[Federal Register Volume 83, Number 150 (Friday, August 3, 2018)]
[Notices]
[Pages 38153-38157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16648]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0270]


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.

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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 
September 4, 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 <a href="/cdn-cgi/l/email-protection#5b3432293a04282e39363228283234351b343639753e342b753c342d"><span class="__cf_email__" data-cfemail="d3bcbaa1b28ca0a6b1bebaa0a0babcbd93bcbeb1fdb6bca3fdb4bca5">[email protected]</span></a>. All 
comments should be identified with the OMB control number 0910-0799. 
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, 
<a href="/cdn-cgi/l/email-protection#8ededccfddfaefe8e8cee8eaefa0e6e6fda0e9e1f8"><span class="__cf_email__" data-cfemail="bceceefdefc8dddadafcdad8dd92d4d4cf92dbd3ca">[email protected]</span></a>.

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

OMB Control Number 0910-0799--Reinstatement

I. Background

    From 1998 to 2008, FDA's National Retail Food Team conducted a 
study to measure trends in the occurrence of foodborne illness risk 
factors, preparation practices, and employee behaviors most commonly 
reported to the Centers for Disease Control and Prevention as 
contributing factors to foodborne illness outbreaks at the retail 
level. Specifically, data was collected by FDA specialists in retail 
and foodservice establishments at 5-year intervals (1998, 2003, and 
2008) to observe and document trends in the occurrence of the following 
foodborne illness risk factors:
    <bullet> Food from Unsafe Sources,
    <bullet> Poor Personal Hygiene,
    <bullet> Inadequate Cooking,
    <bullet> Improper Holding/Time and Temperature, and
    <bullet> 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 additional data collections planned for 
2017 to 2018 and 2021 to 2022.
    FDA recently completed the baseline data collection in select 
healthcare, school, and retail food store facility types in 2015 to 
2016. This proposed study will also span 10 years with additional data 
collections planned for 2019 to 2020 (the subject of this information 
collection request reinstatement) and 2023 to 2024 (which will be 
posted in the Federal Register at the next renewal).

    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:
                               <bullet> 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).
                               <bullet> 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:
                                  <bullet> Deli department/operation--
                                   Areas in a retail food store where
                                   foods, such as luncheon meats and
                                   cheeses, are sliced for the customers
                                   and where sandwiches and salads are
                                   prepared onsite or received from a
                                   commissary in bulk containers,
                                   portioned, and displayed. Parts of
                                   deli operations may include:
                                    <bullet> Salad bars, pizza stations,
                                     and other food bars managed by the
                                     deli department manager.
                                    <bullet> 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:

[[Page 38154]]

 
                                  <bullet> Seafood department/operation--
                                   Areas in a retail food store where
                                   seafood is cut, prepared, stored, or
                                   displayed for sale to the consumer.
                                   In retail food stores where the
                                   seafood department is combined with
                                   another department (e.g. meat), the
                                   data collector will only assess the
                                   procedures and practices associated
                                   with the processing of seafood.
                                  <bullet> 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:
    <bullet> Assist FDA with developing retail food safety initiatives 
and policies focused on the control of foodborne illness risk factors;
    <bullet> Identify retail food safety work plan priorities and 
allocate resources to enhance retail food safety nationwide;
    <bullet> Track changes in the occurrence of foodborne illness risk 
factors in retail and foodservice establishments over time; and
    <bullet> 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:
    <bullet> Identify the least and most often occurring foodborne 
illness risk factors and food safety behaviors/practices in healthcare, 
school, restaurant, and retail food store facility types during each 
data collection period;
    <bullet> Track improvement and/or regression trends in the 
occurrence of foodborne illness risk factors during the 10-year study 
period;
    <bullet> Examine potential correlations between operational 
characteristics of food establishments and the control of foodborne 
illness risk factors;
    <bullet> Examine potential correlations between elements within 
regulatory retail food protection programs and the control of foodborne 
illness risk factors; and
    <bullet> Determine the extent to which food safety management 
systems and the presence of a certified food protection manager impact 
the occurrence of foodborne illness risk factors.
    The methodology to be used for this information collection is 
described as follows. To obtain a sufficient number of observations to 
conduct statistically significant analysis, FDA will conduct 
approximately 400 data collections in each facility type. This sample 
size has been calculated to provide for sufficient observations to be 
95 percent confident that the compliance percentage is within 5 percent 
of the true compliance percentage.
    A geographical information system database containing a listing of 
businesses throughout the United States provides the establishment 
inventory for the data collections. FDA samples establishments from the 
inventory based on the descriptions in table 1. FDA does not intend to 
sample operations that handle only prepackaged food items or conduct 
low-risk food preparation activities. The ``FDA Food Code'' contains a 
grouping of establishments by risk, based on the type of food 
preparation that is normally conducted within the operation (Ref. 5). 
The intent is to sample establishments that fall under risk categories 
2 through 4.
    FDA has approximately 25 Regional Retail Food Specialists 
(Specialists) who serve as the data collectors for the 10-year study. 
The Specialists are geographically dispersed throughout the United 
States and possess technical expertise in retail food safety and a 
solid understanding of the operations within each of the facility types 
to be surveyed. The Specialists are also standardized by FDA's Center 
for Food Safety and Applied Nutrition personnel in the application and 
interpretation of the FDA Food Code (Ref. 5).
    Sampling zones have been established that are equal to the 150-mile 
radius around a Specialist's home location. The sample is selected 
randomly from among all eligible establishments located within these 
sampling zones. The Specialists are generally located in major 
metropolitan areas (i.e., population centers) across the contiguous 
United States. Population centers usually contain a large concentration 
of the establishments FDA intends to sample. Sampling from the 150-mile 
radius sampling zones around the Specialists' home locations provides 
three advantages to the study:
    1. It provides a cross-section of urban and rural areas from which 
to sample the eligible establishments.
    2. It represents a mix of small, medium, and large regulatory 
entities having jurisdiction over the eligible establishments.
    3. It reduces overnight travel and therefore reduces travel costs 
incurred by the Agency to collect data.
    The sample for each data collection period is evenly distributed 
among Specialists. Given that participation in the study by industry is 
voluntary and the status of any given randomly selected establishment 
is subject to change, substitute establishments have been selected for 
each Specialist for cases where the institutional foodservice, school, 
or retail food store facility is misclassified, closed, or otherwise 
unavailable, unable, or unwilling to participate.
    Prior to conducting the data collection, Specialists contact the 
State or local jurisdiction that has regulatory responsibility for 
conducting retail food inspections for the selected establishment. The 
Specialist verifies with the jurisdiction that the facility has been 
properly classified for the purposes of the study and is still in 
operation. The Specialist ascertains whether the selected facility is 
under legal notice from the State or local regulatory authority. If the 
selected facility is under legal notice, the Specialist will not 
conduct a data collection, and a substitute establishment will be used. 
An invitation is extended to the State or local regulatory authority to 
accompany the Specialist on the data collection visit.
    A standard form is used by the Specialists during each data 
collection. The form is divided into three sections: Section 1--
``Establishment Information''; Section 2--``Regulatory Authority 
Information''; and Section 3--``Foodborne Illness Risk Factor and

[[Page 38155]]

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 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\1\ 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.
---------------------------------------------------------------------------

    \1\ https://foodprotection.umn.edu/.
---------------------------------------------------------------------------

    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.
    In the Federal Register of February 7, 2018 (83 FR 5441), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received two comments.
    (Comment 1) National Association of County and City Health 
Officials (NACCHO) provided comments related to the following areas:
    a. Supports FDA's efforts to reduce the occurrence of foodborne 
illness through the proposed study and activities on retail food 
safety.
    b. Recommends that Assisted Living Facilities should be included in 
the facility types surveyed in the study.
    c. Recommends that FDA interview food handlers at retail food 
facilities.
    d. Strongly urges FDA to use weighted random sampling to select 
retail food facilities for the study and consider more factors for 
establishing sampling zones.
    e. Recommends that FDA work with State and local health departments 
to obtain data needed.
    (Response 1) FDA provides the following responses to the comments 
provided by NACCHO:
    a. FDA thanks the submitter for supporting FDA's efforts to reduce 
the occurrence of foodborne illness through the proposed study and 
activities on retail food safety.
    b. The information collection identifies assisted living facilities 
within the Long-Term Care category. The study protocol defines Long-
Term Care Facilities as foodservice operations that prepare meals for 
residents in a group care living setting such as nursing homes and 
assisted living centers.
    c. The study data collection protocol combines direct observations 
of procedures and practices and interaction with both the Person In 
Charge and front line food employees.
    d. Sampling zones for this information collection contain 
approximately 59 percent of all healthcare establishments, 59 percent 
of all school establishments, and 61 percent of all retail food store 
establishments in the contiguous United States. The sample size of the 
information collections provides sufficient observations to be 95 
percent confident that compliance percentages derived from the data 
collections are within 5 percent of their actual occurrence.
    e. 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 the 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.
    (Comment 2) Academy of Nutrition and Dietetics commented that they 
support the proposed information collection for 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 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 institutional operations at the retail 
level, the Academy provided the following comments:
    a. Seeks clarification related to health systems as to whether FDA 
will focus on the central facilities in hospital food service due to 
their higher potential reach, impact, and risk.
    b. Seeks clarification whether the survey will be part of routine 
inspections or in addition to them and whether the information 
collections will be scheduled or unannounced.
    c. Seeks clarification on how FDA will analyze the information 
collected and which data points will be tied to

[[Page 38156]]

which outcomes. (Response 2) FDA thanks the submitter for their comment 
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.
    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 edition of 
the FDA Model Food Code. Provisions of the Food Code identify when 
handwashing and no bare hand contact with ready-to-eat food are 
required during food preparation and service. The current 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 
institutional operations at the retail level, FDA provides the 
following responses:
    a. The data collection protocol provides the definition of the 
hospital facility type that will be the focus of information 
collection. It is described as foodservice operations that provide 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).
    b. The data collections are unannounced and separate from any 
regulatory routine inspections. Industry's participation in the study 
is voluntary. This methodology allows for assessment of direct 
observations related to the foodborne illness risk factors during food 
preparation and service.
    c. The study is designed to investigate data points focused on the 
relationship between food safety management systems, certified food 
protection managers, and the occurrence of risk factors and food safety 
behaviors/practices commonly associated with foodborne illness in the 
randomly selected facility.
    Data items 1 through 10 are considered primary data items. Each of 
the primary data items has been placed under the appropriate FDA 
foodborne illness risk factor category that will be used as the key 
indicator for FDA's statistical analysis for the study:

<bullet> Risk Factor--Poor Personal Hygiene
    (1) Employees practice proper handwashing
    (2) Food Employees do not contact ready-to-eat foods with bare 
hands
<bullet> Contaminated Equipment/Protection from Contamination
    (3) Food is protected from cross-contamination during storage, 
preparation, and display
    (4) Food contact surfaces are properly cleaned and sanitized
<bullet> Improper Holding/Time and Temperature
    (5) Foods requiring refrigeration are held at the proper 
temperature
    (6) Foods displayed or stored hot are held at the proper 
temperature
    (7) Foods are cooled properly
    (8) Refrigerated, ready-to-eat foods are properly date marked and 
discarded within 7 days of preparation or opening
<bullet> Inadequate Cooking
    (9) Raw animal foods are cooked to required temperatures
    (10) Cooked foods are reheated to required temperatures

    The burden for the 2019 to 2020 data collection is as follows. For 
each data collection, the respondents will include: (1) The person in 
charge of the selected facility (whether it be a healthcare facility, 
school, or supermarket/grocery store) and (2) the program director (or 
designated individual) of the respective regulatory authority. To 
provide the sufficient number of observations needed to conduct a 
statistically significant analysis of the data, FDA has determined that 
400 data collections will be required in each of the three facility 
types. Therefore, the total number of responses will be 2,400 (400 data 
collections x 3 facility types x 2 respondents per data collection).
    The burden associated with the completion of Sections 1 and 3 of 
the form is specific to the persons in charge of the selected 
facilities. It includes the time it will take the person in charge to 
accompany the data collector during the site visit and answer the data 
collector's questions. The burden related to the completion of Section 
2 of the form is specific to the program directors (or designated 
individuals) of the respective regulatory authorities. It includes the 
time it will take to answer the data collectors' questions and is the 
same regardless of the facility type.
    To calculate the estimate of the hours per response, FDA uses the 
average data collection duration for similar facility types during the 
FDA's 2008 Risk Factor Study plus an additional 30 minutes (0.5 hour) 
for the information related to Section 2 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 
hour) 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 healthcare facility 
types is 180 minutes (150 + 30) (3 hours), in schools is 150 minutes 
(120 + 30) (2.5 hours), and retail food stores is 210 minutes (180 + 
30) (3.5 hours).
    Based on the number of entry refusals from the 2015 to 2016 
baseline data collection, we estimate a refusal rate of 2 percent for 
the data collections within healthcare, school, and retail food store 
facility types. The estimate of the time per non-respondent is 5 
minutes (0.08 hour) 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:

[[Page 38157]]



                                                     Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                              Number of       Total                         Number of
          Activity             Number of    responses per    annual     Number of  non-   responses per    Total  annual    Average  burden      Total
                              respondents    respondent     responses     respondents     non-respondent   non-responses     per  response       hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
2019-2020 Data Collection             400               1         400  ................  ...............  ..............  2.5...............       1,000
 (Healthcare Facilities)--
 Completion of Sections 1
 and 3.
2019-2020 Data Collection             400               1         400  ................  ...............  ..............  2.................         800
 (Schools)--Completion of
 Sections 1 and 3.
2019-2020 Data Collection             400               1         400  ................  ...............  ..............  3.................       1,200
 (Retail Food Stores)--
 Completion of Sections 1
 and 3.
2019-2020 Data Collection-          1,200               1       1,200  ................  ...............  ..............  0.5 (30 minutes)..         600
 Completion of Section 2--
 All Facility Types.
2019-2020 Data Collection-    ...........  ..............  ..........                24                1              24  0.08 (5 minutes)..        1.92
 Entry Refusals--All
 Facility Types.
                             ---------------------------------------------------------------------------------------------------------------------------
    Total...................  ...........  ..............  ..........  ................  ...............  ..............  ..................    3,601.92
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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/FoodborneIllnessRiskFactorReduction/ucm224321.htm.
    4. FDA National Retail Food Team. ``FDA Trend Analysis Report on 
the Occurrence of Foodborne Illness Risk Factors in Selected 
Institutional Foodservice, Restaurant, and Retail Food Store 
Facility Types (1998-2008).'' Available at: https://wayback.archive-it.org/7993/20170406022950/https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/ucm223293.htm.
    5. ``FDA Food Code.'' Available at:https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/default.htm.

    Dated: July 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16648 Filed 8-2-18; 8:45 am]
 BILLING CODE 4164-01-P


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