FDA Collecting Data for Foodborne Illness Risk Factor Study

By: Commander Diane Kelsch,  U.S. Food and Drug Administration

(October 29, 2013) FDA Regional Retail Food Specialists will begin collecting data for the 2013-2023 Foodborne Illness Risk Factor study this fall.  Whether or not your facility is one of the randomly selected facilities identified to participate in the study, this article provides some general information regarding the study, the data collection process, and how the data will be used.


FDA is responsible for providing technical assistance to approximately 75 state and territorial agencies and more than 2,300 local departments that assume primary responsibility for working with the industry on preventing foodborne illnesses.

The data collected from these studies provides FDA a solid foundation for developing a national retail food program model that can be used by federal, state, local, and tribal agencies 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.

What is the FDA Foodborne Illness Risk Factor Study?

In 1998, FDA’s National Retail Food Team initiated a ten-year voluntary study to measure trends in the occurrence of foodborne illness risk factors – preparation practices and employee behaviors most commonly reported to the Centers for Disease Control and Prevention (CDC) as contributing factors to foodborne illness outbreaks at the retail level.  Specifically, the study included data collection inspections of various types of retail and foodservice establishments at five-year intervals (1998, 2003, and 2008) in order to observe and document trends in the occurrence of the following foodborne illness risk factors:

●  Food from Unsafe Sources

●  Poor Personal Hygiene

●  Inadequate Cooking

●  Improper Holding/Time and Temperature

●  Contaminated Equipment/Protection from Contamination

Data from all three data collection periods were analyzed to detect trends in improvement or regression over time and to determine whether progress had been made toward the goal of reducing the occurrence of foodborne illness risk factors in selected retail and foodservice facility types.

What types of retail food service facilities will be involved and when will data collections occur?

The scope of the study includes three major segments of the retail and foodservice industries that account for over a million varied and diverse types of operations in the United States:

  • Restaurants
    • Fast food and Full service
    • Retail Food Stores
  • Institutional Foodservice
    • Hospitals
    • Nursing Homes, and
    • Elementary schools (Kindergarten through 5th grade)
  • Retail Food Stores
    • Deli Departments/Stores
    • Meat & Poultry Departments/Markets
    • Seafood Departments/Stores
    • Produce Department/Markets

For the 2013-20223 study, FDA will begin collecting data in the fall of 2013, with the initial data collection for select restaurant facility types, followed by the initial data collection for select institutional facility types in 2014 and select retail food facility types in 2015.  The results of the initial data collection for each of the facility types will serve as the baseline measurement from which trends will be analyzed.  Two additional data collection periods for each of the facility types are planned at three-year intervals after the initial data collection for purposes of analyzing trends.

How are facilities selected?

Facilities are randomly selected as part of a nationwide research project.  A geographical information system (GIS) database containing a listing of businesses throughout the U.S. will be used as the establishment inventory for the data collection.  The random selection of establishments from the GIS database will be performed by the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) Biostatistics Branch and the sample size allows for a broad sampling of facility types throughout the U.S.

Will I be notified, in advance, if my facility was selected for participation?

Data collection visits will be unannounced.  The intent of the data collection is to observe the operation in its normal mode, without special preparation to accommodate the data collection visit.

Is participation mandatory?

No, your participation is voluntary.

Is the data collection considered a regulatory visit and how long will it take?

This is not a regulatory visit; no inspection report will be left with your facility.

The expected length of the data collection will be 90-120 minutes.  Approximate 30 minutes of the data collection will focus on obtaining information on the nature of your operation.

Should an observation be made of a food safety procedure or practice that poses a significant public health risk, every effort will be made to work with an operator to ensure that the appropriate corrective action is taken to alleviate the hazard.  Should a situation arise where a significant public health risk cannot be resolved during the data collection, the regulatory authority that has issued your permit will be contacted to work with you to ensure corrective action is taken.

An exit briefing will be provided at the end of the visit to discuss significant findings that may assist you in enhancing the effectiveness of your food safety system.  If significant food safety issues are identified, they will be brought to the attention of the person-in-charge or responsible employee to determine the appropriate corrective action based on the current FDA Food Code.

Your questions regarding the data collection process or food safety issues in general are encouraged as part of the visit to your facility.

How will the data be used?

The FDA will use this research for identifying best practices within the industry and directing limited resources to areas that will provide the most significant public health benefits.

The project is designed to protect the privacy of participating establishments to the extent the law permits.  The data collected is tabulated using broad industry segments and is not associated with any specific establishment. Your facility’s name will not appear on any reports or public documents.

If you have additional questions about the study, please feel free to contact Diane Kelsch, FDA Regional Retail Food Specialist at diane.keslch@fda.hhs.gov

Commander Diane L. Kelsch is a Regional Retail Food Specialist with the U.S. Food and Drug Administration, Southeast Region, State Cooperative Programs.