[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]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0547]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Survey on the Occurrence of Foodborne Illness Risk
Factors in Selected Retail and Foodservice Facility Types (2013-2022)
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 ``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\
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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
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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.
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\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
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Industry segment Facility type Description
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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.
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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\
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No. of
Activity No. of responses per Total annual Average burden Total hours
respondents respondent responses per response
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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).........................
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Total....................... .............. .............. .............. .............. 5,450
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\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