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, 40856-40860 [2021-16199]
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Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices
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Rm. 7301, Silver Spring, MD 20993–
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SUPPLEMENTARY INFORMATION:
1 Under section 745A(a) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
379k–1(a)), at least 24 months after the issuance of
a final guidance document in which FDA has
specified the electronic format for submitting
certain submission types to the Agency, such
content must be submitted electronically and in the
format specified by FDA.
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Dated: July 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–16187 Filed 7–28–21; 8:45 am]
BILLING CODE 4164–01–P
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.
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.
SUMMARY:
Submit written comments
(including recommendations) on the
collection of information by August 30,
2021.
DATES:
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.
ADDRESSES:
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.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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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 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/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
40857
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.
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 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
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• 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
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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
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
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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.
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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 establishmentidentifying 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
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collection, the respondents will include:
(1) The person in charge of the selected
facility (whether it be a fast- food or fullservice 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 × 2
facility types × 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:
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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-foodrisk-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 fullservice 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 fastfood 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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Activity
Number of
respondents
2021–2022 Data Collection (Fast-Food Restaurants)—Completion
of Sections 1 and 3 ......
2021–2022 Data Collection (Full-Service Restaurants)—Completion
of Sections 1 and 3 ......
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Number of
responses
per
respondent
Total annual
responses
Number
of nonrespondents
Number of
responses
per nonrespondent
Total
annual nonresponses
Average
burden per
response
Total
hours
400
1
400
....................
....................
....................
1.36
544
400
1
400
....................
....................
....................
1.73
692
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TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Activity
Number of
responses
per
respondent
Number of
respondents
Number
of nonrespondents
Number of
responses
per nonrespondent
Total
annual nonresponses
Average
burden per
response
Total
hours
2021–2022 Data Collection-Completion of Section 2—All Facility
Types ............................
800
1
800
....................
....................
....................
0.5 (30
minutes)
400
2021–2022 Data Collection-Entry Refusals—All
Facility Types ...............
....................
....................
....................
16
1
16
0.08 (5
minutes)
1.28
Total Hours ...............
....................
....................
....................
....................
....................
....................
....................
1,637.28
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.
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Total annual
responses
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
VerDate Sep<11>2014
19:19 Jul 28, 2021
Jkt 253001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–New]
Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before September 27,
2021.
SUMMARY:
Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–New–60D
and project title for reference, to
ADDRESSES:
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
Sherrette A. Funn, email:
Sherrette.Funn@hhs.gov, or call (202)
795–7714 the Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Institutional
Review Board (IRB) Records for HHS/
OASH Consultation Process.
Type of Collection: New.
OMB No.: OS–0990–New.
Abstract: The Office of the Assistant
Secretary for Health, Office for Human
Research Protections is requesting a new
approval from the Office of Management
and Budget of the Office for Human
Research Protections (OHRP)
requirement that Institutional Review
Board records be submitted when an
IRB or its institution request an HHS
consultation process, for proposed
research involving, respectively: (1)
Pregnant women, human fetuses and
neonates; (2) prisoners; or, (3) children,
as subjects that are not otherwise
approval by an IRB. The Office of the
Assistant Secretary for Health, on behalf
of the Secretary of HHS, may determine
that such research can be conducted or
supported by HHS after consulting with
experts and allowing for public review
of, and comment on, the proposed
research.
Likely Respondents: Institutional
Review Boards (IRBs).
E:\FR\FM\29JYN1.SGM
29JYN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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,
[email protected].
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
