[Federal Register Volume 79, Number 242 (Wednesday, December 17, 2014)]
[Notices]
[Pages 75158-75161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29478]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2033]


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) 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 are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on a survey entitled ``Survey on the 
Occurrence of Foodborne Illness Risk Factors in Selected Institutional 
Foodservice and Retail Food Stores Facility Types (2015-2025).''

DATES: Submit either electronic or written comments on the collection 
of information by February 17, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://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, [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 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 (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,

[[Page 75159]]

     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
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        Facility type                         Description
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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.
                               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

[[Page 75160]]

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.
    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.
    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

[[Page 75161]]

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.

                                                     Table 2--Estimated Annual Reporting Burden \1\
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                                                              Number of                              Number of
                                                 Number of    responses      Total      Number of    responses      Total        Average
                   Activity                     respondents      per         annual        non-       per non-   annual non-   burden per    Total hours
                                                              respondent   responses   respondents   respondent   responses     response
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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                  400            1          400  ...........  ...........  ...........          3         1,200
 Stores)_Completion of Sections 1 and 3.......
2015-2016 Data Collection-Completion of               1,200            1        1,200  ...........  ...........  ...........          0.5         600
 Section 2_All Facility Types.................
2017-2018 Data Collection-Entry Refusals_All    ...........  ...........  ...........           24            1           24      \2\ 0.08          1.92
 Facility Types...............................
                                               ---------------------------------------------------------------------------------------------------------
    Total Hours...............................  ...........  ...........  ...........  ...........  ...........  ...........  ............      3,601.92
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ (5 minutes.)

II. References

    The following reference has 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 http://regulations.gov.

1. ``Report of the FDA Retail Food Program Database of Foodborne 
Illness Risk Factors (2000).'' Available at: http://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: http://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: http://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: http://www.fda.gov/downloads/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/UCM224152.pdf.
5. FDA Food Code. Available at: http://www.fda.gov/FoodCode.

    Dated: December 8, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29478 Filed 12-16-14; 8:45 am]
BILLING CODE 4164-01-P