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U.S. Department of Health and Human Services


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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


Table of Contents

  2. Acknowledgements

    1. Part A. Background
    2. Part B. Study Design and Objectives
    3. Part C. Introduction
    1. Part A. Selection of Facility Types
    2. Part B. Eligibility of Establishments for Selection
    3. Part C. Selection of Data Collectors
    4. Part D. Selection of Geographic Locations
    5. Part E. Selection of Establishments Using Comparison Set Establishment Lists
    6. Part F. Number of Inspections Conducted
    7. Part G. Data Collection Form
    8. Part H. Data Collection Procedures
    9. Part I. Average Time Per Data Collection
    1. Part A. Recommendation for the Foodservice and Retail Food Store Industries
    2. Part B. Recommendations for Retail Food Regulatory Programs
    1. Part A. Field Operational Limitations
    2. Part B. Statistical Limitations
      • Cook Temperatures Pork, Ratites, Injected Meats
      • Hot Holding Potentially Hazardous Foods at 135 °F (57 °C)
      • Employee Health
      • Juice and Eggs
      • Highly Susceptible Populations




In 1998, the U.S. Food and Drug Administration's (FDA) National Retail Food Team initiated a study to measure the occurrence of food preparation practices and employee behaviors most commonly reported to the Centers for Disease Control and Prevention (CDC) as contributing factors in foodborne illness outbreaks. Specifically, this study called for conducting data collection inspections of various types of foodservice and retail food establishments at five-year intervals to observe and document the occurrence of the following contributing factors:

  • Food from Unsafe Sources
  • Improper Holding/Time and Temperature
  • Inadequate Cooking
  • Poor Personal Hygiene
  • Contaminated Equipment/Prevention of Contamination

For the purposes of this long-term study, FDA designates these contributing factors as "foodborne illness risk factors."

The first report in the study was issued in August 2000 and presented data collected in 1998. This 2004 report is the second report in the series and presents data collected in 2003. A third data collection is scheduled for 2008.

The 2000 report called attention to the need for greater active managerial control of foodborne illness risk factors. It suggested that more innovative and effective strategies to improve food safety practices in retail and foodservice establishments were needed. The report highlighted operational areas most in need of improvement including employee handwashing, cold holding of potentially hazardous foods, date marking of ready-to-eat foods, and cleaning and sanitizing of food contact surfaces.

In 2003, FDA Regional Retail Food Specialists collected data during site-visits of over 900 establishments representing nine distinct facility types. Direct observations, supplemented with information gained from discussions with management and food workers, were used to document the establishments' compliance status for forty-two individual data items based on provisions in the 1997 FDA Food Code. In each establishment, the compliance status for each data item was recorded in terms of IN Compliance, Out of Compliance, Not Observed (meaning the behavior or practice was not observed during the visit), or Not Applicable (meaning the behavior or practice did not apply to the establishment).

For each of the nine facility types, the percentage of observations recorded as Out of Compliance is presented for each risk factor and for the individual data items related to those risk factors most in need of priority attention. The Percent Out of Compliance value for each risk factor was calculated by dividing the total number of Out of Compliance observations of data items in the risk factor by the total number of observations (IN compliance and Out of Compliance) of data items in the risk factor. The Percent Out of Compliance for an individual data item is the proportion of establishments where that data item was Out of Compliance when the practice or procedure could be observed.

The data presented in this report indicate that the same risk factors and data items identified as problem areas in the 2000 report remain in need of priority attention. This indicates that industry and regulatory efforts to promote active managerial control of these risk factors must be strengthened. In all facility types, the Out of Compliance percentages remained high for data items related to the following risk factors:

  • Improper Holding/Time and Temperature
  • Poor Personal Hygiene
  • Contaminated Equipment/Prevention of Contamination

For the improper holding/time and temperature risk factor, the high Percent Out of Compliance values were most commonly associated with improper cold holding of potentially hazardous food (PHF) and inadequate date marking of refrigerated ready-toeat PHF.

Within the poor personal hygiene risk factor, the proper, adequate handwashing data item had the highest Percent Out of Compliance value for every facility type. Percent Out of Compliance values for proper, adequate handwashing ranged from approximately 34% for hospital foodservice to approximately 73% for full service restaurants.

Of the data items related to the contaminated equipment/protection from contamination risk factor, improper cleaning and sanitizing of food contact surfaces before use was the item most commonly observed to be Out of Compliance in each facility type. Percent Out of Compliance values for this data item ranged from 25% in elementary schools to 58% in deli departments.

This report also includes a comparison between the data collected from food establishments that had a Certified Food Protection Manager (CFPM) from a program recognized by the Conference for Food Protection and those that did not. The data suggests that the presence of a certified manager has a positive effect on the control of certain risk factors, especially in fast food restaurants, full service restaurants, meat and poultry departments, and produce departments. Poor personal hygiene appears to be the risk factor for which the presence of a certified manager had the most positive effect.

The 2003 data collection effort included several supplemental data items that were not included in the 1998 data collection. While the forty-two primary data items in the study remained the same from 1998 to 2003, the supplemental data items addressed changes made to the FDA Food Code since 1998. These items related to the cooking temperature for pork, minimum hot holding temperatures, employee health, juice, eggs, and highly susceptible populations. Data gathered for the supplemental data items suggest that reducing the minimum hot holding temperature for potentially hazardous foods from 140 °F (60 °C) to 135 °F (57 °C) and reducing the minimum cooking temperature for pork from 155 °F (68 °C) to 145 °F (63 °C) had minimal effect on the industry's control of these risk factors.

Results from the 2003 data collection indicate that the recommendations made to foodservice and retail food operators and regulators in the 2000 Report need to be reemphasized. Foodservice and retail food operators must ensure that their management systems are designed to achieve active managerial control over the risk factors. Likewise, regulators must ensure that their inspection, education, and enforcement efforts are geared toward the control of the risk factors commonly found to be Out of Compliance.



The following individuals and/or entities are to be recognized for their invaluable contributions to the development of this report and the implementation of this project:


  • Center for Food Safety and Applied Nutrition (CFSAN)
    • Jerome Schneidman, Division of Mathematics
    • Marc Boyer, Division of Mathematics
    • Margaret Boone, Division of Cooperative Programs
  • Office of Regulatory Affairs (ORA)
    • Regional Retail Food Specialists
    • Robert Brands, Division of Federal - State Relations (DFSR)
    • Kevin Smith, DFSR
  • National Retail Food Steering Committee
    • Richard Barnes, ORA, Director of DFSR, Committee Chair
    • Faye Feldstein, CFSAN, Office of Compliance, Director of Division of Cooperative Programs
    • Glenda Lewis, CFSAN, OC/DCP/Retail Food Protection Team (NRFPT), Team Leader,
    • Shirley Bohm, CFSAN, OC/DCP/RFPT, team representative
    • Linda Collins, ORA, Regional Retail Food Specialist, field team representative
    • John Powell, ORA, Regional Retail Food Specialist, field team representative
    • Jim Fear, ORA, Manager State Training, Division of Human Resource Development (DHRD), DHRD team representative


State and local regulatory jurisdiction representatives who accompanied the FDA Regional Food Specialists on data collection inspections.


Industry food service managers of selected participant establishments for their cooperation and assistance during the data collection.


Questions and Answers on the 2004 Report January 2005

Slide Presentation: Measuring the Effectiveness of the Nation's Foodservice and Retail Food Protection System September 2004

* Temporarily unavailable on the web.