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, 35367-35370 [2015-15077]
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Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 / Notices
II. Paperwork Reduction Act of 1995
This guidance contains information
collection provisions that are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collection of information
requested in the guidance is covered
under FDA regulations at 21 CFR part
314 and approved under OMB control
number 0910–0001.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: June 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–15076 Filed 6–18–15; 8:45 am]
BILLING CODE 4164–01–P
35367
Food and Drug Administration
Survey on the Occurrence of Foodborne
Illness Risk Factors in Selected
Institutional Foodservice and Retail
Food Stores Facility Types (2015–2025)
[Docket No. FDA–2014–N–2033]
(OMB Control Number 0910-NEW)
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
I. Background
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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: Fax written comments on the
collection of information by July 20,
2015.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title Survey on the Occurrence of
Foodborne Illness Risk Factors in
Selected Institutional Foodservice and
Retail Food Stores Facility Types. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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.
SUMMARY:
From 1998–2008, 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 (1998, 2003, and
2008) (Refs. 1–3). 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 is proposing to collect data in
select institutional foodservice 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 and
2023–2024.
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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:
• 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.
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35368
Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 / Notices
TABLE 1—DESCRIPTION OF THE FACILITY TYPES INCLUDED IN THE SURVEY—Continued
Facility type
Description
Schools (K–12) ...............................
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Retail Food Stores ..........................
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.
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.
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 on-site 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:
• Meat and seafood department/operation—Areas in a retail food store where raw animal food products,
such as beef, pork, poultry, or seafood, are cut, prepared, stored, or displayed for sale to the consumer.
• 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 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 (42 U.S.C.
243, section 311(a)). Responsibility for
carrying out the provisions of the 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 foodborne illness risk
factors that are in most need of priority
attention during each data collection
period;
• Track trends in the occurrence of
foodborne illness risk factors over time;
• Examine potential correlations
between operational characteristics of
food establishments and the control of
foodborne illness risk factors;
• Examine potential correlations
between elements within regulatory
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retail food protection programs and the
control of foodborne illness risk factors;
and
• Evaluate the impact of industry
food safety management systems in
controlling the occurrence of foodborne
illness risk factors.
The methodology to be used for this
information collection is described as
follows. In order 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
will be used as the establishment
inventory for the data collections. FDA
will sample 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
will 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
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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 will be established
which are equal to the 150 mile radius
around a Specialist’s home location.
The sample will be 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 will be 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 will
be selected for each Specialist for cases
where the restaurant facility is
misclassified, closed, or otherwise
unavailable, unable, or unwilling to
participate.
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Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 / Notices
Prior to conducting the data
collection, Specialists will contact the
state or local jurisdiction that has
regulatory responsibility for conducting
retail food inspections for the selected
establishment. The Specialist will verify
with the jurisdiction that the facility has
been properly classified for the
purposes of the study and is still in
operation. The Specialist will also
ascertain 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 will be extended to the state
or local regulatory authority to
accompany the Specialist on the data
collection visit.
A standard form will be 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 will be obtained during an
interview with the establishment owner
or person in charge by the Specialist
and will include a standard set of
questions.
The information in section 2—
‘‘Regulatory Authority Information’’ will
be 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 being implemented by the
facility; and part C for assessing the
frequency and extent of food employee
hand washing. The information in part
A will be 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 will be 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
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developed and implemented food safety
management systems. The information
in part C will be collected by making
direct observations of food employee
hand washing. No questions will be
asked in the completion of section 3,
part C of the form.
FDA will collect 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, will also be
collected. Data will be consolidated and
reported in a manner that does not
reveal the identity of any establishment
included in the study.
FDA is working with the National
Center for Food Protection and Defense
to develop a Web-based platform in
FoodSHIELD to collect, store, and
analyze data for the Retail Risk Factor
Study. Once developed, this platform
will be accessible to state, local,
territorial, and tribal regulatory
jurisdictions to collect data relevant to
their own risk factor studies. FDA is
currently transitioning from the manual
entry of data to the use of hand-held
technology. Contingent upon the
completion of the Web-based platform,
FDA intends to pilot test the use of
hand-held technology during its 2015–
2016 risk factor study data collection in
institutional foodservice and retail food
store facility types, with the goal to have
it fully implemented by the next the
data collection in restaurant facility
types that will occur in 2017–2018.
When a data collector is assigned a
specific establishment, he or she will
conduct the data collection and enter
the information into the Web-based data
platform. The interface will support the
manual entering of data, as well as the
ability to upload a fillable PDF.
In the Federal Register of December
17, 2014 (79 FR 75158), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
The burden for this collection of
information is as follows. For each data
collection, the respondents will include:
(1) The person in charge of the selected
facility type (whether it be a healthcare
facility, school, or supermarket/grocery
store); and (2) the program director (or
designated individual) of the respective
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35369
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 three
facility types. Therefore, the total
number of responses will be 2,400 (400
data collections × 3 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. It includes the
time it will take the persons in charge
to accompany the data collectors during
the site visit and answer the data
collectors’ 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 will use the average
data collection duration for similar
facility types during FDA’s 2008 Risk
Factor Study (Ref. 3) plus an extra 30
minutes (0.5 hours) for the information
collection 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. The total burden estimate for a
data collection, including both the
program director’s and the person in
charge’s responses, in healthcare facility
types is 180 minutes (150 + 30) (3
hours), in schools is 150 minutes (120
+ 30) (2.5 hours), and in retail food
stores is 210 minutes (180 + 30) (3.5
hours).
Based on the number of entry refusals
from the 2013–2014 Risk Factor Study
in the restaurant facility types, we
estimate a refusal rate of 2 percent in the
institutional foodservice 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.
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Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 / Notices
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
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
....................
....................
....................
2.5
1,000
400
1
400
....................
....................
....................
2
800
400
1
400
....................
....................
....................
3
1,200
2015–2016 Data Collection (Healthcare Facilities)—Completion of Sections 1 and 3 .........
2015–2016 Data Collection (Schools)—Completion of Sections 1 and 3 ...........................
2015–2016 Data Collection (Retail Food
Stores)—Completion of Sections 1 and 3 .....
2015–2016 Data Collection-Completion of Section 2—All Facility Types ...............................
2017–2018 Data Collection-Entry Refusals—
All Facility Types ...........................................
1,200
1
1,200
....................
....................
....................
0.5
600
....................
....................
....................
24
1
24
0.08
(5 minutes)
1.92
Total Hours ................................................
....................
....................
....................
....................
....................
....................
....................
3,601.92
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
II. References
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The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://regulations.gov.
1. ‘‘Report of the FDA Retail Food Program
Database of Foodborne Illness Risk Factors
(2000).’’ Available at: https://www.fda.gov/
downloads/Food/FoodSafety/
RetailFoodProtection/
FoodborneIllnessandRiskFactorReduction/
RetailFoodRiskFactorStudies/
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://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://www.fda.gov/downloads/
Food/FoodSafety/RetailFoodProtection/
FoodborneIllnessandRiskFactorReduction/
RetailFoodRiskFactorStudies/
UCM224682.pdf.
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://www.fda.gov/
downloads/Food/FoodSafety/
RetailFoodProtection/
FoodborneIllnessandRiskFactorReduction/
RetailFoodRiskFactorStudies/
UCM224152.pdf.
5. FDA Food Code. Available at: https://
www.fda.gov/FoodCode.
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Dated: June 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–15077 Filed 6–18–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0438]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Early Food Safety
Evaluation of New Non-Pesticidal
Proteins Produced by New Plant
Varieties Intended for Food Use
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies must publish a
notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection provisions of
FDA’s procedures for early food safety
evaluation of new non-pesticidal
proteins produced by new plant
varieties intended for food use,
including bioengineered food plants.
DATES: Submit either electronic or
written comments on the collection of
information by August 18, 2015.
ADDRESSES: Submit electronic
comments on the collection of
SUMMARY:
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information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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 extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, we are publishing this
notice of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, we invite
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of our functions, including whether the
information will have practical utility;
(2) the accuracy of our estimate of the
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 80, Number 118 (Friday, June 19, 2015)]
[Notices]
[Pages 35367-35370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15077]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-2033]
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, 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: Fax written comments on the collection of information by July
20, 2015.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-NEW and
title Survey on the Occurrence of Foodborne Illness Risk Factors in
Selected Institutional Foodservice and Retail Food Stores Facility
Types. Also include the FDA docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
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 (2015-
2025)
(OMB Control Number 0910-NEW)
I. Background
From 1998-2008, 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 (1998, 2003, and 2008) (Refs. 1-3). 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 is proposing to collect data in select
institutional foodservice 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 and 2023-2024.
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:
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.
[[Page 35368]]
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:
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 on-site 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:
Meat and seafood department/
operation--Areas in a retail food
store where raw animal food
products, such as beef, pork,
poultry, or seafood, are cut,
prepared, stored, or displayed for
sale to the consumer.
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 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 (42 U.S.C. 243, section 311(a)).
Responsibility for carrying out the provisions of the 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 foodborne illness risk factors that are in
most need of priority attention during each data collection period;
Track trends in the occurrence of foodborne illness risk
factors over time;
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
Evaluate the impact of industry food safety management
systems in controlling the occurrence of foodborne illness risk
factors.
The methodology to be used for this information collection is
described as follows. In order 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 will be used as the
establishment inventory for the data collections. FDA will sample
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 will 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 will be established which are equal to the 150 mile
radius around a Specialist's home location. The sample will be 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 will be 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 will be
selected for each Specialist for cases where the restaurant facility is
misclassified, closed, or otherwise unavailable, unable, or unwilling
to participate.
[[Page 35369]]
Prior to conducting the data collection, Specialists will contact
the state or local jurisdiction that has regulatory responsibility for
conducting retail food inspections for the selected establishment. The
Specialist will verify with the jurisdiction that the facility has been
properly classified for the purposes of the study and is still in
operation. The Specialist will also ascertain 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 will be extended to the state
or local regulatory authority to accompany the Specialist on the data
collection visit.
A standard form will be 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 will be obtained during an
interview with the establishment owner or person in charge by the
Specialist and will include a standard set of questions.
The information in section 2--``Regulatory Authority Information''
will be 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 being implemented by the
facility; and part C for assessing the frequency and extent of food
employee hand washing. The information in part A will be 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 will be 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 will be collected by making direct
observations of food employee hand washing. No questions will be asked
in the completion of section 3, part C of the form.
FDA will collect 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, will also be collected. Data will be consolidated
and reported in a manner that does not reveal the identity of any
establishment included in the study.
FDA is working with the National Center for Food Protection and
Defense to develop a Web-based platform in FoodSHIELD to collect,
store, and analyze data for the Retail Risk Factor Study. Once
developed, this platform will be accessible to state, local,
territorial, and tribal regulatory jurisdictions to collect data
relevant to their own risk factor studies. FDA is currently
transitioning from the manual entry of data to the use of hand-held
technology. Contingent upon the completion of the Web-based platform,
FDA intends to pilot test the use of hand-held technology during its
2015-2016 risk factor study data collection in institutional
foodservice and retail food store facility types, with the goal to have
it fully implemented by the next the data collection in restaurant
facility types that will occur in 2017-2018. When a data collector is
assigned a specific establishment, he or she will conduct the data
collection and enter the information into the Web-based data platform.
The interface will support the manual entering of data, as well as the
ability to upload a fillable PDF.
In the Federal Register of December 17, 2014 (79 FR 75158), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
The burden for this collection of information is as follows. For
each data collection, the respondents will include: (1) The person in
charge of the selected facility type (whether it be a healthcare
facility, school, or supermarket/grocery store); 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 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 persons in charge to
accompany the data collectors during the site visit and answer the data
collectors' 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 will use
the average data collection duration for similar facility types during
FDA's 2008 Risk Factor Study (Ref. 3) plus an extra 30 minutes (0.5
hours) for the information collection 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. The total burden estimate for a data
collection, including both the program director's and the person in
charge's responses, in healthcare facility types is 180 minutes (150 +
30) (3 hours), in schools is 150 minutes (120 + 30) (2.5 hours), and in
retail food stores is 210 minutes (180 + 30) (3.5 hours).
Based on the number of entry refusals from the 2013-2014 Risk
Factor Study in the restaurant facility types, we estimate a refusal
rate of 2 percent in the institutional foodservice 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.
[[Page 35370]]
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
2015-2016 Data Collection (Healthcare 400 1 400 ........... ........... ........... 2.5 1,000
Facilities)--Completion of Sections 1 and 3....
2015-2016 Data Collection (Schools)--Completion 400 1 400 ........... ........... ........... 2 800
of Sections 1 and 3............................
2015-2016 Data Collection (Retail Food Stores)-- 400 1 400 ........... ........... ........... 3 1,200
Completion of Sections 1 and 3.................
2015-2016 Data Collection-Completion of Section 1,200 1 1,200 ........... ........... ........... 0.5 600
2--All Facility Types..........................
2017-2018 Data Collection-Entry Refusals--All ........... ........... ........... 24 1 24 0.08 1.92
Facility Types................................. (5 minutes)
-------------------------------------------------------------------------------------------------------
Total Hours................................. ........... ........... ........... ........... ........... ........... ........... 3,601.92
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
II. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at https://regulations.gov.
1. ``Report of the FDA Retail Food Program Database of Foodborne
Illness Risk Factors (2000).'' Available at: https://www.fda.gov/downloads/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/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://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://www.fda.gov/downloads/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/UCM224682.pdf.
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://www.fda.gov/downloads/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/UCM224152.pdf.
5. FDA Food Code. Available at: https://www.fda.gov/FoodCode.
Dated: June 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15077 Filed 6-18-15; 8:45 am]
BILLING CODE 4164-01-P
