[Federal Register Volume 83, Number 26 (Wednesday, February 7, 2018)]
[Notices]
[Pages 5441-5445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02413]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0270]
Agency Information Collection Activities; Proposed Collection;
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, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed reinstatement of an existing collection of information,
and to allow 60 days for public comment in response to the notice. This
notice solicits comments on the ``Survey on the Occurrence of Foodborne
Illness Risk Factors in Selected Institutional Foodservice and Retail
Food Stores Facility Types.''
DATES: Submit either electronic or written comments on the collection
of information by April 9, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 9, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 9, 2018. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any
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confidential information that you or a third party may not wish to be
posted, such as medical information, your or anyone else's Social
Security number, or confidential business information, such as a
manufacturing process. Please note that if you include your name,
contact information, or other information that identifies you in the
body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-N-0270 for ``Survey on the Occurrence of Foodborne Illness
Risk Factors in Selected Institutional Foodservice and Retail Food
Stores Facility Types.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
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: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed reinstatement of an existing collection of information
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Survey on the Occurrence of Foodborne Illness Risk Factors in Selected
Institutional Foodservice and Retail Food Stores Facility Types
OMB Control Number 0910-0799--Reinstatement
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) 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 (1998, 2003, and 2008) (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 additional data collections planned for
2017-2018 and 2021-2022.
FDA recently completed the baseline data collection in select
health care, school, and retail food store facility types in 2015-2016.
This proposed study will also span 10 years with additional data
collections planned for 2019-2020 (the subject of this information
collection request reinstatement) and 2023-2024 (which
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will be posted in the Federal Register at the next renewal).
Table 1--Description of the Facility Types Included in the Survey
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Facility type Description
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Health Care Facilities....... Hospitals and long-term care facilities
foodservice operations that prepare
meals for highly susceptible populations
as defined as follows:
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).
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,
health care facilities that do not
prepare or serve food to a highly
susceptible population, such as mental
health care 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:
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:
Salad bars, pizza stations, and
other food bars managed by the deli
department manager.
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:
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.
Produce department/operation--
Areas in a retail food store where
produce is cut, prepared, stored, or
displayed for sale to the consumer. A
produce operation may include salad bars
or juice stations that are managed by
the produce manager.
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The purpose of the study is to:
Assist FDA with developing retail food safety initiatives
and policies focused on the control of foodborne illness risk factors;
Identify retail food safety work plan priorities and
allocate resources to enhance retail food safety nationwide;
Track changes in the occurrence of foodborne illness risk
factors in retail and foodservice establishments over time; and
Inform recommendations to the retail and foodservice
industry and State, local, tribal, and territorial regulatory
professionals on reducing the occurrence of foodborne illness risk
factors.
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 the study are to:
Identify the least and most often occurring foodborne
illness risk factors and food safety behaviors/practices in health
care, school, restaurant, and retail food store facility types during
each data collection period;
Track improvement and/or regression trends in the
occurrence of foodborne illness risk factors during the 10-year study
period;
Examine potential correlations between operational
characteristics of food establishments and the control of foodborne
illness risk factors;
Examine potential correlations between elements within
regulatory retail food protection programs and the control of foodborne
illness risk factors; and
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.
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 25 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 150-mile
radius
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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 150-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 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 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 follow up questions of facility
management to obtain information on the extent to which the food
establishment has developed and implemented food safety management
systems. The information in Part C is collected by making direct
observations of food employee 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 2015-2016 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. FDA continues to
assess the feasibility for fully 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 2019-2020 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 health care 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. It 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. It includes the
time it will take to answer the data collectors' questions and is the
same regardless of the facility type.
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 health
care 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
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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 health care 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 2015-2016 baseline
data collection, we estimate a refusal rate of 2 percent for the data
collections within health care, school, and retail food store facility
types. The estimate of the time per non-respondent is 5 minutes (0.08
hours) for the person in charge to listen to the purpose of the visit
and provide a verbal refusal of entry.
FDA estimates the burden of this collection of information as
follows:
Table 2--Estimated Annual Reporting Burden 1
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Number of Number of
Number of responses Total Number of responses Total Average burden per Total
Activity respondents per annual non- per non- annual non- response hours
respondent responses respondents respondent responses
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2019-2020 Data Collection (Health 400 1 400 ........... ........... ........... 2.5....................... 1,000
Care Facilities)--Completion of
Sections 1 and 3.
2019-2020 Data Collection 400 1 400 ........... ........... ........... 2......................... 800
(Schools)--Completion of Sections
1 and 3.
2019-2020 Data Collection (Retail 400 1 400 ........... ........... ........... 3......................... 1,200
Food Stores)--Completion of
Sections 1 and 3.
2019-2020 Data Collection- 1,200 1 1,200 ........... ........... ........... .5 (30 minutes)........... 600
Completion of Section 2--All
Facility Types.
2019-2020 Data Collection-Entry ........... ........... ........... 24 1 24 .08 (5 minutes)........... 1.92
Refusals--All Facility Types.
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Total.......................... ........... ........... ........... ........... ........... ........... .......................... 3,601.92
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1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The burden for this information collection has not changed since
the last OMB approval.
II. References
The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.
1. ``Report of the FDA Retail Food Program Database of Foodborne
Illness Risk Factors'' (2000). Available at: https://wayback.archive-it.org/7993/20170406023019/https://www.fda.gov/downloads/Food/GuidanceRegulation/UCM123546.pdf.
2. ``FDA Report on the Occurrence of Foodborne Illness Risk Factors
in Selected Institutional Foodservice, Restaurant, and Retail Food
Store Facility Types'' (2004). Available at: https://wayback.archive-it.org/7993/20170406023011/https://www.fda.gov/downloads/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/UCM423850.pdf.
3. ``FDA Report on the Occurrence of Foodborne Illness Risk Factors
in Selected Institutional Foodservice, Restaurant, and Retail Food
Store Facility Types'' (2009). Available at: https://wayback.archive-it.org/7993/20170406023004/https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/ucm224321.htm.
4. FDA National Retail Food Team. ``FDA Trend Analysis Report on the
Occurrence of Foodborne Illness Risk Factors in Selected
Institutional Foodservice, Restaurant, and Retail Food Store
Facility Types (1998-2008).'' Available at: https://wayback.archive-it.org/7993/20170406022950/https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/ucm223293.htm.
5. ``FDA Food Code.'' Available at: https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/default.htm.
Dated: January 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02413 Filed 2-6-18; 8:45 am]
BILLING CODE 4164-01-P