[Federal Register Volume 83, Number 26 (Wednesday, February 7, 2018)]
[Notices]
[Pages 5433-5436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02414]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Survey on the Occurrence of Foodborne Illness Risk 
Factors in Selected Retail and Foodservice Facility Types

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA 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 extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on ``Survey on the Occurrence of Foodborne 
Illness Risk Factors in Selected Retail and Foodservice 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 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-2012-N-0547 for ``Survey on the Occurrence of Foodborne Illness 
Risk Factors in Selected Retail and Foodservice 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

[[Page 5434]]

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, 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 
Retail and Foodservice Facility Types

OMB Control Number 0910-0744--Extension

I. Background

    From 1998 to 2008, FDA's National Retail Food Team conducted a 
study to measure trends in the occurrence of foodborne illness risk 
factors, preparation practices, and employee behaviors most commonly 
reported to the Centers for Disease Control and Prevention as 
contributing factors to foodborne illness outbreaks at the retail 
level. Specifically, data was collected by FDA Specialists in retail 
and foodservice establishments at 5-year intervals (1998, 2003, and 
2008) 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 a data collection currently being 
conducted in 2017-2018 and another data collection planned for 2021-
2022 (the subject of this information collection request extension).

    Table 1--Description of the Facility Types Included in the Survey
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           Facility type                         Description
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Full Service Restaurants..........  A restaurant where customers place
                                     their order at their table, are
                                     served their meal at the table,
                                     receive the service of the wait
                                     staff, and pay at the end of the
                                     meal.
Fast Food Restaurants.............  A restaurant that is not a full
                                     service restaurant. This includes
                                     restaurants commonly referred to as
                                     quick service restaurants and fast
                                     casual restaurants.
------------------------------------------------------------------------

    The 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 retail and 
foodservice 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 Retail Food Specialists (Specialists) who 
serve as the data collectors for the 10-year study. The Specialists are 
geographically dispersed throughout the

[[Page 5435]]

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 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 restaurant facility is 
misclassified, closed, or otherwise unavailable, unable, or unwilling 
to participate.
    Prior to conducting the data collection, Specialists contact the 
State or local jurisdiction that has regulatory responsibility for 
conducting retail food inspections for the selected establishment. The 
Specialist verifies with the jurisdiction that the facility has been 
properly classified for the purposes of the study and is still in 
operation. The Specialist ascertains whether the selected facility is 
under legal notice from the State or local regulatory authority. If the 
selected facility is under legal notice, the Specialist will not 
conduct a data collection, and a substitute establishment will be used. 
An invitation is extended to the State or local regulatory authority to 
accompany the Specialist on the data collection visit.
    A standard form is used by the Specialists during each data 
collection. The form is divided into three sections: Section 1--
``Establishment Information''; Section 2--``Regulatory Authority 
Information''; and Section 3--``Foodborne Illness Risk Factor and Food 
Safety Management System Assessment.'' The information in Section 1--
``Establishment Information'' of the form is obtained during an 
interview with the establishment owner or person in charge by the 
Specialist and includes a standard set of questions.
    The information in Section 2--``Regulatory Authority Information'' 
is obtained during an interview with the program director of the State 
or local jurisdiction that has regulatory responsibility for conducting 
inspections for the selected establishment. Section 3 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 2021-2022 data collection is as follows. For 
each data collection, the respondents will include: (1) The person in 
charge of the selected facility (whether it be a fast food or full 
service restaurant) and (2) the program director (or designated 
individual) of the respective regulatory authority. To provide the 
sufficient number of observations needed to conduct a statistically 
significant analysis of the data, FDA has determined that 400 data 
collections will be required in each of the two restaurant facility 
types. Therefore, the total number of responses will be 1,600 (400 data 
collections x 2 facility types x 2 respondents per data collection).
    The burden associated with the completion of Sections 1 and 3 of 
the form is specific to the persons in charge of the selected 
facilities. 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 will use 
the average

[[Page 5436]]

data collection duration for the same facility types during the 2013-
2014 data collection. FDA estimates that it will take the persons in 
charge of full service restaurants and fast food restaurants 104 
minutes (1.73 hours) and 82 minutes (1.36 hours), respectively, to 
accompany the data collectors while they complete Sections 1 and 3 of 
the form. In comparison, for the 2013-2014 data collection, the burden 
estimate was 106 minutes (1.76 hours) in full service restaurants and 
73 minutes (1.21 hours) in fast food restaurants. FDA estimates that it 
will take the program director (or designated individual) of the 
respective regulatory authority 30 minutes (0.5 hours) to answer the 
questions related to Section 2 of the form. This burden estimate is 
unchanged from the last data collection. Hence, the total burden 
estimate for a data collection in a full service restaurant, including 
the responses of both the program director and the person in charge, is 
134 minutes (104 + 30) (2.23 hours). The total burden estimate for a 
data collection in a fast food restaurant, including the responses of 
both the program director and the person in charge, is 112 minutes (82 
+ 30) (1.86 hours).
    Based on the number of entry refusals from the 2013-2014 baseline 
data collection, we estimate a refusal rate of 2 percent for the data 
collections within restaurant facility types. The estimate of the time 
per non-respondent is 5 minutes (0.08 hours) for the person in charge 
to listen to the purpose of the visit and provide a verbal refusal of 
entry.
    FDA estimates the burden of this collection of information as 
follows:

                                                                         Table 2--Estimated Annual Reporting Burden \1\
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                               Number of
                                               Number of       Number of     Total  annual  Number of  non- responses  per   Total  annual
                 Activity                     respondents   responses  per     responses      respondents        non-       non- responses      Average  burden per  response       Total hours
                                                               respondent                                     respondent
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
2021-2022 Data Collection (Fast Food                   400               1             400  ..............  ..............  ..............  1.36................................             544
 Restaurants)--Completion of Sections 1
 and 3.
2021-2022 Data Collection (Full Service                400               1             400  ..............  ..............  ..............  1.73................................             692
 Restaurants)--Completion of Sections 1
 and 3.
2021-2022 Data Collection-Completion of                800               1             800  ..............  ..............  ..............  0.5 (30 minutes)....................             400
 Section 2--All Facility Types.
2021-2022 Data Collection-Entry Refusals--               -               -               -              16               1              16  0.08 (5 minutes)....................            1.28
 All Facility Types.
                                           -----------------------------------------------------------------------------------------------------------------------------------------------------
Total Hours...............................  ..............  ..............  ..............  ..............  ..............  ..............  ....................................        1,637.28
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    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/FoodCode.


    Dated: January 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02414 Filed 2-6-18; 8:45 am]
 BILLING CODE 4164-01-P


