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

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July 29, 2021

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Health and Human Services DepartmentFood and Drug Administration

Abstract

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.

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<title>Federal Register, Volume 86 Issue 143 (Thursday, July 29, 2021)</title>
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[Federal Register Volume 86, Number 143 (Thursday, July 29, 2021)]
[Notices]
[Pages 40856-40860]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-16199]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Survey on the
Occurrence of Foodborne Illness Risk Factors in Selected Retail and
Foodservice Facility Types

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <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: 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#633331223017020505230507024d0b0b104d040c15"><span class="__cf_email__" data-cfemail="feaeacbfad8a9f9898be989a9fd096968dd0999188">[email&#160;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 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:
<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 (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:
<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 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 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:
<bullet> Restaurants
<bullet> Healthcare Facilities
<bullet> Schools (K-12)
<bullet> 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 <a href="https://www.fda.gov/food/retail-food-protection/retail-food-risk-factor-study">https://www.fda.gov/food/retail-food-protection/retail-food-risk-factor-study</a>
along with the technical report, with much of the data commonly
requested for independent analysis.
h. FDA acknowledges the benefit of peer review. For any manuscripts
published resulting from the dataset, peer review is sought. For the
technical report of the data, FDA will continue to utilize the format
which is familiar to and accepted by our stakeholders.
To calculate the estimate of the hours per response, FDA will use
the average data collection duration for the same facility types during
the 2015-2016 data collection. FDA estimates that it will take the
persons in charge of full-service restaurants and fast-food restaurants
104 minutes (1.73 hours) and 82 minutes (1.36 hours), respectively, to
accompany the data collectors while they complete Sections 1 and 3 of
the form. In comparison, for the 2017-2018 data collection, the burden
estimate was 106 minutes (1.76 hours) in full-service restaurants and
73 minutes (1.21 hours) in fast-food restaurants. FDA estimates that it
will take the program director (or designated individual) of the
respective regulatory authority 30 minutes (0.5 hours) to answer the
questions related to Section 2 of the form. This burden estimate is
unchanged from the last data collection. Hence, the total burden
estimate for a data collection in a full-service restaurant, including
both the program director's and the person in charge's responses, is
134 minutes (104 + 30) (2.23 hours). The total burden estimate for a
data collection in a fast-food restaurant, including both the program
director's and the person in charge's responses, is 112 minutes (82 +
30) (1.86 hours).
Based on the number of entry refusals from the 2017-2018 data
collection, we estimate a refusal rate of 2 percent for the data
collections within restaurant facility types. The estimate of the time
per non-respondent is 5 minutes (0.08 hours) for the person in charge
to listen to the purpose of the visit and provide a verbal refusal of
entry.
FDA estimates the burden of this collection of information as
follows:

Table 2--Estimated Annual Reporting Burden 1
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Number of Number of
Number of responses Total Number of responses Total Average
Activity respondents per annual non- per non- annual non- burden per Total hours
respondent responses respondents respondent responses response
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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)
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Total Hours................................. ........... ........... ........... ........... ........... ........... ........... 1,637.28
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1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.

II. References

The following references are on display in the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240-402-7500 and are available for viewing
by interested persons between 9 a.m. and 4 p.m., Monday through Friday;
they are also available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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 <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).'' (2010). 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>.
5. FDA, ``FDA Food Code.'' Available at <a href="https://www.fda.gov/FoodCode">https://www.fda.gov/FoodCode</a>.

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

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