[Federal Register Volume 86, Number 143 (Thursday, July 29, 2021)]
[Notices]
[Pages 40856-40860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16199]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0547]


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 Retail and 
Foodservice Facility Types

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by August 30, 2021.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0744. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

[[Page 40857]]

Survey on the Occurrence of Foodborne Illness Risk Factors in Selected 
Retail and Foodservice Facility Types

OMB Control Number 0910-0744--Extension

I. Background

    From 1998 to 2008, 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 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/Cross-Contamination.
    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 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 2013-2014, FDA 
initiated a new study in full-service and fast-food restaurants. This 
study will span 10 years with data collections completed in 2013-2014 
and 2017-2018, and an additional collection planned for 2021-2022. 
Three data collections are necessary to trend the data. Data collected 
in 2013-2014 is published, and data from 2017-2018 is currently being 
evaluated for trends and significance.

    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.
------------------------------------------------------------------------

    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 
311(a)). 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 5.10(a)(2) 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
     Determine whether the occurrence of foodborne illness risk 
factors and 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).
    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 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 FDA's 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 Specialist's 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

[[Page 40858]]

Specialists. Given that participation in the study by industry is 
voluntary and the status of any given randomly selected establishment 
is subject to change, substitute establishments have been selected for 
each Specialist for cases where the restaurant facility is 
misclassified, closed, or otherwise unavailable, unable, or unwilling 
to participate.
    Prior to conducting the data collection, Specialists contact the 
State or local jurisdiction that has regulatory responsibility for 
conducting retail food inspections for the selected establishment. The 
Specialist verifies with the jurisdiction that the facility has been 
properly classified for the purposes of the study and is still in 
operation. The Specialist ascertains whether the selected facility is 
under legal notice from the State or local regulatory authority. If the 
selected facility is under legal notice, the Specialist will not 
conduct a data collection, and a substitute establishment will be used. 
An invitation is extended to the State or local regulatory authority to 
accompany the Specialist on the data collection visit.
    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--``Foodborne Illness Risk Factor and Food Safety 
Management System Assessment'' 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 followup 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. 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. For the 2015-2016 data collection, FDA piloted the use of 
hand-held technology for capturing the data onsite during the data 
collection visits. The tablets that were made available for the data 
collections were part of a broader Agency initiative focused on 
internal uses of hand-held technology. The tablets provided for the 
data collection presented several technical and logistical challenges 
and increased the time burden associated with the data collection as 
compared to the manual entry of data collections. For these reasons, 
FDA will not be further evaluating hand-held technology in subsequent 
data collections during the 10-year study period.
    When a data collector is assigned a specific establishment, he or 
she conducts the data collection and enters the information into the 
web-based data platform. The interface will support the manual entering 
of data, as well as the ability to directly enter information in the 
database via a web browser.
    The burden for the 2021-2022 data collection is as follows. For 
each data collection, the respondents will include: (1) The person in 
charge of the selected facility (whether it be a fast- food or full-
service restaurant); and (2) the program director (or designated 
individual) of the respective regulatory authority. In order to provide 
the sufficient number of observations needed to conduct a statistically 
significant analysis of the data, FDA has determined that 400 data 
collections will be required in each of the two restaurant facility 
types. Therefore, the total number of responses will be 1,600 (400 data 
collections x 2 facility types x 2 respondents per data collection).
    The burden associated with the completion of Sections 1 and 3 of 
the form 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. The 
burden includes the time it will take to answer the data collectors' 
questions and is the same regardless of the facility type.
    In the Federal Register of March 16, 2021 (86 FR 14433), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received two comments; only one comment 
we received was responsive to the four collection of information topics 
solicited.
    (Comment) The Academy of Nutrition and Dietetics (the Academy) 
commented that they support the proposed information collection for the 
survey on the occurrence of foodborne illness risk factors in various 
settings. The Academy provided comments pertaining to the following 
general areas of the study:
    a. Question whether 90 minutes is adequate for surveying larger 
facilities.
    b. Request FDA evaluate the impact of conducting surveys during 
peak hours of operation.
    c. Suggest that the use of gloves is not adequately addressed in 
the survey.
    d. Encourage continued efforts to simplify and standardize 
expiration dates.
    Related to foodservice operations at the retail level, the Academy 
provided the following comments:
    e. FDA consider modifying the survey to account for new foods and 
new means of conveying food.
    The Academy provided the following comment specific to pandemic-
related considerations:

[[Page 40859]]

    f. FDA consider modifying the survey to include trends for hot-
holding and online delivery due to the COVID-19 pandemic.
    The Academy also provided comments related to statistical analysis 
and data sharing:
    g. FDA make the dataset public for further analysis.
    h. FDA consider peer review of the report.
    (Response) FDA thanks the submitter for their comments and 
appreciates their support. Regarding general areas of the study, FDA 
provides the following responses:
    a. The current 10-year study estimates 90 minutes as the average 
time needed to adequately collect necessary information, taking into 
account both small and large facilities. This average time is 
consistent with the amount of time burden estimated for the previous 
data collection periods and provides a sufficient timeframe to observe 
food safety practices and procedures that are the focus of the study.
    b. Based on the methodology of the study, the information 
collection is performed during hours of operation of the randomly 
selected facility. Data collections are scheduled at times that provide 
the best opportunity to observe food preparation activities, which 
often include peak operations.
    c. Information collection related to handwashing and no bare hand 
contact with ready-to-eat foods, which may include use of gloves, is 
based on assessment of observations against the most current addition 
of the FDA Model Food Code. Provisions of the FDA Food Code identify 
when handwashing and no bare hand contact with ready-to-eat food are 
required during food preparation and service. The current FDA Food Code 
does not recognize the use of hand antiseptics in lieu of handwashing 
during food preparation and service.
    d. The scope of this data collection focuses on foodborne illness 
risk factors and does not include assessment of expiration dates of 
manufactured foods as part of this research assessment.
    Related to foodservice operations at the retail level, FDA provides 
the following responses:
    e. The study design accounts for a variety of food conveyances in 
the retail food setting. The study includes four 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
     Healthcare Facilities
     Schools (K-12)
     Retail Food Stores
    Related to the Academy's comments on pandemic-related 
considerations, FDA provides the following response:
    f. The study design is based on operations regardless of 
extenuating circumstances. While there is utility in investigating the 
trends in food service, this study must focus its efforts throughout 
the 10-year period to ensure data can be adequately trended. Two of the 
three data collections for this trending were already complete before 
the pandemic and a singular data point with these new metrics would not 
be of much utility. FDA fully supports the New Era of Smarter Food 
Safety blueprint and endeavors to collect data to support that effort.
    Regarding statistical analysis and data sharing, FDA provides the 
following responses:
    g. FDA strives to ensure the data is available to parties upon 
request. Additionally, a new Topline Summary is published to https://www.fda.gov/food/retail-food-protection/retail-food-risk-factor-study 
along with the technical report, with much of the data commonly 
requested for independent analysis.
    h. FDA acknowledges the benefit of peer review. For any manuscripts 
published resulting from the dataset, peer review is sought. For the 
technical report of the data, FDA will continue to utilize the format 
which is familiar to and accepted by our stakeholders.
    To calculate the estimate of the hours per response, FDA will use 
the average data collection duration for the same facility types during 
the 2015-2016 data collection. FDA estimates that it will take the 
persons in charge of full-service restaurants and fast-food restaurants 
104 minutes (1.73 hours) and 82 minutes (1.36 hours), respectively, to 
accompany the data collectors while they complete Sections 1 and 3 of 
the form. In comparison, for the 2017-2018 data collection, the burden 
estimate was 106 minutes (1.76 hours) in full-service restaurants and 
73 minutes (1.21 hours) in fast-food restaurants. FDA estimates that it 
will take the program director (or designated individual) of the 
respective regulatory authority 30 minutes (0.5 hours) to answer the 
questions related to Section 2 of the form. This burden estimate is 
unchanged from the last data collection. Hence, the total burden 
estimate for a data collection in a full-service restaurant, including 
both the program director's and the person in charge's responses, is 
134 minutes (104 + 30) (2.23 hours). The total burden estimate for a 
data collection in a fast-food restaurant, including both the program 
director's and the person in charge's responses, is 112 minutes (82 + 
30) (1.86 hours).
    Based on the number of entry refusals from the 2017-2018 data 
collection, we estimate a refusal rate of 2 percent for the data 
collections within restaurant facility types. The estimate of the time 
per non-respondent is 5 minutes (0.08 hours) for the person in charge 
to listen to the purpose of the visit and provide a verbal refusal of 
entry.
    FDA estimates the burden of this collection of information as 
follows:

                                                      Table 2--Estimated Annual Reporting Burden 1
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                                                                Number of                              Number of
                                                   Number of    responses      Total      Number of    responses      Total       Average
                    Activity                      respondents      per         annual        non-       per non-   annual non-   burden per  Total hours
                                                                respondent   responses   respondents   respondent   responses     response
--------------------------------------------------------------------------------------------------------------------------------------------------------
2021-2022 Data Collection (Fast-Food                      400            1          400  ...........  ...........  ...........         1.36          544
 Restaurants)--Completion of Sections 1 and 3...
2021-2022 Data Collection (Full-Service                   400            1          400  ...........  ...........  ...........         1.73          692
 Restaurants)--Completion of Sections 1 and 3...

[[Page 40860]]

 
2021-2022 Data Collection-Completion of Section           800            1          800  ...........  ...........  ...........      0.5 (30          400
 2--All Facility Types..........................                                                                                   minutes)
2021-2022 Data Collection-Entry Refusals--All     ...........  ...........  ...........           16            1           16      0.08 (5         1.28
 Facility Types.................................                                                                                   minutes)
                                                 -------------------------------------------------------------------------------------------------------
    Total Hours.................................  ...........  ...........  ...........  ...........  ...........  ...........  ...........     1,637.28
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1 There are no capital costs or 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 no adjustments to our burden 
estimate.

II. References

    The following references are on display in the Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500 and are available for viewing 
by interested persons between 9 a.m. and 4 p.m., Monday through Friday; 
they are also available electronically at https://www.regulations.gov. 
FDA has verified the website addresses, as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.

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.
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).'' (2010). Available at https://wayback.archive-it.org/7993/20170406022950/https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/ucm223293.htm.
5. FDA, ``FDA Food Code.'' Available at https://www.fda.gov/FoodCode.

    Dated: July 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16199 Filed 7-28-21; 8:45 am]
BILLING CODE 4164-01-P


