Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Restaurant and Retail Foodservice Facility Types (2024)

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Department of Health and Human Services

Food and Drug Administration

[Docket No. FDA-2024-N-0021]

Food and Drug Administration, HHS.

Notice.

OMB Control Number 0910-0744—Revision

This information collection supports food safety projects administered by FDA. The FDA's National Retail Food Team conducted a 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 as contributing factors to foodborne illness outbreaks at the retail level. Specifically, data was collected in retail and foodservice establishments at 5-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, and
Contaminated Equipment/Cross-Contamination.

FDA developed reports summarizing the findings for each of the three data collection periods, released in 2000, 2004, and 2009.^[1 2 3] 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.^[4]

Using this 10-year survey as a foundation, FDA initiated a new study in full-service and fast-food restaurants. This study will include data collections completed in 2013-2014 and 2017-2018. An additional collection planned for 2021-2022 was halted due to the COVID-19 pandemic; however, an additional data collection is planned for 2023-2025 (the subject of this information collection request extension). Three data collections are necessary to trend the data.

Table 1—Description of the Facility Types Included in the Survey
Facility type	Description
Full-Service Restaurants	A restaurant where customers place their orders at their tables, are served their meals at the tables, receive the services of the wait staff, and pay at the end of the meals.
Fast-Food Restaurants	A restaurant that is not a full-service restaurant. This includes restaurants commonly referred to as quick-service restaurants and fast, casual restaurants.
Retail Food Stores	Supermarkets and grocery stores that have a deli department/operation as described as follows:
	• Deli department/operation—Areas in a retail food store where foods, such as luncheon meats and cheeses, are sliced for the customers and where sandwiches and salads are prepared onsite or received from a commissary in bulk containers, portioned, and displayed. Parts of deli operations may include:
	• Salad bars, pizza stations, and other food bars managed by the deli department manager.
	• Areas where other foods are cooked or prepared and offered for sale as ready-to-eat and are managed by the deli department manager.
	Data will also be collected in the following areas of a supermarket or grocery store, if present:
	• Seafood department/operation—Areas in a retail food store where seafood is cut, prepared, stored, or displayed for sale to the consumer. In retail food stores where the seafood department is combined with another department ( e.g., meat), the data collector will only assess the procedures and practices associated with the processing of seafood.
	• Produce department/operation—Areas in a retail food store where produce is cut, prepared, stored, or displayed for sale to the consumer. A produce operation may include salad bars or juice stations that are managed by the produce manager.

The results of this study period will be used to:

Develop retail food safety initiatives, policies, and targeted intervention strategies focused on controlling foodborne illness risk factors;
Provide technical assistance to State, local, tribal, and territorial regulatory professionals;
Identify FDA retail work plan priorities; and
Inform FDA resource allocation to enhance retail food safety nationwide.

The objectives of this study are to:

Identify the least and most often occurring foodborne illness risk factors and food safety behaviors/practices in restaurants within the United States;
Determine the extent to which Food Safety Management Systems and the presence of a Certified Food Protection Manager impact the occurrence of foodborne illness risk factors and food safety behaviors/practices; and
Determine whether the occurrence of foodborne illness risk factors food safety behaviors/practices in delis differs based on an establishment's risk categorization and status as a single-unit or multiple-unit operation (e.g., restaurants that are part of an operation with two or more units).

A geographical information system database containing a listing of businesses throughout the United States provides the establishment inventory for the data collections. FDA samples establishments from the inventory based on the descriptions in table 1. FDA does not intend to sample operations that handle only prepackaged food items or conduct low-risk food preparation activities. The “FDA Food Code” contains a grouping of establishments by risk, based on the type of food preparation that is normally conducted ( print page 70654) within the operation.^[5] The intent is to sample establishments that fall under risk categories 2 through 4.

FDA has approximately 25 Retail Food Specialists (Specialists) who serve as the data collectors for the study. A standard form is used by the Specialists during each data collection. The form is divided into three sections: Section 1—“Establishment Information”; Section 2—“Regulatory Authority Information”; and Section 3—“Foodborne Illness Risk Factor and Food Safety Management System Assessment.” The information in Section 1 “Establishment Information” of the form is obtained during an interview with the establishment owner or person in charge by the Specialist and includes a standard set of questions. The information in Section 2 “Regulatory Authority Information” is obtained during an interview with the program director of the State or local jurisdiction that has regulatory responsibility for conducting inspections for the selected establishment.

Section 3 includes three parts: Part A for tabulating the Specialists' observations of the food employees' behaviors and practices in limiting contamination, proliferation, and survival of food safety hazards; Part B for assessing the food safety management system being implemented by the facility; and Part C for assessing the frequency and extent of food employee handwashing. The information in Part A is collected from the Specialists' direct observations of food employee behaviors and practices. Infrequent, nonstandard questions may be asked by the Specialists if clarification is needed on the food safety procedure or practice being observed. The information in Part B is collected by making direct observations and asking follow-up questions of facility management to obtain information on the extent to which the food establishment has developed and implemented food safety management systems. The information in Part C is collected by making direct observations of food employee handwashing. No questions are asked in the completion of Section 3, Part C of the form.

FDA collects the following information associated with the establishment's identity: establishment name, street address, city, State, ZIP Code, county, industry segment, and facility type. The establishment-identifying information is collected to ensure the data collections are not duplicative. Other information related to the nature of the operation, such as seating capacity and number of employees per shift, is also collected.

The burden associated with the completion of Sections 1 and 3 of Form FDA 3967 is specific to the persons in charge of the selected facilities. The burden includes the time it will take the person in charge to accompany the data collector during the site visit and answer the data collector's questions. The burden related to the completion of Section 2 of the form is specific to the program directors (or designated individuals) of the respective regulatory authorities. This burden includes the time it will take to answer the data collectors' questions and is the same regardless of the facility type. Data will be consolidated and reported in a manner that does not reveal the identity of any establishment included in the study.

FDA has collaborated with the Food Protection and Defense Institute to develop a web-based platform in FoodSHIELD to collect, store, and analyze data for the Retail Risk Factor Study. This platform is accessible to State, local, territorial, and tribal regulatory jurisdictions to collect data relevant to their own risk factor studies. Data will be consolidated and reported in a manner that does not reveal the identity of any establishment included in the study.

In the Federal Register of March 6, 2024 (89 FR 15996), FDA published a 60-day notice requesting public comment on the proposed collection of information. One comment was received. It was in favor of the study, but it was not responsive to the four collection of information topics solicited.

FDA estimates the burden of this collection of information as follows:

Table 2—Estimated Annual Reporting Burden ¹
Activity	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
Fast-Food and Full-Service Restaurants—Form FDA 3966	400	1	400	2	800
Retail Food Stores—Form FDA 3967	400	1	400	2	800
Entry Refusals—All Facility Types	24	1	24	0.08 (5 minutes)	2
Total					1,602
¹ There are no capital costs of operating and maintenance costs associated with this collection of information.

Based on a review of the information collection since our last request for OMB approval, we have made adjustments to our burden estimate. On our own initiative, however, and for efficiency of Agency operations, we are revising the information collection to include and consolidate related information collection found in 0910-0799. Since the publication of the 60-day notice, we made adjustments to our burden estimate. Our estimated burden for the information collection reflects a decrease of 35 total burden hours and a corresponding decrease of 792 total annual responses.

Dated: August 27, 2024.

Lauren K. Roth,

Associate Commissioner for Policy.

1. FDA, “Report of the FDA Retail Food Program Database of Foodborne Illness Risk Factors (2000).” Available at https://wayback.archive-it.org/7993/20170406023019/https://www.fda.gov/downloads/Food/GuidanceRegulation/UCM123546.pdf.

2. FDA, “FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (2004).” Available at https://wayback.archive-it.org/7993/20170406023011/https://www.fda.gov/downloads/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/UCM423850.pdf.

3. FDA, “FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (2009).” Available at https://wayback.archive-it.org/7993/20170406023004/https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/ucm224321.htm.

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4. FDA National Retail Food Team, “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).” Available at https://wayback.archive-it.org/7993/20170406022950/https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/ucm223293.htm.

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5. FDA, “FDA Food Code.” Available at https://www.fda.gov/FoodCode.

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[FR Doc. 2024-19574 Filed 8-29-24; 8:45 am]

BILLING CODE 4164-01-P