Notice2024-19574
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
Primary source
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Published
August 30, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 169 (Friday, August 30, 2024)</title>
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[Federal Register Volume 89, Number 169 (Friday, August 30, 2024)]
[Notices]
[Pages 70652-70654]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-19574]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0021]
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
AGENCY: Food and Drug Administration, 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 30, 2024.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#78282a392b0c191e1e381e1c195610100b561f170e"><span class="__cf_email__" data-cfemail="2e7e7c6f7d5a4f48486e484a4f0046465d00494158">[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.
[[Page 70653]]
Survey on the Occurrence of Foodborne Illness Risk Factors in Selected
Restaurant and Retail Foodservice Facility Types
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:
<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, released in 2000, 2004, and
2009.<SUP>1 2 3</SUP> 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\
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\1\ FDA, ``Report of the FDA Retail Food Program Database of
Foodborne Illness Risk Factors (2000).'' Available at <a href="https://wayback.archive-it.org/7993/20170406023019/https://www.fda.gov/downloads/Food/GuidanceRegulation/UCM123546.pdf">https://wayback.archive-it.org/7993/20170406023019/https://www.fda.gov/downloads/Food/GuidanceRegulation/UCM123546.pdf</a>.
\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 <a href="https://wayback.archive-it.org/7993/20170406023011/https://www.fda.gov/downloads/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/UCM423850.pdf">https://wayback.archive-it.org/7993/20170406023011/https://www.fda.gov/downloads/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/UCM423850.pdf</a>.
\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 <a href="https://wayback.archive-it.org/7993/20170406023004/https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/ucm224321.htm">https://wayback.archive-it.org/7993/20170406023004/https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/ucm224321.htm</a>.
\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 <a href="https://wayback.archive-it.org/7993/20170406022950/https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/ucm223293.htm">https://wayback.archive-it.org/7993/20170406022950/https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/ucm223293.htm</a>.
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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
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Facility type Description
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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:
<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.
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The results of this 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 objectives of this study are to:
<bullet> Identify the least and most often occurring foodborne
illness risk factors and food safety behaviors/practices in restaurants
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 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
[[Page 70654]]
within the operation.\5\ The intent is to sample establishments that
fall under risk categories 2 through 4.
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\5\ FDA, ``FDA Food Code.'' Available at <a href="https://www.fda.gov/FoodCode">https://www.fda.gov/FoodCode</a>.
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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\
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Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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Fast-Food and Full-Service Restaurants--Form 400 1 400 2........................................ 800
FDA 3966.
Retail Food Stores--Form FDA 3967............ 400 1 400 2........................................ 800
Entry Refusals--All Facility Types........... 24 1 24 0.08 (5 minutes)......................... 2
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Total.................................... .............. .............. .............. ......................................... 1,602
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\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.
[FR Doc. 2024-19574 Filed 8-29-24; 8:45 am]
BILLING CODE 4164-01-P
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