tier 2 74 22 96

Tier 3 3,691 954 4,645

Total 3,818 983 4,801

44
45

7.0 CONCLUSION

The purpose of this report is to develop a transparent and data-driven approach for selecting 9 

CFR regulations used to prioritize certain 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 FY2016 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. Eighty five percent of the regulations on the FY2015 PHR list are also on 

the FY2016 PHR list.

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

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

establishments are candidates to receive a for cause FSA. Table 7-1 presents the FY2016 PHR 

upper 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). The 

FY2015 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 FY2016 PHR Upper Cut Points

Operation Type FY2016 PHR Cut Points FY2015 PHR Cut Points

Processing 4.80% 6.55%

Combination 9.25% 9.37%

45
46

8.0 REFERENCES

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

and Slaughter Establishments, Public Health Decision Criteria. 

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

teria_Report.pdf) 

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

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

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

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

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

Subcommittee Two, Issue Two: Data Analysis. 

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

46
47

APPENDIX A: FY2016 PHR REGULATIONS 

Table A-1 presents the list of fifty four FY2016 Public Health Regulations (PHRs). On average, 

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

enforcement action 5.4 times higher than the PHR noncompliance rates for establishments with 

no pathogen positive or enforcement action. 

Table A-1 List of FY2016 PHRs

List of FY2016 PHRs Description

310.18 Contamination of carcasses, organs, or other parts

416.1 Operate in a manner to prevent insanitary conditions

416.14 Evaluate effectiveness of SSOP's & maintain plan

301.2_Adulterated Adulterated

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

310.22(c) Disposal of SRM

310.22(e)(1)

Written procedures for removal, segregation, and disposition of 

SRMs

310.22(e)(3)

Evaluate effectiveness of procedures for removal, segregation,and 

disposition of SRMs

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

310.22(f)(2)

Use of routine operational sanitation procedures on equipment used 

to cut through SRMs

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

318.10(b) Products requiring treatment to destroy trichinae

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

381.1_Adulterated Adulterated

381.193(a) Poultry not intended for human food in commerce

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

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

381.71(a) Condemnation on ante mortem inspection

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

381.91(a) Certain contaminated carcasses to be condemned

381.91(b)

Reprocessing of carcasses accidentally contaminated with digestive 

tract contents.

381.94(a)* Verification criteria for E. coli testing poultry

416.12(c) plan identifies procedures for pre-op

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

416.13 

Implementation of 

SOP's

Implementation of SSOP

416.15(a) Appropriate corrective actions

416.15(b) Corrective action, procedures for

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

47
48

List of FY2016 PHRs Description

416.3(b)

Constructed, located & operated in a manner that does not deter 

inspection

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

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

416.4(d)

Product processing, handling, storage, loading, unloading, and 

during transportation must be protected

417.2(c) Contents of HACCP Plan

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

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

417.3(a)(2) CCP is under control

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

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

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

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

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

417.3(b)(4) Reassessment

417.3(c) Document corrective actions

417.4(a) Adequacy of HACCP in controlling food safety hazards

417.4(b) Reassessment of hazard analysis

417.5(a)(1) Written hazard analysis

417.5(a)(2) Written HACCP plan

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

417.5(f) Official Review

430.4(a) Lm, post-lethality exposed RTE

430.4(b)(2) Alternative 2

430.4(b)(3) Alternative 3

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

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

48
49

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 FY2016 PHRs is presented in Appendix A. The list of FY2015 

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 FSAs.

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

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

continue to receive routine inspection procedures plus a for-cause FSA.

Number of PHR Non-compliances

PHR NC Rate =

Total Number of PHR Inspection Verifications

49
50

APPENDIX C: FY2016 CANDIDATE REGULATIONS 

Table C-1 presents the list of 134 candidate regulations. The noncompliance rates in Table C-1 

are based on PHIS data for January 1, 2014 through December 31, 2014. 

Table C- 1 FY2016 Candidate regulations 

FY2016 Candidate 

regulations

FY2015 

PHR

Mandatory 

Regulation

Total FSIS 

Verifications

Total 

NCs1

NC1 Rate

301.2_Adulterated Yes 10,736 267 2.49%

304.3(a) 849 1 0.12%

304.3(c) 1,099 11 1.00%

309.2(a) 857 9 1.05%

309.3 160 - 0.00%

309.4 131 1 0.76%

309.5 21 - 0.00%

309.9 19 - 0.00%

310.18 Yes Yes 111,174 1,383 1.24%

310.18(a) Yes 177,448 1,367 0.77%

310.18(b) 14,372 3 0.02%

310.22(b) 10,970 30 0.27%

310.22(c) Yes 63,633 145 0.23%

310.22(d)(2) 191 - 0.00%

310.22(e)(1) 14,763 164 1.11%

310.22(e)(2) 7,373 64 0.87%

310.22(e)(3) 9,253 58 0.63%

310.22(e)(4)(i) Yes 114,717 267 0.23%

310.22(f)(2) Yes 24,302 35 0.14%

310.22(g)(1) 2,520 5 0.20%

310.22(g)(4) 2,240 11 0.49%

310.25(a) Yes 30,517 250 0.82%

310.25(b) 335 1 0.30%

310.25(b)(3)(ii) 262 - 0.00%

310.3 Yes 3,778 152 4.02%

311.16 123 6 4.88%

311.17 133 1 0.75%

311.24 10 - 0.00%

315.2 106 - 0.00%

316.6 11,264 69 0.61%

317.24(a) 4,885 17 0.35%

318.1(b) 91,453 23 0.03%

318.10(b) 2,384 15 0.63%

318.10(c)(1) 2,968 5 0.17%

318.10(c)(2) 976 4 0.41%

50
51

FY2016 Candidate 

regulations

FY2015 

PHR

Mandatory 

Regulation

Total FSIS 

Verifications

Total 

NCs1

NC1 Rate

318.10(c)(3) 629 4 0.64%

318.14(a) 179 2 1.12%

318.14(b) 947 - 0.00%

318.14(c) 52 - 0.00%

318.16(b) 436 - 0.00%

318.17(a)(1)(2) 4,218 15 0.36%

318.17(b) 915 3 0.33%

318.17(c) 41 - 0.00%

318.2(a) 50,886 115 0.23%

318.2(d) Yes 8,162 35 0.43%

318.23(b)(1) 595 11 1.85%

318.23(b)(3) 20 2 10.00%

318.23(c)(1) 142 1 0.70%

318.23(c)(2) 19 - 0.00%

318.23(c)(4) 45 - 0.00%

318.23(c)(5) 23 - 0.00%

318.24 2,147 6 0.28%

318.303 Yes 8,165 8 0.10%

318.308 Yes 4,636 9 0.19%

318.6(b)(1) 4,238 1 0.02%

318.6(b)(4) 7,617 - 0.00%

318.6(b)(6) 12,089 1 0.01%

318.6(b)(8) 396 - 0.00%

319.5(b) 118 - 0.00%

354.242(b) 135 1 0.74%

354.242(h) 52 - 0.00%

354.243(a) 27 - 0.00%

381.1_Adulterated Yes 14,401 254 1.76%

381.144(a) 1,926 2 0.10%

381.150(a) 2,072 26 1.25%

381.150(c) 115 2 1.74%

381.150(d) 9 1 11.11%

381.151(a) 64 1 1.56%

381.193(a) 141 7 4.96%

381.22(a) 387 - 0.00%

381.22(b) 1,378 6 0.44%

381.22(c) Yes 421 2 0.48%

381.310 Yes 4,677 1 0.02%

381.311 Yes 4,550 - 0.00%

381.37(a) 1,892 9 0.48%

51
52

FY2016 Candidate 

regulations

FY2015 

PHR

Mandatory 

Regulation

Total FSIS 

Verifications

Total 

NCs1

NC1 Rate

381.65(a) Yes 85,204 1,192 1.40%

381.65(f) Yes Yes 685,989 8,601 1.25%

381.71(a) 4,681 289 6.17%

381.72(a) 255 - 0.00%

381.72(b) 3 - 0.00%

381.76(a)* 24,800 543 2.19%

381.83 Yes 207,242 64 0.03%

381.85 414 - 0.00%

381.91(a) Yes 11,771 36 0.31%

381.91(b) Yes Yes 21,658 221 1.02%

381.94(a)* Yes 10,855 40 0.37%

381.94(b) Yes 552 2 0.36%

381.94(b)(3)(ii) 94 - 0.00%

416.1 Yes Yes 671,607 27,662 4.12%

416.12(c) 48,437 139 0.29%

416.12(d) 60,414 201 0.33%

416.13 Implementation 

of SOP's 10,199 23 0.23%

416.14 Yes Yes 1,572,946 4,793 0.30%

416.15 Corrective 

Actions 742 7 0.94%

416.15(a) Yes Yes 60,614 1,285 2.12%

416.15(b) Yes Yes 43,360 1,201 2.77%

416.16(a) Yes Yes 2,825,726 5,214 0.18%

416.3(b) Yes Yes 72,359 717 0.99%

416.3(c) Yes Yes 70,304 928 1.32%

416.4(a) Yes Yes 310,531 23,099 7.44%

416.4(d) Yes Yes 293,529 24,001 8.18%

416.5(c) Yes Yes 35,683 18 0.05%

416.6 2,944 170 5.77%

417.2(c) Yes 35,631 220 0.62%

417.2(c)(4) Yes Yes 1,389,469 9,076 0.65%

417.3 Corrective actions 454 - 0.00%

417.3(a) 1,516 3 0.20%

417.3(a)(1) Yes Yes 30,011 790 2.63%

417.3(a)(2) Yes Yes 148,936 883 0.59%

417.3(a)(3) Yes Yes 26,634 876 3.29%

417.3(a)(4) Yes Yes 47,735 544 1.14%

417.3(b)(1) Yes Yes 3,943 203 5.15%

417.3(b)(2) Yes Yes 4,750 189 3.98%

52
53

FY2016 Candidate 

regulations

FY2015 

PHR

Mandatory 

Regulation

Total FSIS 

Verifications

Total 

NCs1

NC1 Rate

417.3(b)(3) Yes Yes 18,989 184 0.97%

417.3(b)(4) Yes Yes 18,407 247 1.34%

417.3(c) Yes Yes 5,582 380 6.81%

417.4(a) Yes Yes 8,276 269 3.25%

417.4(a)(1) Yes Yes 3,828 133 3.47%

417.4(a)(3) 3 - 0.00%

417.4(b) Yes Yes 21,427 110 0.51%

417.5(a)(1) Yes Yes 1,290,988 4,708 0.36%

417.5(a)(2) Yes Yes 1,196,755 1,967 0.16%

417.5(a)(3) Yes Yes 1,453,547 5,102 0.35%

417.5(f) Yes 92,466 110 0.12%

417.6 529 164 31.00%

430.4(a) Yes Yes 291,241 211 0.07%

430.4(b)(1) 1,637 3 0.18%

430.4(b)(2) Yes 13,117 139 1.06%

430.4(b)(3) Yes 25,156 336 1.34%

430.4(c)(2) Yes Yes 276,296 240 0.09%

430.4(c)(3) Yes Yes 294,820 167 0.06%

430.4(c)(4) 2,524 17 0.67%

430.4(c)(5) 5,417 32 0.59%

430.4(c)(6) 5,945 116 1.95%

1. NC = Noncompliance 

53
54

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, 2013 to December 31, 

2014. 

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

period January 1, 2014 to December 31, 2014. 

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 Cohen effect size is 0.5 or greater. 

9. The final list of FY2015 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. 

54
55

APPENDIX E: COMPARISON OF FY2016 PHR LIST WITH FY2015 PHR 

LIST

Table E-1 presents a comparison of the FY2016 PHR list with the FY2015 PHR list (See FSIS ( 

2014) for the FY2015 PHR list)). Eighty five percent of the regulations on the FY2015 PHR list 

are also on the FY2016 PHR list.

Table E- 1 Comparison of FY2016 Public Health Regulations with FY2015 PHR List

List of FY2016 

PHRs

Description On FY2015 

PHR List

310.18 Contamination of carcasses, organs, or other parts Yes

416.1

Operate in a manner to prevent insanitary 

conditions Yes

416.14 Evaluate effectiveness of SSOP's & maintain plan Yes

301.2_Adulterated Adulterated Yes

310.18(a)

Carcasses, organs, and other parts handled in a 

sanitary manner No

310.22(c) Disposal of SRM No

310.22(e)(1)

Written procedures for removal, segregation, and 

disposition of SRMs No

310.22(e)(3)

Evaluate effectiveness of procedures for removal, 

segregation,and disposition of SRMs No

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

310.22(f)(2)

Use of routine operational sanitation procedures on 

equipment used to cut through SRMs Yes

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

318.10(b) Products requiring treatment to destroy trichinae No

318.2(a) All products subject to reinspection by program 

employees

No

381.1_Adulterated Adulterated Yes

381.193(a) Poultry not intended for human food in commerce No

381.65(a)

Clean and sanitary practices; products not 

adulterated Yes

381.65(f)

Zero-tolerance for visible fecal material entering 

chiller Yes

381.71(a) Condemnation on ante mortem inspection No

381.76(a)* Post-mortem inspection, when required, extent. No

381.91(a) Certain contaminated carcasses to be condemned No

381.91(b)

Reprocessing of carcasses accidentally 

contaminated with digestive tract contents. Yes

381.94(a)* Verification criteria for E. coli testing poultry Yes

416.12(c) plan identifies procedures for pre-op No

55
56

List of FY2016 

PHRs

Description On FY2015 

PHR List

416.12(d)

plan list frequency for each procedure & 

responsible individual No

416.13 

Implementation of 

SOP's

Implementation of SSOP

No

416.15(a) Appropriate corrective actions Yes

416.15(b) Corrective action, procedures for Yes

416.16(a)

daily records required, responsible individual, 

initialed and dated Yes

416.3(b)

Constructed, located & operated in a manner that 

does not deter inspection Yes

416.3(c)

Receptacles for storing inedible material must 

identify permitted use Yes

416.4(a)

Food contact surface, cleaning & sanitizing as 

frequency Yes

416.4(d)

Product processing, handling, storage, loading, 

unloading, and during transportation must be 

protected Yes

417.2(c) Contents of HACCP Plan Yes

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

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

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

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

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

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

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

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

417.3(b)(4) Reassessment Yes

417.3(c) Document corrective actions Yes

417.4(a) Adequacy of HACCP in controlling food safety 

hazards

Yes

417.4(b) Reassessment of hazard analysis Yes

417.5(a)(1) Written hazard analysis Yes

417.5(a)(2) Written HACCP plan Yes

417.5(a)(3)

Records documentation and monitoring of CCP's 

and Critical Limits Yes

417.5(f) Official Review Yes

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

430.4(b)(2) Alternative 2 Yes

430.4(b)(3) Alternative 3 Yes

56
57

List of FY2016 

PHRs

Description On FY2015 

PHR List

430.4(c)(2)

Lm, documentation that supports decision in hazard 

analysis Yes

430.4(c)(3)

Lm, maintain sanitation in post-lethality processing 

environment Yes

There are seven regulations from the FY2015 PHR list that no longer appear in the FY2016 PHR 

list. These seven regulations are shown in Table E-2. 

Table E- 2 Regulation from the FY2015 PHR list no longer on the FY2016 PHR list

Regulation Description

310.3 Carcasses and parts in certain instances to be retained.

381.83 (HIMP ONLY) Septicemia or toxemia

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

381.22(c) Conduct hazard analysis & develop HACCP plan for new product

381.94(b) Exceeds Pathogen reduction performance standards for Salmonella

416.5(c) Employees who appears to have any abnormal source of microbial contamination

417.4(a)(1) Initial validation

57
58

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 40 verifications and at least one non-compliance are 

considered. 

58
59

Figure F- 1 Log Transformed Non-zero Non-Compliance Rates of PHRs with 40 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 40 or More Verifications 3 

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

Processing) Establishments

These distributions are approximately normally distributed. The Shapiro-Wilk test for normality 

W statistics for the two distributions are 0.991 and 0.990, 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.

59
60

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

with 40 or More Verifications 3 Months before a Pathogen Positive or Enforcement Action 

for Processing Establishments

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

with 40 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 40 or more PHR verification inspections and at least one noncompliance. 

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 

60
61

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 83 Tier 1 establishments per month based solely 

on the PHR criteria. The subset of the 83 establishments that have not had an FSA in the past 6 

months will receive a for cause FSA.

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

Number of 

Establishments

Mean Standard 

Deviation 

Tier Distribution 

(Number of 

Establishments)

Q1CY2014 Tier1 90

Both 1,020 -4.55 1.11 Tier2 157

Processing 4,018 -4.92 0.98 Tier3 4,791

Q2CY2014 Tier1 90

Both 1,020 -4.54 1.11 Tier2 155

Processing 4,018 -4.92 0.98 Tier3 4,793

Q3CY2014 Tier1 84

Both 1,031 -4.63 1.11 Tier2 137

Processing 4,020 -4.94 0.96 Tier3 4,830

Q4CY2014 Tier1 66

Both 1,039 -4.66 1.09 Tier2 132

Processing 3,994 -5.05 0.92 Tier3 4,835

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 56 for cause FSAs in the February 2015 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 -4.60 -4.96

Standard Deviation 1.11 0.96

61
62

Table F- 3 February 2015 Tier Distribution Based on the PHR Criteria Only

Classification Plants

Tier 1 56

Tier 2 115

Tier 3 4,848

Total 5,019

F-2 Scheduling FSAs Using Seven Criteria 

Table F-4 presents the Tier distribution of establishments when using all seven decision criteria, 

including the FY2016 PHR regulations and the cut points defined from Table F-2. The table is 

derived from data for the three month period December 1, 2014 – February 28, 2015. 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 February 2015 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 70 60

Tier 2 114 96

Tier 3 4,849 4,645

Total 5,033 4,801

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 4,000 79.48% 63 90.00% Yes

Combination 1,033 20.52% 7 10.00% Yes

Totals 5,033 100.00% 70 100.00%

Table F-6 presents the distribution of Tier 1 establishments (as determined using only the PHR 

criteria) among different product categories. There is a statistically significant difference 

between the percentage of establishments producing a given product category and the percentage 

62
63

of establishments in Tier 1 for that product category in Beef Slaughter, Pork Slaughter and 

Ground Pork. 

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 

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 197 3.93% 2 3.57% No

Turkey Slaughter 51 1.02% - 0.00% No

Beef Slaughter 621 12.37% 2 3.57% Yes

Pork Slaughter 589 11.74% - 0.00% Yes

Ground Beef 1,597 31.82% 12 21.43% No

Comminuted Chicken 803 16.00% 10 17.86% No

Comminuted Turkey 313 6.24% 3 5.36% No

Ground Pork 1,721 34.29% 11 19.64% Yes

RTE 2,495 49.71% 31 55.36% No

Poultry Combination 395 7.87% 4 7.14% No

Total Number of 

Establishments 5,019 56

63