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Questions and Answers on the FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (2004)

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The U.S. Food and Drug Administration's (FDA) National Retail Food Team has released a report on certain food preparation practices and employee behaviors in 9 food facility types that are most frequently reported to the Centers for Disease Control and Prevention as contributing factors to foodborne illness outbreaks. The following questions and answers may help provide a better understanding of the report and its contents.

 What is the purpose of this study?

The 2004 "FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types" (the Report) is an effort to observe and document food safety practices and employee behaviors that have the potential to contribute to foodborne illness. The study is designed to collect this data in selected foodservice and retail food establishments at five-year intervals. These data collection efforts are designed to get an accurate picture of the extent to which foodservice and retail food operations have active managerial control over contributing factors to foodborne illness. Using data from multiple collection periods, FDA hopes to evaluate trends and determine whether progress is being made toward the goals of reducing the occurrence of food safety practices and employee behaviors that could contribute to foodborne illnesses.

 How does FDA define a foodborne illness risk factor?

In developing the design for this study, the U.S. Food and Drug Administration's National Retail Food Team used information from the Centers for Disease Control and Prevention's (CDC) Surveillance Report for 1988 - 1992 to identify which food safety practices should be the focus of its data collection efforts. This CDC surveillance report identified food safety practices and employee behaviors most associated with foodborne illness outbreaks. Some of these reported contributing factors relate to food safety concerns within foodservice and retail food store facility types and include: food from unsafe sources, improper holding/time and temperature, inadequate cooking, poor personal hygiene, and contaminated equipment/prevention of contamination.

For the purposes of this study FDA designated these five areas as foodborne illness risk factors. FDA added another category to assess control of potential chemical hazards. It is important that one not confuse the term risk factor as it is used in this FDA study with another use of the same term which is to describe characteristics of the person, food, or location that are statistically linked to an illness by an epidemiological investigation. The results for the FDA 2004 Report should not be used to infer a correlation between the occurrence of a foodborne illness risk factor with the actual occurrence of human illness.

 What is the scope of this study?

The 2004 Report provides a summary of not one FDA study but 9 separate studies, one for each of the nine facility types. These 9 facilities types are drawn from 3 targeted industry segments - Institutional Foodservice, Restaurants and Retail Food Stores.

Institutional Foodservice

  • Hospitals
  • Nursing Homes
  • Elementary Schools

Restaurants

  • Fast Food
  • Full Service

Retail Food Stores

  • Deli Operations
  • Meat and Poultry
  • Seafood Departments/Stores
  • Produce Departments/Markets

The results from the data should not be used to compare one facility type with another. Different food safety practices and employee behaviors are observed within each of the 9 facility types.

The data presented in the 2004 study were collected in 2003 during 926 inspections of foodservice and retail food facilities across the U.S as part of a 10-year plan for data collection during 1998, 2003, and 2008.

 How are observations of food safety practices and employee behaviors recorded for later analysis?

The data collection tool used to record the data for the study includes 42 individual data items sorted among the 5 foodborne illness risk factor categories and the other chemical category. Dividing each of the foodborne illness risk factors into individual data items allows the study to assess what specific food safety practices and employee behaviors are in most need of attention.

For each individual data item, the data collector determined whether it was:

  • IN - In Compliance with 1997 Food Code provisions;
  • OUT - Out of Compliance with 1997 Food Code provisions;
  • N.O. - Not Observed. The N.O. marking is used when an item is a usual practice in the foodservice or retail food operation, but the practice was not observed during the time of inspection; or
  • N.A. - Not Applicable. The N.A. marking was used when an item was not part of the foodservice or retail food operation.

The same 42 data items will be assessed for each of the data collection periods in the study (1998, 2003, and 2008). The critical limits and standards contained in the 1997 FDA Food Code will be used to assess each of these 42 data items for all 3 data collection periods.

 Since the FDA Food Code is updated on a periodic basis, why continue to assess the 42 data items using the 1997 Food Code criteria?

One of the purposes of the project is to track changes related to industry's efforts to control foodborne illness risk factors over time. For this type of study, the standard of measurement used to evaluate these comparisons - in this case the 1997 Food Code - must remain constant for each of the data collection periods.

Suppose the recommended standard in the Food Code was relaxed between data collection periods in the study and the data item was changed accordingly. Let's say that the next data collection shows an improvement in the IN Compliance percentage for that data item. One would not know if the improvement was due to an improvement in employee food safety practices or whether it was due to the change in the Food Code standard.

The study is designed to track changes in industry's active managerial control of food safety practices and employee behaviors; not simply compliance with regulatory standards.

 Won't changes to the Food Code influence the compliance percentages for the risk factors and therefore the study results?

FDA is assessing what impact changes to the Food Code may have on the compliance percentages for individual data items and foodborne illness risk factors.

The data collection form contains a section titled, Supplemental Items. These additional items were added to assess some industry food safety practices not addressed in the first report and assess what impact, if any, changes in the Food Code may have on the data results. Only a couple of data items from the original study contain standards or critical limits that have been changed since the release of the 1997 Food Code.

 How are the three types of compliance percentages calculated?

Three levels of data analysis are conducted for each of the 9 facility types:

  1. An Out of Compliance percentage is determined for each of the individual data items;
  2. An Out of Compliance percentage is determined for each foodborne illness risk factor; and
  3. An overall IN Compliance percentage for all the 42 data items is determined.

A. Out of Compliance Percentage - Individual Data Items

The Out of Compliance percentage for an individual data item is calculated by dividing the total number of observations that are Out of Compliance by the total number of observations (both IN and OUT). Not Observed and Not Applicable markings are not used to determine Out of Compliance percentages. This is because the study is designed to be an assessment of actual observations.

Note that an observation is defined as the totality of the evaluations of a single data item for one establishment. For example, if handwashing was evaluated 10 times in an establishment and one or more of these evaluations was "out of compliance" then the observation would be considered "Out of Compliance". If all 10 evaluations were "in compliance", then the observation would be considered "IN Compliance".

The Out of Compliance percentage for a data item represents the proportion of establishments where that data item was found Out of Compliance at least once when the practice or procedure could be observed. For example, the report shows a 40% Out of Compliance percentage for proper, adequate handwashing in nursing homes. This percentage should NOT be interpreted to mean that food workers were not washing their hands properly 40% of the time.

What the 40% Out of Compliance percentage means is that in 4 out of 10 nursing home establishments where handwashing was observed, there was at least one instance of improper or inadequate handwashing.

B. Out of Compliance Percentage - Foodborne Illness Risk Factors

The second level of analysis is to determine the Out of Compliance percentage for each of the foodborne illness risk factors for each of the facility types. Each of the risk factors is comprised of a number of individual data items. The Out of Compliance percentage for each foodborne illness risk factor is determined by dividing the total number of Out of Compliance observations of all the data items that comprise a risk factor by the total number of observations (both IN and OUT) made of those data items.

For example, the Poor Personal Hygiene risk factor is comprised of 5 data items. The Out of Compliance percentage is determined by dividing the total Out of Compliance observations of these 5 data items by the total number of observations (both IN and OUT) of the 5 data items.

C. Overall IN Compliance percentage - each of the 9 facility types

The third level of data analysis is to determine the Overall IN Compliance percentage for each of the 9 facility types. This is done by dividing the total number of IN Compliance observations of all 42 data items by the total number of observations (both IN and OUT) made of those data items. The 1998 Overall IN Compliance percentage represents the study's Baseline measurement for each facility type.

 What are the limitations of this study?

Two limitations were imposed by the nature of the inspection process. First, the timing of the inspection could not always coincide with some of the procedures FDA wanted to observe, such as an establishment receiving food items from their suppliers or the end-of-the-day breakdown and storage of food products.

Second, the length of inspection time did not always provide an opportunity to observe completion of an important food process. This is particularly true of the cooling process for cooked foods.

Although data on foodservice and retail food establishments throughout the country have been collected for this study, it was not designed to support comparisons of foodborne illness risk factors across states, counties, cities, or regions of the U.S. Similarly, there is not enough data to justify comparisons of chains of restaurants or chains of grocery stores.

 What will FDA do with information in this report?

FDA has developed a strategic plan directed toward establishing a national retail food program model that regulatory agencies can use to:

  • identify essential food safety program performance measurements;
  • assess strengths and gaps in the design, structure, and delivery of program services;
  • establish program priorities and intervention strategies focused on reducing the occurrence of foodborne illness risk factors; and
  • create a mechanism that justifies program resources and allocates them to program areas that will provide the most significant public health benefits.

The FDA Voluntary National Retail Food Regulatory Program Standards (Program Standards) provide a framework for public health administrators to assess their retail food protection program using national recognized criteria. Endorsed by the Conference for Food Protection, the Program Standards are not based on minimum criteria but rather set a high bar for an effective public health food safety program to aspire to.

The Program Standards are comprised of nine separate Standards. The criteria established for each of these program areas are designed to address important retail food protection issues:

Standard No. 1 - Regulatory Foundation

Are regulatory requirements that apply to food establishments based on science and sound public health interventions? Does the agency have the statutory authority to effectively enforce its requirements?

Standard No. 2 - Trained Regulatory Staff

Does the program ensure that personnel are properly trained and standardized in the essential elements of food safety and effective inspection and enforcement principles?

Standard No. 3 - Inspection Program Based on HACCP Principles

Do facility inspections focus on the status of the key foodborne illness risk factors and the correction of out-of-control risk factors through active managerial control by the operator?

Standard No. 4 - Uniform Inspection Program

Does the agency have a quality assurance program that promotes uniform interpretation and application of the regulatory requirements and policies?

Standard No. 5 - Foodborne Illness and Food Security Preparedness and Response

Are reports of foodborne illness, injury and intentional contamination investigated, analyzed, and documented in an effective manner?

Standard No. 6 - Compliance and Enforcement

Do agency compliance procedures result in the timely correction of out-of-control risk factors? Are appropriate enforcement actions taken when necessary and are they applied consistently across the industry?

Standard No. 7 - Industry and Community Relations

Does the program foster communication and information exchange between it and the regulated industry, consumers, and other stakeholders?

Standard No. 8 - Program Support and Resources

Does the program have the funding, staff, and equipment needed to support an effective risk-based food safety program?

Standard No. 9 - Program Assessment

Does the program strive for excellence in the services it provides? Does the program employ the "best practices" to achieve a reduction in foodborne illness risk factors?

The criteria are not intended as pass/fail criteria, but instead they direct an enrolled agency toward a desired set of performance outcomes. By working toward the stated performance outcomes, an agency will position itself to achieve the greatest public health benefit given the resource constraints under which it operates. Each Standard requires that program management take a hard look at the structure and implementation of its program.

 Since some of the same recommendations were issued in both the 2000 and 2004 report, does this mean the industry has not followed past recommendations on proper food handling?

One of the most important findings from the original 2000 Report was that the following three foodborne illness risk factors were identified as the areas in most need of attention:

  • Improper Holding/Time and Temperature
  • Poor Personal Hygiene
  • Contaminated Equipment/Protection from Contamination

The data results in the 2004 Report once again identify these 3 foodborne illness risk factors and the individual data items that comprise them as priorities for all the facility types. This is not meant to imply that a comparison is being made between the two reports. It is simply noting that as two stand alone studies, conducted at different time intervals (1998 and 2003), they identify, for the most part, the same food safety practices and employee behaviors as priorities.

Many establishments within the foodservice and retail food segment of the industry have taken proactive measures to enhance the effectiveness of their food safety management systems. At the same time, more and more regulatory agencies are incorporating a risk-based inspection methodology into their food inspection programs. The identification of the same areas in these stand alone reports does not necessarily mean that regulatory and industry intervention strategies in response to the first report have been ineffective. At this time, there is simply not enough data upon which to draw any meaningful conclusions as to the impact of these intervention strategies. The study design requires a minimum of 3, possibly more, data collection periods, to assess improvement or regression patterns related to the control of foodborne illness risk factors.

 Are Certified Food Protection Managers helpful in a food establishment?

It appears that the presence of a Certified Food Protection Manager has a positive effect on compliance. Four facility types had overall IN Compliance percentages that were significantly higher in establishments with a Certified Food Protection Manager than in establishments without one. There was also a significantly higher percent IN Compliance for establishments with a Certified Food Protection Manager than for those without one for specific risk factors in some facility types.

 What should I do with this report?

For many food safety professionals there will be a normal and understandable urge to focus on the out of compliance percentages for the risk factors and data items. This fixation on compliance percentage numbers can, however, draw attention from one of the more important uses of the data results. The 2004 Report should be used as a strengths/weaknesses assessment of a regulatory retail food protection program or an industry food safety management system.

For industry, when the study identifies a food safety practice or employee behaviors as having a high out of compliance percentage, the question to ask is what procedures or processes are currently in place to ensure active managerial control of that specific item? Assess existing food safety management systems to ensure there are not any gaps in control measures for the specific item identified.

For regulatory food safety professionals, an examination should be made of current food inspection protocols to ensure that food safety practices and employee behaviors with high out of compliance percentages are inspection priorities. Is time being taken to assess industry's active managerial control of these areas?

The 2004 Report is intended to be read, and the data interpreted, as a stand alone study. It provides important insights into the effectiveness of regulatory and industry efforts to enhance the level of public health protection within foodservice and retail food store facility types. If the nation's foodservice and retail food protection system is to be significantly improved, the industry and regulatory communities must remain focused in their efforts to reduce the individual data items identified in the 2004 Report as having the most significant Out of Compliance percentages.


FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (2004) September 14, 2004