CDC-FDA Collaboration Matrix

ICR ATTACHMENT E

Sponsoring
Agency
Brief
Description
of Data
Collection
Activity

Matrix Comparing CDC and FDA Data Collection Initiatives

Foodborne Illness Risk Factor
Study
FDA
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This study collects data on the
occurrence of foodborne illness
risk factors in various retail and
foodservice facility types over
time.
This study examines potential
correlations between various
industry and regulatory
operational/policy variables and
risk factor control.

EHS-Net Food Safety Studies
CDC
These studies collect data that describes
retail food preparation and food safety
practices (with a focus on environmental
antecedents and risk factors associated
with foodborne illness) and examines
relationships between the retail
environment (e.g., establishment and
manager characteristics),food
preparation, and food safety practices.
The studies have focused on the
following retail food safety topics:
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Differences between outbreak and
non-outbreak restaurants
Beef handling practices
Chicken handling practices
Egg handling practices
Leafy greens handling practices
Tomato handling practices
Food cooling practices
Microwave practices
Beef grinding practices
Ill worker practices
Handwashing practices
Kitchen manager certification
Listeria prevention practices
Allergen management
Food worker practices

The National Outbreak
Reporting System (NORS)
CDC

National Environmental Assessment
Reporting System (NEARS)
CDC

This is a surveillance system that
collects reports of enteric illness
outbreaks caused by bacterial, viral,
parasitic, chemical, toxin, and
unknown agents, as well as
waterborne outbreaks of nonenteric illness. The focus is
epidemiologic and limited
laboratory data from enteric
foodborne illness, person to person
and animal disease outbreak
investigations. These data are
reported by the state
Epidemiologists and includes state
summaries of:

This is a surveillance system that collects
environmental data from foodborne
illness outbreak environmental
assessments conducted by
environmental health specialists/food
safety specialists (EHS/FSS) as part of an
outbreak investigation, focusing on retail
food service. Data is collected by
EHS/FSS and includes data from specific
retail and foodservice establishments’
foodborne illness outbreak
environmental assessments including:

• Date and location of outbreak
• Primary cases
o # lab confirmed (% by sex)
o # Probable cases (% by sex)
o Outcomes (by age group)
• Incubation period
• Signs and symptoms
• Etiology information
• Food Vehicle info
• Pathogen info
http://www.cdc.gov/nors/forms.ht
ml

• General outbreak information
• General information about the food
service establishment
• Information on policies and practices
from a manager interview
• Observations of food preparation and
the food service establishments
• Information on sampling
• Data on the implicated or suspected
food
o Characteristics of specific ingredients
and multi-ingredient foods
o Processes used for preparation
• Contributing factor data
https://www.cdc.gov/nceh/ehs/nears/

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Matrix Comparing CDC and FDA Data Collection Initiatives
Foodborne Illness Risk Factor Study

EHS-Net Food Safety Studies

FDA

CDC

Sponsoring
Agency
Purpose

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Objectives

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Assist the FDA with developing
retail food safety initiatives and
policies focused on the control
of foodborne illness risk factors.
Identify retail food work plan
priorities and allocate resources
to enhance retail food safety
nationwide.
Track changes in the occurrence
of foodborne illness risk factors
in retail and foodservice
establishments over time.
Inform recommendations to the
retail and foodservice industry
and state, local, tribal, and
territorial regulatory
professionals on reducing the
occurrence of foodborne illness
risk factors.

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Identify the foodborne illness
risk factors that are least and
most occurring during each data
collection period.
Determine whether the
occurrence of food safety
behaviors/practices in a food
establishment’s is impacted by
its’ risk categorization and/or

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Collect data that will help identify
and understand environmental
factors associated with foodborne
illness.
Translate findings into improved
prevention efforts.
Develop training for environmental
health specialists.
Strengthen collaboration among
epidemiology, laboratory, and
environmental health programs.

The National Outbreak
Reporting System (NORS)
CDC

National Environmental Assessment
Reporting System (NEARS)
CDC

Support reporting to CDC by local,
state, and territorial health
departments in the United States of
all enteric illness outbreaks
transmitted by food, contact with
environmental sources, infected
persons or animals, or unknown
modes of transmission and
waterborne illness outbreaks.

Identify factors that can be routinely
monitored by food safety programs to
prevent or reduce the risk for foodborne
outbreaks associated with foodservice
establishments.
Provide food safety program officials
with information to:
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Describe retail food establishment
food preparation and food safety
policies and practices.

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Determine how retail food
establishment and worker
characteristics are related to food
preparation and food safety policies
and practices.

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Better understand the human
health impacts of outbreaks.
Understand settings where
outbreaks occur.
Evaluate the causes and
contributing factors of
outbreaks.
Determine major modes of
transmission for agents that

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Take food safety actions and
assess effectiveness,
Support program evaluation,
Develop or modify program
policies or regulations based on
sound data,
Train environmental health
specialists about environmental
causes related to foodborne illness
outbreaks, and
Help prevent foodborne illness
outbreaks associated with
restaurants and other food venues
(such as banquet facilities, schools,
and other institutions).
Identify and monitor contributing
factors and their environmental
antecedents.
Establish a detailed characterization
of food vehicles and monitor food
vehicle trends.
Establish the basis for hypothesis
generation about environmental
factors that may contribute to

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Matrix Comparing CDC and FDA Data Collection Initiatives
Foodborne Illness Risk Factor Study

EHS-Net Food Safety Studies

FDA

CDC

Sponsoring
Agency
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Intended
Use of the
Data

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operational characteristics.
Examine whether potential
correlations exist between
elements within regulatory
retail food protection programs
and the occurrence of
foodborne illness risk factors
and food safety
behaviors/practices commonly
associated with foodborne
illness in retail.
Determine the extent to which
industry food safety
management systems and the
presence of certified food
protection manager impact the
occurrence of foodborne illness
risk factors.
Inform agency retail food safety
policies and initiatives.
Identify retail food work plan
priorities and allocate resources
to enhance retail food safety
nationwide.
Provide stakeholders with
information about changes in
the occurrence of foodborne
illness risk factors in retail and
foodservice establishments over
time.
Inform recommendations on
best practices and targeted
intervention strategies for the

The National Outbreak
Reporting System (NORS)
CDC

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The data will be used by CDC to develop
food safety prevention and intervention
recommendations for environmental
public health programs and the retail
food establishment industry.

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cause illness.
Help evaluate the burden of
waterborne and enteric illness
outbreaks in the United States
and its territories.
Develop guidance and
recommendations for
preventing future outbreaks.

To provide information about
national outbreak trends.
To learn lessons for preventing
future outbreaks.

National Environmental Assessment
Reporting System (NEARS)
CDC

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foodborne illness outbreak events.
Guide the planning, implementation,
and evaluation of food safety
programs.

• To understand how and why
foodborne illness outbreaks occur
 Identify contributing factors
causing foodborne illness
outbreaks
 Identify environmental
antecedents causing foodborne
illness outbreaks
• Provide science-based information for
hypothesis generation about
foodborne illness outbreaks
• Provide science-based information to
inform food safety policy and practice
recommendations
• Provide data to food safety programs

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Matrix Comparing CDC and FDA Data Collection Initiatives
Foodborne Illness Risk Factor Study

EHS-Net Food Safety Studies

FDA

CDC

Sponsoring
Agency

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How the
Collection
Informs the
Food
Protection
Efforts of
the Sister
Agency

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The National Outbreak
Reporting System (NORS)
CDC

retail and foodservice industry
and state, local, and tribal
regulators.
Track trends in the occurrence
of foodborne illness risk factors
over time.

The Risk Factor Study provides
valuable data on food safety
practices of concern (i.e.
practices that are not performed
at an acceptable level by food
employees); CDC can use these
data to help identify food safety
topics for its studies (i.e., topics
for which more detailed data
are needed, data that can
inform the development of
prevention and intervention
strategies).
Since NEARS does not conduct
case control studies to identify
what risk factors generally exist
in non-outbreak situations, CDC
can use data from the FDA Risk
Factor Study to identify the
current status of risk factor
occurrence in retail and
foodservice establishments of

National Environmental Assessment
Reporting System (NEARS)
CDC

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The Risk Factor Study is
comprehensive in nature, whereas
CDC’s studies have focused on
specific foods or food safety policies
and practices (e.g., handwashing).
The targeted nature of the data
received from CDC studies helps FDA
develop national strategies,
initiatives, guidance, and policy that
aim to reduce the occurrence of risk
factors that lead to foodborne illness
and outbreaks.
Changes in policy may result in
changes to the data collected as part
of the FDA Risk Factor Study.

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Information reported into
NORS helps FDA better
understand the human health
impacts of outbreaks and the
specific setting where
outbreaks occur.
Understanding the causes and
contributing factors to
outbreaks and the major
modes of transmission for
agents that cause illness helps
FDA in developing guidance,
recommendations, and policy
for preventing future
outbreaks.
Information on the burden of
foodborne illness outbreaks in
the U.S. helps FDA leverage for
more resources.

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about time and resources used in
foodborne illness outbreak
investigations.
Share data with epidemiology and
laboratory programs involved in
outbreak investigations and use data as
part of the larger outbreak
investigation that might include any
combination of local, state and federal
food safety officials depending on the
outbreak.
NEARS collects data on contributing
factors and environmental
antecedents directly contributing to
a specific outbreak in retail and
foodservice establishments.
This data helps FDA understand the
behaviors and practices that
commonly lead to foodborne illness
outbreaks at the retail level.
Information on environmental
antecedents helps FDA understand
the reasons why FDA recommended
policies and practices are not always
followed.
FDA may use contributing factor and
environmental antecedent data from
NEARS to develop science-based
national strategies, initiatives,
guidance, and policies aimed at
reducing the occurrence of risk
factors that lead to foodborne illness
and outbreaks.

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Matrix Comparing CDC and FDA Data Collection Initiatives
Foodborne Illness Risk Factor Study

EHS-Net Food Safety Studies

FDA

CDC

Sponsoring
Agency

The National Outbreak
Reporting System (NORS)
CDC

similar type to the outbreak
establishments. These data can
help CDC and FDA understand if
what is seen in outbreak
establishments is different from
the situations commonly seen in
the general population of retail
and foodservice establishments.
Food Chain
Sector
(Retail,
Manufactured Food,
Multiple
Commodity
Areas,
Consumers,
Farm,
Other?)

Retail

National Environmental Assessment
Reporting System (NEARS)
CDC
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Retail

NORS does not focus on a specific
food chain sector. Information
related to a food chain sector might
be collected as part of the outbreak
investigation, but it is not
specifically reported into NORS
unless it is put in a Notes section.

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Provides guidance to FDA on CDC’s
current terminology and
categorization related to foodborne
illness risk factors. FDA seeks to
report results from its Study on the
occurrence of foodborne illness risk
factors using terminology and
categorization that is consistent with
CDC.
Currently, NEARS focuses on
collecting data in food service
establishments and retail food
stores.
NEARS can also be used to collect
data from other types of food chain
sectors if outbreak information is
collected.

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Matrix Comparing CDC and FDA Data Collection Initiatives

Sponsoring
Agency
Data Collection
Type (e.g. study,
surveillance
system – active or
passive, etc.)
Data Collectors/
Providers
Entities from
which the data is
collected
(restaurants,
grocery stores,
regulators,
epidemiologists,
etc.)

Data Collection
Method (e.g. field
collection
(interview or
observation), selfreporting (net
survey)

Foodborne Illness Risk Factor Study

EHS-Net Food Safety Studies

The National Outbreak
Reporting System (NORS)

FDA

CDC

CDC

National Environmental
Assessment Reporting System
(NEARS)
CDC

Study

Study

Surveillance system (passive)

Surveillance system (passive)

Approximately 25 FDA Retail Food
Specialists standardized by FDA
Center for Food Safety and Applied
Nutrition (CFSAN)
Restaurants, Institutional
Foodservice, and Retail Food Stores

EHS-Net Food Research Sites (current
sites: CA, MN, NY State, NY City, RI, TN,
Harris County Texas, Southern Nevada
Health District)
Restaurants (with the exception of the
Listeria study, for which entities were
retail delis)

State Epidemiologists

State and local food safety
program officials conducting
foodborne illness outbreak
environmental assessments
Any retail or foodservice
establishment that has been
implicated or is suspected of being
involved in an outbreak.

Field collection (interviews,
observations, record/SOP reviews)

Field collection (interviews, surveys,
observations)

Data is collected from individuals
who are sick by state and local
epidemiologist. The data in this
surveillance system is
epidemiologic data. It represents
a summary of the state
epidemiologic data including
total number of ill, pathogen(s)
implicated in the outbreak, and
where potential exposures
happened as determined by the
outbreak investigation.
Data is reported by state
epidemiologists and is a summary
of the outbreak investigation
epidemiologic and laboratory
data

Data is voluntarily reported by
environmental health specialist at
the local and state levels.
Environmental health specialists in
food safety programs focus on
collecting environmental factor
data during foodborne illness
outbreak investigations during
environmental assessments. The
environmental factors identified

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Matrix Comparing CDC and FDA Data Collection Initiatives
Foodborne Illness Risk Factor Study

EHS-Net Food Safety Studies

The National Outbreak
Reporting System (NORS)

FDA

CDC

CDC

Sponsoring
Agency

National Environmental
Assessment Reporting System
(NEARS)
CDC
during these environmental
assessment activities include
contributing factors and
environmental antecedents.
These data identify how and why
the food became contaminated
with pathogens and how and why
these pathogens were not
eliminated before ingestion.
Environmental assessments
typically involve: interviews with
food service establishment
managers to determine
characteristics of the
establishment and food safety
policies and practices; interviews
with food preparers to determine
their individual food handling
practices, hygiene practices, and
other circumstances review of
records on food source, shipping
and handling; observations of food
preparation and handling practices
and environmental sampling
(samples from floors, food
preparation equipment, etc.).

Sample
Methodology
(describe random
selection and

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Sample is drawn from a
geographical information system
(GIS) database containing a
listing of businesses throughout

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The respondent universe is all
eligible (eligibility criteria varies for
each study) retail food
establishments in selected

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No sampling is conducted.
States are encouraged to
report all foodborne illness
outbreaks that are

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No sampling is conducted.
Data on all outbreaks
occurring in the jurisdictions
of participating food safety

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Matrix Comparing CDC and FDA Data Collection Initiatives

Sponsoring
Agency
scope/
representative
nature of the
establishments
included in the
data collection)

Foodborne Illness Risk Factor Study

EHS-Net Food Safety Studies

The National Outbreak
Reporting System (NORS)

FDA

CDC

CDC

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the U.S.
FDA performs a series of
filtering steps to ensure
establishments are classified
into the appropriate facility type
defined by the study and are
considered eligible to
participate.
Risk categorization is used to
help determine eligibility -- To
further determine the pool of
establishments eligible for
selection, establishments that
handle only pre-packaged food
items or conduct low-risk food
preparation activities are
excluded.
The data collectors (i.e.
Specialists) are located near
major metropolitan areas (i.e.
population centers) across the
contiguous United States.
Population centers usually
contain a large concentration of
state and local regulatory
jurisdictions.
Eligible establishments are
randomly selected from among
all establishments located
within a 150-mile radius of each
of the Specialists’ home
locations (zip codes).
Using the 150 mile radius

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jurisdictions in the EHS-Net sites.
Currently, there are 8 EHS-Net sites
(CA, MN, NY, NYC, RI, TN, Harris
County TX, Southern Nevada Health
District).
For each study, each EHS-Net site
selects the jurisdictions in which
they will collect data for the study.
Based on convenience, the
jurisdictions are usually the counties
within driving distance of the EHSNet site office. Each site then sends a
list of all establishments in those
jurisdictions to the CDC. The CDC
then draws a random sample of
establishments from those lists for
each site. For most studies, each
site collects data in 40-50
establishments, totaling to 320-400
establishments per study.
While the number of areas included
in EHS-Net is small, they are
demographically diverse and provide
good geographical coverage of the
U.S. (northeast, mid-west, south,
and west). The results of the EHSNet studies can be used to
generalize to the population of retail
food establishments in the EHS-Net
sites. Furthermore, the geographic

National Environmental
Assessment Reporting System
(NEARS)
CDC

investigated.

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programs will be reported to
NEARS. Thus, we will be
utilizing a convenience sample
of voluntary participating
programs and not obtaining a
statistical sample.
The data reported through
this system are collected
primarily from foodborne
illness outbreak
environmental assessments.
Specifically, data collected by
regulatory programs during
their investigation of
foodborne illness outbreaks.

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Matrix Comparing CDC and FDA Data Collection Initiatives
Foodborne Illness Risk Factor Study

EHS-Net Food Safety Studies

The National Outbreak
Reporting System (NORS)

FDA

CDC

CDC

Sponsoring
Agency

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Data Collection
Tool Used

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sampling zones provides a
relatively good cross section of
urban and rural areas from
which to sample the eligible
establishments. It also
represents a good mix of small,
medium, and large regulatory
entities having jurisdiction over
the eligible establishments.
For the first restaurant data
collection period (2013-2014),
the sample was drawn from
approximately 62% of all
restaurant establishments in the
contiguous U.S.
425 fast food restaurant and
396 full service restaurant data
collection inspections per facility
type yielded sufficient
observations to be 95%
confident that the compliance
percentage is within 5% of the
true compliance percentage.
A single data collection form is
used to capture general
information about the
establishment and regulatory
authority; food employees’
behaviors and practices related
to 19 data items related to
personal hygiene and food
storage, preparation, and
service; the industry food safety

National Environmental
Assessment Reporting System
(NEARS)
CDC

and demographic variability across
these sites suggests that CDC may be
able to use data collected from these
studies to draw conclusions that are
likely relevant to establishments in
other parts of the U.S.

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Interview, observation, and survey
forms are part of protocol
development for each EHS-Net
study. The FDA Food Code
recommendations are used as the
standard for all EHS-Net studies.
Data are reported electronically to
CDC through the Environmental
Health Specialists Network
Information System (EHSNIS)

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NORS has a specific set of
general outbreak
classification questions and a
specific food section to be
completed for any
foodborne illness outbreak.
Data include:

• Primary mode of transmission
• Investigation methods

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Environmental Assessments
are dependent on the specific
outbreak investigation and
there is not a specific tool that
can be used to conduct an
environmental assessment
during a foodborne illness
outbreak. NEARS includes
systematic data that should
be collected and processed

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Matrix Comparing CDC and FDA Data Collection Initiatives

Sponsoring
Agency

Foodborne Illness Risk Factor Study

EHS-Net Food Safety Studies

The National Outbreak
Reporting System (NORS)

FDA

CDC

CDC

management being employed;
and the frequency of food
employee hand washing. The
most current version of the FDA
Food Code is used as a basis for
assessing control of each of the
data items. The compliance
status of the data items is
recorded IN Compliance, OUT of
Compliance, Not Observed, or
Not Applicable, based on
marking instructions provided to
the data collectors.

Resources (Web
links, etc.)

http://www.fda.gov/Food/Guidance
Regulation/RetailFoodProtection/Fo
odborneIllnessRiskFactorReduction/
ucm2006816.htm

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Dates
Primary case data
Incubation data
Signs and symptoms
Secondary cases
Recall and traceback
Reporting agency
Etiology
Samples
Exposure
Food

http://www.cdc.gov/nors/pdf/N
ORS_CDC_5213.pdf

https://www.cdc.gov/nceh/ehs/ehsnet/f
oodsafety.htm

http://www.cdc.gov/nors/about.
html

National Environmental
Assessment Reporting System
(NEARS)
CDC
during an outbreak
investigation
• NEARS incudes :
o General Information on
the outbreak and the
food establishment
o Data from manager
interviews
o Data from observations
o Data about the implicated
food(s)
o Data from sampling
o Data about contributing
factors
• NEARS does have a
standardized manager
interview that represents the
minimum information that
should be collected to
describe current policies and
practices in the establishment
• Data are reported
electronically to CDC through
the Environmental Health
Specialist Network
Information System (EHSNIS).
https://www.cdc.gov/nceh/ehs/ne
ars/

SUMMARY
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Matrix Comparing CDC and FDA Data Collection Initiatives

CDC and FDA have discussed how our respective studies and surveillance systems inform and influence one another. Each of our studies and/or
surveillance systems collects unique, but related, information that is vital to informing policy and intervention strategy development to reduce
foodborne illness at the retail level. For example:
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CDC uses data from FDA’s Risk Factor Study to help identify food safety topics for its studies (i.e. topics for which more detailed data are
needed to develop prevention and intervention strategies).
Since NEARS collects information on outbreak establishments only, CDC uses data from FDA’s Risk Factor Study to identify the current status of
risk factor occurrence in non-outbreak establishments of similar type to the outbreak establishments. These data help CDC and FDA
understand if what is seen in outbreak establishments is different from the situations commonly seen in the general population of retail and
foodservice establishments.
Data collected through NEARS identifies contributing factors of particular concern (e.g., the most common contributing factors; contributing
factors that increase over time). FDA then ensures that its data collection focuses on these factors. Conversely, data collected through the FDA
Factor Study identifies factors that may need to be focused on in NEARS.

CDC and FDA plan to conduct joint annual reviews of the data collected through our various data collections systems. These reviews will be used to
determine if changes are needed to future information collections to ensure the data collected are optimal to meet our collective needs and missions
to reduce foodborne illness.
DEFINITIONS
Foodborne Illness Environmental Assessment: The systems-based component of an outbreak investigation that fully describes how the environment
contributed to the introduction and/or transmission of agents that cause illness or could cause illness. Environment is everything external to the host,
including air, food, water, animals, plants, climate, etc., as well as people and the social and built environments. All aspects of the external
environment can be listed as variables that, in relation to transmission, are neutral, conducive, or protective. From this description, contributing
factors and environmental antecedents to an outbreak can be determined.
Contributing Factor: A factor that directly or indirectly cause an outbreak or likely caused an outbreak by contributing to contamination and survival
of the etiologic agents or suspected agents and possibly supporting their growth or proliferation. A contributing factor can be biological, behavioral, or
attitudinal; or an element of the physical or social environment; or the result of policies related to the problem. Contributing factors are what
happened to cause a foodborne outbreak. Based on data from previous outbreaks, FDA and CDC have developed a list of contributing factors and
have grouped them into three categories:
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Matrix Comparing CDC and FDA Data Collection Initiatives

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Contamination factor - A factor related to how the agent got onto or into the food vehicle. These are associated with contamination of food
with foodborne illness pathogens (e.g., a worker with a foodborne illness handles ready-to-eat food bare-handed and contaminates the food
with pathogens).
Proliferation factor - A factor relate to how microbial agents are able to increase in numbers and/or produce toxic products before the vehicle
is ingested. These are associated with proliferation of foodborne illness pathogens in food (e.g., cold food is not held at a temperature cold
enough to prevent proliferation of pathogens)
Survival factor- A factor related to processes or steps that should have eliminated or reduced an agent (pathogen) in the food. These are
associated with survival of foodborne illness pathogens in food (e.g., raw meat is not cooked to a temperature hot enough to kill the
pathogens with which it is contaminated)

Environmental Antecedents: Supporting factor(s) leading to the contamination, survival, or increase of biological or chemical agents in food. They
may be related to people, equipment, food process, food type, economics, or other circumstances. In other words, environmental antecedents are the
reason why contributing factors occur. Environmental antecedents are sometimes referred to as root causes of outbreaks.
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Economic environmental antecedents are those associated with the costs and profit margins of food facilities. For example, poor profit margins
may contribute to inadequate staffing, training or equipment maintenance.
Equipment environmental antecedents are those associated with the physical layout and equipment of food facilities. For example, poor
equipment maintenance can lead to food being stored and cooked at improper temperatures.
Food environmental antecedents are those associated with the inherent qualities of food, such as, pH levels, texture, and viscosity. For
example, the texture of leafy greens makes them difficult to clean; the thickness of some foods may require specialized cooling practices for
those foods.
People environmental antecedents are those associated with the individuals working in food facilities and the food safety culture in which they
work. Examples of people antecedents include workers’ cultural background, gender, education, experience, and food safety attitudes.
Examples of food safety culture antecedents include management emphasis on food safety and reinforcement of safe food preparation
through reward or punishment systems.
Process environmental antecedents are those associated with the characteristics of the processes used to grow, store, prepare, and cook food.
For example, the complexity of the food process (i.e., how many steps are involved in the process) is associated with food safety risk.

Foodborne Illness Risk Factors: The CDC Surveillance Report for 1998 - 2002 identified the most significant contributing factors to foodborne disease
outbreaks in which contributing factors were reported during that period. Five of these broad categories of contributing factors directly relate to food
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Matrix Comparing CDC and FDA Data Collection Initiatives

safety concerns in retail and foodservice establishments and are collectively termed by FDA as “foodborne illness risk factors.” The foodborne illness
risk factors are:
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Food from Unsafe Sources.
o Food is not received from safe sources.
Inadequate Cooking Temperatures.
o Raw animal foods are not cooked to required temperatures.
o Cooked foods are not reheated for hot holding to the required temperatures.
Improper Holding Temperatures.
o Foods requiring refrigeration are not held at the proper temperature.
o Foods displayed or stored hot are not held at the proper temperature.
o Foods are not cooled properly.
o Refrigerated, ready-to-eat foods are not properly date marked and/or discarded within 7 days of preparation or opening.
Contaminated Equipment/Protection from Contamination.
o Food is not protected from cross-contamination during storage, preparation, and display.
o Food contact surfaces are not properly cleaned and sanitized.
Poor Personal Hygiene.
o Employees do not practice proper handwashing.
o Food employees contact ready-to-eat foods with bare hands.
o Food employees working when ill.

FDA RISK FACTOR STUDY VS. CDC RESTAURANT FOOD SAFETY STUDIES
Similarities
Both the FDA Risk Factor Study and the CDC Restaurant Food Safety Studies collect standardized data on retail food establishment food safety
practices/risk factors. Both agencies’ studies are valuable in that they provide real-world data that identify retail food establishment food safety issues
and environmental factors (e.g., establishment and manager characteristics) associated with these issues. These data are critical to foodborne illness
prevention and intervention efforts.
Differences
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Matrix Comparing CDC and FDA Data Collection Initiatives

There are some important differences between the design and objectives of the FDA’s Risk Factor Study and CDC’s Restaurant Food Safety Studies.
Specifically:
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•
•
•

The FDA study collects targeted, but limited, data on a wide range of food safety practices/risk factors, while each CDC study collects extensive,
detailed data on one specific food safety practice, risk factor, or food.
The FDA study collects longitudinal data (series of observations more than once in the same study population over a period of time) while the
CDC studies are typically only cross-sectional (involves analysis of data collected from a population in one specific point in time).
The FDA study collects data in a wide range of retail food establishment types, while the CDC studies collect data in restaurants and delis only
(as these establishment types account for half of all foodborne illness outbreaks).
The FDA Study attempts to characterize food safety practices in food establishments across the continental United States and therefore
collects data from a geographically diverse sample. CDC studies typically gather data from a smaller geographic location, such as from a single
state or a limited number of regulatory jurisdictions.

FDA RISK FACTOR STUDY VS. CDC SURVEILLANCE SYSTEMS
FDA’s Risk Factor Study measures the occurrence of practices and behaviors commonly identified as contributing factors to foodborne illness
outbreaks in retail and foodservice establishments. The retail and foodservice establishments from which data are collected are selected randomly
without consideration of their involvement in a foodborne illness outbreak. The FDA Risk Factor Study provides data on practices and behaviors that
occur on a normal, day-to-day basis in a wide range of retail establishment types. The data from this study allow FDA to identify risk factors most in
need of intervention efforts, as well as assess trends in the occurrence of risk factors over time. The data collected are representative of real-time
conditions in the establishment.
In contrast, NEARS collects data on contributing factors and environmental antecedents directly contributing to a specific outbreak in retail and
foodservice establishments. NEARS provides data on practices and behaviors that occur in a foodborne illness outbreak.

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