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IV. Recommendations, V. Field and Statistical Limitations, and VI. New Areas of Study of the FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (2004)

Table of contents


The following recommendations are directed toward enhancing the effectiveness of regulatory and industry retail food protection programs. These recommendations are focused on a nationwide effort to reduce the occurrence of foodborne illness risk factors within institutional foodservice, restaurant and retail food store facilities. Each of the foodborne illness risk factors encompasses a number of food safety practices and employee behaviors. These practices and behaviors are captured by the individual data items in this report and are based on the food safety provisions of the 1997 FDA Food Code.

Section III, Results and Discussion, emphasized the importance of identifying the gaps in the active managerial control of foodborne illness risk factors for each of the facility types. Active managerial control involves purposefully incorporating specific actions and procedures into a food operation to achieve control over foodborne illness risk factors. If the safety of food is to be significantly improved, foodservice and retail food managers must establish effective control over these food safety practices and employee behaviors.

A. Recommendations for Foodservice and Retail Food Industries

Ultimate responsibility for the development and maintenance of effective food safety systems lies with the management of institutional foodservice, restaurant and retail food store operations. Individual operators responsible for the day-to-day management of these facilities play a key role in preventing foodborne illness.

Food safety management systems can take many forms. Every establishment has some type of a set pattern of procedures, even if it is simply described as "the way we do things." Some establishments have implemented effective food safety management systems by establishing controls for food preparation methods and monitoring processes common to their operation. Many others, however, rely on vague unmonitored procedures. At a minimum, an operator's food safety management system should be based on achieving the same level of safety established by the critical limits in the Food Code.

The 2000 Baseline Report made the following recommendations for industry to establish active managerial control of foodborne illness risk factors:

  • Develop and implement written Standard Operating Procedures (SOPs) that address the risk factors. These SOPs should detail procedures specific to the operation for time/temperature control of potentially hazardous food, personal hygiene, and measures to prevent food from being contaminated.
  • Provide the necessary resources, equipment, and supplies to implement the SOPs. Items such as temperature measurement devices, preferably thermocouples, test papers, temperature logs, hand soap, towels, and chemical sanitizers are crucial to the successful control of specific risk factors.
  • Assess SOPs to ensure control over all risk factors. Critical limits and measurable standards for control of the risk factors should be incorporated into SOPs. Critical limits provide a means for measuring the effectiveness of an establishment's food safety procedures.
  • Establish monitoring procedures that focus on critical processes and practices. Monitoring procedures will only be effective if employees are given the knowledge, skills, and responsibility for food safety.
  • Identify methods to routinely assess the effectiveness of the SOPs. This assessment approach could be based on an internal review, regulatory inspection results, or third party evaluation.

The importance of each of these recommendations is reinforced by the results of the 2003 data collection effort. The percentage of establishments that were found to be Out of Compliance with data items related to poor personal hygiene, time/temperature control, and contaminated equipment remained high in 2003. This suggests that industry efforts to achieve active managerial control over these risk factors, and to adequately train employees, still needs to be improved. Managing food safety risk factors must be a fully integrated part of every business operation if it is to significantly reduce the risk of foodborne illness.

Section III, Results and Discussion, provides a national overview of the food safety practices and procedures most in need of improvement for each facility type. As a start, industry operators should evaluate how well they are controlling these areas within their own operations. When weaknesses are discovered in the food safety system, action must be initiated to correct the immediate problem and ensure active managerial control of the risk factor.

To assist industry in the development of management systems designed to control foodborne illness risk factors, FDA has developed a guidance document, Managing Food Safety: A HACCP Principles Guide for Operators of Food Establishments at the Retail Level.


B. Recommendations for Regulatory Retail Food Protection Programs

The high percent of establishments found to be Out of Compliance with many of the data items covered in this study indicates that regulatory agencies need to do more to affect change in the food safety practices and behaviors in foodservice and retail food establishments. In conjunction with their industry partners, regulatory agencies should focus their efforts on reducing the occurrence of the risk factors highlighted in Section III of this report. The recommendations below may assist agencies toward this goal.

To assist professionals responsible for regulatory foodservice and retail food inspections, FDA has developed a guidance document, Managing Food Safety: A Regulator's Guide for Applying HACCP Principles to Risk-Based Retail and Food Service Inspections and Evaluating Voluntary Food Safety Management Systems. As of the printing date of this report, the guidance document was not available on the FDA web site. A copy can be obtained by contacting one of the FDA Regional Retail Food Specialists listed in Appendix J.

Conducting quality inspections

Inspection focus. The risk factors should be the primary focus of every inspection. Inspectors must understand the public health reasons, and be able to correctly apply the underlying regulatory requirements, for the control of each risk factor.

Inspection tools. Use of an inspection form that directs the inspector to routinely document the compliance status (In, Out, Not Observed, Not Applicable) for practices and behaviors related to the risk factors is recommended. An inspector must also be properly equipped with other necessary inspection tools, such as accurate temperature measuring devices (thermocouples) and sanitizer test kits, to assess an establishment's compliance with certain risk factors.

Inspection timing. The time of day that inspections are conducted may need to be varied based on the operation. Inspectors may need flexible schedules to ensure observations of critical food preparation practices that routinely occur before or after the traditional inspector's working hours. Observing and documenting practices related to risk factors, such as cooling of PHF and proper handwashing, may require slightly longer inspections.

Providing on-site education and achieving voluntary compliance

Recognize any existing industry QA and training programs. Inspectors should recognize an establishment's existing quality assurance and employee training programs and reinforce those components that lead to active managerial control of risk factors.

Establish a dialog with operators. Inspectors should discuss out-of-control risk factors with establishment operators and suggest appropriate control measures.

Obtain immediate corrective action. Inspectors should require immediate corrective action for risk factors found to be Out of Compliance with regulatory requirements. Immediate corrective action should be verified and documented before the inspector leaves the facility.

Assist in developing SOPs and Risk Control Plans. Inspectors should assist operators in developing management plans that describe the specific actions to be taken to achieve long-term control of Out of Compliance risk factors. For example, a risk control plan is a concisely written management plan developed by the retail or foodservice operator with input from the regulatory authority. Risk control plans can be used as both education and compliance tools for addressing out-of-control risk factors.

Implementing a consistent and effective enforcement protocol

Develop enforcement procedures. Well-defined, step-by-step procedures are needed for bringing enforcement actions against facilities that repeatedly fail to achieve compliance with requirements related to foodborne illness risk factors.

Ensure credibility. The enforcement process must be applied fairly and uniformly and with consistency when risk factors are repeatedly out-of-control.

Continuous program improvement

The recommendations described above are captured in the Voluntary National Retail Food Regulatory Program Standards (Program Standards). The Program Standards apply to the operation and management of a retail food regulatory program that is focused on the reduction of foodborne illness risk factors and the promotion of active managerial control of these risk factors. Through a process of self-assessment, agencies may use the Standards to evaluate the effectiveness of their food safety program.

While the Program Standards represent the retail food safety program to which we ultimately aspire, they begin by providing a foundation which all regulatory programs can build upon through a continuous improvement process. Managers of regulatory inspection programs are encouraged to review existing practices and procedures to ensure that current program activities target reducing the occurrence of those risk factors identified in Section III, Reports and Discussion.

The Program Standards encourage state and local jurisdictions to establish studies of the occurrence of foodborne illness risk factors that are specific to their geographic area of responsibility. To assist agencies interested in conducting a baseline study in their own jurisdictions, FDA has prepared a manual and developed a software program designed to manage and analyze the data collected. Information about the data collection manual and software package can be obtained from an FDA Regional Retail Food Specialist.



How a research project is designed and implemented impacts the interpretation of the data. Earlier in this report, some internal and external factors influencing the design and scope of the project were discussed. All field studies involving data analysis have uncontrollable factors that place limitations on how the data is collected, analyzed, and reported. These factors can be placed in two broad categories:

  1. Field Operational Limitations
  2. Statistical Limitations

A.   Field Operational Limitations

Attempts were made to observe the same risk-related data items that appear on the data collection form presented under Methodology, Section II, at each establishment. The foodservice and retail food industry is dynamic. There is no set pattern of operation within foodservice and retail food store facilities upon which data collections can be scheduled to be assured of observing all the data items. This results in variations in total number of observations for each of the data items.

The framework that Specialists used to collect the data mirrored the process currently employed by state and local inspectors conducting routine inspections. The factors that impacted the ability of Specialists to observe the specific employee food safety practices and behaviors included establishment type, the season of the year, the time of day the survey was conducted, and the length of time available for each inspection.

Some data items that had a low number of observations included:

  • Foods received according to law, cooled to 41 °F (5 °C) within 4 hours
  • Cooked PHF cooled from 140 °F (60 °C) to 70 °F (21 °C) within 2 hours and from 140 °F (60 °C) to 41 °F (5 °C) in a total of 6 hours
  • PHF (from ambient ingredients) cooled to 41 °F (5 °C) or below within 4 hours
  • Roasts, including formed roasts, cooked to 130 °F (54 °C) for 112 minutes
  • Wild game animals cooked to 165 °F (74 °C) for 15 seconds
  • As required, written documentation of parasite destruction maintained for 90 days for fish products
  • Critical Control Point (CCP) monitoring records maintained in accordance with HACCP Plan when required

Some of these data items require a significant period of time to assess compliance with regard to time/temperature standards or they involve processes or operational steps that occur outside traditional regulatory work hours; and documentation of these steps or processes may not have been available at the time of the survey. Other data items related to foods that are not commonly found on the menus of the facility types inspected.

B.   Statistical Limitations

Sample Design

Since a random selection of all facility types in the United States would not be possible from a financial or logistical perspective, an alternative method was selected. Comparison sets were developed in five FDA Regions throughout the country. The current picture of compliance with the risk factors reflects the entire U.S. to the extent that the comparison sets are representative of the overall industry.

Because the facilities were not selected randomly from the entire U.S., statistical estimates of the precision with which they estimate the entire U.S. for each facility type cannot be provided. We only have a common sense opinion that being spread across the U.S. in the same pattern that FDA stations its Specialists should give a reasonable approximation of the U.S. compliance picture.

The geographical distribution of Specialists throughout the country in relatively high density population centers allowed for a broad sampling throughout all regions of the U.S. The choice of data collection locations, therefore, was based on the Specialists' geographical areas of responsibility and provided a reasonably convenient design for estimating national risk-related behaviors and practices.

The size of the sample was determined to assure with 95% confidence that if a particular data item has a compliance percentage of no more than 60%, then the study would indicate a compliance rate of no more than 70%.

A challenge inherent in measuring trends is uncontrolled variation in samples. The design of this project controlled this variation by the use of the comparison sets. A typical comparison set consisted of ten or more establishments of the same facility type in the same general geographic area. Where the number of establishments for a facility type within a designated geographic area was small, such as with nursing homes and hospitals, much bigger geographic areas were required than for facility types such as fast food that were more numerous. In areas with limited numbers of nursing homes and hospitals, a comparison set included a minimum of four establishments.

The establishments in each comparison set were placed in alphabetical order and sequentially numbered. The Specialists then used a table of random numbers, supplied by CFSAN's Division of Mathematics, to select the particular establishment to inspect. Comparison set establishment lists, compiled by the Specialists, have been archived and will be used again in future studies. A different establishment is randomly selected from the same comparison set establishment list for each data collection period. This randomness gives the same chance of selecting establishments having varying degrees of compliance, thus preventing selection bias. Since each comparison set is made up of similar establishments, the sample variability is greatly reduced.

This project is designed to establish a national baseline on the occurrence of foodborne illness risk factors within the foodservice and retail food industry. The way the samples were selected and the size of the data set do not support comparisons of individual Specialists geographical areas, states, cities or even regions of the U.S. Not only would it be statistically inappropriate, but such comparisons might be combined with other information, such as the locations of FDA Retail Food Specialists, to identify some of the likely comparison sets. This information would bias future studies.

In addition, the project is not designed to support comparisons of chains of fast food restaurants or chains of grocery stores. There is no statistical justification for looking at reduced sets of results particular to, e.g., two chains of restaurants and drawing conclusions from the differences.

Comparing data over time

A summary of the 1998 Baseline IN Compliance percentages for ALL data items for each facility was presented in Table 1. This report makes no attempt to analyze the difference in IN Compliance percentages between the 1998 and 2003 results. When designing a study to compare just two periods in time, pairing of facilities is considered important. This study made no attempt to satisfy that condition.

Although the data collected in 2003 is part of a larger study designed to measure changes in IN Compliance percentages over time, this data collection period provided only the second data point in the study progression. Since a minimum of three data collection periods is necessary for the measurement of a trend, the results from the 2003 data collection period presented in this report should be interpreted as a stand-alone study.

Having three data collection periods is a necessary condition for the determination of a trend, but it is not a sufficient condition. It is theoretically possible to find a trend with three data collection periods, but the impact of the limitations discussed in this section may make documentation of a trend difficult even with the additional data point. Additional data collection periods may need to be included in the study.

At the beginning of the study design, it was anticipated that the number of observable and applicable responses for each data item would vary. The total number of observations for each data item is likely to change from one data collection period to another. When analyzing data from two data collection periods, the variation in the number of observations makes it difficult to draw statistical conclusions between the overall compliance percentages or the risk factor compliance percentages. Changes in the number of observations of data items may be attributed to:

  • Sample variations
  • Changes in industry practices
  • Quality assurance issues associated with the data collection tool

Sampling variations. The frequency at which a data item can be observed during each data collection period may change due to sampling establishments within the same facility type that have different food products and procedures.

Changes in industry practices. If a change in an overall industry practice results in more inspectors marking not applicable (NA) rather than IN or Out of Compliance, then there may be a change in the total number of observations for a given data item from one data collection period to the next. This may result in a corresponding change in the relative weight of that data item in the compliance percentage for the relevant risk factor. For example, if numerous establishments have shifted from using raw shell eggs to using pasteurized egg products, the number of observations related to inadequate cooking will go down from one data collection period to the next. Therefore, a lower Out of Compliance percentage for the inadequate cook risk factor may not be reported, even though the new industry practice represents improved active managerial control.

Quality assurance, After the 1998 data collection period, a thorough quality assurance review of the marking instructions was conducted for each data item. There were a few data items from the original baseline for which it was necessary to clarify the marking instructions and in one case a slight modification to the data item itself was necessary. Clarifying marking instructions and modifying data items can affect the number of observations for specific data items and in turn the compliance percentages for the risk factors and the overall baseline.

Impact of changes in number of observations from one data collection period to another. Increases or decreases in the number of observations made for a given data item will have an impact on IN Compliance percentages for the corresponding risk factor. All else being equal, a decrease in total observations for a high IN Compliance data item can offset an increase in the IN Compliance percentages for other data items.

For example, consider a risk factor that is comprised of two data items - Item A and Item B. The following chart provides a fictitious summary of observations made of each of the data items in 1998 and 2003.

  1998 2003
Data Item A 50 100 50% 50 100 50%
Data Item B 100 100 100% 50 50 100%
Overall 150 200 75% 100 150 67%


In the above illustration, Data Item A has the same total number of observations (100) and total number of IN Compliance observations (50) for both 1998 and 2003. For each of these data collection periods the IN Compliance percentage for Data Item A is 50%. Data Item B has a 100% IN Compliance percentage for both 1998 and 2003. In 2003, however, fifty less observations were made of Data Item B.

The IN Compliance percentages for Data Item A (50%) and Data Item B (100%) were exactly the same for both data collection periods. The impact of the fifty less observations for the high IN Compliance data Item (B) lowered the overall IN Compliance percentage for the risk factor from 75% in 1998 to 67% in 2003.

If an attempt is made to compare the 2003 IN Compliance percentage (67%) with the 1998 IN Compliance percentage (75%), an erroneous conclusion might be made that the degree of control of this risk factor had regressed by 8%. The underlying cause for the 8% regression, however, is not due to less control of the risk factor but rather a result of fewer observations (fifty less) for data item B which in both data collection periods had an IN Compliance percentage of 100%.

The potential impact of the above scenario on the different data collection periods in this study can be compounded because the Overall IN Compliance percentage upon which trends are being measured is a weighted average of the IN Compliance percentages for forty-two data items. The weights are the number of observations for each data item and are not identical between data collection periods. Therefore, making statistical comparisons between data collection periods becomes difficult. The impact of this weighting issue will be examined for each of the data collection periods.




Minimizing the occurrence of foodborne illness risk factors in a foodservice or retail food operation does not happen by accident. The importance of having knowledgeable and effective management on-site during all hours of operation cannot be overstated. The person in charge of a food establishment is responsible for ensuring that policies and procedures that prevent the transmission of foodborne disease are routinely followed and that corrective actions are taken as needed to protect the health of the consumer.

If the person in charge is knowledgeable about the relationship between the prevention of foodborne illness and the various operations, practices, and behaviors that take place in the food establishment, then he or she will be in a far better position to exert active managerial control over the important foodborne illness risk factors. Encouraging or requiring certification as a food protection manager is one means by which the food industry and regulatory authorities have sought to increase establishment managers' knowledge of food safety.

During the 2003 data collection, Specialists were instructed to determine whether the facility being inspected had a Certified Food Protection Manager on site. For the purposes of this study, Specialists were instructed to circle YES on the Certified Food Protection Manager line on the facility information portion of the Baseline Data Collection Form if the person in charge had been certified by any one of five certification programs whose examinations had been recognized by the Conference for Food Protection (CFP) at the time the data collection effort started. If the person in charge was not a Certified Food Protection Manager or had been certified by an organization not recognized by the CFP, Specialists were instructed to circle NO on the Baseline Data Collection Form.

One reason this information was collected was to get a better picture of the extent to which Certified Food Protection Managers are present in the various facility types during hours of operation. The Food Code does not mandate certification but does recognize food protection manager certification by an accredited program as one means by which a person in charge can demonstrate knowledge of foodborne illness prevention, application of HACCP principles and the requirements of the Food Code. The number of inspected establishments of each facility type with and without a Certified Food Protection Manager (as determined by the criteria described above) is shown in Table 32.

Table 32
Inspected Facilities With and Without a Certified Food Protection Manager
Facility Type # Of Inspected Facilities
Certified Food
Protection Manager
# Of Inspected Facilities
Certified Food
Protection Manager
Hospitals 80 17
Nursing Homes 54 40
Elementary Schools 56 42
Fast Food Restaurants 71 37
Full Service Restaurants 50 49
Delis 50 58
Meat & Poultry 49 60
Seafood 51 54
Produce 44 64


Impact of Certified Food Protection Managers for each facility type

It appears that the presence of a Certified Food Protection Manager has a positive effect on the overall Percent IN Compliance within some facility types.

Four facility types had Overall IN Compliance percentages (all 42 data items combined) that were significantly higher in establishments with a Certified Food Protection Manager than in establishments without a Certified Food Protection Manager. These facility types are identified with bold type in Table 33 on page 149. In the five remaining facility types, the differences were not statistically significant(1).


Table 33
Effect of Manager Certification on the Overall Percent IN Compliance by
Facility Type
(2003 Data Collection Form - Sections 1 - 16 (42 Data Items)*
Facility type Manager Certified Manager Not Certified Difference
(% IN)
# IN #OUT % IN # IN # OUT % IN
Hospitals 1345 347 79.5 277 69 80.1 -0.6
Nursing Homes 864 187 82.2 583 167 77.7 4.5
Elementary Schools 772 158 83.0 562 120 82.4 0.6
Fast Food Restaurants  1014  274  78.7  407  222  64.7  14.0
Full Service Restaurants  678  344  66.3  559  431  56.5  9.8
Delis 660 287 69.7 707 309 69.6 0.1
Meat and Poultry  540  98  84.6  572  181  76.0  8.6
Seafood 643 158 80.3 616 165 78.9 1.4
Produce  439  90  83.0  506  165  75.4  7.6

* The figures in Table 33 do not include the Supplemental Data Items found in Sections 17 - 23 of the Data Collection Form (pages 24 - 25)


Effect of Certified Food Protection Managers on the risk factors

Table 34 presents the risk factors for which the Percent IN Compliance for establishments with Certified Food Protection Managers was significantly higher than those without Certified Food Protection Managers.

Table 34
Risk Factors with Statistically Significant Differences
Between Establishments
WITH and WITHOUT a Certified Food Protection Manager
Facility Type Risk Factor
Fast Food Restaurants
  • Improper Holding/Time and Temperature
  • Contaminated Equipment/Protection from Contamination
Full Service Restaurants
  • Poor Personal Hygiene;
  • Contaminated Equipment/Protection from Contamination
Meat and Poultry Departments
  • Poor Personal Hygiene
Produce Departments
  • Poor Personal Hygiene

Specific data for each of the six risk factors are presented in Tables 35 A-F. These tables show the Percent IN Compliance recorded in establishments that had a Certified Food Protection Manager present and those that did not.

There was no risk factor for which the IN Compliance percentage for establishments without a certified manager exceeded the percentage for establishments with a certified manager in a statistically significant manner(2).

Table 35A
Food from Unsafe Source
Effect of Manager Certification on Percent IN Compliance by Facility Type
Facility type Manager Certified Manager Not Certified Difference
(% IN)
# IN #OUT % IN # IN # OUT % IN
Hospitals 160 0 160 100% 33 1 34 97.1% 2.9%
Nursing Homes 106 4 110 96.4% 78 2 80 97.5% -1.1%
Elementary Schools 109 3 112 97.3% 81 6 87 93.1% 4.2%
Fast Food Restaurants 139 3 142 97.9% 72 2 74 97.3% 0.6%
Full Service Restaurants 113 18 131 86.3% 108 15 123 87.8% -1.5%
Delis 97 4 101 96.0% 113 7 120 94.2% 1.8%
Meat and Poultry 108 2 110 98.2% 122 10 132 92.4% 5.8%
Seafood 161 25 186 86.6% 162 22 184 88.0% -1.4%
Produce 91 0 91 100% 128 4 132 97.0% 3.0%


Table 35B
Inadequate Cooking
Effect of Manager Certification on Percent IN Compliance by Facility Type
Facility type Manager Certified Manager Not Certified Difference
(% IN)
# IN #OUT % IN # IN # OUT % IN
Hospitals 206 12 218 94.5% 33 4 37 89.2% 5.3%
Elementary Schools 60 1 61 98.4% 36 2 38 94.7% 3.7%
Fast Food Restaurants 130 13 143 90.9% 39 4 43 90.7% 0.2%
Full Service Restaurants 104 13 117 88.9% 98 25 123 79.7% 9.2%
Delis 67 4 71 94.4% 72 10 82 87.8% 6.6%
Meat and Poultry 1 0 1 100% 0 1 1 0% 100%
Seafood 3 1 4 75.0% 2 1 3 66.7% 8.3%
Produce 0 0 0 NA 2 0 2 100% NA


Table 35C
Improper Holding/Time-Temperature
Effect of Manager Certification on Percent IN Compliance by Facility Type
Facility type Manager Certified Manager Not Certified Difference
(% IN)
# IN #OUT % IN # IN # OUT % IN
Hospitals 254 182 436 58.3% 60 30 90 66.7% -8.4%
Nursing Homes 190 83 273 69.6% 131 59 190 68.9% 0.7%
Elementary Schools 152 65 217 70.1% 113 53 166 68.1% 2.0%
Fast Food Restaurants  187  98  285  65.6%  65  82  147  44.2%  21.4%
Full Service Restaurants 96 146 242 39.7% 74 154 228 32.5% 7.2%
Delis 98 152 250 39.2% 76 163 239 31.8% 7.4%
Meat and Poultry 50 24 74 67.6% 63 24 87 72.4% -4.8%
Seafood 73 51 124 58.7% 57 44 101 56.4% 2.3%
Produce 54 43 97 55.7% 48 56 104 46.2% 9.5%


Table 35D
Contamination of Equipment/Protection from Contamination
Effect of Manager Certification on Percent IN Compliance by Facility Type
Facility type Manager Certified Manager Not Certified Difference
(% IN)
# IN #OUT % IN # IN # OUT % IN
Hospitals 304 70 374 81.3% 66 16 82 80.5% 0.8%
Nursing Homes 201 44 245 82.0% 134 42 176 76.1% 5.9%
Elementary Schools 165 30 195 84.6% 129 16 145 89.0% -4.4%
Fast Food Restaurants  239  46  285  83.9%  100  49  149  67.1%  16.8%
Full Service Restaurants 148 71 219 67.6% 126 92 218 57.8% 9.8%
Delis 165 49 214 77.1% 168 53 221 76.0% 1.1%
Meat and Poultry 163 40 203 80.3% 168 67 235 71.5% 8.8%
Seafood 161 44 205 78.5% 174 40 214 81.3% -2.8%
Produce 105 20 125 84.0% 112 36 148 75.7% 8.3%


Table 35E
Poor Personal Hygiene
Effect of Manager Certification on Percent IN Compliance by Facility Type
Facility type Manager Certified Manager Not Certified Difference
(% IN)
# IN #OUT % IN # IN # OUT % IN
Hospitals 331 68 399 83.0% 65 16 81 80.3% 2.7%
Nursing Homes 218 42 260 83.8% 141 49 190 74.2% 9.6%
Elementary Schools 236 42 278 84.9% 164 36 200 82.0% 2.9%
Fast Food Restaurants 257 95 352 73.0% 107 70 177 60.5% 12.5%
Full Service Restaurants  167  80  247  67.6%  117  123  240  48.8%  18.8%
Delis 184 62 246 74.8% 220 62 282 78.0% -3.2%
Meat and Poultry  163  26  189  86.2%  171  65  236  72.5%  13.7%
Seafood 191 29 220 86.8% 176 45 221 79.6% 7.2%
Produce  118  18  136  86.8%  133  54  187  71.1%  15.7%


Table 35F
Effect of Manager Certification on Percent IN Compliance by Facility Type
Facility type Manager Certified Manager Not Certified Difference
(% IN)
# IN #OUT % IN # IN # OUT % IN
Hospitals 90 15 105 85.7% 20 2 22 90.9% -5.2%
Nursing Homes 56 10 66 84.9% 39 11 50 78.0% 6.9%
Elementary Schools 50 17 67 74.6% 39 7 46 84.8% -10.2%
Fast Food Restaurants 62 19 81 76.5% 24 15 39 61.5% 15.0%
Full Service Restaurants 50 16 66 75.8% 36 22 58 62.1% 13.7%
Delis 49 16 65 75.4% 58 14 72 80.6% -5.2%
Meat and Poultry 55 6 61 90.2% 48 14 62 77.4% 12.8%
Seafood 54 8 62 87.1% 45 13 58 77.6% 9.5%
Prodcue 71 9 80 88.8% 83 15 98 84.7% 4.1%



1 When assessing the statistical significance of the differences between facility types that have certified food protection managers and non certified food protection managers, the Bonferroni adjustment procedure for multiple comparisons was used. This method requires that the probability of committing one or more type 1 errors is .05. Since there are nine facility types, nine comparisons were made resulting in a type 1 error rate to be far smaller than .05 for each comparison. In fact, the p-value required to conclude that a significant difference existed was .0056 or less.

2 The same multiple comparison method was used to assess the statistical significance of the differences between risk factors within the different facility types that have certified food protection managers and non-certified food protection managers. Since there are approximately fifty-four comparisons (there are six risk factors for each facility type and nine facility types; however, for several of the risk factors inadequate sample size or violation of the rules relating to the normal approximation of the sampling distribution of the sample proportion made the statistical test inappropriate) we required a p-value of .0005 or less to conclude that a significant difference existed. In this case the probability of committing one or more type 1 errors is .05.



Although the original forty-two data items used for the 1998 baseline collection were retained in the 2003 data collection, additional data items were added in an effort to gain a better understanding of various industry practices and procedures not addressed in the 1998 baseline collection project. These supplemental data items address practices and procedures related to either foodborne illness risk factors or public health interventions. The following are subject areas that were included in the supplemental data collection:

  • Cooking temperatures for pork, ratites, and injected meats
  • Hot holding of potentially hazardous food
  • Employee health
  • Juice treatment
  • Cooling and cold holding of raw shell eggs
  • Special requirements for establishments serving highly susceptible populations

Cooking Temperatures for Pork, Ratites, and Injected Meats

In the 1997 FDA Food Code and in the 1998 baseline collection, the critical limit for cooking all pork, ratites such as ostrich and emu, and injected meats was 155 °F (68 °C) for 15 seconds. Subsequent research showed that a lower temperature was adequate for destroying the biological hazards in pork; thus, the critical limit for cooking pork was changed in the 1999 FDA Food Code to 145 °F (63 °C) for 15 seconds. The critical limit for cooking ratites and injected meats remained unchanged.

Supplemental data items were added to assess whether lowering the cooking temperature of pork had any effect on industry's ability to control this data item. FDA established three separate data items related to the cooking of pork and ratites:

  • Cooking of pork, ratites, and injected meats to 155 °F (68 °C) or above for 15 seconds (Data Item - 4G);
  • Cooking of pork to 145 °F (63 °C) or above for 15 seconds (Data Items - 17A); and
  • Cooking of ratites and injected meats to 155 °F (68 °C) above for 15 seconds (Data Item - 17B).

As shown in Table 36, there were too few observations during the 2003 data collection to make conclusions about what effect, if any, lowering the cooking temperature for pork had on industry's ability to control this data item.

Table 36
Observations Made of Pork, Ratites, and Injected Meats Cooked to 155 °F (68 °C) for 15 Seconds (Data Item 4G)
Pork Being Cooked to 145 °F (63 °C) for 15 Seconds (Data Item 17A) and Ratites/Injected Meats Cooked to 155 °F (68 °C) (Data Item 17B)
Facility Type Total IN Observations
Cooking All to 155 °F
Total OUT Observations
Cooking All to 155 °F
Total Total IN Observations
Cooking Pork to 145 °F; Ratites/Injected Meats to 155 °F
Total OUT
Cooking Pork to 145 °F; Ratites/Injected Meats to 155 °F
Hospitals 17 1 18 19 0 19
Nursing Homes 14 0 14 14 0 14
Elementary Schools 0 0 0 0 0 0
Fast Food Restaurants 4 0 4 4 0 4
Full Service Restaurants 11 2 13 14 0 14
Delis 15 1 16 18 0 18
Meat & Poultry 0 0 0 0 0 0
Seafood 0 0 0 0 0 0
Produce 0 0 0 0 0 0

Hot Holding Potentially Hazardous Foods at 135 °F (57 °C)

In the 1997 FDA Food Code and in the 1998 baseline collection, the critical limit for hot holding potentially hazardous food was 140 °F (59 °C). This temperature was lowered to 135 °F (57 °C) in the 2003 Food Code Supplement. A supplemental data item was added for hot holding at 135 °F (57 °C) to better assess industry's practices and procedures related to control of this data item.

As shown in Table 37, changing the hot holding to 135 °F (57 °C) had minimal impact on industry's control of this data item. There were not enough observations to draw any conclusions for the meat and poultry, seafood, and produce facility types.

Table 37
Hot Holding at 140 °F (Data Item 8A)
Hot Holding at 135 °F (Data Item 18A)
Facility Type Total
140 °F
Total Out
140 °F
Total 140 °F % IN
140 °F
Total IN
135 °F
Total Out 135 °F Total 135 °F % IN
135 °F
Hospitals 59 36 95 62.1% 65 30 95 68.4% 6.3%
Nursing Homes 53 17 70 75.7% 54 16 70 77.1% 1.4%
Elementary Schools 61 21 82 74.4% 62 20 82 75.6% 1.2%
Fast Food Rest. 66 28 94 70.2% 71 23 94 75.5% 5.3%
Full Service Rest. 45 42 87 51.7% 48 39 87 55.2% 3.5%
Delis 38 59 97 39.2% 41 56 97 42.3% 3.1%
Meat & Poultry* 0 2 2 0%* 1 1 2 50.0%* 50.0%*
Seafood* 3 3 6 50.0%* 3 3 6 50.0%* 0%*
Produce* 6 0 6 100%* 6 0 6 100%* 0%*

* The number of observations for these 3 facility types is too low to make comparisons

Employee Health

The employee health portion of Chapter 2 of the 2001 FDA Food Code is one of the key public health interventions for preventing foodborne illness resulting from infected food workers. Given the importance of employee health issues in preventing foodborne illness, FDA desires to gain a better understanding of industry practices and procedures related to this public health intervention. Although documentation is not specifically required to demonstrate compliance with Chapter 2 of the 2001 FDA Food Code, FDA wanted to assess the prevalence of formal, written employee health policies implemented by industry. Specifically, Specialists were instructed to determine if an establishment had a written policy for addressing the following:

  • Medical questionnaire upon a conditional offer of employment
  • When to exclude or restrict food employees based on illnesses or symptoms
  • When to remove exclusions or restrictions
  • Responsibility of food employees to report certain illnesses and symptoms to the person in charge
  • Responsibility of the person in charge to report illnesses to the regulatory authority

As shown in Table 38, lack of a formal, written employee health policy was noted in all facility types.

Table 38
Facility Type Total IN Total Out Total Obs. Percent IN
Hospitals 29 68 97  29.9%
Nursing Homes 12 82 94  12.8%
Elementary Schools 12 86 98  12.2%
Fast Food Restaurants 16 92 98  14.8%
Full Service Restaurants 7 92 99  7.1%
Delis 18 90 108  16.7%
Meat & Poultry 18 91 109  16.5%
Seafood 17 88 105  16.2%
Produce 18 90 108  16.7%


Juice and Eggs

The 2001 FDA Food Code includes provisions to address the treatment of packaged juice at the retail level. Specifically, juice packaged at the retail level must be pasteurized or otherwise treated to attain a 5-log reduction of the most pertinent microorganism or bear a warning label. Across all facility types, only thirteen total observations of juice treatment were noted during the 2003 baseline collection. As a result, the sample size for these data items is too small to draw any conclusions.

In addition, the 2001 FDA Food Code includes provisions to address the cold holding and cooling of raw shell eggs. Specifically, FDA was looking at industry's control of cold holding raw shell eggs at an ambient temperature of 45 °F (7.2 °C) and the cooling of raw shell eggs by being placed under refrigeration at an ambient temperature of 45 °F (7.2 °C) after receipt.

As shown in Table 39, hospitals, nursing homes, elementary schools, fast food restaurants, and full service restaurants appear to have control over the proper cold holding of raw shell eggs. There were not enough observations to make any conclusions about cold holding of raw shell eggs for the other facility types. For the cooling of raw shell eggs, there were not enough observations to draw any conclusion for any of the facility types.

Table 39
Cold Holding of Eggs (Data Item - 22A)
Facility Type Total IN Total Out Total Obs. Percent IN
Hospitals 75 0 75  100.0%
Nursing Homes 77 2 79  97.5%
Elementary Schools 30 0 30  100.0%
Fast Food Restaurants 29 2 31  93.6%
Full Service Restaurants 71 13 84  84.5%
Delis 18 3 21  85.7%
Meat & Poultry 4 1 5  80.0%
Seafood 0 0 0  --
Produce 11 4 15  73.3%

Highly Susceptible Populations

Lastly, FDA wanted to assess the compliance status of institutions with regard to three specific requirements in the 2001 FDA Food Code related to the prevention of foodborne illness in highly susceptible populations:

  • Prohibiting the service of juice bearing a warning label (untreated or unpasteurized juice) (Data Item - 23A)
  • Use of pasteurized eggs (no use of raw shell eggs, with exceptions, as ingredients in certain foods or when combined and cooked) (Data Item - 23B)
  • No raw or undercooked animal foods or sprouts served (Data Item - 23C)

As shown in Table 40, there were no Out of Compliance observations in institutional facility types for data item 23A. This indicates managerial control of this item in institutional foodservice settings.

Table 40
Prepackaged Juice/
Beverage Containing Juice with Warning Label (Data Item - 23A)
Facility Type Total
Hospitals 96 0 96  100%
Nursing Homes 90 0 90  100%
Elementary Schools 85 0 85  100%

Elementary schools and hospitals appear to have active managerial control over data items 23B (Table 41) and 23C (Table 42) related to the use of pasteurized eggs and no raw or undercooked animal foods being served, respectively. The data suggests that some nursing homes may need to ensure compliance with requirements pertaining to the use of unpasteurized eggs in light of the risk associated with Salmonella Enteritidis in undercooked shell eggs.

Table 41
Pasteurized Eggs or
Eggs Substituted for Raw Shell Eggs (Data Item - 23B)
Facility Type Total
Hospitals 71 4 75  94.7%
Nursing Homes 47 18 65  72.3%
Elementary Schools 37 4 41  90.2%


 Table 42
Raw or Partially Cooked Animal Food and
Raw Seed Sprouts not Served (Data Item - 23C)
Facility Type Total
Hospitals 90 2 92  97.8%
Nursing Homes 73 10 83  87.9%
Elementary Schools 70 0 70  100%