Notice2021-16700
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 5, 2021
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
<html>
<head>
<title>Federal Register, Volume 86 Issue 148 (Thursday, August 5, 2021)</title>
</head>
<body><pre>
[Federal Register Volume 86, Number 148 (Thursday, August 5, 2021)]
[Notices]
[Pages 42845-42849]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-16700]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0270]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Survey on the
Occurrence of Foodborne Illness Risk Factors in Selected Institutional
Foodservice and Retail Food Stores Facility Types
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by September 7, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <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 0910-0799. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
<a href="/cdn-cgi/l/email-protection#9bcbc9dac8effafdfddbfdfffab5f3f3e8b5fcf4ed"><span class="__cf_email__" data-cfemail="8ededccfddfaefe8e8cee8eaefa0e6e6fda0e9e1f8">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Survey on the Occurrence of Foodborne Illness Risk Factors in Selected
Institutional Foodservice and Retail Food Stores Facility Types
OMB Control Number 0910-0799--Extension
I. Background
From 1998 to 2008, FDA's National Retail Food Team conducted a
study to measure trends in the occurrence of foodborne illness risk
factors, preparation practices, and employee behaviors most commonly
reported to the Centers for Disease Control and Prevention as
contributing factors to foodborne illness outbreaks at the retail
level. Specifically, data were collected by FDA Specialists in retail
and foodservice establishments at 5-year intervals (1998, 2003, and
2008) to observe and document trends in the occurrence of the following
foodborne illness risk factors:
<bullet> Food from Unsafe Sources,
<bullet> Poor Personal Hygiene,
<bullet> Inadequate Cooking,
<bullet> Improper Holding/Time and Temperature, and
<bullet> Contaminated Equipment/Cross-Contamination.
FDA developed reports summarizing the findings for each of the
three data collection periods, which were released in 2000, 2004, and
2009 (Refs. 1 to 3). Data from all three data collection periods were
analyzed to detect trends in improvement or regression over time and to
determine whether progress had been made toward the goal of reducing
the occurrence of foodborne illness risk factors in selected retail and
foodservice facility types (Ref. 4).
Using this 10-year survey as a foundation, in 2013 to 2014, FDA
initiated a new study period. This study will span 10 years. FDA
completed the baseline data collection in select healthcare, schools,
and retail food store facility types in 2015 to 2016, and these data
are being evaluated for trends and significance. A second data
collection began in 2019 to 2020 and will be completed if it is safe to
do so (pending COVID-19 pandemic), and an additional data collection is
planned for 2023 to 2024 (the subject of this information collection
request extension). Three data collections are necessary to trend the
data.
Table 1--Description of the Facility Types Included in the Survey
------------------------------------------------------------------------
Facility type Description
------------------------------------------------------------------------
Healthcare Facilities............. Hospitals and long-term care
facilities foodservice
operations that prepare meals
for highly susceptible
populations as defined as
follows:
[[Page 42846]]
<bullet> Hospitals--A foodservice
operation that provides for the
nutritional needs of inpatients
by preparing meals and
transporting them to the
patient's room and/or serving
meals in a cafeteria setting
(meals in the cafeteria may also
be served to hospital staff and
visitors).
<bullet> Long-term care
facilities--A foodservice
operation that prepares meals
for the residents in a group
care living setting such as
nursing homes and assisted
living facilities.
Note: For the purposes of this
study, healthcare facilities that
do not prepare or serve food to a
highly susceptible population, such
as mental healthcare facilities,
are not included in this facility
type category.
Schools (K-12).................... Foodservice operations that have the
primary function of preparing and
serving meals for students in one
or more grade levels from
kindergarten through grade 12. A
school foodservice may be part of a
public or private institution.
Retail Food Stores................ Supermarkets and grocery stores that
have a deli department/operation as
described as follows:
<bullet> Deli department/
operation--Areas in a retail
food store where foods, such as
luncheon meats and cheeses, are
sliced for the customers and
where sandwiches and salads are
prepared onsite or received from
a commissary in bulk containers,
portioned, and displayed. Parts
of deli operations may include:
<bullet> Salad bars, pizza
stations, and other food bars
managed by the deli department
manager.
<bullet> Areas where other foods
are cooked or prepared and
offered for sale as ready-to-eat
and are managed by the deli
department manager.
Data will also be collected in the
following areas of a supermarket or
grocery store, if present:
<bullet> Seafood department/
operation--Areas in a retail
food store where seafood is cut,
prepared, stored, or displayed
for sale to the consumer. In
retail food stores where the
seafood department is combined
with another department (e.g.,
meat), the data collector will
only assess the procedures and
practices associated with the
processing of seafood.
<bullet> Produce department/
operation--Areas in a retail
food store where produce is cut,
prepared, stored, or displayed
for sale to the consumer. A
produce operation may include
salad bars or juice stations
that are managed by the produce
manager.
------------------------------------------------------------------------
The results of this 10-year study period will be used to:
<bullet> Develop retail food safety initiatives, policies, and
targeted intervention strategies focused on controlling foodborne
illness risk factors;
<bullet> provide technical assistance to State, local, tribal, and
territorial regulatory professionals;
<bullet> identify FDA retail work plan priorities; and
<bullet> inform FDA resource allocation to enhance retail food
safety nationwide.
The statutory basis for FDA conducting this study is derived from
the Public Health Service Act (PHS Act) (42 U.S.C. 243, section
311(a)). Responsibility for carrying out the provisions of the PHS Act
relative to food protection was transferred to the Commissioner of Food
and Drugs in 1968 (21 CFR 5.10(a)(2) and (4)). Additionally, the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and the
Economy Act (31 U.S.C. 1535) require FDA to provide assistance to other
Federal, State, and local government bodies.
The objectives of this study are to:
<bullet> Identify the least and most often occurring foodborne
illness risk factors and food safety behaviors/practices in select
retail food establishments within the United States.
<bullet> determine the extent to which food safety management
systems and the presence of a certified food protection manager impact
the occurrence of foodborne illness risk factors and food safety
behaviors/practices; and
<bullet> determine whether the occurrence of foodborne illness risk
factors and food safety behaviors/practices in delis differs based on
an establishment's risk categorization and status as a single-unit or
multiple-unit operation (e.g., establishments that are part of an
operation with two or more units).
The methodology to be used for this information collection is
described as follows. To obtain a sufficient number of observations to
conduct statistically significant analysis, FDA will conduct
approximately 400 data collections in each facility type. This sample
size has been calculated to provide for sufficient observations to be
95 percent confident that the compliance percentage is within 5 percent
of the true compliance percentage.
A geographical information system database containing a listing of
businesses throughout the United States provides the establishment
inventory for the data collections. FDA samples establishments from the
inventory based on the descriptions in table 1. FDA does not intend to
sample operations that handle only prepackaged food items or conduct
low-risk food preparation activities. The ``FDA Food Code'' contains a
grouping of establishments by risk, based on the type of food
preparation that is normally conducted within the operation (Ref. 5).
The intent is to sample establishments that fall under risk categories
2 through 4.
FDA has approximately 23 Regional Retail Food Specialists
(Specialists) who serve as the data collectors for the 10-year study.
The Specialists are geographically dispersed throughout the United
States and possess technical expertise in retail food safety and a
solid understanding of the operations within each of the facility types
to be surveyed. The Specialists are also standardized by FDA's Center
for Food Safety and Applied Nutrition personnel in the application and
interpretation of the FDA Food Code (Ref. 5).
Sampling zones have been established that are equal to the 175-mile
radius around a Specialist's home location. The sample is selected
randomly from among all eligible establishments located within these
sampling zones. The Specialists are generally located in major
metropolitan areas (i.e., population centers) across the contiguous
United States. Population centers usually contain a large concentration
of the establishments FDA intends to sample. Sampling from the 175-mile
radius sampling zones around the Specialists' home locations provides
three advantages to the study:
1. It provides a cross-section of urban and rural areas from which
to sample the eligible establishments.
2. It represents a mix of small, medium, and large regulatory
entities having jurisdiction over the eligible establishments.
[[Page 42847]]
3. It reduces overnight travel and therefore reduces travel costs
incurred by the Agency to collect data.
The sample for each data collection period is evenly distributed
among Specialists. Given that participation in the study by industry is
voluntary and the status of any given randomly selected establishment
is subject to change, substitute establishments have been selected for
each Specialist for cases where the institutional foodservice, school,
or retail food store facility is misclassified, closed, or otherwise
unavailable, unable, or unwilling to participate.
Prior to conducting the data collection, Specialists contact the
State or local jurisdiction that has regulatory responsibility for
conducting retail food inspections for the selected establishment. The
Specialist verifies with the jurisdiction that the facility has been
properly classified for the purposes of the study and is still in
operation. The Specialist ascertains whether the selected facility is
under legal notice from the State or local regulatory authority. If the
selected facility is under legal notice, the Specialist will not
conduct a data collection, and a substitute establishment will be used.
An invitation is extended to the State or local regulatory authority to
accompany the Specialist on the data collection visit.
A standard form is used by the Specialists during each data
collection. The form is divided into three sections: Section 1--
``Establishment Information''; Section 2--``Regulatory Authority
Information''; and Section 3--``Foodborne Illness Risk Factor and Food
Safety Management System Assessment.'' The information in Section 1--
``Establishment Information'' of the form is obtained during an
interview with the establishment owner or person in charge by the
Specialist and includes a standard set of questions.
The information in Section 2--``Regulatory Authority Information''
is obtained during an interview with the program director of the State
or local jurisdiction that has regulatory responsibility for conducting
inspections for the selected establishment. Section 3--``Foodborne
Illness Risk Factor and Food Safety Management System Assessment''
includes three parts: Part A for tabulating the Specialists'
observations of the food employees' behaviors and practices in limiting
contamination, proliferation, and survival of food safety hazards; Part
B for assessing the food safety management system being implemented by
the facility; and Part C for assessing the frequency and extent of food
employee hand washing. The information in Part A is collected from the
Specialists' direct observations of food employee behaviors and
practices. Infrequent, nonstandard questions may be asked by the
Specialists if clarification is needed on the food safety procedure or
practice being observed. The information in Part B is collected by
making direct observations and asking followup questions of facility
management to obtain information on the extent to which the food
establishment has developed and implemented food safety management
systems. The information in Part C is collected by making direct
observations of food employee hand washing. No questions are asked in
the completion of Section 3, Part C of the form.
FDA collects the following information associated with the
establishment's identity: Establishment name, street address, city,
State, ZIP Code, county, industry segment, and facility type. The
establishment identifying information is collected to ensure the data
collections are not duplicative. Other information related to the
nature of the operation, such as seating capacity and number of
employees per shift, is also collected. Data will be consolidated and
reported in a manner that does not reveal the identity of any
establishment included in the study.
FDA has collaborated with the Food Protection and Defense Institute
to develop a web-based platform in FoodSHIELD to collect, store, and
analyze data for the Retail Risk Factor Study. This platform is
accessible to State, local, territorial, and tribal regulatory
jurisdictions to collect data relevant to their own risk factor
studies. For the 2015 to 2016 data collection, FDA piloted the use of
hand-held technology for capturing the data onsite during the data
collection visits. The tablets that were made available for the data
collections were part of a broader FDA initiative focused on internal
uses of hand-held technology. The tablets provided for the data
collection presented several technical and logistical challenges and
increased the time burden associated with the data collection as
compared to the manual entry of data collections. For these reasons,
FDA will not be incorporating use of hand-held technology in subsequent
data collections during the 10-year study period.
When a data collector is assigned a specific establishment, he or
she conducts the data collection and enters the information into the
web-based data platform. The interface will support the manual entering
of data, as well as the ability to directly enter information in the
database via a web browser.
The burden for the 2023 to 2024 data collection is as follows. For
each data collection, the respondents will include: (1) The person in
charge of the selected facility (whether it be a healthcare facility,
school, or supermarket/grocery store); and (2) the program director (or
designated individual) of the respective regulatory authority. To
provide the sufficient number of observations needed to conduct a
statistically significant analysis of the data, FDA has determined that
400 data collections will be required in each of the three facility
types. Therefore, the total number of responses will be 2,400 (400 data
collections x 3 facility types x 2 respondents per data collection).
The burden associated with the completion of Sections 1 and 3 of
the form is specific to the persons in charge of the selected
facilities. The burden includes the time it will take the person in
charge to accompany the data collector during the site visit and answer
the data collector's questions. The burden related to the completion of
Section 2 of the form is specific to the program directors (or
designated individuals) of the respective regulatory authorities. This
burden includes the time it will take to answer the data collectors'
questions and is the same regardless of the facility type.
In the Federal Register of February 18, 2021 (86 FR 10087), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment.
(Comment) An interested citizen submitted the following comment:
a. The previous 10-year study conducted by FDA did not mention
negative trends in the ``other'' category, which included information
about contamination risk factors as they relate to food or color
additives, poisonous or toxic materials, or storage of poisonous or
toxic materials for retail sale. This negative trend should be
reported.
b. In the 2013 to 2014 report on restaurants the ``other''
contamination risk factor did not appear in the report. This should
remain the same as the previous 10-year study for comparison purposes.
c. FDA should keep chemicals as a risk factor for future research
on the occurrence of foodborne illness risk factors.
(Response) FDA acknowledges the submission of the question from a
concerned citizen and provides the following response:
[[Page 42848]]
a. FDA acknowledges the commenter's concern on a perceived lack of
reporting on negative trends within the previous 10-year study.
b. FDA report on the results of the 2013 to 2014 data collection
was the first report with the new study design of the 10-year study.
One of the significant design changes from the 1998 to 2008 Study is
the reduction of the number of data items from 42 to 10. The focus on
the 10 primary data items provides the opportunity to obtain enough
observations of food safety practices and procedures to report
statistically significant study conclusions and correlations.
In an effort to focus messaging on the most prevalent food safety
practices and behaviors found out of compliance, secondary data items
(items 11-19) were not reported at that time. FDA focused the report on
the primary 10 data items that directly correspond with the foodborne
illness risk factors included in the study. The new study design
includes ``Other Areas of Interest'' that support the primary data
items or track an area that is not likely to have a sufficient enough
number of observations for statistical purposes but is an important
food safety practice within the retail segment of the industry--such as
Item 18, ``Toxic materials are identified, used, and stored properly as
outlined in the marking instructions'', (Attachment B). The current
data collection continues to collect information on the provisions
within the food code that address the safe storage, handling, and use
of toxic and poisonous substances. If significant findings occur, FDA
is committed to reporting those findings. From the 2015 data collection
forward, FDA will be publishing a topline summary report to include
information on data items 11-18. These reports can be accessed at
<a href="https://www.fda.gov/retailfoodriskfactorstudy">https://www.fda.gov/retailfoodriskfactorstudy</a>.
c. While not listed as one of the five main foodborne illness risk
factors in the current study design, controlling chemicals and toxic
substances in food service facilities is important to prevent injury
and illness and FDA recognizes this. The information gathered in Data
Item 18 as described above helps FDA keep a pulse on risky behaviors
surrounding toxic or poisonous materials in retail facilities. The
purpose of the current 10-year study is primarily to collect
information on the five foodborne illness risk factors and study to
elucidate relationships between the foodborne illness risk factors and
food safety management systems, and certified food protection managers.
To calculate the estimate of the hours per response, FDA uses the
average data collection duration for similar facility types during the
FDA's 2008 Risk Factor Study (Ref. 3) plus an additional 30 minutes
(0.5 hours) for the information related to Section 3, Part B of the
form. FDA estimates that it will take the persons in charge of
healthcare facility types, schools, and retail food stores 150 minutes
(2.5 hours), 120 minutes (2 hours), and 180 minutes (3 hours),
respectively, to accompany the data collectors while they complete
Sections 1 and 3 of the form. FDA estimates that it will take the
program director (or designated individual) of the respective
regulatory authority 30 minutes (0.5 hours) to answer the questions
related to Section 2 of the form. This burden estimate is unchanged
from the last data collection. Hence, the total burden estimate for a
data collection in healthcare facility types is 180 minutes (150 + 30)
(3 hours), in schools is 150 minutes (120 + 30) (2.5 hours), and retail
food stores is 210 minutes (180 + 30) (3.5 hours).
Based on the number of entry refusals from the 2015 to 2016
baseline data collection, we estimate a refusal rate of 2 percent for
the data collections within healthcare, school, and retail food store
facility types. The estimate of the time per non-respondent is 5
minutes (0.08 hours) for the person in charge to listen to the purpose
of the visit and provide a verbal refusal of entry.
FDA estimates the burden of this collection of information as
follows:
Table 2--Estimated Annual Reporting Burden \1\
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Number of Number of Total annual Number of non- responses per Total annual Total
Activity respondents responses per responses respondents non- non-responses Average burden per response hours
respondent respondent
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
2023-2024 Data Collection (Healthcare 400 1 400 .............. .............. .............. 2.5................................. 1,000
Facilities)--Completion of Sections 1 and 3.
2023-2024 Data Collection (Schools)--Completion 400 1 400 .............. .............. .............. 2................................... 800
of Sections 1 and 3.
2023-2024 Data Collection (Retail Food Stores)-- 400 1 400 .............. .............. .............. 3................................... 1,200
Completion of Sections 1 and 3.
2023-2024 Data Collection-Completion of Section 1,200 1 1,200 .............. .............. .............. 0.5 (30 minutes).................... 600
2--All Facility Types.
2023-2024 Data Collection-Entry Refusals--All .............. .............. .............. 24 1 24 0.08 (5 minutes).................... 1.92
Facility Types.
------------------------------------------------------------------------------------------------------------------------------------------------
Total...................................... .............. .............. .............. .............. .............. .............. .................................... 3,601.92
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\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. ``Report of the FDA Retail Food Program Database of Foodborne
Illness Risk
[[Page 42849]]
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 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 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 Food Code.'' Available at: <a href="https://www.fda.gov/food/retail-food-protection/fda-food-code">https://www.fda.gov/food/retail-food-protection/fda-food-code</a>.
Dated: July 28, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16700 Filed 8-4-21; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on August 5, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.