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Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types OMB Control Number 09100744
Extension I. Background From 1998 to 2008, FDAs 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 by FDA Specialists 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/CrossContamination.
FDA developed reports summarizing the findings for each of the three data collection periods, released in 2000, 2004, and 2009 Refs. 1 to 3. Data from all three data collection periods were analyzed to detect trends in improvement or regression over time
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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 Ref. 4.
Using this 10-year survey as a foundation, in 20132014, FDA initiated a new study in full-service and fast-food restaurants. This study will span 10
years with data collections completed in 20132014 and 20172018, and an additional collection planned for 2021
2022. Three data collections are necessary to trend the data. Data collected in 20132014 is published, and data from 20172018 is currently being evaluated for trends and significance.

TABLE 1DESCRIPTION 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.
A restaurant that is not a full-service restaurant. This includes restaurants commonly referred to as quickservice restaurants and fast, casual restaurants.

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Fast-Food Restaurants

The results of this 10-year 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 statutory basis for FDA
conducting this study is derived from the Public Health Service Act PHS Act 42 U.S.C. 243, section 311a.
Responsibility for carrying out the provisions of the PHS Act relative to food protection was transferred to the Commissioner of Food and Drugs in 1968 21 CFR 5.10a2 and 4.
Additionally, the Federal Food, Drug, and Cosmetic Act 21 U.S.C. 301 et seq.
and the Economy Act 31 U.S.C. 1535
require FDA to provide assistance to other Federal, State, and local government bodies.
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
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Determine whether the occurrence of foodborne illness risk factors and food safety behaviors/practices in delis differs based on an establishments 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.
The methodology to be used for this information collection is described as follows. To obtain a sufficient number of observations to conduct statistically significant analysis, FDA will conduct approximately 400 data collections in each facility type. This sample size has been calculated to provide for sufficient observations to be 95 percent confident that the compliance percentage is within 5 percent of the true compliance percentage.
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 within the operation Ref. 5. The intent is to sample establishments that fall under risk categories 2 through 4.
FDA has approximately 23 Retail Food Specialists Specialists who serve
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as the data collectors for the 10-year study. The Specialists are geographically dispersed throughout the United States and possess technical expertise in retail food safety and a solid understanding of the operations within each of the facility types to be surveyed.
The Specialists are also standardized by FDAs Center for Food Safety and Applied Nutrition personnel in the application and interpretation of the FDA Food Code Ref. 5.
Sampling zones have been established that are equal to the 175-mile radius around a Specialists home location.
The sample is selected randomly from among all eligible establishments located within these sampling zones.
The Specialists are generally located in major metropolitan areas i.e., population centers across the contiguous United States. Population centers usually contain a large concentration of the establishments FDA intends to sample. Sampling from the 175-mile radius sampling zones around the Specialists home locations provides three advantages to the study:
1. It provides a cross-section of urban and rural areas from which to sample the eligible establishments.
2. It represents a mix of small, medium, and large regulatory entities having jurisdiction over the eligible establishments.
3. It reduces overnight travel and, therefore, reduces travel costs incurred by the Agency to collect data.
The sample for each data collection period is evenly distributed among
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