[Federal Register Volume 86, Number 148 (Thursday, August 5, 2021)]
[Notices]
[Pages 42845-42849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16700]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0270]


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 Institutional 
Foodservice and Retail Food Stores Facility Types

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) 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 September 7, 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 0910-0799. 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, 
<a href="/cdn-cgi/l/email-protection#9bcbc9dac8effafdfddbfdfffab5f3f3e8b5fcf4ed"><span class="__cf_email__" data-cfemail="8ededccfddfaefe8e8cee8eaefa0e6e6fda0e9e1f8">[email protected]</span></a>.

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.

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

OMB Control Number 0910-0799--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 were collected by FDA Specialists in retail 
and foodservice establishments at 5-year intervals (1998, 2003, and 
2008) to observe and document trends in the occurrence of the following 
foodborne illness risk factors:
    <bullet> Food from Unsafe Sources,
    <bullet> Poor Personal Hygiene,
    <bullet> Inadequate Cooking,
    <bullet> Improper Holding/Time and Temperature, and
    <bullet> Contaminated Equipment/Cross-Contamination.
    FDA developed reports summarizing the findings for each of the 
three data collection periods, which were 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 to 2014, FDA 
initiated a new study period. This study will span 10 years. FDA 
completed the baseline data collection in select healthcare, schools, 
and retail food store facility types in 2015 to 2016, and these data 
are being evaluated for trends and significance. A second data 
collection began in 2019 to 2020 and will be completed if it is safe to 
do so (pending COVID-19 pandemic), and an additional data collection is 
planned for 2023 to 2024 (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
------------------------------------------------------------------------
Healthcare Facilities.............     Hospitals and long-term care
                                        facilities foodservice
                                        operations that prepare meals
                                        for highly susceptible
                                        populations as defined as
                                        follows:

[[Page 42846]]

 
                                       <bullet> Hospitals--A foodservice
                                        operation that provides for the
                                        nutritional needs of inpatients
                                        by preparing meals and
                                        transporting them to the
                                        patient's room and/or serving
                                        meals in a cafeteria setting
                                        (meals in the cafeteria may also
                                        be served to hospital staff and
                                        visitors).
                                       <bullet> Long-term care
                                        facilities--A foodservice
                                        operation that prepares meals
                                        for the residents in a group
                                        care living setting such as
                                        nursing homes and assisted
                                        living facilities.
                                    Note: For the purposes of this
                                     study, healthcare facilities that
                                     do not prepare or serve food to a
                                     highly susceptible population, such
                                     as mental healthcare facilities,
                                     are not included in this facility
                                     type category.
Schools (K-12)....................  Foodservice operations that have the
                                     primary function of preparing and
                                     serving meals for students in one
                                     or more grade levels from
                                     kindergarten through grade 12. A
                                     school foodservice may be part of a
                                     public or private institution.
Retail Food Stores................  Supermarkets and grocery stores that
                                     have a deli department/operation as
                                     described as follows:
                                       <bullet> 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:
                                       <bullet> Salad bars, pizza
                                        stations, and other food bars
                                        managed by the deli department
                                        manager.
                                       <bullet> 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:
                                       <bullet> 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.
                                       <bullet> 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 10-year study period will be used to:
    <bullet> Develop retail food safety initiatives, policies, and 
targeted intervention strategies focused on controlling foodborne 
illness risk factors;
    <bullet> provide technical assistance to State, local, tribal, and 
territorial regulatory professionals;
    <bullet> identify FDA retail work plan priorities; and
    <bullet> 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:
    <bullet> Identify the least and most often occurring foodborne 
illness risk factors and food safety behaviors/practices in select 
retail food establishments within the United States.
    <bullet> 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
    <bullet> 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., establishments 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 Regional 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.

[[Page 42847]]

    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 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 institutional foodservice, school, 
or retail food store 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 hand washing. 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 hand washing. 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 to 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 FDA 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 incorporating use of 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 2023 to 2024 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 healthcare facility, 
school, or supermarket/grocery store); and (2) the program director (or 
designated individual) of the respective regulatory authority. 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 three facility 
types. Therefore, the total number of responses will be 2,400 (400 data 
collections x 3 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. This 
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 February 18, 2021 (86 FR 10087), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment.
    (Comment) An interested citizen submitted the following comment:
    a. The previous 10-year study conducted by FDA did not mention 
negative trends in the ``other'' category, which included information 
about contamination risk factors as they relate to food or color 
additives, poisonous or toxic materials, or storage of poisonous or 
toxic materials for retail sale. This negative trend should be 
reported.
    b. In the 2013 to 2014 report on restaurants the ``other'' 
contamination risk factor did not appear in the report. This should 
remain the same as the previous 10-year study for comparison purposes.
    c. FDA should keep chemicals as a risk factor for future research 
on the occurrence of foodborne illness risk factors.
    (Response) FDA acknowledges the submission of the question from a 
concerned citizen and provides the following response:

[[Page 42848]]

    a. FDA acknowledges the commenter's concern on a perceived lack of 
reporting on negative trends within the previous 10-year study.
    b. FDA report on the results of the 2013 to 2014 data collection 
was the first report with the new study design of the 10-year study. 
One of the significant design changes from the 1998 to 2008 Study is 
the reduction of the number of data items from 42 to 10. The focus on 
the 10 primary data items provides the opportunity to obtain enough 
observations of food safety practices and procedures to report 
statistically significant study conclusions and correlations.
    In an effort to focus messaging on the most prevalent food safety 
practices and behaviors found out of compliance, secondary data items 
(items 11-19) were not reported at that time. FDA focused the report on 
the primary 10 data items that directly correspond with the foodborne 
illness risk factors included in the study. The new study design 
includes ``Other Areas of Interest'' that support the primary data 
items or track an area that is not likely to have a sufficient enough 
number of observations for statistical purposes but is an important 
food safety practice within the retail segment of the industry--such as 
Item 18, ``Toxic materials are identified, used, and stored properly as 
outlined in the marking instructions'', (Attachment B). The current 
data collection continues to collect information on the provisions 
within the food code that address the safe storage, handling, and use 
of toxic and poisonous substances. If significant findings occur, FDA 
is committed to reporting those findings. From the 2015 data collection 
forward, FDA will be publishing a topline summary report to include 
information on data items 11-18. These reports can be accessed at 
https://www.fda.gov/retailfoodriskfactorstudy.
    c. While not listed as one of the five main foodborne illness risk 
factors in the current study design, controlling chemicals and toxic 
substances in food service facilities is important to prevent injury 
and illness and FDA recognizes this. The information gathered in Data 
Item 18 as described above helps FDA keep a pulse on risky behaviors 
surrounding toxic or poisonous materials in retail facilities. The 
purpose of the current 10-year study is primarily to collect 
information on the five foodborne illness risk factors and study to 
elucidate relationships between the foodborne illness risk factors and 
food safety management systems, and certified food protection managers.
    To calculate the estimate of the hours per response, FDA uses the 
average data collection duration for similar facility types during the 
FDA's 2008 Risk Factor Study (Ref. 3) plus an additional 30 minutes 
(0.5 hours) for the information related to Section 3, Part B of the 
form. FDA estimates that it will take the persons in charge of 
healthcare facility types, schools, and retail food stores 150 minutes 
(2.5 hours), 120 minutes (2 hours), and 180 minutes (3 hours), 
respectively, to accompany the data collectors while they complete 
Sections 1 and 3 of the form. 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 healthcare facility types is 180 minutes (150 + 30) 
(3 hours), in schools is 150 minutes (120 + 30) (2.5 hours), and retail 
food stores is 210 minutes (180 + 30) (3.5 hours).
    Based on the number of entry refusals from the 2015 to 2016 
baseline data collection, we estimate a refusal rate of 2 percent for 
the data collections within healthcare, school, and retail food store 
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     Total annual   Number of non-   responses per   Total annual                                           Total
                    Activity                       respondents    responses per     responses      respondents        non-        non-responses       Average burden per response        hours
                                                                   respondent                                      respondent
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2023-2024 Data Collection (Healthcare                       400               1             400  ..............  ..............  ..............  2.5.................................      1,000
 Facilities)--Completion of Sections 1 and 3.
2023-2024 Data Collection (Schools)--Completion             400               1             400  ..............  ..............  ..............  2...................................        800
 of Sections 1 and 3.
2023-2024 Data Collection (Retail Food Stores)--            400               1             400  ..............  ..............  ..............  3...................................      1,200
 Completion of Sections 1 and 3.
2023-2024 Data Collection-Completion of Section           1,200               1           1,200  ..............  ..............  ..............  0.5 (30 minutes)....................        600
 2--All Facility Types.
2023-2024 Data Collection-Entry Refusals--All    ..............  ..............  ..............              24               1              24  0.08 (5 minutes)....................       1.92
 Facility Types.
                                                ------------------------------------------------------------------------------------------------------------------------------------------------
    Total......................................  ..............  ..............  ..............  ..............  ..............  ..............  ....................................   3,601.92
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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. ``Report of the FDA Retail Food Program Database of Foodborne 
Illness Risk

[[Page 42849]]

Factors (2000).'' Available at: https://wayback.archive-it.org/7993/20170406023019/https://www.fda.gov/downloads/Food/GuidanceRegulation/UCM123546.pdf.
2. ``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 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 Food Code.'' Available at: https://www.fda.gov/food/retail-food-protection/fda-food-code.

    Dated: July 28, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16700 Filed 8-4-21; 8:45 am]
BILLING CODE 4164-01-P


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