2-28-13 Study Protocol
ICR ATTACHMENT A
U.S. Food and Drug Administration
Study on the Occurrence of
Foodborne Illness Risk Factors
in Selected Retail and Foodservice Facility Types (2013-2023)
(Restaurant Segment)
Protocol for the Data Collection
Revised February 28, 2013
Study on the Occurrence of Foodborne Illness Risk Factors
in Selected Retail and Foodservice Facility Types (2013-2022)
(Restaurant Segment)
Protocol for the Data Collection
TABLE OF CONTENTS
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Page |
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I. |
Background……………………………………………………………….. |
1 |
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II. |
2013-2022 Study Objectives and Purpose ………….…………………… |
1 |
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III. |
Industry Segments and Facility Types Included in the Study…………. |
2 |
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IV. |
Data Collection Cycles……………………………………………………. |
4 |
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V. |
Selection of Data Collectors……………………………………………… |
5 |
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VI. |
Random Selection of Establishments…...……………………………….. |
5 |
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VII. |
Sample Size ……………...…………………………………....…………... |
6 |
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VIII. |
Preparing for the 2013 Data Collection in Select Restaurant Facilities. |
6 |
Data Collection Procedures and Training…….……………………………… |
6 |
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Verification of Eligibility of Randomly Selected Restaurants……………….. |
7 |
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Working with State and Local Regulatory Authorities ……………………… |
7 |
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Calibration of Temperature Measuring Devices……………………………… |
8 |
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IX. |
Conducting the Data Collection………………………………………….. |
8 |
Unannounced Data Collection Visits……...…….……………………………… |
8 |
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Discuss Purpose of the Data Collection……………………….……………….. |
8 |
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Conduct a Quick Walk-through……………………..…………………………... |
8 |
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Focus on the Primary Data Items………………..……………………………… |
9 |
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Other Areas of Interest – Data Items…….……………………………………… |
10 |
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Information Statements………………………...……………………….………… |
10 |
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Documenting Observation of Food Safety Practices………………………… |
11 |
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Recording Food Product Temperatures….…….……………………………… |
12 |
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Handwashing Frequency Assessment………………………………………….. |
13 |
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Assessment of Food Safety Management Systems...…………………………... |
13 |
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Establishment Information…………………………...…………………………... |
16 |
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Corrective Actions – Observations the Pose a Significant Public Health Risk ...…………………………........................................................................ |
16 |
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Exit Briefing with the Person in charge………..……………………………… |
16 |
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X. |
Entering the Data – Transition from ACCESS Database to Web-Based Platform |
17 |
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XI. |
Use of Hand Held Technology ………………………………. |
17 |
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XII. |
Reports From Previous FDA Retail Food Risk Factor Studies...……… |
18 |
Study on the Occurrence of Foodborne Illness Risk Factors
in Selected Retail and Foodservice Facility Types (2013-2022)
(Restaurant Segment)
Protocol for the Data Collection
STUDY PROTOCL ATTACHMENTS
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Page |
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Attachment A |
FDA – Retail Food Program, Foodborne Illness Risk Factor Study – Data Collection Form…………………………………... |
20 |
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Attachment B |
Introductory Letter for Establishments Selected for the Study…. |
37 |
I. Background
In 1998, the U.S. Food and Drug Administration’s (FDA) National Retail Food Team initiated a ten-year voluntary 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 (CDC) as contributing factors to foodborne illness outbreaks at the retail level. Specifically, the study included data collection inspections of various types of retail and foodservice establishments at five-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). 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.
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.
II. 2013-2023 Study Objectives and Purpose
Using this ten-year study as a foundation, FDA has developed a new study design. The design of the new study 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;
Potential correlations between operational aspects of the industry, such as average number of meals per day, number of employees, complexity of food preparation, and the control of foodborne illness risk factors;
Potential correlations between elements within regulatory retail food protection programs, such as enrollment in the FDA Voluntary National Retail Food Regulatory Program Standards, timing of regulatory inspections, grading systems, posting of inspections results, manager certification requirements and required food handler training, and the control of foodborne illness risk factors, and
The impact of industry food safety management systems in controlling the occurrence of foodborne illness risk factors.
The results of the study will be used to:
Provide FDA research information that will assist the agency develop retail food safety initiatives and policies focused on the control of foodborne illness risk factors;
Identify retail food work plan priorities and allocates 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 interventions strategies to assist the retail and foodservice industry and state, local, and tribal regulatory professionals with reducing the occurrence of foodborne illness risk factors.
III. Industry Segments and Facility Types Included in the Study
The scope of the Study includes three 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
Institutional Foodservice
Retail Food Stores
For this study, nine facility types have been chosen from these three different foodservice and retail food industry segments. Tables 1-3 provide a description of each facility type comprising each industry segment included in the study.
Table 1: Description of Facility Types that Comprise the Restaurant Industry Segment
Industry Segment
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Facility Type
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Description
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Restaurants
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Full Service Restaurants
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Establishments 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.
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Fast Food Restaurants
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Also referred to as quick service restaurants and defined as any restaurant that is not a full service restaurant. Customers generally order and pay for their meals at a counter.
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Table 2: Description of Facility Types that Comprise the Institutional Foodservice
Industry Segment
Industry Segment
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Facility Type
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Description
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Institutional Foodservice
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Hospitals
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Foodservice operations that serve patients, staff, and hospital visitors in a traditional hospital setting. Individuals who are acutely ill to those who are immune-compromised are a target population for the data collection.
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Nursing Homes
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Foodservice operations that serve highly susceptible populations living in a group care setting. The elderly (55+ years) is the target populations for the data collection. Also includes assisted living facilities.
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Elementary Schools (K-5)
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Foodservice operations that serve students from one or more grade levels from preschool through Grade 5. Young children are a target population for the data collection.
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Table 3: Description of Facility Types that Comprise the Retail Food Store Industry Segment
Industry Segment
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Facility Type
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Description
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Retail Food Stores
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Deli Departments/Stores
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Departments in retail food stores or stand-alone 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 on-site or received from a commissary in bulk containers, portioned, and displayed. Freestanding cheese shops are categorized as delis. Parts of the deli may include:
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Meat & Poultry Departments/Markets
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Meat and poultry departments in a retail food store, as well as any freestanding meat market or butcher shop that sells raw meat or poultry directly to the consumer.
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Seafood Departments/Markets
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Seafood departments in a retail food store and freestanding seafood markets that sell seafood directly to the consumer including the preparation 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.
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Produce Departments/Markets
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Areas or departments where produce is cut, prepared, stored, or displayed. A produce department may include salad bars or juicer stations that are managed by the produce managers
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IV. Data Collection Cycles
In 2013, 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, FDA plans to conduct annual data collections beginning in October, 2013 with the initial data collection for select restaurant facility types, followed by the initial data collection for select institutional facility types in October, 2014 and select retail food facility types in October, 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 three-year intervals after the initial data collection for purposes of analyzing trends. The scheduled data collection cycles are described in Table 4.
TABLE 4. SUMMARY OF DATA COLLECTION TIME FRAMES
INDUSTRY SEGMENT
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FACILITY TYPE
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FDA FY YEAR FOR INITIAL DATA COLLECTION (Baseline Measurement)
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2ND DATA COLLECTION PERIOD
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3RD DATA COLLECTION PERIOD |
Restaurants
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Full Service Restaurants
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2014
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2017
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2020
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Fast Food Restaurants
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Institutional Foodservice
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Hospitals
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2015
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2018
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2021
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Nursing Homes
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Elementary Schools (K-5)
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Retail Food Store
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Deli Departments/Stores
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2016
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2019
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2022
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Meat & Poultry Depts./Markets
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Seafood Depts./Markets
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Produce Depts./Markets
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NOTE: Data collections for each of the facility types within an industry segment will be conducted using a three-year interval period.
V. Selection of Data Collectors
FDA has approximately 25 Regional Retail Food Specialists (Specialists) who will serve as the data collectors for the ten-year study. The Specialists are geographically-dispersed throughout the U.S. and possess technical expertise in retail food safety and a solid understanding of the operations within each of the facility types selected for the study. The Specialists are also standardized by FDA’s CFSAN personnel in the application and interpretation of the FDA Food Code.
VI. Random Selection of Establishments
A geographical information system (GIS) database containing a listing of businesses throughout the U.S. will be used as the establishment inventory for the data collection. The geographical distribution of Specialists throughout the U.S. allows for a broad sampling of facility types in all regions of the U.S.; 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. This model provides a reasonably convenient, cost-effective design for generating nationally representative estimates of the prevalence of foodborne illness risk factors and trends of improvement and regression over time.
The random selection of establishments from the GIS database will be performed by the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) Biostatistics Branch. Prior to distributing the selected establishments to the Specialists, the Biostatistics Branch, working with members of FDA’s National Retail Food Team, will perform an initial review to ensure establishments are correctly classified and considered eligible to participate in the study based on the facility type descriptions in Tables 1-3.
To further determine the pool of establishments eligible for selection, an effort will be made to exclude operations that handle only pre-packaged food items or conduct low-risk food preparation activities. Annex 5, Table 1 – Risk Categorization of Food Establishments of the 2009 FDA Food Code contains a grouping of establishments by risk, based on the type of food preparation that is normally conducted within the operation. The vast majority of selected establishments are to be chosen from risk categories 2 through 4.
VII. Sample Size
In order to obtain a sufficient number of observations to conduct statistically significant analysis, the FDA CFSAN Biostatistics Branch has determined, based on the previous ten-year foodborne illness risk factor study, that approximately 400 data collection inspections of each facility type are needed during initial and subsequent data collection periods. This sample size provides sufficient observations to be 95% confident that compliance percentages derived from the data collections are within 5% of their actual occurrence.
The sample for each data collection period will be evenly distributed among the Specialists.
Given the participation in the study by the 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 facility is misclassified, closed, or otherwise unable or unwilling to participate. The inventory of substitute establishments will remain with the FDA CFSAN Biostatistics Branch until needed by a Specialist to replace an ineligible establishment that was included on their original list.
VIII. Preparing for the 2013 Data Collection in Select Restaurant Facility Types
Data
Collection Procedures and Training
Each Specialist will
attend a training workshop prior to initiating the data collection.
The training will be provided by members of the FDA National Retail
Food Team that have been responsible for the design and assessment of
all the Retail Food Risk Factor Study elements. The training will
cover all the study components with particular emphasis on the data
collection protocol and marking instructions for the data collection
form. A draft of the FDA – Retail Food Program, Foodborne
Illness Risk Factor Study Data Collection Form (Data Collection Form)
that will be used for the 2013 Study period focused on the restaurant
segment of the industry is included as Attachment A. The workshop
training will include written instructions for completing the data
collection form that will be used to record the observations made
during the visits to restaurants that have been selected for the
study.
Verification
of Eligibility of Randomly Selected Restaurants
Each
Specialist will receive from FDA’s CFSAN Biostatistics Branch,
a set of restaurant facilities within their primary area of
responsibility that have been randomly selected for the study. Prior
to conducting the data collection, the Specialist will contact the
state or local jurisdiction that has regulatory responsibility for
conducting retail food inspections for the selected establishment.
The Specialist will verify that the restaurant facility has been
properly classified (in the correct facility type category) for the
purposes of the study and is still in operation. The Specialist
should also ascertain whether the selected restaurant is under legal
notice from the state or local regulatory authority. If the selected
restaurant is under legal notice, the Specialist will not conduct a
data collection in that establishment. The Specialist will remove
the restaurant from their sample inventory and contact the FDA CFSAN
Biostatistics Branch for a substitute restaurant facility. The
Specialist should also obtain a substitute facility from the FDA
CFSAN Biostatistics Branch for any situation where the originally
selected restaurant is closed or otherwise inaccessible to conduct a
data collection.
Working
with State and Local Regulatory Authorities
As part of
the initial contact with the state or local regulatory authority, the
Specialist will obtain information from the jurisdiction pertaining
to the items listed under the heading, “Information on the
Regulatory Authority,” found on pages 2 and 3 of the Data
Collection Form (Attachment A). At that time, the Specialist will
collect the information for the following data collection fields:
Name of Jurisdiction with Regulatory Oversight;
Enrolled in FDA Retail Food Program Standards;
Jurisdiction Meets Standard 1;
Dates of the Two Most Recent Regulatory Routine Inspections;
Jurisdiction Uses a Grading System;
Type of Grading System;
Jurisdiction’s Program Includes Public Reporting of Inspection Results;
Inspections Report By;
Jurisdiction Has a Mandatory Food Protection Manager Certification Requirement;
Scope of Food Protection Manager Certification Requirement;
Food Protection Manager Certification Program Elements;
Jurisdiction Requires Food Handler Cards; and
Type of Training/Test for Food Handler Card.
Guidance for completing these data collection information fields is included on pages 5 – 13 in the FDA Retail Food Program, Foodborne illness Risk Factor Study - Marking Instructions for the Data Collection Form.
The
Specialist will extend an invitation to the state or local regulatory
authority to accompany him or her on the data collection visit.
Should the regulatory authority accept, the Specialist should
strongly recommend that the state or local regulatory authority
refrain from conducting a regulatory compliance inspection during the
data collection visit.
Calibration
of Temperature Measuring Devices
Specialists must ensure
that thermometers used for each data collection are accurate. The
Specialists must calibrate their thermometers prior to each
establishment data collection visit.
IX. Conducting the Data Collection
Unannounced Data Collection Visits
Each
data collection visit is to be unannounced. The intent is to observe
the operation in its normal mode, without special preparation to
accommodate the data collection visit.
Discuss Purpose of the Data Collection
Upon
arrival to the establishment, the Specialist will explain to the
owner the purpose of the visit. An introductory letter that explains
the purpose of the data collection visit and the study should be used
in addition to a verbal explanation. A sample letter is provided in
Attachment B. If entry into the selected establishment is denied by
the owner or person in charge, the Specialist will not conduct a data
collection. The Specialist will contact the FDA CFSAN Biostatistics
Branch and request a substitute restaurant establishment as a
replacement.
Conduct a Quick Walk-Through
The primary purpose of the data collection is to observe food safety practices and employee behaviors that are associated with the control of foodborne illness risk factors. After discussing the purpose of the data collection and developing a rapport with the person in charge, the Specialist is to conduct a quick (two to three minute) walk-though of the establishment’s kitchen. The goal of the quick walk-though is to identify the critical food preparation processes being conducted at the time of the inspection so that inspection priorities and flow can be determined. For each critical activity observed during the walk-through, the Specialist should determine whether the activity is static (one that will likely be the same over the course in the inspection) or dynamic (one that will likely be completed soon or will change quickly over the course of the inspection).
In addition, the Specialist will need to consider the data that will be needed over the course of the inspection to adequately assess the activities being performed. For instance, if cooling or reheated for hot holding are observed during the quick walk-through, the Specialist will likely need multiple temperature measurements over time to ascertain whether the procedures being used are effective.
During the quick walk-through, the Specialist should ask the operator whether cooking, preparation, cooling, reheating, or receiving are currently being conducted.
Specialists should set priorities for the inspection based on the quick walk-through and responses to the operator’s questions about the specific activities being conducted at the time of the inspection.
A review of the establishment’s menu can provide important information on the type of processes conducted in the operation, but it should be integrated as part of the data collection and not done as a separate interview activity with the person in charge. The Specialist is to use the menu as an information resource as the data collection is being conducted.
Focus on the Primary Data Items
The data collection is intended to be targeted on the control of foodborne illness risk factors. It is not an intended to be a comprehensive assessment of compliance with Food Code requirements. The focus of the data collection is to be on observations of the primary data items listed on the data collection form.
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 which will be used as the key
indicators for FDA’s statistical analysis for the study:
Risk Factor –Poor Personal Hygiene
#1 – Employees practice proper handwashing
#2 – Food Employees do not contact ready-to-eat foods with bare hands
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
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
Inadequate Cooking
#9
– Raw animal foods are cooked to required temperatures
#10
– Cooked foods are reheated to required temperatures
For each data collection, the Specialists should make every effort to observe procedures and practices related to the primary data items. Comprehensive guidance for marking observations of primary data items is provided on pages 43 – 64 of the FDA Retail Food Program, Foodborne Illness Risk Factor Study – Marking Instruction for the Data Collection Form.
Other Areas of Interest – Data Items
Data items 11 through 19 are listed under the heading “Other Areas of Interest.”
These food safety practices and procedures directly support active managerial control of the foodborne illness risk factor areas addressed under the primary data items:
Other Areas of Interest
Data Item #11 – Handwashing facilities are accessible and properly maintained
Data Item #12 – Employees practice good hygiene
Data Item #13 – Consumers are properly advised of risks of consuming raw or undercooked animal foods
Data Item #14 – Time alone is properly used as a public health control
Data Item #15 – Facilities have adequate equipment and tools for ensuring food temperature control and sanitization of food contact surfaces
Data Item #16 – Special processes are conducted in compliance with issued variance / HACCP Plan, when required
Data Item #17 – Food is received from safe sources
Data Item #18 – Toxic materials are identified, used and stored properly
Data Item #19 – Management and food employees are trained in food allergy awareness as it relates to their assigned duties
Specialists should be cognizant of opportunities to observe these data items during the data collection. The same type of risk assessment and dynamic-static evaluation used for the primary data items can also be applied to those listed under the “Other Areas of Interest” in establishing priorities for the data collection. For example, assessing whether an establishment has an accurate thermometer for checking internal food temperatures or whether there is a chemical test kit for checking sanitization concentration, which are part of data item 15, can be done at anytime during the data collection because these items are static in nature. In contrast, the opportunity to assess a reduced oxygen packaging process during the data inspection is dynamic because quantitative measurements must be made at critical production points. A reduced oxygen packaging process also has an inherently high food safety risk if done improperly.
Comprehensive guidance for marking observations of data items listed under the “Other Areas of Interest” is provided on pages 65 – 78 of the FDA Retail Food Program, Foodborne Illness Risk Factor Study – Marking Instruction for the Data Collection Form.
Information Statements
Under most of the data items, a list of information statements is provided. These information statements are preceded by a letter for organization purposes and describe a specific observation (food safety practice) associated with the overarching data item under which it is listed. For example, the information statements for the Data Item #1 –
Employees practice proper handwashing are:
Hands are cleaned and properly washed using hand cleanser / water supply / appropriate drying methods / length of time as specified in Section 2-301.12 of the Food Code.
Hands are cleaned and properly washed when required as specified in 2-301.14 of the Food Code.
The information statements provide a method for:
Conducting comparisons with the previous ten-year risk factor study (1998-2008). Some of the information statements were included as data items on the data collection form used for the first study;
Recording observations made. Data collectors have an option to check a box rather than write a narrative statement; and
Enhancing quality assurance pertaining to the interpretation of the data collected. Standard statements provide a means for maintaining uniformity and consistency among multiple data collectors.
Documenting Observations of Food Safety Practices
Using the current version of the FDA Food Code, the data collector will determine whether the observations made of the employee food safety practices or behaviors contained in the information statements were IN Compliance, OUT of Compliance, Not Observed (NO), or Not Applicable (NA). The recorded markings of the information statements are then used to determine the compliance status of the corresponding data item.
An observation is based on an evaluation of one or more occurrences of a data item or information statement at an establishment. Specific instructions for marking each data item and information statement are provided in the FDA Retail Food Program, Foodborne Illness Risk Factor Study – Marking Instruction for the Data Collection Form. The four marking options are defined as follows:
IN – means that all observed occurrences were IN Compliance with the appropriate FDA Food Code provision for the data item or information statement.
OUT – means that one or more of the observations made were OUT of Compliance with the appropriate FDA Food Code provision for the data item or information statement. An explanation of the specific criteria used for determining OUT of Compliance for each data item is to be recorded by the data collector on the data collection form.
NO – means the data item or information statement was Not Observed during the inspection. The NO marking is used when an information statement is a usual practice in the food establishment, but the practice is NOT observed during the time of the inspection.
NA – means the data item or information statement is Not Applicable. The NA marking is used when a data item or information statement is NOT a function of the food establishment.
Quantitative
measurements are to be made with calibrated thermocouples, heat
sensitive tape or maximum registering thermometers, and chemical test
strips. Quantitative temperature measurements are to be recorded in
the food temperature charts provided on the data collection form.
Sanitization measurements should be recorded in the comment section
for the specific data item observed.
Recording Food Product Temperatures
The Specialist will record ALL food product temperatures measured during the data collection in the charts provided under data items that contain specific product temperature critical limits. A partial illustration for the temperature chart for data item #5 – is provided below:
Cold Holding Temperatures Recorded During the Data Collection (List all temperatures taken)
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FOOD PRODUCT
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FOOD TEMP.
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FOOD CODE CRITICAL LIMIT
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TYPE OF COLD HOLDING EQUIPMENT
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FOOD PRODUCT
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FOOD TEMP.
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FOOD CODE CRITICAL LIMIT
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TYPE OF COLD HOLDING EQUIPMENT
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Cooked Chicken
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40ºF
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41ºF
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Walk-in Cooler
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Diced Ham
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44ºF
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41ºF
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Refrigerated Sandwich Preperation Table
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Raw Hamburger Patty
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52ºF
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41ºF
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Refrigeration Drawer Preparation Line
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Cooked Pasta
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39ºF
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41ºF
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Walk-in Cooler
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The ACCESS database that will be used to record the data has been designed to provide a drop down menu for the Food Code Critical Limits for each temperature-based data item. Using the food product temperature entered by the Specialist, the ACCESS database has been programmed to automatically calculate the difference between the food product temperature recorded by the Specialist and the Food Code critical limit. The ACCESS system will then use this information to automatically enter the correct totals in the summary of product temperatures table depicted below. The Specialist will not have to manually complete the product temperature summary tables.
NUMBER OF FOOD PRODUCT TEMPERATURES
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SUMMARY COLD HOLDING PRODUCT TEMPERATURE CATEGORIES
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3
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I. – Number of product temperature measurements IN Compliance with Food Code critical limits
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2
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II. – Number of OUT of Compliance product temperature measurements 1ºF - 2ºF above Food Code critical limits
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1
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III. – Number of OUT of Compliance product temperature measurements 3ºF - 4ºF above Food Code critical limits
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1
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IV. – Number of OUT of Compliance product temperature measurements 5ºF - 9ºF above Food Code critical limits
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1
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V. – Number of OUT of Compliance product temperature measurements 10ºF or more above Food Code critical limits
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Handwashing Frequency Assessment
The
Specialist will record all of his or her handwashing observations
during the regular data collection using the “Handwashing
Frequency Assessment” located under data item #1 –
Employees practice proper handwashing on the Data Collection Form
(Attachment A). Over the course of the data collection visit, the
Specialist will record a tally of each time an employee is observed
doing the following:
Washing hands properly and when required,
Washing hands improperly, or
Failing to wash hand when required.
Specialists should recognize their limitations with this aspect of the Study. The assessment of handwashing frequency in the context of this study is intended to provide a broad-based indicator of handwashing practices and will not be used to draw statistical correlations. It will be impossible to assess every activity during which handwashing should occur so the precision needed for statistical analysis will not be achievable. Specialists should not forgo an opportunity to observe a food safety practice or procedure related to a primary data item in order to observe food employees who may need to wash their hands at some point in an ongoing food preparation activity.
Handwashing frequency data will be collected throughout the normal course of the data collection for other food safety procedures and practices. Additional inspection time should not be allocated for collection of this data.
Assessment of Food Safety Management Systems
In addition to collecting information on compliance with the FDA Food Code, Specialists will obtain information on the extent to which food establishments have developed and implemented food safety management systems. FDA will use this information to examine the correlations, if any, between the degree to which management systems are in place and the control of foodborne illness risk factors.
The Food Safety Management System Assessment will be conducted during the same establishment visit but independent from the determination of Food Code compliance for individual data items. The Food Safety Management System Assessment is to be conducted at an appropriate time so it does not compromise a Specialist’s opportunity to observe food safety practices or procedures related to the primary data items.
The 2013 data collection will focus on the food safety management system in place to control four key foodborne illness risk factors and selected items for each as presented below:
Poor Personal Hygiene
Data Item #1 – Employees practice proper handwashing
Data Item #2 – Employees do not contact ready-to-eat foods with bare hands
Contaminated Equipment / Protection Food from Contamination
Data Item #3 – Food is protected from cross-contamination during storage,
preparation, and display
Data Item #4 – Food contact surfaces are properly cleaned and sanitized
Improper Holding / Time-Temperature Control
Data Item #5 – Foods requiring refrigeration are held at the proper
temperature
Data Item #6 – Foods displayed or stored hot are held at the proper
temperature
Data Item #7 – Foods are cooled properly
Data Item #8 – Refrigerated, ready-to-eats foods are properly date marked and
discarded within 7 days of preparation or opening
Inadequate Cooking
Data Item #9 – Raw animal foods are cooked to required temperatures
Data item #10 – Cooked foods are reheated to required temperatures
Each randomly selected restaurant will have a management system assessment conducted for ONE of the four foodborne illness risk factor areas described above. The FDA CFSAN Biostatistics Branch will randomly select the risk factor area for which a food safety management system assessment is to be conducted for each restaurant establishment.
Examples of the types of questions that the Specialist may ask to assess an establishment’s food safety management system for cooking raw animal foods are presented below. This list is not intended to be all-inclusive, nor is the expectation that a Specialist ask all the questions provided or ask them in any specific order. The intent is to provide a framework for obtaining the necessary information on what type of procedures are in place for cooking; what training is provided to food employees to ensure they follow the established cooking procedures, and what type of system is in place to monitor final cook temperatures. This same type of framework can be customized and applied to each of the risk factor areas.
Are specific procedures (directions) in place for cooking foods?
Are the cooking procedures product specific (roasts; hamburgers, etc)?
Are any cooking procedures based on equipment temperature for a set amount of time?
Is a slow cook process used for any of the food products (roasts)?
Do you receive steaks that are from whole muscle-intact beef?
How do your food employees know the correct cooking temperatures?
How are cooking temperatures monitored to ensure the food is ready for service to the customer?
What type of equipment is used to measure the final internal product cooking temperature?
What actions do employees take when food does not reach proper temperature?
Do you maintain any type of cooking logs or records?
Are there any meats that are partially cooked or seared then cooled in preparation for large volumes?
Are raw animal foods cooked to customer order (rare, medium-rare, medium, well-done)? If so, what food items?
If foods are cooked to customer order does the establishment have a consumer advisory?
The Specialist evaluates the presence and adequacy of all three management system elements (procedures, training, and monitoring) for all the data items listed under the selected risk factor. For each data item that falls under the assigned risk factor, a separate assessment will be made of the three food safety management system components using a rating scale of 1 to 4. The rating number reflects the relative degree to which each component of the management system is developed and implemented by the food establishment.
Each rating number is broadly defined below:
1
– Non-Existent: No system in place or haphazardly
implemented (no defined structure or frequency for implementation).
2
– Underdeveloped: System is in early development. Efforts
are being made, but there are crucial gaps in completeness and/or
consistency.
3
– Well Developed: System is complete, consistent and
oral, or a combination
of oral and written. The preponderance
of the management
system is oral.
4 – Well-Developed & System is complete, consistent and written. The
Documented
preponderance of the management system is written. This is
the goal for all establishments.
Establishment Information
During the course of the data collection, the Specialist obtains information from the owner/person in charge related to items listed in the following Sections on pages 1, 4, and 5 of the Data Collection Form (Attachment A):
Establishment Information
Establishments that are Part of Multi-Unit Operations
Manager Certification
Employee Health Policy
Guidance for completing the information fields associated with these sections of the data collection form is provided on pages 1 – 4 and 14 – 23 of the FDA Retail Food Program, Foodborne Illness Risk Factor Study – Marking Instructions for the Data Collection Form.
This information can be obtained at any time during the data collection and should not take precedence over, or inhibit, the Specialist’s observations of actual food safety practices and procedures related to the primary data items. Specialists should consider the static nature of this information and prioritize the collection of this information accordingly.
Corrective Actions – Observations that Pose a Significant Public Health Risk
Though industry participation in the Study is voluntary, correction action is to be obtained for observations that pose a significant public health risk. If conditions observed during the data collection visit pose a significant public health risk, the Specialist is to discuss the situation with the person in charge and seek to obtain voluntary corrective action. FDA’s experience from data collections performed as part of its previous study indicate that in all but a few instances, industry responded in a cooperative and responsible manner to alleviate potential public health risks.
Should an instance occur where an observation during the data collection poses a significant public health risk and corrective action cannot be voluntarily obtained, the Specialist should contact the appropriate regulatory authority to ensure appropriate corrective actions are taken. This is an example of a situation where it is advantageous to have the responsible regulatory authority accompany the Specialist during the data collection.
Exit Briefing with Person in charge
The data collection visit is conducted as part of a research project and is not intended to be a regulatory compliance inspection. No written report is left with the establishment. Upon completion of the data collection, the Specialist conducts an exit briefing with the owner or person in charge to discuss significant findings and answer any questions.
X. Entering the Data – Transition from ACCESS Database to Web-Based Platform
During the 2013-2014 restaurant data collection, each Specialist was provided with a copy of an ACCESS database software program that had been specifically formatted to store and analyze data collected during the study. The Specialists manually entered their observations for each of the data items and information statements for the selected establishment into the ACCESS database.
Over the past three years, FDA has been working with the National Center for Food Protection and Defense (NCFPD) to develop and maintain a web-based database platform for the retail food risk factor study. The web-based database platform will be located as part of the FoodSHIELD site. The FoodSHIELD database has been designed not only for use by FDA but for state/local/tribal jurisdictions seeking a system to store and maintain data from their own studies. Firewalls have been built into the design of the database system to maintain the security and integrity of data entered by each jurisdiction.
The
database system also contains the option of “permission-based”
sharing of data between jurisdictions. This feature has the
potential of creating more robust data sets for analyzing trends in
the occurrence of foodborne illness risk factors over time within the
retail food segment of the industry.
For the 2017-2018
restaurant data collection, FDA will use the web-based database
platform located in FoodSHIELD to store and maintain the data from
the Study. During this period of time, By the end of 2016, FDA will
have uploaded the data from the 2013-2014 restaurant data collection
from the ACCESS database to the FoodSHIELD system. The uploading of
the 2013-2014 restaurant data will provide the foundation for
assessing improvement and/or regression trends in the control of
foodborne illness risk factors over the three data collection periods
planned for the Study.
XI. Use of Hand Held Technology
The FoodSHIELD retail food risk factor study database has been designed to accommodate both manual entry of data and uploading electronic reports from hand held technology. During the 2015-2016 data collection in health care; schools; and retail food stores, FDA will begin the transition process from manual data entry to the use of hand held technology. As part of an agency-wide initiative to assess the use of hand held technology, FDA will have 5 Specialists conduct their data collections using hand held tablets. The information from the hand held tablets will be transferred “real-time” into the FoodSHIELD database via a web browser. Based on the lessons-learned from the hand-held technology pilot, FDA will assess the type of equipment and support system needed to fully integrate hand held technology for the 2017-2018 restaurant data collection.
Webinar trainings and pilot data entries will be conducted so Specialists have a solid understanding of the data entry features built into the FoodSHIELD system. Specialists designated for the use of hand-held technology will conduct field pilot testing of the equipment and upload data to the FoodSHIELD database prior to the start of the 2017-2018 data collection period.
XII. Reports from Previous FDA Retail Food Risk Factors Studies
The following reports from FDA’s previous risk factors studies are available from the following web links:
Report of the FDA Retail Food Program Database of Foodborne Illness Risk Factors (2000)
http://www.fda.gov/downloads/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/ucm123546.pdf
Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (2004)
http://www.fda.gov/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/ucm089696.htm
Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (2009)
http://www.fda.gov/downloads/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/UCM224682.pdf
Trend Analysis Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (1998 – 2008)
http://www.fda.gov/downloads/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/UCM224152.pdf
STUDY PROTOCOL
ATTACHMENTS
FDA RETAIL FOOD PROGRAM
FOODBORNE ILLNESS RISK FACTOR STUDY
DATA COLLECTION FORM
ESTABLISHMENT INFORMATION
|
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Date:
|
Data Collector:
|
||
Time In:
|
Time Out: |
Total Time in Minutes:
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|
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Establishment Name:
|
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Street Address:
|
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City:
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State: |
Zip: |
County: |
Industry Segment:
|
Facility Type: |
Risk Categorization: |
|
|
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Seating Capacity:
|
Average Number of Meals Per Day:
|
||
Maximum Number of Employees Per Shift:
|
Number of Employees Present at Time of Visit:
|
||
Activity level at the time of visit (Select ONE): Light Moderate Heavy
|
|||
ESTABLISHMENTS THAT ARE PART OF MULTI-UNIT OPERATIONS
|
|||
Establishment is part of a Multi-Unit Operation: YES NO
|
|||
Number of Individual Units that are part of the Multi-Unit Operation (Enter the number of units provided by the person in charge):
|
|||
Ownership of Establishment (Select ONE of the following):
Company-Owned
Franchise
Unsure
|
|||
If Franchise – number of units owned by the franchisee (Enter the number of units provided by the person in charge):
|
|||
FDA RETAIL FOOD PROGRAM
FOODBORNE ILLNESS RISK FACTOR STUDY
DATA COLLECTION FORM
INFORMATION ON THE REGULATORY AUTHORITY
|
Name of Jurisdiction with Regulatory Oversight:
|
|
Enrolled in FDA Retail Food Program Standards: YES NO
|
Jurisdiction Meets Standard 1 (Select ONE of the following):
YES – Self Reported
YES – Verified by Audit
NO – Jurisdiction does not meet Standard 1
|
|
Dates of the Two Most Recent Regulatory Routine Inspections: Date 1: Date 2:
|
|
Jurisdiction Uses a Grading System (Select ONE of the following):
YES – Numerical Score
YES – Letter Grade
YES – Color Graphic
YES – Numerical Score and Letter Grade
YES – Numerical Score and Color Graphic
YES – Letter Grade and Color Graphic
YES – Numerical Score, Letter Grade, and Color Graphic
YES – Other
NO – Jurisdiction does not have a grading system
|
If “Other” describe:
|
|
Jurisdiction’s Program Includes Public Reporting of Inspection Results (Select ONE of the following):
YES – Posting on-site
YES – Posting on the Internet
YES – Posting on-site and Posting on the Internet
YES – Other
NO – Jurisdiction does not require inspections to be publically reported
|
If “Other” describe:
|
|
Jurisdiction Has a Mandatory Food Protection Manager Certification Requirement (Select ONE of the following):
YES – Based ONLY on successful completion of an ANSI-Accredited Program
YES – Other Food Protection Manager Certification Program (not an ANSI-Accredited Program)
YES – Other AND Reciprocal Acceptance of an ANSI Accredited Program
NO – Jurisdiction does not have a mandatory Food Protection Manager Certification Requirement
|
If “Other” (Select ONE of the following) Other includes a required Training Component Other includes a Test other than exams offered through an ANSI Accredited Programs Other includes a required Training Component AND Test other than exam offered through an ANSI Accredited Program
|
If “Other” describe:
|
|
INFORMATION ON THE REGULATORY AUTHORITY (continued from previous page)
|
Scope of Food Protection Manager Certification Requirement (Select ONE of the following):
Person in Charge – One Per Establishment
Person in Charge – Present at All Times
Supervisory Employee – One Per Establishment
Supervisory Employee – Present at All Times
Other
|
If “Other” describe:
|
|
Jurisdiction Requires Food Handler Card (Select ONE of the following):
YES – Required Training
YES – Required Test
YES – Required Training and Test
YES – Other
NO – Jurisdiction does NOT require Food Handler Cards
|
If “Other” describe:
|
FDA RETAIL FOOD PROGRAM
FOODBORNE ILLNESS RISK FACTOR STUDY
DATA COLLECTION FORM
MANAGER CERTIFICATION
|
||
1. Is there a certified food protection manager EMPLOYED at the establishment (Select ONE)?
YES – Certificate Available
YES – Certificate NOT Available
NO – No certified food protection managers are employed at the establishment
If the marking above contains a “YES” response, indicate the Type of Certification below (Select ONE)
ANSI-Accredited
Other
Unsure
|
||
|
||
2. Is there an employee who is a certified food protection manager PRESENT during the data collection (Select ONE)?
YES – Certificate Available
YES – Certificate NOT Available
NO – No certified food protection managers are present during the data collection
If the marking above contains a “YES” response, indicate the Type of Certification below (Select ONE)
ANSI-Accredited
Other
Unsure
|
||
|
||
3. Is the PERSON IN CHARGE at the time of the data collection a certified food protection manager (Select ONE)?
YES – Certificate Available
YES – Certificate NOT Available
NO – The person in charge at the time of the data collection is NOT a certified food protection manager
If the marking above contains a “YES” response, indicate the Type of Certification below (Select ONE)
ANSI-Accredited
Other
Unsure
|
||
|
||
4. Is the establishment’s policy to have a certified food protection manager present at all times? YES NO
|
||
|
|
|
If “Other” for one or more of the responses to questions 1 – 3, describe:
|
||
FDA RETAIL FOOD PROGRAM
FOODBORNE ILLNESS RISK FACTOR STUDY
DATA COLLECTION FORM
EMPLOYEE HEALTH POLICY
|
YES – Employees exhibiting illness symptoms or conditions observed within the establishment
NO – Employees exhibiting illness symptoms or conditions NOT observed within the establishment
|
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YES – Policy is ORAL
YES – Policy is WRITTEN
NO – No Policy in place
|
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YES – Policy is ORAL
YES – Policy is WRITTEN
NO – No Policy in place
|
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YES – Policy is ORAL
YES – Policy is WRITTEN
NO – No Policy in place
|
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YES – Policy is ORAL
YES – Policy is WRITTEN
NO – No Policy in place
|
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YES – Policy is ORAL
YES – Policy is WRITTEN
NO – No Policy in place
|
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YES
NO
|
Risk Factor – Poor Personal Hygiene (Items 1&2)
IN
|
OUT
|
NO
|
NA
|
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||||||||
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||||||||
IN
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OUT
|
NO
|
NA
|
Description of HANDWASHING OBSERVATIONS
|
||||||||
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||||||||
COMMENTS:
|
||||||||||||
HANDWASHING FREQUENCY ASSESSMENT
|
||||||||||||
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C1
Employee observed washing hands properly and when required
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C2
Employee observed washing hands improperly
|
C3
Employee observed failing to wash hand when required
|
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TOTAL COUNT
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|||||||||
FOOD SAFETY MANAGEMENT SYSTEM ASSESSMENT
|
||||||||||||
PROCEDURES |
TRAINING |
MONITORING |
||||||||||
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1 |
COMMENTS:
|
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1 |
COMMENTS:
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1 |
COMMENTS:
|
||||
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2 |
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2 |
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2 |
|||||||
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3 |
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3 |
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3 |
|||||||
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4 |
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4 |
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4 |
|||||||
IN
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OUT
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NO
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NA
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||||||||
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||||||||
COMMENTS:
|
||||||||||||
FOOD SAFETY MANAGEMENT SYSTEM ASSESSMENT
|
||||||||||||
PROCEDURES |
TRAINING |
MONITORING |
||||||||||
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1 |
COMMENTS:
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1 |
COMMENTS:
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1 |
COMMENTS:
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2 |
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2 |
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2 |
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3 |
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3 |
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3 |
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4 |
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4 |
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4 |
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Risk Factor – Contaminated Equipment / Protection from Contamination (Items 3&4)
IN
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OUT
|
NO
|
NA
|
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||||||||
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||||||||
IN
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OUT
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NO
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NA
|
Description of FOOD Contamination OBSERVATIONS
|
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||||||||
COMMENTS:
|
||||||||||||
FOOD SAFETY MANAGEMENT SYSTEM ASSESSMENT
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||||||||||||
PROCEDURES |
TRAINING |
MONITORING |
||||||||||
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1 |
COMMENTS:
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1 |
COMMENTS:
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1 |
COMMENTS:
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2 |
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2 |
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2 |
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3 |
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3 |
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3 |
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4 |
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4 |
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4 |
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IN
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OUT |
NO
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NA
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|||||||
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|||||||
IN
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OUT
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NO
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NA
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Description of Food Contact Surfaces OBSERVATIONS
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|||||||
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|||||||
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|||||||
COMMENTS:
|
|||||||||||
FOOD SAFETY MANAGEMENT SYSTEM ASSESSMENT
|
|||||||||||
PROCEDURES |
TRAINING |
MONITORING |
|||||||||
|
1 |
COMMENTS:
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1 |
COMMENTS:
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1 |
COMMENTS:
|
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2 |
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2 |
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2 |
||||||
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3 |
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3 |
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3 |
||||||
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4 |
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4 |
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4 |
||||||
Risk Factor – Improper Holding / Time and Temperature Risk (Items 5-8)
IN
|
OUT
|
NO
|
NA
|
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||||||||||||||||
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||||||||||||||||
IN
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OUT
|
NO
|
NA
|
Description of Cold Holding Temperature OBSERVATIONS
|
||||||||||||||||
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||||||||||||||||
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||||||||||||||||
COMMENTS:
|
||||||||||||||||||||
Cold Holding Temperatures Recorded During the Data Collection (List all temperatures taken)
|
||||||||||||||||||||
FOOD PRODUCT
|
FOOD TEMP.
|
FOOD CODE CRITICAL LIMIT
|
TYPE OF COLD HOLDING EQUIPMENT
|
FOOD PRODUCT
|
FOOD TEMP.
|
FOOD CODE CRITICAL LIMIT
|
TYPE OF COLD HOLDING EQUIPMENT
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NUMBER OF FOOD PRODUCT TEMPERATURES
|
SUMMARY COLD HOLDING PRODUCT TEMPERATURE CATEGORIES
|
|||||||||||||||||||
|
I. – Number of product temperature measurements IN Compliance with Food Code critical limits
|
|||||||||||||||||||
|
II. – Number of OUT of Compliance product temperature measurements 1ºF - 2ºF above Food Code critical limits
|
|||||||||||||||||||
|
III. – Number of OUT of Compliance product temperature measurements 3ºF - 4ºF above Food Code critical limits
|
|||||||||||||||||||
|
IV. – Number of OUT of Compliance product temperature measurements 5ºF - 9ºF above Food Code critical limits
|
|||||||||||||||||||
|
V. – Number of OUT of Compliance product temperature measurements 10ºF or more above Food Code critical limits
|
|||||||||||||||||||
FOOD SAFETY MANAGEMENT SYSTEM ASSESSMENT
|
||||||||||||||||||||
PROCEDURES |
TRAINING |
MONITORING |
||||||||||||||||||
|
1 |
COMMENTS:
|
|
1 |
COMMENTS:
|
|
1 |
COMMENTS:
|
||||||||||||
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2 |
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2 |
|
2 |
|||||||||||||||
|
3 |
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3 |
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3 |
|||||||||||||||
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4 |
|
4 |
|
4 |
|||||||||||||||
IN
|
OUT
|
NO
|
NA
|
|
|||||||||||||||||
\ |
|
|
|
|
|||||||||||||||||
IN
|
OUT
|
NO
|
NA
|
Description of Hot Holding Temperature OBSERVATIONS
|
|||||||||||||||||
|
|
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|
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|||||||||||||||||
|
|
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|
|||||||||||||||||
|
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|
|
|||||||||||||||||
COMMENTS:
|
|||||||||||||||||||||
Hot Holding Temperatures Recorded During the Data Collection (List all temperatures taken)
|
|||||||||||||||||||||
FOOD PRODUCT
|
FOOD TEMP.
|
FOOD CODE CRITICAL LIMIT
|
TYPE OF HOT HOLDING EQUIPMENT
|
FOOD PRODUCT
|
FOOD TEMP.
|
FOOD CODE CRITICAL LIMIT
|
TYPE OF HOT HOLDING EQUIPMENT
|
||||||||||||||
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||||||||||||||
NUMBER OF FOOD PRODUCT TEMPERATURES
|
SUMMARY HOT HOLDING PRODUCT TEMPERATURE CATEGORIES
|
||||||||||||||||||||
|
I. – Number of product temperature measurements IN Compliance with Food Code critical limits
|
||||||||||||||||||||
|
II. – Number of OUT of Compliance product temperature measurements 1ºF - 2ºF below Food Code critical limits
|
||||||||||||||||||||
|
III. – Number of OUT of Compliance product temperature measurements 3ºF - 4ºF below Food Code critical limits
|
||||||||||||||||||||
|
IV. – Number of OUT of Compliance product temperature measurements 5ºF - 9ºF below Food Code critical limits
|
||||||||||||||||||||
|
V. – Number of OUT of Compliance product temperature measurements 10ºF or more below Food Code critical limits
|
||||||||||||||||||||
FOOD SAFETY MANAGEMENT SYSTEM ASSESSMENT
|
|||||||||||||||||||||
PROCEDURES |
TRAINING |
MONITORING |
|||||||||||||||||||
|
1 |
COMMENTS:
|
|
1 |
COMMENTS:
|
|
1 |
COMMENTS:
|
|||||||||||||
|
2 |
|
2 |
|
2 |
||||||||||||||||
|
3 |
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3 |
|
3 |
||||||||||||||||
|
4 |
|
4 |
|
4 |
||||||||||||||||
IN
|
OUT
|
NO
|
NA
|
|
|||||||||||||
|
|
|
|
|
|||||||||||||
IN
|
OUT
|
NO
|
NA
|
Description of Cooling Temperature OBSERVATIONS
|
|||||||||||||
|
|
|
|
|
|||||||||||||
|
|
|
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|
|||||||||||||
|
|
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|
|
|||||||||||||
|
|
|
|
|
|||||||||||||
COMMENTS: |
|||||||||||||||||
Cooling Temperatures Recorded During the Data Collection (List all temperatures taken)
|
|||||||||||||||||
FOOD PRODUCT
|
FOOD COOLING TEMP. #1
|
FOOD COOLING TEMP. #2
|
TOTAL TIME IN MINUTES
|
FOOD CODE CRITICAL LIMIT
|
TYPE OF EQUIPMENT USED TO COOL FOOD
|
||||||||||||
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||||||||||||
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||||||||||||
FOOD SAFTEY MANAGEMENT SYSTEM ASSESSMENT
|
|||||||||||||||||
PROCEDURES |
TRAINING |
MONITORING |
|||||||||||||||
|
1 |
COMMENTS:
|
|
1 |
COMMENTS:
|
|
1 |
COMMENTS:
|
|||||||||
|
2 |
|
2 |
|
2 |
||||||||||||
|
3 |
|
3 |
|
3 |
||||||||||||
|
4 |
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4 |
|
4 |
||||||||||||
IN
|
OUT
|
NO
|
NA
|
|
||||||||
|
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|
||||||||
IN
|
OUT
|
NO
|
NA
|
Description of Date Marking OBSERVATIONS
|
||||||||
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||||||||
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||||||||
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||||||||
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||||||||
COMMENTS:
|
||||||||||||
FOOD SAFETY MANAGEMENT SYSTEM ASSESSMENT
|
||||||||||||
PROCEDURES |
TRAINING |
MONITORING |
||||||||||
|
1 |
COMMENTS:
|
|
1 |
COMMENTS:
|
|
1 |
COMMENTS:
|
||||
|
2 |
|
2 |
|
2 |
|||||||
|
3 |
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3 |
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3 |
|||||||
|
4 |
|
4 |
|
4 |
|||||||
Risk Factor – Inadequate Cooking (Items 9&10)
|
IN
|
OUT
|
NO
|
NA
|
|
|||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
|
|
|||||||||||||||||
|
IN
|
OUT
|
NO
|
NA
|
Description of Cooking Temperature OBSERVATIONS
|
|||||||||||||||||
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|
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|||||||||||||||||
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|||||||||||||||||
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|||||||||||||||||
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|||||||||||||||||
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|||||||||||||||||
|
|
|
|
|
|
|||||||||||||||||
|
COMMENTS: |
|||||||||||||||||||||
|
Cooking Temperatures Recorded During the Data Collection (List all temperatures taken)
|
|||||||||||||||||||||
|
FOOD PRODUCT
|
FINAL COOK TEMP.
|
FOOD CODE CRITICAL LIMIT
|
CONSUMER ADVISORY
|
FOOD PRODUCT
|
FINAL COOK TEMP.
|
FOOD CODE CRITICAL LIMIT
|
CONSUMER ADVISORY
|
||||||||||||||
|
YES
|
NO
|
YES
|
NO
|
||||||||||||||||||
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||||||||||||
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||||||||||||
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||||||||||||
|
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|
|
|
||||||||||||
|
NUMBER OF FOOD PRODUCT TEMPERATURES
|
SUMMARY COOKING FOOD PRODUCT TEMPERATURE CATEGORIES
|
||||||||||||||||||||
|
|
I. – Number of product temperature measurements IN Compliance with Food Code critical limits
|
||||||||||||||||||||
|
|
II. – Number of OUT of Compliance product temperature measurements 1ºF - 2ºF below Food Code critical limits
|
||||||||||||||||||||
|
|
III. – Number of OUT of Compliance product temperature measurements 3ºF - 4ºF below Food Code critical limits
|
||||||||||||||||||||
|
|
IV. – Number of OUT of Compliance product temperature measurements 5ºF - 9ºF below Food Code critical limits
|
||||||||||||||||||||
|
|
V. – Number of OUT of Compliance product temperature measurements 10ºF or more below Food Code critical limits
|
||||||||||||||||||||
|
FOOD SAFETY MANAGEMENT SYSTEM ASSESSMENT
|
|||||||||||||||||||||
PROCEDURES |
TRAINING |
MONITORING |
||||||||||||||||||||
|
1 |
COMMENTS:
|
|
1 |
COMMENTS:
|
|
1 |
COMMENTS:
|
||||||||||||||
|
2 |
|
2 |
|
2 |
|||||||||||||||||
|
3 |
|
3 |
|
3 |
|||||||||||||||||
|
4 |
|
4 |
|
4 |
|||||||||||||||||
IN
|
OUT
|
NO
|
NA
|
|
|||||||||||||||
|
|
|
|
|
|||||||||||||||
IN
|
OUT
|
NO
|
NA
|
Description of Reheating Temperature OBSERVATIONS
|
|||||||||||||||
|
|
|
|
|
|||||||||||||||
|
|
|
|
|
|||||||||||||||
|
|
|
|
|
|||||||||||||||
COMMENTS:
|
|||||||||||||||||||
Reheating Temperatures Recorded During the Data Collection (List all temperatures taken)
|
|||||||||||||||||||
FOOD PRODUCT
|
FINAL REHEAT TEMP.
|
FOOD CODE CRITICAL LIMIT
|
FOOD PRODUCT
|
FINAL REHEAT TEMP.
|
FOOD CODE CRITICAL LIMIT
|
||||||||||||||
|
|
|
|
|
|
||||||||||||||
|
|
|
|
|
|
||||||||||||||
|
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||||||||||||||
|
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||||||||||||||
|
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||||||||||||||
|
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|
||||||||||||||
|
|
|
|
|
|
||||||||||||||
NUMBER OF FOOD PRODUCT TEMPERATURES
|
SUMMARY REHEATED FOOD PRODUCT TEMPERATURE CATEGORIES
|
||||||||||||||||||
|
I. – Number of product temperature measurements IN Compliance with Food Code critical limits
|
||||||||||||||||||
|
II. – Number of OUT of Compliance product temperature measurements 1ºF - 2ºF below Food Code critical limits
|
||||||||||||||||||
|
III. – Number of OUT of Compliance product temperature measurements 3ºF - 4ºF below Food Code critical limits
|
||||||||||||||||||
|
IV. – Number of OUT of Compliance product temperature measurements 5ºF - 9ºF below Food Code critical limits
|
||||||||||||||||||
|
V. – Number of OUT of Compliance product temperature measurements 10ºF or more below Food Code critical limits
|
||||||||||||||||||
FOOD SAFETY MANAGEMENT SYSTEM ASSESSMENT
|
|||||||||||||||||||
PROCEDURES |
TRAINING |
MONITORING |
|||||||||||||||||
|
1 |
COMMENTS:
|
|
1 |
COMMENTS:
|
|
1 |
COMMENTS:
|
|||||||||||
|
2 |
|
2 |
|
2 |
||||||||||||||
|
3 |
|
3 |
|
3 |
||||||||||||||
|
4 |
|
4 |
|
4 |
||||||||||||||
Other Areas of Interest (Items 11-19)
NOTE: This section will be used to develop data items that are not part of the primary research area for Retail Food Risk Factor Study but may provide important information that will assist other food safety initiatives within the agency
IN
|
OUT
|
NO
|
NA
|
|
|
|
|
|
|
IN
|
OUT
|
NO
|
NA
|
Description of OBSERVATIONS of Handwashing Facilities
|
|
|
|
|
|
|
|
|
|
|
COMMENTS:
|
||||
IN
|
OUT
|
NO
|
NA
|
|
|
|
|
|
|
IN
|
OUT
|
NO
|
NA
|
Description of Good Hygienic Practices OBSERVATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COMMENTS:
|
||||
IN
|
OUT
|
NO
|
NA
|
|
|
|
|
|
|
COMMENTS:
|
||||
IN
|
OUT
|
NO
|
NA
|
|
|
|
|
|
|
IN
|
OUT
|
NO
|
NA
|
Description of Time as a public health control OBSERVATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COMMENTS:
|
||||
IN
|
OUT
|
NO
|
NA
|
|
|
|
|
|
|
IN
|
OUT
|
NO
|
NA
|
Description of OBSERVATIONS for temperature control
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COMMENTS:
|
||||
IN
|
OUT
|
NO
|
NA
|
|
|
|
|
|
|
IN
|
OUT
|
NO
|
NA
|
Description of OBSERVATIONS of Specialized Processes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COMMENTS:
|
||||
IN
|
OUT
|
NO
|
NA
|
|
|
|
|
|
|
IN
|
OUT
|
NO
|
NA
|
Description of FOOD SOURCE OBSERVATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COMMENTS:
|
||||
IN
|
OUT
|
NO
|
NA
|
|
|
|
|
|
|
IN
|
OUT
|
NO
|
NA
|
Description of Toxic Materials OBSERVATIONS
|
|
|
|
|
|
|
|
|
|
|
COMMENTS:
|
||||
IN
|
OUT
|
NO
|
NA
|
|
|
|
|
|
|
IN
|
OUT
|
NO
|
NA
|
Description of Allergen Awareness OBSERVATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COMMENTS: |
||||
[DATE]
Dear Owner/Manager:
Your facility has been randomly selected as part of a nationwide research project designed to assess food preparation procedures and practices specific to the various segments of the retail food industry. The U.S. Food and Drug Administration (FDA) will use this research for identifying best practices within the industry and directing limited resources to areas that will provide the most significant public health benefits.
This is not a regulatory visit. Your participation is voluntary. No inspection report will be left with your facility. This is a research project designed to focus on the implementation of food safety procedures and practices within the retail food industry that are designed to protect the public health. The expected length of the data collection will be 90-120 minutes. Approximate 30 minutes of the data collection will focus on obtaining information on the nature of your operation.
Should an observation be made of a food safety procedure or practice that poses a significant public health risk, every effort will be made to work with you to ensure that the appropriate corrective action is taken to alleviate the hazard. Should a situation arise where a significant public health risk cannot be resolved during the data collection, the regulatory authority that has issued your permit will be contacted to work with you to ensure corrective action is taken.
An exit briefing will be provided at the end of the visit to discuss significant findings that may assist you in enhancing the effectiveness of your food safety system. If significant food safety issues are identified, they will be brought to the attention of the person-in-charge or responsible employee to determine the appropriate corrective action based on the current FDA Food Code. Your questions regarding the data collection process or food safety issues in general are encouraged as part of the visit to your facility.
Your facility’s name will not appear on any reports or public documents. The research project is designed to protect the privacy of participating establishments to the extent the law permits. The data collected is tabulated using broad industry segments and is not associated with any specific establishment.
FDA is responsible for providing technical assistance to approximately 75 state and territorial agencies and more than 2,300 local departments that assume primary responsibility for working with the industry on preventing foodborne illnesses. Beginning in 1998, FDA began collecting data related to direct observations made of food safety practices within institutional foodservice, restaurant, and retail food segments of the industry. From the data collected, FDA provides guidance to regulatory and industry food safety professionals to assist them in addressing food safety issues that have the most significant impact on protecting the public health.
FDA’s previous research studies can be accessed and downloaded from the following web link:
Public Reporting burden of this collection of information is estimated to average 73 minutes per response for the person in charge of a fast food restaurant, 106 minutes for the person of charge of a full service restaurant, and 30 minutes for the program director (or designated individual) of the regulatory authority. This includes the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., P150-400B, Rockville, MD 20850. PRAStaff@fda.hhs.gov. OMB Control #0910-0744. Expires August 13, 2015
Thank you for your willingness to cooperate in this important endeavor. It is through this type of cooperative effort that government and the food service industry seek to provide safe and wholesome food to the consuming public.
In the future, should you have any questions regarding this study or other food safety issues, please do not hesitate to contact me at [Specialist’s phone number].
Sincerely
[Specialist’s contact information]
| File Type | application/msword |
| Author | john.marcello |
| Last Modified By | Mizrachi, Ila |
| File Modified | 2015-07-30 |
| File Created | 2015-07-30 |