
[Federal Register Volume 77, Number 118 (Tuesday, June 19, 2012)]
[Notices]
[Pages 36544-36548]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14850]


-----------------------------------------------------------------------

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 (2013-2022)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 ``Occurrence of Foodborne 
Illness Risk Factors in Selected Retail and Foodservice Facility Types 
(2013-2022).''

DATES: Submit written or electronic comments on the collection of 
information by August 20, 2012.

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: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-7726, Ila.Mizrachi@fda.hhs.gov.

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 (2013-2022)--(OMB Control Number 
0910-NEW)

I. Background

    In 1998, the U.S. Food and Drug Administration's National Retail 
Food Team initiated a 10-year voluntary survey 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 (CDC) as contributing factors to foodborne 
illness outbreaks at the retail level. Specifically, the survey 
included data collection inspections of various types

[[Page 36545]]

of retail and foodservice establishments at 5-year intervals (1998, 
2003, and 2008) in order to observe and document trends in the 
occurrence of the following foodborne illness risk factors:
     Food from Unsafe Sources.
     Poor Personal Hygiene.
     Inadequate Cooking.
     Improper Holding/Time and Temperature.
     Contaminated Equipment/Protection from 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).
    The research obtained from these studies provides FDA a solid 
foundation for developing a national retail food program model that can 
be used by Federal, state, local, and tribal agencies to:
     Identify essential food safety program performance 
measurements;
     Assess strengths and gaps in the design, structure, and 
delivery of program services;
     Establish program priorities and intervention strategies 
focused on reducing the occurrence of foodborne illness risk factors; 
and
     Create a mechanism that justifies program resources and 
allocates them to program areas that will provide the most significant 
public health benefits.
    Using this 10-year survey as a foundation, FDA is proposing to 
conduct a new voluntary survey encompassing annual data collections 
over a 10-year period. The survey will determine the following for each 
facility type included in the study:
     The foodborne illness risk factors that are in most need 
of priority attention during each data collection period;
     Trends of improvement or regression in foodborne illness 
risk factor occurrence over time; and
     The impact of industry food safety management systems in 
controlling the occurrence of foodborne illness risk factors.
    The results of the proposed study will be used to:
     Formulate Agency retail food safety policies and 
initiatives;
     Identify retail food work plan priorities and allocate 
resources to enhance retail food safety nationwide;
     Generate nationally representative estimates of the 
prevalence of foodborne illness risk factors and trends of improvement 
and regression over time; and
     Recommend best practices and targeted intervention 
strategies to assist the retail and foodservice industry and state, 
local, and tribal regulators with reducing foodborne illness risk 
factors.
    The statutory basis for FDA conducting this survey is the Public 
Health Service Act (the PHS Act) (42 U.S.C. 243, section 311(a)) (Also 
21 CFR 5.10(a)(2) and (4)), which requires that FDA provide assistance 
to state and local governments relative to the prevention and 
suppression of communicable diseases. In addition, the PHS Act requires 
that FDA cooperate with and aid state and local authorities in the 
enforcement of their health regulations and provide advice on matters 
relating to the preservation and improvement of public health. 
Additionally, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301) 
and Economy Act (31 U.S.C. 1535) require that FDA provide assistance to 
other Federal, state, and local governmental bodies.
    In 2012, FDA will conduct a pilot data collection to practice the 
use of the data collection form and methods and test exportation of the 
pilot data into a central repository. Following the pilot, the Agency 
plans to conduct annual data collections beginning in 2013 with the 
initial data collection for select restaurant facility types, followed 
by the initial data collection for select institutional foodservice 
facility types in 2014 and select retail food store facility types in 
2015. The results of the initial data collection for each of the 
facility types will serve as the baseline measurement from which trends 
will be analyzed. Two additional data collection periods for each of 
the facility types are planned at 3-year intervals after the initial 
data collection for purposes of analyzing trends.

                               Table 1--Summary of Data Collection Time Frames \1\
----------------------------------------------------------------------------------------------------------------
                                                         Year for initial
                                      Facility types      data collection      Second data      Third and final
         Industry segment            included in the         (baseline      collection period   data collection
                                          survey           measurement)                              period
----------------------------------------------------------------------------------------------------------------
Restaurants......................  Full Service                       2013               2016               2019
                                    Restaurants
                                   Fast Food
                                    Restaurants.
Institutional Foodservice........  Hospitals                          2014               2017               2020
                                   Nursing Homes......
                                   Elementary Schools
                                    (K-6).
Retail Food Stores...............  Deli Departments/                  2015               2018               2021
                                    Stores
                                   Meat and Poultry
                                    Departments/
                                    Markets.
                                   Seafood Departments/
                                    Markets.
                                   Produce Departments/
                                    Markets.
----------------------------------------------------------------------------------------------------------------
\1\ Data collections for each of the facility types within an industry segment will be conducted using a 3-year
  interval period. Initial data collection will serve as the baseline. Subsequent collections will provide the
  data needed to analyze trends.

    A description of the facility types included in the proposed survey 
is included in table 2:

                        Table 2--Description of the Facility Types Included in the Survey
----------------------------------------------------------------------------------------------------------------
           Industry segment                 Facility type                          Description
----------------------------------------------------------------------------------------------------------------
Restaurants..........................  Full Service             Establishments where customers place their order
                                        Restaurants.             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.

[[Page 36546]]

 
                                       Fast Food Restaurants..  Also referred to as quick service restaurants
                                                                 and defined as any restaurant that is not a
                                                                 full service restaurant.
Institutional Foodservice............  Hospitals..............  Foodservice operations that serve patients,
                                                                 staff, and hospital visitors in a traditional
                                                                 hospital setting. Individuals who are acutely
                                                                 ill to those who are immunocompromised are a
                                                                 target population for data collection.
                                       Nursing Homes..........  Foodservice operations that serve highly
                                                                 susceptible populations living in a group care
                                                                 setting. The elderly (55+ years) is the target
                                                                 population for the data collection. Also
                                                                 includes assisted living facilities.
                                       Elementary Schools (K-   Foodservice operations that serve students from
                                        6).                      one or more grade levels from preschool through
                                                                 Grade 5. Young children are a target population
                                                                 for the data collection.
Retail Food Stores...................  Deli Departments/Stores  Departments in retail food stores where
                                                                 potentially hazardous foods (time/temperature
                                                                 control for safety foods) such as luncheon
                                                                 meats and cheeses are sliced for the customer
                                                                 and where sandwiches and salads are prepared
                                                                 onsite or received from a commissary in bulk
                                                                 containers, portioned, and displayed.
                                                                 Freestanding cheese shops are categorized as
                                                                 delis. Parts of the deli may also include:
                                                                   Salad bars and other food bars
                                                                maintained by the deli department manager;
                                                                   Areas where meat or poultry are
                                                                cooked and offered for sale as ready-to-eat;
                                                                   Pizza stands; and
                                                                   Limited bakery operations attached to
                                                                or adjacent the deli.
                                       Meat and Poultry         Meat and poultry departments in a retail food
                                        Departments/Markets.     store, as well as any freestanding meat market
                                                                 or butcher shop that sells raw meat or poultry
                                                                 directly to the consumer.
                                       Seafood Departments/     Seafood departments in retail food stores and
                                        Markets.                 freestanding seafood markets that sell seafood
                                                                 directly to the consumer including the
                                                                 preparation and sale of raw and/or ready-to-eat
                                                                 seafood. In-store sushi bars are considered
                                                                 part of the seafood department for the purposes
                                                                 of the data collection.
                                       Produce Departments/     Areas or departments where produce is cut,
                                        Markets.                 prepared, stored, or displayed. A produce
                                                                 department may include salad bars that are
                                                                 managed by the produce manager, as well as
                                                                 juicers.
----------------------------------------------------------------------------------------------------------------

    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's Center for Food 
Safety and Applied Nutrition (CFSAN) Biostatistical Branch, in 
collaboration with the FDA National Retail Food Team, will perform a 
series of filtering processes of the various database food 
establishment categories to ensure establishments are correctly 
classified and considered eligible to participate in the survey based 
on the descriptions in table 2.
    To further determine the pool of establishments eligible for 
selection, an effort will be made to exclude 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 vast majority of selected 
establishments are to be chosen from risk categories 2 through 4.
    FDA has approximately 25 Regional Retail Food Specialists 
(Specialists) who will serve as the data collectors for the 10-year 
study. The Specialists are geographically dispersed throughout the 
United States and possess technical expertise in retail food safety and 
a solid understanding of the operations within each of the facility 
types to be surveyed. The Specialists are also standardized by FDA's 
CFSAN personnel in the application and interpretation of the FDA Model 
Food Code (Ref. 5). The geographical distribution of Specialists 
throughout the United States allows for a broad sampling of facility 
types in all regions of the United States; therefore, establishments 
will be randomly selected to participate in the study from among all 
eligible establishments located within a 150-mile radius of each of the 
Specialists' home locations.
    The pilot will include approximately 4 data collection inspections 
for each of the approximately 25 Specialists, or a total of 100 
inspections. In order to obtain a sufficient number of observations to 
conduct statistically significant analysis, the FDA CFSAN 
Biostatistical Branch has determined, based on the previous 10-year 
foodborne illness risk factor study that was performed, that 
approximately 400 data collection inspections of each facility type are 
needed during the initial and subsequent data collection periods. 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 data collection form will be used by the Specialists 
during each inspection. 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. Section 3 includes three parts 
(parts A-C) for tabulating the Specialists' observations of the food 
employees' behaviors and practices in limiting contamination, 
proliferation, and survival of food safety hazards (part A);

[[Page 36547]]

the industry food safety management being implemented by the facility 
(part B); and the frequency of food employee hand washing (part C).
    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, 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. For Section 3, part B of the form, Specialists 
will make direct observations and ask follow up questions of industry 
management to obtain information on the extent to which the food 
establishments have developed and implemented food safety management 
systems. Section 3, part C of the form will involve direct observations 
of hand washing frequency by the Specialists. No questions will be 
asked in the completion of this part of the form.
    Due to the infrequent and nonstandard nature of the questions that 
may or may not be asked to clarify direct observations made by the 
Specialists in completing Section 3, parts A and C of the data 
collection form, only the burden associated with the information 
collection related to the completion of Sections 1 and 2 and Section 3, 
part B of the form is included in burden estimates. For each data 
collection, the respondents will include the person in charge of the 
selected facility and the program director of the respective regulatory 
authority. For the pilot, 25 Specialists will conduct 4 data collection 
inspections; thus, FDA estimates the number of respondents to be 200 
(25 Specialists x 4 data collection inspections x 2 respondents per 
data collection). The estimate of the hours per response is based on 
its previous experience with collecting similar information in previous 
data collection efforts. We estimate that it will take each of the 
respondents 15 minutes (0.25 hours) to answer the questions related to 
Sections 1 and 2 and Section 3, part B of the form, for a total of 50 
hours. FDA bases its estimate of the number of respondents during the 
subsequent activities (data collections) on 400 inspections being 
conducted in each facility type. FDA CFSAN's Biostatistical Branch has 
determined that 400 inspections are necessary to provide the sufficient 
number of observations needed to conduct a statistically significant 
analysis of the data. The data collections in the Restaurant Segment 
will occur in 2013, 2016, and 2019, and will each consist of 1,600 
respondents. We estimate that it will take each respondent 15 minutes 
(0.25 hours) to answer the questions related to Sections 1 and 2 and 
Section 3, part B of the form, for a total of 400 hours. The data 
collections in the Institutional Foodservice Segment will occur in 
2014, 2017, and 2020, and will each consist of 2,400 respondents. We 
estimate that it will take each respondent 15 minutes (0.25 hours) to 
answer the questions related to Sections 1 and 2 and Section 3, part B 
of the form, for a total of 600 hours. The data collections in the 
Retail Food Store Segment will occur in 2015, 2018, and 2021, and will 
each consist of 3,200 respondents. We estimate that it will take a 
respondent 15 minutes (0.25 hours) to answer the questions related to 
Sections 1 and 2 and Section 3, part B of the form, for a total of 800 
hours. Thus, the total estimated burden is 5,450 hours.

                                 Table 3--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                      No. of
            Activity                  No. of       responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
2012 Pilot Data Collection to                200               1             200            0.25              50
 Practice Use of Form and                                                           (15 minutes)
 Methods and Exportation of Data
 Into Central Repository........
2013 Baseline Data Collection--            1,600               1           1,600            0.25             400
 Restaurant Segment (includes                                                       (15 minutes)
 two facility types)............
2014 Baseline Data Collection--            2,400               1           2,400            0.25             600
 Institutional Foodservice                                                          (15 minutes)
 Segment (includes three
 facility types)................
2015 Baseline Data Collection--            3,200               1           3,200            0.25             800
 Retail Food Store Segment                                                          (15 minutes)
 (includes four facility types).
2016 Second Data Collection--              1,600               1           1,600            0.25             400
 Restaurant Segment (includes                                                       (15 minutes)
 two facility types)............
2017 Second Data Collection--              2,400               1           2,400            0.25             600
 Institutional Foodservice                                                          (15 minutes)
 Segment (includes three
 facility types)................
2018 Second Data Collection--              3,200               1           3,200            0.25             800
 Retail Food Store Segment                                                          (15 minutes)
 (includes four facility types).
2019 Third and Final Data                  1,600               1           1,600            0.25             400
 Collection--Restaurant Segment                                                     (15 minutes)
 (includes two facility types)..
2020 Third and Final Data                  2,400               1           2,400            0.25             600
 Collection--Institutional                                                          (15 minutes)
 Foodservice Segment (includes
 three facility types)..........
2021 Third and Final Data                  3,200               1           3,200            0.25             800
 Collection--Retail Food Store                                                      (15 minutes)
 Segment (includes four facility
 types).........................

[[Page 36548]]

 
    Total.......................  ..............  ..............  ..............  ..............           5,450
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

II. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site addresses, but we are not responsible 
for any subsequent changes to the Web sites after this document 
publishes in the Federal Register.)
    1. Report of the FDA Retail Food Program Steering Committee. 
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/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/ucm089696.htm.
    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 Model Food Code. Available at: http://www.fda.gov/Food/FoodSafety/RetailFoodProtection/FoodCode/default.htm.

    Dated: June 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14850 Filed 6-18-12; 8:45 am]
BILLING CODE 4160-01-P


