[Federal Register Volume 83, Number 146 (Monday, July 30, 2018)]
[Notices]
[Pages 36594-36598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16189]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 Retail and 
Foodservice Facility Types

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 August 
29, 2018.

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 [email protected]. All 
comments should be identified with the OMB control number 0910-0744. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

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 
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 to 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 to 2018 and another data collection planned for 2021 
to 2022 (the subject of this information collection request extension).

[[Page 36595]]



    Table 1--Description of the Facility Types Included in the Survey
------------------------------------------------------------------------
        Facility type                         Description
------------------------------------------------------------------------
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 (FD&C 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 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

[[Page 36596]]

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 followup questions of facility 
management to obtain information on the extent to which the food 
establishment has developed and implemented food safety management 
systems. The information in Part C is collected by making direct 
observations of food employee hand washing. No questions are asked in 
the completion of Section 3, Part C of the form.
    FDA collects the following information associated with the 
establishment's identity: Establishment name, street address, city, 
state, zip code, county, industry segment, and facility type. The 
establishment identifying information is collected to ensure the data 
collections are not duplicative. Other information related to the 
nature of the operation, such as seating capacity and number of 
employees per shift, is also collected. Data will be consolidated and 
reported in a manner that does not reveal the identity of any 
establishment included in the study.
    FDA has collaborated with the Food Protection and Defense Institute 
to develop a web-based platform in FoodSHIELD to collect, store, and 
analyze data for the Retail Risk Factor Study. This platform is 
accessible to State, local, territorial, and tribal regulatory 
jurisdictions to collect data relevant to their own risk factor 
studies. For the 2015 to 2016 data collection, FDA piloted the use of 
hand-held technology for capturing the data onsite during the data 
collection visits. The tablets that were made available for the data 
collections were part of a broader 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 to 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.
    In the Federal Register of February 7, 2018 (83 FR 5433), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received two comments.
    (Comment 1) We received comments related to FDA's authority for 
collaboration with State and local governments regarding food safety at 
the retail level.
    (Response 1) The statutory basis for FDA conducting this survey is 
the PHS Act, which requires that FDA provide assistance to State and 
local governments relative to the prevention and suppression of 
communicable diseases. 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 FD&C 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.
    (Comment 2) The Academy of Nutrition and Dietetics (the Academy) 
commented that they support the proposed information collection for the 
survey on the occurrence of foodborne illness risk factors in various 
settings. The Academy provided comments pertaining to the following 
general areas of the study:
    a. Question as to whether 90 minutes is adequate for surveying 
larger facilities.
    b. Request FDA evaluate the impact of conducting surveys during 
non-peak hours of operation.
    c. Suggest that the use of gloves is not adequately addressed in 
the survey.
    d. Recommend adding a food allergy component.
    e. Encourage continued efforts to simplify and standardize 
expiration dates.
    Related to foodservice operations at the retail level, the Academy 
provided the following comments:
    a. Suggest that FDA consider conducting the survey by using local 
inspectors who already inspect facilities for other purposes.
    b. Suggest that educational efforts should be culturally guided, 
provided in multiple languages, and include photos or illustrations to 
facilitate remediation.
    c. FDA consider modifying the survey to account for new foods and 
new means of conveying food.
    (Response 2) FDA thanks the submitter for their comments and 
appreciates their support. Regarding general areas of the study, FDA 
provides the following responses:
    a. The current 10-year study estimates 90 minutes as the average 
time needed to adequately collect necessary information, taking into 
account both small and large facilities. This average time is 
consistent with the amount of time burden estimated for the previous 
data collection periods and provides a sufficient timeframe to observe 
food safety practices and procedures that are the focus of the study.
    b. Based on the methodology of the study, the information 
collection is performed during hours of operation of the randomly 
selected facility. Data collections are scheduled at times that provide 
the best opportunity to observe food preparation activities.

[[Page 36597]]

    c. Information collection related to handwashing and no bare hand 
contact with ready to eat foods, which may include use of gloves, is 
based on assessment of observations against the most current addition 
of the FDA Model Food Code. Provisions of the FDA Food Code identify 
when handwashing and no bare hand contact with ready to eat food are 
required during food preparation and service. The current FDA Food Code 
does not recognize the use of hand antiseptics in lieu of handwashing 
during food preparation and service.
    d. The study is collecting information regarding the knowledge of 
the person in charge related to food allergens and training of food 
service employees on allergy awareness as it relates to their assigned 
duties in their facility.
    e. The scope of this data collection focuses on foodborne illness 
risk factors and does not include assessment of expiration dates of 
manufactured foods as part of this research assessment.
    Related to foodservice operations at the retail level, FDA provides 
the following responses:
    a. This type of research requires a standardized design and 
methodology to ensure that the occurrences of the foodborne illness 
risk factors are uniformly assessed. Retail Food Specialists are 
standardized by Center for Food Safety and Applied Nutrition and have a 
strong working knowledge of retail food industry. State and local 
regulators are encouraged to accompany the data collectors during the 
data collection.
    b. The research from this study facilitates the development of 
culturally guided, multi-language education outreach materials that can 
be shared with regulatory and industry partners.
    c. The study design accounts for a variety of food conveyances in 
the retail food setting. The study includes four major segments of the 
retail and foodservice industries that account for over a million 
varied and diverse types of operations in the United States:

 Restaurants
 Healthcare Facilities
 Schools (K-12)
 Retail Food Stores

    To calculate the estimate of the hours per response, FDA will use 
the average data collection duration for the same facility types during 
the 2013 to 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 to 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 to 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    responses      Total      Number of    responses      Total        Average burden per
              Activity               respondents      per         annual        non-       per non-   annual non-          response          Total hours
                                                   respondent   responses   respondents   respondent   responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
2021-2022 Data Collection (Fast              400            1          400  ...........  ...........  ...........  1.36....................          544
 Food Restaurants)--Completion of
 Sections 1 and 3.
2021-2022 Data Collection (Full              400            1          400  ...........  ...........  ...........  1.73....................          692
 Service Restaurants)--Completion
 of Sections 1 and 3.
2021-2022 Data Collection-                   800            1          800  ...........  ...........  ...........  0.5 (30 minutes)........          400
 Completion of Section 2--All
 Facility Types.
2021-2022 Data Collection-Entry      ...........  ...........  ...........           16            1           16  0.08 (5 minutes)........         1.28
 Refusals--All Facility Types.
                                    --------------------------------------------------------------------------------------------------------------------
    Total Hours....................  ...........  ...........  ...........  ...........  ...........  ...........  ........................     1,637.28
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 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/

[[Page 36598]]

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: July 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16189 Filed 7-27-18; 8:45 am]
 BILLING CODE 4164-01-P