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U.S. Department of Health and Human Services

Food

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FDA Trend Analysis Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (1998-2008)

This document presents findings from the Food and Drug Administration’s (FDA) National Retail Food Team ten-year study to measure trends in the occurrence of food preparation practices and employee behaviors at the retail and foodservice level that are believed to most commonly contribute to foodborne illness outbreaks. Observational data collected in retail and foodservice establishments across the United States in 1998, 2003, and 2008 have been presented in three separate reports that are available on FDA’s website (www.fda.gov/RetailFoodProtection). FDA analyzed the data from these three reports to detect improvement or regression trends over the ten-year period.  The data in this Trend Report suggest that the control of certain foodborne illness risk factors improved over the 10-year period in most facility types, but that compliance with important requirements in the FDA Food Code needs further improvement in order to adequately prevent foodborne illness outbreaks.     

Available in PDF (5.81 MB) .

ACKNOWLEDGEMENTS 

EXECUTIVE SUMMARY

CONTENTS

  1. INTRODUCTION AND PURPOSE
    Part A. Background
    Part B. Study Design, Objectives, and Scope
    Part C. Introduction

  2. METHODOLOGY
    Part A. Selection of Facility Types
    Part B. Eligibility of Establishments for Selection
    Part C. Selection of Data Collectors
    Part D. Selection of Geographic Locations
    Part E. Summary of Data Collection Procedures

  3. 1998-2008 TREND ANALYSIS SUMMARY
    Part A. Trends by Facility Type for All 42 Data Items
    Part B. Foodborne Illness Risk Factor Trends for Facility Types
    Part C. Data Item Trends for Each Foodborne Illness Risk Factor
    - Contaminated Equipment/Protection from Contamination
    - Food from Unsafe Sources
    - Improper Holding/Time and Temperature
    - Inadequate Cooking
    - Poor Personal Hygiene 29

  4. TREND ANALYSIS FOR EACH FACILITY TYPE
    Institutional Food Service
    - Hospitals 
    - Nursing Homes
    - Elementary Schools 
    Restaurants
    - Fast Food 
    - Full Service 
    Retail Food
    - Deli Departments/Stores 
    - Meat and Poultry Markets/Departments 
    - Seafood Markets/Departments
    - Produce Markets/Departments

  5. STATISTICAL METHODS 
    Part A. Introduction
    Part B. Comparison Set Lists 
    Part C. Quality Assurance
    Part D. Weight of Data Items 
    Part E. Standard of Measurement
    Part F. Statistical Methods 

  6. CONCLUSIONS AND AREAS OF FUTURE STUDY 

  7. APPENDICES
    Data Summary Format Appendices A - H 
    Appendix A Data Summary – Hospitals 
    Appendix B Data Summary – Nursing Homes 
    Appendix C Data Summary – Elementary Schools
    Appendix D Data Summary – Fast Food Restaurants 
    Appendix E Data Summary – Full Service Restaurants
    Appendix F Data Summary – Deli Departments/Stores
    Appendix G Data Summary – Meat and Poultry Markets/Departments
    Appendix H Data Summary – Seafood Markets/Departments
    Appendix I Data Summary – Produce Markets/Departments 
    Appendix J Directory – FDA National Retail Food Team 
    Appendix K Resources – Web Site Locations for Referenced Documents  


ACKNOWLEDGEMENTS

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:

FDA:

Center for Food Safety and Applied Nutrition (CFSAN)
Marc Boyer, Biostatistics Branch
Martine Ferguson, Biostatistics Branch
Jerome Schneidman, Biostatistics Branch

Office of Regulatory Affairs (ORA)
Regional Retail Food Specialists
Richard Barnes, Division of Federal-State Relations (DFSR) (retired)

National Retail Food Steering Committee
Kevin Smith, CFSAN, Director, Retail Food and Cooperative Program Coordination Staff
Elizabeth O’Malley, Director of Cooperative Programs – Northeast Region, Field Team Representative
Glenda Lewis, CFSAN, OC/DCP/Retail Food Protection Team (RFPT) –Team Leader, Team Representative
Shirley Bohm, CFSAN, OC/DCP/RFPT, Team Representative (retired) 
Kathryn Kennedy, ORA, Regional Retail Food Specialist, Field Team Representative
Steve Nattrass, ORA, Regional Retail Food Specialist, Field Team Representative
Jim Fear, ORA, Manager State Training Team, Division of Human Resource Development (DHRD), DHRD Team Representative

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

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


EXECUTIVE SUMMARY

This document presents findings from the Food and Drug Administration’s (FDA) National Retail Food Team ten-year study to measure trends in the occurrence of food preparation practices and employee behaviors at the retail and foodservice level that are believed to most commonly contribute to foodborne illness outbreaks. Observational data collected in retail and foodservice establishments across the United States in 1998, 2003, and 2008 have been presented in three separate reports that are available on FDA’s website (www.fda.gov/RetailFoodProtection). FDA analyzed the data from these three reports to detect improvement or regression trends over the ten-year period.  The data in this Trend Report suggest that the control of certain foodborne illness risk factors improved over the 10-year period in most facility types, but that compliance with important requirements in the FDA Food Code needs further improvement in order to adequately prevent foodborne illness outbreaks.     

The results of the trend analysis are reported separately for nine facility types from three different segments of the retail and foodservice industry:

Institutional Foodservice

  • Hospitals
  • Nursing Homes
  • Elementary Schools (K-5)

Restaurants

  • Fast Food
  • Full Service

Retail Food Stores

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

Direct observations made by FDA specialists, supplemented with information gained from interviews with management and food employees, were used to document the establishments’ compliance status for 42 individual data items. These items comprise the contents of 5 major risk factor categories and are based on the provisions of the 1997 FDA Food Code (See Appendix I, page 138). In each establishment, the status for each data item was recorded as In Compliance, Out of Compliance, Not Observed (meaning the behavior or practices was not observed during the visit), or Not Applicable (meaning the behavior or practices did not apply to the establishment).

For each of the nine facility types, the report presents trends as follows:

  • the overall In Compliance percentage for all 42 data items combined;
  • the collective In Compliance percentage for each of five important foodborne illness risk factors: (1) Food from Unsafe Source; (2) Poor Personal Hygiene; (3) Inadequate Cooking; (4) Improper Holding/Time and Temperature, and (5) Contaminated Equipment/Protection from Contamination; and
  • the In Compliance percentage for each of individual 42 data items. 

In each category, the most significant improvements were typically achieved in those items that had relatively high Out of Compliance percentages at the beginning of the 10-year study. Despite significant improvements in many facility types, the following three Risk Factors--Improper Holding/Time and Temperature, Poor Personal Hygiene, and Contaminated Equipment/Protection from Contamination-- continue to be most in need of priority attention by both industry and regulators. The 2009 FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types, which is being released concurrently with this Trend Report, calls attention to those items and makes recommendations to the industry and regulatory community for addressing inadequate compliance.  

Overall In Compliance percentages (all 42 data items combined)

The trend analysis revealed that the Overall In Compliance percentage improved in all facility types. In five out of the nine facility types, listed below, the improvement was considered statistically significant (using the Cochran Armitage trend test).  

    • Elementary Schools;

    • Fast Food Restaurants;

    • Full Service Restaurants;

    • Meat and Poultry Markets/Departments, and

    • Produce Markets/Departments.

The report also shows that, in two facility types (Meat and Poultry Departments and Produce Departments), targets set by FDA in 1998 for improved compliance percentages were achieved.

In Compliance percentages for foodborne illness risk factors

Eight of the nine facility types showed a statistically significant increase for the In Compliance percentage of at least one of the five foodborne illness risk factors. The In Compliance percentages for the risk factors in Nursing Homes stayed relatively static during the study period. There were no facility types that showed a statistically significant decrease in the In Compliance percentage for a foodborne illness risk factor.

For example, a statistically significant improvement for the Poor Personal Hygiene risk factor was observed over the 10-year study period in the following facility types:

    • Elementary Schools;

    • Fast Food Restaurants;

    • Full Service Restaurants;

    • Deli Departments/Stores;

    • Meat and Poultry Markets/Departments;

    • Seafood Markets/Departments, and

    • Produce Markets/Departments.

A statistically significant improvement in the Improper Holding/Time and Temperature risk factor was observed in:

    • Elementary Schools;

    • Fast Food Restaurants;

    • Full Service Restaurants;

    • Meat and Poultry Markets/Departments, and

    • Produce Markets/Departments.

Notwithstanding these improvements, in many facility types, the compliance percentages remained low in 2008 for many of these risk factors, suggesting the need for greater emphasis on their control.

In Compliance percentage for individual data items

Although four facility types showed statistically significant improvement in the Proper, Adequate Handwashing data item, the study suggests that obtaining full compliance in this area continues to be a challenge for many facility types. For example, in 2008, handwashing practices were observed to be out of compliance at least once in approximately 3 out 4 full service restaurants and roughly half of retail delis.   

This report suggests that, in many facility types, there has been significant improvement in Food Code compliance in areas where recent efforts by industry and regulatory community have been focused. For example, 6 of 9 facility types showed statistically significant improvement in the area of preventing bare hand contact with ready-to-eat foods and 7 of the 9 facility types showed statistically significant improvement the proper date marking of refrigerated ready-to-eat foods. 

Of interest to FDA for future similar studies is assessing the impact of various industry and regulatory intervention strategies designed to enhance compliance and improve the managerial control of foodborne illness risk factors within retail and foodservice establishments. Examining the correlation between the occurrence of risk factors and the actual incidence of foodborne illness is also of interest to FDA.