Voluntary Hazard Analysis and Critical Control Point Manuals for Operators and Regulators of Retail and Food Service Establishments

Managing Food Safety:
A Regulator’s Manual
For Applying HACCP
Principles to Risk-based
Retail and Food Service
Inspections and
Evaluating Voluntary Food
Safety Management
Systems
Additional copies are available from:
Office of Compliance
Division of Cooperative Programs (HFS-625)
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
(Tel) 301-436-2350
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
[April 2006]
OMB Control No. 0910-0578
Expiration Date: 03/31/2009
See additional PRA statement in Annex 8 of this manual

Managing Food Safety: A Regulator’s Manual For Applying HACCP
Principles to Risk-based Retail and Food Service Inspections and
Evaluating Voluntary Food Safety Management Systems
Table of Contents
CHAPTER 1

INTRODUCTION............................................................................... 1

PURPOSE AND SCOPE................................................................................................. 1
BACKGROUND .............................................................................................................. 2
What are Foodborne Illness Risk Factors? ................................................................ 2
What is Meant by Active Managerial Control?............................................................ 3
How are HACCP Principles Being Used in Retail and Food Service?........................ 4
SUMMARY...................................................................................................................... 5
CHAPTER 2

CONDUCTING RISK-BASED INSPECTIONS .................................. 6

THE FOCUS OF RISK-BASED INSPECTIONS.............................................................. 6
SETTING THE EXAMPLE............................................................................................... 7
ESTABLISHING INSPECTION PRIORITIES .................................................................. 8
Establishing an Open Dialogue with the Person In Charge........................................ 8
Reviewing Previous Inspection Reports ..................................................................... 9
Conducting a Menu/Food List Review........................................................................ 9
Conducting a Quick Walk-Through........................................................................... 10
EVALUATING EXISTING FOOD SAFETY MANAGEMENT SYSTEMS ....................... 11
DETERMINING PROCESS FLOWS ............................................................................. 12
THE HAZARD ANALYSIS............................................................................................. 14
DETERMINING RISK FACTORS IN PROCESS FLOWS ............................................. 15
Facility-wide Considerations..................................................................................... 16
Food Preparation Process 1..................................................................................... 16
Food Preparation Process 2..................................................................................... 17
Food Preparation Process 3..................................................................................... 18
ASSESSING ACTIVE MANAGERIAL CONTROL OF RISK FACTORS ....................... 19
EVALUATING BASIC SANITATION AND FACILITIES................................................. 19
SUMMARY.................................................................................................................... 20
CHAPTER 3

INTERVENTION STRATEGIES ...................................................... 21

THE ROLE OF INTERVENTION STRATEGIES IN COMPLIANCE AND
ENFORCEMENT...................................................................................................... 21
ON-SITE CORRECTION............................................................................................... 22
DETERMINING THE APPROPRIATE ON-SITE CORRECTION .................................. 23
Limitations of Reheating as an On-site Correction .................................................. 24
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LONG-TERM COMPLIANCE ........................................................................................ 27
Equipment and Layout ............................................................................................. 27
Buyer Specifications................................................................................................. 28
Recipe/Process Instructions..................................................................................... 28
First-In-First-Out (FIFO) ........................................................................................... 28
Standard Operating Procedures (SOPs) .................................................................. 28
Risk Control Plans (RCPs) ...................................................................................... 29
Voluntary Food Safety Management Systems based on HACCP Principles ........... 30
SUMMARY.................................................................................................................... 30
CHAPTER 4

REVIEWING VOLUNTARY FOOD SAFETY
MANAGEMENT SYSTEMS................................................................. 31

VOLUNTARY FOOD SAFETY MANAGEMENT SYSTEM BASED ON HACCP
PRINCIPLES ............................................................................................................ 31
VALIDATION................................................................................................................. 32
FIELD VERIFICATION .................................................................................................. 35
THE VERIFICATION PROCESS .................................................................................. 35
Step 1 - Document Review....................................................................................... 36
Step 2 - Record Review ........................................................................................... 36
Special Considerations Regarding Records............................................................. 38
Step 3 - On-site Verification ..................................................................................... 39
Verification Report.................................................................................................... 40
SUMMARY.................................................................................................................... 40
GLOSSARY .................................................................................................................. 41
ANNEX 1

REFERENCES .................................................................................. 46

ANNEX 2

SAMPLE HACCP TABLES ................................................................ 53

ANNEX 3

HAZARD ANALYSIS.......................................................................... 59

ANNEX 4

FOOD SAFETY QUESTIONS............................................................ 68

ANNEX 5

SAMPLE RISK CONTROL PLAN ...................................................... 71

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ANNEX 6

SUGGESTED INTERVENTION STRATEGIES FOR
OUT-OF-CONTROL PROCEDURES................................................. 75

ANNEX 7

VERIFICATION INSPECTION CHECKLIST ...................................... 76

ANNEX 8

PAPERWORK REDUCTION ACT OF 1995 ...................................... 81

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Chapter 1 - Introduction

PURPOSE AND SCOPE
There is no doubt that you, the state, local, or tribal health inspector, play a significant
role in reducing foodborne illness in your jurisdiction, yet your job can be overwhelming
at times due to diminishing resources, increasing workload with limited staff, and
growing liability. Many of you are continually forced to reassess your priorities due to
increased media attention on food safety, threats from emerging pathogens, and food
security, while being challenged to do more with less while maintaining your
professional integrity.
Although the majority of these challenges are beyond your
control, the allocation of your inspectional time is one
element that you can change and continue to use to your
advantage. You may undoubtedly become frustrated when
you find the same violation at the same establishment,
inspection after inspection. You may be able to change this
pattern by focusing your inspection on the violations most
likely to cause foodborne illness and by assisting retail and
food service operators in the development or enhancement
of food safety management systems to reduce the recurrence
of these violations.
This Manual provides you with a manageable scheme for prioritizing your inspections
using a risk-based approach. The traditional regulatory inspection places emphasis on
assessing compliance with all applicable regulations. The same emphasis may be
placed on structural violations of the code as those violations likely to lead to foodborne
illness. Although this type of inspection has done a great deal to improve basic
sanitation and to upgrade food facilities in the United States, it emphasizes reactive
rather than preventive measures. The traditional regulatory inspection only seeks to
obtain correction of food safety concerns that already exist, rather than to prevent future
violations from occurring.
Each individual in the food chain from farmer to processor
to retailer to consumer has some responsibility for food
safety. The ultimate responsibility for food safety at the
retail level lies not with the regulatory authority but with
retail and food service operators and their ability to develop
and maintain effective food safety management systems.
Nevertheless, you can help industry with this responsibility
by utilizing a risk-based inspection approach to identify

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strengths and weaknesses in their systems and suggesting possible
solutions for improvement during inspections.
This Manual was written to provide a "roadmap" for evaluating retail
and food service establishments based on the application of HACCP
principles. The acronym “HACCP” stands for “Hazard Analysis and
Critical Control Point.” It is a preventive approach implemented by
industry to control food safety hazards. Using HACCP principles
during inspections will help to assist you in evaluating the effectiveness
of food safety management systems implemented by industry.
The voluntary strategies presented in this Manual also foster food
safety partnerships between you and your retail or food service operators, which will
facilitate your active role in improving their existing food safety management systems.
Please note that this Manual is not a comprehensive resource for learning about
HACCP principles; therefore, you should have a basic understanding of the principles of
HACCP before using this Manual. Annex 1 lists several resources that are available to
you should you require a more comprehensive explanation of HACCP.
Many regulatory jurisdictions are already conducting risk-based inspections using
HACCP principles and other innovative approaches. This Manual is based on
experience gained from many of these approaches and is provided to you, the
regulatory food safety professional, to help you enhance the effectiveness of your
inspections by incorporating a risk-based approach.

BACKGROUND
What are Foodborne Illness Risk Factors?
In an ideal world, determining the effectiveness of a retail and food service regulatory
program would be based on the occurrence of foodborne illness within that jurisdiction.
The occurrence of foodborne illness is, however, underreported, making it an unreliable
program measurement. As an alternative, the occurrence of foodborne illness risk
factors can be used to gauge program effectiveness.
The Centers for Disease Control and Prevention (CDC) Surveillance Report for 19931997, “Surveillance for Foodborne-Disease Outbreaks – United States,” identifies the
most significant contributing factors to foodborne illness. Five of these broad categories
of contributing factors directly relate to food safety concerns within retail and food
service establishments and are collectively termed by the FDA as “foodborne illness risk
factors.”

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The foodborne illness risk factors are:
•
•
•
•
•

Food from Unsafe Sources
Inadequate Cooking
Improper Holding Temperatures
Contaminated Equipment
Poor Personal Hygiene

Until recently, there were no standardized, systematically-compiled statistics for the
incidence of occurrence of foodborne illness risk factors in retail or food service
facilities. As a result, implementation of food safety management systems designed to
improve conditions leading to out-of-control risk factors was difficult.
In 2000, FDA completed a project designed to fill this information void and published its
results in the Report of the FDA Retail Food Program Database of Foodborne Illness
Risk Factors. The report, commonly referred to as the “FDA Baseline Report,” is
provided to regulators and industry with the expectation that it will be used to focus
greater attention and increased resources on the control of risk factors. A copy of the
report is available from FDA through the following website:
http://www.cfsan.fda.gov/~dms/retrsk.html.
The measurable trends identified in CDC’s 1993 - 1997 Surveillance Report and in
FDA’s Baseline Report indicate that routine regulatory inspections should place an
increased focus on assessing an establishment’s active managerial control over the five
CDC-identified risk factors.

What is Meant by Active Managerial Control?
The term “active managerial control” is used extensively throughout this
Manual to describe industry’s responsibility for developing and
implementing food safety management systems to reduce the
occurrence of foodborne illness risk factors. Although the term may be
new to some, the basic management principles are probably already
being used in the day-to-day operations of most of the establishments
you regulate.
Active managerial control means the purposeful incorporation of specific
actions or procedures by industry management into the operation of
their business to attain control over foodborne illness risk factors. It
embodies a preventive rather than reactive approach to food safety
through a continuous system of monitoring and verification.
There are many tools that can be used by industry to provide active managerial control
of risk factors. Elements of an effective food safety management system may include
the following:

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•
•
•
•
•
•
•
•
•
•
•

Certified food protection managers who have shown a proficiency of required
information by passing a test that is part of an accredited program
Standard operating procedures (SOPs) for performing critical operational steps in
a food preparation process such as cooling
Recipe cards that contain the specific steps for preparing a food item and the
food safety critical limits such as final cooking temperatures that need to be
monitored and verified
Purchase specifications
Equipment and facility design and maintenance
Monitoring procedures
Record keeping
Employee health policy for restricting or excluding ill employees
Manager and employee training
On-going quality control and assurance
Specific goal-oriented plans, like Risk Control Plans (RCPs), that outline
procedures for controlling specific foodborne illness risk factors

How are HACCP Principles Being Used in Retail and Food Service?
For several decades, food safety professionals have recognized the importance of
HACCP principles for controlling risk factors that directly contribute to foodborne illness.
Within the retail and food service industries, the implementation of these science-based
food safety management principles varies.
Many multi-unit corporations and institutions, as well as independent operators, have
developed effective food safety management systems that incorporate the seven
principles of HACCP. The FDA document, "Managing Food Safety: A Manual for the
Voluntary Implementation of HACCP Principles for Operators of Food Service and
Retail Establishments,” is designed to aid industry in establishing effective, voluntary
food safety management systems based on the principles of HACCP. The manual is
available from FDA through the following website:
http://www.cfsan.fda.gov/~dms/hret2toc.html.
The products made in retail and food service operations are as varied as the methods
and processes used to make them. The resources available to retail and food service
operators to help them with identifying and controlling the risk factors particular to their
operations also vary. Due to this diversity, implementation of “textbook HACCP” is
impractical in most retail and food service operations.
Like many other quality assurance programs, the principles of HACCP provide a
common-sense approach to identifying and controlling “problems.” Consequently,
many food safety management systems at the retail level incorporate some, if not all, of
the principles of HACCP. Given the diversity of retail and food service operations,
however, it is important for you to recognize that there is more than one “correct”
application of HACCP principles. Regulatory inspection programs must be flexible
4

enough to operate in a complementary and effective manner in this dynamic retail
environment.
The DRAFT FDA Voluntary National Retail Food Regulatory Program Standards
establish a framework that regulatory agencies can use to –
•
•
•

Design and manage a comprehensive, risk-based retail food safety program
Provide direction and focus on the causative factors of foodborne illness based
on HACCP principles
Reinforce sanitation, operational, and environmental prerequisite programs

The complete set of Program Standards is available from FDA through the following
website: http://www.cfsan.fda.gov/~dms/ret-toc.html.

SUMMARY
The ultimate responsibility for food safety at the retail level lies with retail and food
service operators and their ability to develop and maintain effective food safety
management systems. The goal of this Manual is to provide you with a practical,
HACCP-based approach to evaluate industry’s active managerial control of foodborne
illness risk factors. It is essential that regulatory program managers design an
inspection program based on HACCP principles that guides and supports their field staff
in assisting operators with incorporating these principles into their routine activities.
Since food safety management systems are designed by retail and food service
operators to best meet their own needs, you will need to use a risk-based methodology
during your inspections to uncover the systems being used and to evaluate their
effectiveness.

5

Chapter 2 – Conducting Risk-based Inspections

Regardless of the resource limitations you may have, you can still use the principles of
HACCP to guide your inspections. Many of you already have the technical food safety
knowledge needed to effectively use a HACCP approach.
For the purposes of this discussion, “hazards” are defined as the specific biological,
chemical, or physical properties or agents that, if uncontrolled, may lead to illness or
injury. Risk factors are the poor conditions, procedures, or practices that result in outof-control food safety hazards. As stated in Chapter 1, risk factors include –
•
•
•
•
•

Food from Unsafe Sources
Inadequate Cooking
Improper Holding Temperature
Contaminated Equipment
Poor Personal Hygiene

THE FOCUS OF RISK-BASED INSPECTIONS
Conducting a risk-based inspection requires you to focus on
evaluating the degree of active managerial control that an operator
has over risk factors. In order for you to properly assess active
managerial control, you will need to spend the majority of your time
observing the practices and procedures that are likely to lead to outof-control risk factors and asking food workers questions to assess
the operation.
Retail and food service operators implement “control measures” to ensure food safety.
Control measures are actions or activities that are used to prevent, eliminate, or reduce
food safety hazards. You will need to determine the control measures that should be
implemented to prevent the occurrence of risk factors in each food preparation process.
In order to determine the risk factors common to each operation, it is important for you
to understand that the food preparation processes and all the associated control
measures initiated by a retail or food service operator represent a food safety
management system. It will be necessary for you to ask questions in order to gain
information about the system already in place. Once you have done this, you will be
able to determine the degree of active managerial control present in the facility and will
be able to assist the operator in strengthening the system.

6

SETTING THE EXAMPLE
In focusing your inspection, it is important for you to realize that your nonverbal
communication is just as important as your verbal communication in relaying important
food safety messages to retail and food service operators. You set the example for
them to follow during all phases of your inspection. The following are ways that you set
the example:
•

•
•
•
•
•

Washing your hands when entering the food
preparation area at the beginning of the inspection and
after engaging in any activities that might contaminate
your hands
Not working when you are suffering from symptoms
such as diarrhea, fever, vomiting, or jaundice or if you
are diagnosed with a disease transmittable by food
Being careful not to touch ready-to-eat (RTE) food with
your bare hands
Washing and sanitizing your thermocouple probe at
the start of the inspection and between taking
temperatures of foods
Using a proper hair restraint and practicing good
personal hygiene
Being careful not to contaminate clean and sanitized food contact surfaces with
unclean hands or your inspection equipment

As an experienced food safety professional, you already demonstrate these personal
practices in each of your inspections. You will need the additional support of your
program management, however, in providing you with state-of-the-art equipment
needed to perform a risk-based inspection. Utilizing the proper equipment
demonstrates competency and preparedness to the operator and may convince the
operator to also use the appropriate equipment. For instance, when you check the
temperature of thin hamburgers using a needle probe thermocouple, you demonstrate
to the operator the proper method for taking temperatures of thin products. At a
minimum, you should have the following equipment to conduct a risk-based inspection:
•
•
•
•
•

Thermocouple with the appropriate probes for the foods being tested
Alcohol swabs or other suitable equipment for sanitizing probe thermometers
Sanitization test kits
Heat sensitive tape or maximum registering thermometer
Flashlight

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ESTABLISHING INSPECTION PRIORITIES
In planning for inspections you should consider the importance of timing. Several
operational steps at retail such as receiving, preparation, and cooling can only be
evaluated during limited time periods. Times may need to be varied from inspection to
inspection to ensure that all critical processes are evaluated.
With the limited time allotted for inspections, you must develop clear priorities to make
the most efficient use of your time in each facility. Although basic sanitation issues
generally do not change during the course of a routine inspection, critical practices and
procedures leading to risk factors may only be observable during limited time intervals.
For this reason, assessment of the active managerial control of risk factors should
generally be performed before reviewing basic sanitation issues.
By setting priorities early in the inspection, observations attributed to out-of-control risk
factors can be distinguished from those related to general sanitation and maintenance.
You can set priorities by completing four activities early in your inspection:
•
•
•
•

Establishing an open dialogue with the person in charge
Reviewing previous inspection records
Conducting a menu or food list review
Conducting a quick walk-though

Establishing an Open Dialogue with the Person In Charge
Having an open dialogue with the person in charge during
all phases of your inspection gives you an opportunity to
learn important information about the existing food safety
management system. It is important to know both the
strengths and weaknesses of the existing food safety
management system early in your inspection so that you
can focus your inspection on weak areas. For instance,
through your questioning, you learn that the facility cooks
chicken that is used in several end products such as soups
and salads. You also learn that the facility checks the
temperature of the chicken to make sure that it is cooked,
but you quickly realize that no further monitoring is
conducted when the chicken is cooling. Knowing this, you
begin your inspection by checking cooling.
Even if you are unable to have a discussion with the person in charge at the beginning
of the inspection, questions about practices and procedures related to risk factors and
Food Code interventions, like the facility’s employee health policy and consumer
advisory, can certainly be asked as you conduct your inspection. It is important to ask
enough questions to fully understand the system being utilized in the establishment.
8

This is especially true when evaluating whether the employees are adhering to the
established no bare hand contact and handwashing policies.
Asking the person in charge questions about important activities such as receiving,
cooling, and preparation is also important in relating the seriousness of out-of-control
risk factors. If the person in charge has the time, have him or her accompany you as
you conduct your inspection. This will ultimately save you time because you can point
out violations as they are observed. These violations should still be marked on your
inspection form, but you can obtain immediate corrective action to abate the problem
before someone gets sick. You can also use this time to share your knowledge about
critical processes. By communicating the public health rationale behind your
regulations, you will leave the person in charge with a clear understanding for why
active managerial control of risk factors must be a top
priority in the day-to-day operation of the business.

Reviewing Previous Inspection Reports
In order to detect trends of out-of-control risk factors, it is
important for you to review past inspection reports prior
to conducting your inspection. This can be done in your
office or on-site at the facility. This activity is especially important in jurisdictions where
health inspectors rotate from one inspection to the next. If the same risk factor is out-ofcontrol during more than one inspection, it is strongly recommended that the operator
develop an intervention strategy to prevent its recurrence (see Chapter 3). Knowledge
of what has been corrected from the last inspection also gives you the opportunity to
provide some positive feedback to the operator and allows you to track corrected
violations in accordance with your jurisdiction’s policy.

Conducting a Menu/Food List Review
The menu, whether written as in the case of restaurants, or
a list of foods prepared and sold found in retail food stores,
can be reviewed in a fairly simple manner. The review can
either be done simultaneously with a quick walk-through of
the operation (discussed later) or as a discussion with
management at the beginning of the inspection. The
menu/food list also does not need to be reviewed during
every inspection. If a review was done during a recent
inspection, you can simply ask the person in charge if there
have been any changes since the last inspection. A
review of the menu/food list allows you to begin to group
food items into one of three broad process categories
(discussed later) that will allow you to focus your inspection

9

on risk factors associated with each process. Conducting a review of the menu/food list
also allows you to establish inspection priorities by identifying –
•

High-risk foods or high-risk food preparation processes

•

Operational steps requiring further inquiry such as receiving, preparation,
cooking, and cooling

By identifying high-risk foods or high-risk food preparation processes, you can focus
your inspection on those foods or processes that will most likely cause foodborne illness
if uncontrolled. High-risk foods include products like raw chicken that naturally carry a
high pathogenic load. If such products are used in a facility, practices related to crosscontamination and cooking should be a priority during the inspection. If there are foods
that go through the temperature danger zone several times, cooling and holding
practices should be reviewed. If the establishment is primarily a “Cook and Serve”
operation, then time can best be spent on observing cooking practices.
The menu/food list review might be the only time you are made aware
of specialized processes such as formulating a food so that it is not
potentially hazardous or high-risk seasonal menu items such as raw
oysters. Foods such as shellstock and certain fish for raw
consumption require documentation that should be reviewed during
the inspection. You may discover items on the menu such as Caesar
salad or hollandaise sauce. Further inquiry is needed regarding the
preparation of these items since they are sometimes prepared with
raw eggs.
Several operational steps like receiving,
preparation, cooking, and cooling may not be
inspected as vigorously in retail and food service
inspections due, in part, to the hours of the day in
which these steps occur. If a facility is inspected in
the afternoon hours, for example, receiving and
food preparation might have already occurred. You
should ask questions to obtain information about
the operational steps that you cannot directly
observe in order to evaluate the establishment’s
active managerial control.

Conducting a Quick Walk-through
As you discuss the menu or food list with the person in charge, it is suggested that you
conduct a quick walk-through of the facility to observe what is going on at that time.

10

Conducting a quick walk-through is especially important to observe several activities
that might otherwise go unnoticed until later in the inspection:
•
•
•
•
•

Receiving
Food preparation and handling
Cooking
Cooling
Reheating

Noting that receiving or food preparation is occurring at the beginning of the inspection
allows you to take advantage of “real-life” production processes and will help you to
obtain a clear picture of the establishment's true practices. Receiving and food
preparation only occur during limited times, so you may want to stop and observe these
operational steps while they are happening.
For example, during the initial walk-through with the
person in charge, you may see that salad is being
prepared. In response, you might want to take some
time to observe the preparation practices. This also
offers you an excellent opportunity to interact with the
food employees to observe if the food is being properly
handled using utensils and to find out how the
ingredients were received and stored prior to
preparation. Speaking directly to the food service
employees preparing the food is also an excellent way
to assess the effectiveness of the establishment’s food
safety training and Standard Operating Procedures
(SOPs) for critical processes such as cooling.
Early in the inspection, it is also ideal to check the temperatures of potentially
hazardous foods in the cooling process from the morning preparation if the inspection is
in the afternoon or last night’s meal service if the inspection is occurring in the morning.
Also, you might want to ask whether any food is currently being cooked or reheated.
The observations you make, along with the feedback you get from questioning the
person in charge or the food service employees, will help you evaluate whether foods
appear to have been properly processed.

EVALUATING EXISTING FOOD SAFETY MANAGEMENT SYSTEMS
Although some establishments have formal HACCP plans in place, many do not. Even
without a HACCP system, every establishment needs to have active managerial control
of risk factors. This may be achieved through several means, such as training
programs, manager oversight, or standard operating procedures. For example, some

11

establishments incorporate control measures into individual recipes, production
schedules, or employee job descriptions to achieve active managerial control.
While a person in charge may require the maintenance of in-house written records by
employees to ensure that monitoring is being performed using the correct method and
at the proper frequency, risk factors may be managed without the use of formal record
keeping. Monitoring, whether through direct observations or by taking appropriate
measurements, is by far the most important step to ensuring food safety. If an operator
is effectively monitoring all critical activities in the establishment and taking corrective
actions when needed, safe food will result. With a few exceptions, maintaining formal
records at retail is not required; therefore, records may not be in place for use during
your inspection. As a result, it will be necessary to use direct observations and
interviewing to determine whether an establishment is adequately monitoring risk
factors in their existing food safety management system.
Every establishment has some type of set pattern of procedures even if it is simply
described as “the way we do things.” A small, independent operation may not have
written procedures, yet it may have adequate procedures that are routinely followed.
Good communication is required to discover these types of informal management
systems.
Many retail and food service establishments have implemented effective food safety
management systems by establishing controls for the food preparation methods and
processes common to their operation. Control of food preparation processes rather
than individual food items is often called the “process approach” to HACCP. The
process approach using the principles of HACCP can best be described as dividing the
many food items in an operation into three food preparation processes then analyzing
the risk factors associated with each process. By placing managerial controls on
specific operational steps in the flow of food, foodborne illness can be prevented.

DETERMINING PROCESS FLOWS
The flow of food in a retail or food service establishment is the path that food follows
from receiving through service or sale to the consumer. Several activities or stages
make up the flow of food and are called operational steps. Examples of operational
steps include receiving, storing, preparing, cooking, cooling, reheating, holding,
assembling, packaging, and serving. Keep in mind that the terminology used for
operational steps may differ between food service and retail food store operations.
Most food items produced in a retail or food service establishment can be categorized
into one of three preparation processes based on the number of times the food passes
through the temperature danger zone between 41 ºF to 135 ºF:

12

• Process 1: Food Preparation with No Cook Step
Example flow: Receive - Store - Prepare – Hold – Serve
(other food flows are included in this process, but there is no cook step to destroy
pathogens while in the retail or food service facility)
• Process 2: Preparation for Same Day Service
Example flow: Receive - Store - Prepare - Cook – Hold – Serve
(other food flows are included in this process, but there is only one trip through
the temperature danger zone)
• Process 3: Complex Food Preparation
Example flow: Receive - Store - Prepare - Cook - Cool - Reheat - Hot Hold Serve
(other food flows are included in this process, but there are always two or more
complete trips through the temperature danger zone)
A summary of the three food preparation processes in terms of number of times through
the temperature danger zone can be depicted in a Danger Zone diagram. Note that
while foods produced using process 1 may enter the danger zone, they are neither
cooked to destroy pathogens, nor are they hot held. Foods which go through the
danger zone only once are classified as Same Day Service, while foods that go through
more than once are Complex.

The three food preparation processes conducted in retail and food service
establishments are not intended to be all-inclusive. For instance, quick service facilities
may have “cook and serve” processes specific to their operation. These processes are
likely to be different from the “Same Day Service” preparation processes in full service
restaurants since many of their foods are generally cooked and hot held before service.
13

In addition, in retail food stores, operational steps such as packaging and assembly may
be included in all of the food preparation processes prior to being sold to the consumer.
It is also very common for a retail or food service operator to have a single item like a
chicken salad sandwich that is created using several components that may be produced
using more than one kind of food preparation process. It is important for you to
remember that even though variations of the three food preparation process flows are
common, the control measures – actions or activities that can be used to prevent,
eliminate, or reduce food safety hazards – to be implemented in each process will
generally be the same based on the number of times the food goes through the
temperature danger zone.

THE HAZARD ANALYSIS
In the “process approach” to HACCP, conducting a hazard analysis on individual food
items is time and labor intensive and is generally unnecessary. Identifying and
controlling the hazards in each food preparation process listed above achieves the
same control of risk factors as preparing a HACCP plan for each individual product.
Example: An establishment has dozens of food items (including baked chicken and
meatloaf) in the “Preparation for Same Day Service” category. Each of the food items
may have unique hazards (See Annex 3), but regardless of their individual hazards,
control via proper cooking and holding will generally ensure the safety of all of the foods
in this category. An illustration of this concept follows:
•

Even though they have unique hazards, baked chicken and meatloaf are items
frequently grouped in the “Same Day Service” category (Process 2).

•

Salmonella and Campylobacter, as well as spore-formers, such as Bacillus
cereus and Clostridium perfringens, are significant biological hazards in chicken.

•

Significant biological hazards in meatloaf include Salmonella, E. coli O157:H7,
Bacillus cereus, and Clostridium perfringens.

•

Despite their different hazards, the control measure used to kill pathogens in both
these products is cooking to the proper temperature.

•

Additionally, if the products are held after cooking, then proper hot holding or
time control is also necessary to prevent the outgrowth of spore-formers that are
not destroyed by cooking.

As with product-specific HACCP, critical limits for cooking remain specific to each food
item in the process. In the scenario described above, the cooking step for chicken
requires a final internal temperature of 165 ºF for 15 seconds to control the pathogen
load for Salmonella. Meatloaf, on the other hand, is a ground beef product and requires
14

a final internal temperature of 155 ºF for 15 seconds to control the pathogen load for
both Salmonella and E. coli O157:H7. Note that there are some operational steps, such
as refrigerated storage or hot holding, that have critical limits that apply to all foods.
The following table further illustrates this concept. Note that the only unique control
measure applies to the critical limit of the cooking step for each of the products. Other
food safety hazards and control measures may exist that are not depicted here:
Process 2: Preparation for Same Day Service
Example Products
Baked Meatloaf
Example Biological Hazards
Salmonella
E. coli O157:H7
Clostridium perfringens
Bacillus cereus
Various fecal-oral route
pathogens
Refrigeration 41 ºF or below
Example Control Measures
(there may be others)
Cooking at 155 ºF for 15
seconds
Hot Holding at 135 ºF or above
OR Time Control for 4 hours or
less
No bare hand contact with RTE
food, proper handwashing,
exclusion/restriction of ill
employees

Baked Chicken
Salmonella
Campylobacter
Clostridium perfringens
Bacillus cereus
Various fecal-oral route
pathogens
Refrigeration 41 ºF or below
Cooking at 165 ºF for 15
seconds
Hot Holding at 135 ºF or above
OR Time Control for 4 hours or
less
No bare hand contact with RTE
food, proper handwashing,
exclusion/restriction of ill
employees

:

DETERMINING RISK FACTORS IN PROCESS FLOWS
Several of the most common risk factors associated with each food preparation process
are discussed below. Remember that while you should generally focus your inspection
on these risk factors, there may be other risk factors unique to an operation or process
that are not listed here. You should evaluate each operation and food preparation
process independently.

15

Facility-wide Considerations
In order to have active managerial control over personal hygiene and crosscontamination, an operator must implement control measures in all phases of the
operation. The following control measures should be evaluated during your inspection
regardless of the food preparation process used –
•

•
•
•

No bare hand contact with RTE foods (or use of
an approved, alternative procedure) to help
prevent the transfer of viruses, bacteria, or
parasites from hands
Proper handwashing to help prevent the transfer
of viruses, bacteria, or parasites from hands to food
Restriction or exclusion of ill employees to help
prevent the transfer of viruses, bacteria, or
parasites from hands to food
Prevention of cross-contamination of RTE food
or clean and sanitized food contact surfaces with
soiled cutting boards, utensils, aprons, etc. or raw
animal foods

Food Preparation Process 1 – Food Preparation with No Cook Step
Example Flow: RECEIVE – STORE – PREPARE – HOLD – SERVE
Several food flows are represented by this particular process.
Many of these food flows are common to both retail food
stores and food service facilities, while others only apply to
retail operations. Raw, ready-to-eat food, such as sashimi,
raw oysters, and salads, are grouped in this category.
Components of these foods are received raw and will not be
cooked prior to consumption. Foods cooked at the
processing level but that undergo no further cooking at the
retail level before being consumed are also represented in
this category. Examples of these kinds of foods are deli
meats, cheeses, and other pasteurized products. In addition,
foods that are received and sold raw but are to be cooked by
the consumer after purchase, i.e. hamburger meat, chicken,
and steaks, are also included in this category.
All the foods in this category lack a kill (cook) step while at the retail or food service
establishment. In other words, there is no complete trip made through the danger zone
for the purpose of destroying pathogens. During your inspection, you can ensure that
the food received in the facility is as safe as possible by checking that the food is

16

received in good condition and from approved sources. Without a kill step to destroy
pathogens, the primary responsibility of the operator will be to prevent further
contamination by ensuring that employees follow good hygienic practices. In addition,
cross contamination must be prevented by properly storing your products away from
raw animal foods and soiled equipment and utensils. Foodborne illness may result from
ready-to-eat food being held at unsafe temperatures for long periods of time due to the
outgrowth of bacteria.
In addition to the facility-wide considerations, an inspection involving this food
preparation process should focus on ensuring that the facility has active managerial
control over the following:
•
•

•
•
•
•

Cold holding or using time alone to inhibit bacterial
growth and toxin production
Food source (especially for shellfish due to concerns
with viruses, natural toxins, and Vibrio and for certain
marine finfish intended for raw consumption due to
concerns with ciguatera toxin) (See Annex 3)
Receiving temperatures (especially certain species
of marine finfish due to concerns with scombrotoxin)
Date marking of RTE PHF held for more than 24
hours to control the growth of Listeria monocytogenes
Freezing certain species of fish intended for raw
consumption due to parasite concerns (See Annex 3)
Cooling from ambient temperature prevent the
outgrowth of spore-forming or toxin-forming bacteria

Food Preparation Process 2 – Preparation for Same Day Service
Example Flow: RECEIVE – STORE – PREPARE – COOK – HOLD – SERVE
In this food preparation process, food passes through the danger zone only once in the
retail or food service facility before it is served or sold to the consumer. Food is usually
cooked and held hot until served, i.e. fried chicken, but can also be cooked and served
immediately. In addition to the facility-wide considerations, an inspection involving this
food preparation process should focus on ensuring that the facility has active
managerial control over the following:
•

cooking to destroy bacteria and parasites; and

•

hot holding or using time alone to prevent the outgrowth of
spore-forming bacteria.

Food source and receiving temperatures/cold holding prior to cooking
are also important if dealing with certain marine finfish due to
17

concerns with ciguatera toxin and scombrotoxin. Consult Annex 3 for other special
considerations related to seafood.

Food Preparation Process 3 – Complex Food Preparation
Example Flow: RECEIVE – STORE – PREPARE – COOK – COOL – REHEAT – HOT
HOLD – SERVE
Foods prepared in large volumes or in advance for next day service usually follow an
extended process flow. These foods will pass through the temperature danger zone
more than one time; thus, the potential for the growth of spore-forming or toxigenic
bacteria is greater in this process. Failure to adequately control food product
temperatures is one of the most frequently encountered risk factors contributing to
foodborne illness. In addition, foods in this category have the potential to be
recontaminated with Listeria monocytogenes, which could grow during refrigerated
storage. The key to managing the operational steps within this food preparation process
is to minimize the time foods are at unsafe temperatures.
In addition to the facility-wide considerations, an inspection involving this food
preparation process should focus on ensuring that the facility has active managerial
control over the following:
•

cooking to destroy bacteria and
parasites;

•

cooling to prevent the outgrowth of
spore-forming or toxin-forming bacteria;

•

hot and cold holding or using time
alone to inhibit bacterial growth and toxin
formation

•

date marking of RTE PHF held for more
than 24 hours to control the growth of
Listeria monocytogenes

•

reheating for hot holding, if applicable.

Food source and receiving temperatures/cold holding prior to cooking are also important
if dealing with certain marine finfish due to concerns with ciguatera toxin and
scombrotoxin. Consult Annex 3 for other special considerations related to seafood.

18

ASSESSING ACTIVE MANAGERIAL CONTROL OF RISK FACTORS
The Food Code provides specific measurable criteria, often referred to as critical limits,
designed to prevent, eliminate, or reduce hazards in foods. These critical limits are
based on the best available science and pertain to control measures applied at
operational steps. Common examples include time/temperature standards and no bare
hand contact with RTE food.
At a minimum, an operator’s food safety management system should be based on
achieving the same level of safety established by the critical limits in the Food Code.
When determining the degree of active managerial control an operator has over risk
factors, you should observe whether the operator has established the appropriate
control measures and critical limits and whether appropriate monitoring procedures are
in place.
A sample list of questions to assist you in assessing an operator’s active
managerial control of risk factors at operational steps throughout the flow of food
is in Annex 4 of this Manual. This list can be used in conjunction with any inspection
form or simply as a tool to help you organize your inspection. In addition, Annex 4 of
the 2001 FDA Food Code (or Annex 5 in the 2005 FDA Food Code) contains additional
information on assessing the active managerial control of foodborne illness risk factors.

EVALUATING BASIC SANITATION AND FACILITIES
Systems to control basic operational and sanitation conditions within a facility, often
referred to as Good Retail Practices (GRPs), Prerequisite Programs, or Standard
Operating Procedures (SOPs), are the foundation of a successful food safety
management system. With this in mind, consider how the establishment actively
monitors these activities. Just as monitoring is required by the establishment to ensure
that risk factors are controlled, monitoring of basic sanitation conditions in the facility
allows the operator an excellent opportunity to detect weaknesses and initiate actions
for improvement. Although the main focus of an inspection should be on evaluating the
active managerial control of risk factors, overall sanitation should not be overlooked.
Basic operational and sanitation programs must be in place to –
•
•
•

Protect products from contamination by biological, chemical, and physical food
safety hazards
Control bacterial growth that can result from temperature abuse during storage
Maintain equipment

19

Examples of concerns addressed by the programs above include the following:
•

Receiving temperatures

•

Pest control

•

Toxic chemical storage and labeling

•

Food protection (non-critical)

•

Equipment cleaning and maintenance

•

Water

•

Plumbing

•

Toilet facilities

•

Sewage

•

Garbage and refuse disposal

•

Physical facilities

SUMMARY
Although retail and food service operators have the responsibility for establishing food
safety management systems, you, the regulator, have a vital, multi-faceted role in
consumer protection. Your primary responsibility is to ensure the operator has effective
control of risk factors. Once you have conducted a menu review and established a
dialogue with the person in charge and food service workers, you will have enough
information to mentally place menu items into one of the three process flows. Your
inspection can then focus on assessing the operator’s active managerial control of risk
factors associated with each process.
Once out-of-control risk factors are identified, your role shifts to assisting an operator
with strengthening the existing food safety management system through intervention
strategies designed to achieve immediate and long-term compliance. With your help,
retail and food service operators can achieve long-term behavioral change resulting in a
reduction in risk factor occurrence and an increase in public health protection.

20

Chapter 3 - Intervention Strategies

This Chapter will introduce you to intervention strategies designed to immediately
correct out-of-control risk factors and to prevent their recurrence. Your program
manager can incorporate any of these strategies into your jurisdiction’s compliance and
enforcement protocol. You can use several of these strategies as suggestions to
industry for achieving immediate and long-term active managerial control of risk factors.

THE ROLE OF INTERVENTION STRATEGIES IN COMPLIANCE AND
ENFORCEMENT
Compliance and enforcement are essential elements of a regulatory program and
involve all voluntary and involuntary corrections made by the operator. Voluntary
corrections by the operator are referred to in this Manual as “intervention strategies.”
Intervention strategies can be divided into two groups:
•

Those designed to achieve immediate on-site correction

•

Those designed to achieve long-term compliance
Successful intervention strategies for out-of-control risk factors
can be tailored to each operation’s resources and needs. This
will require you to work with the operator to identify
weaknesses in their existing food safety management system
and consulting with them to strengthen any weak areas noted.
Intervention strategies can also be adopted as part of a
progressive compliance and enforcement program. Many
jurisdictions around the country have successfully used the
intervention strategy concept as a “first step” in their
compliance and enforcement protocol. If the operator is willing
to work with you to gain ownership of food safety, a long-term
behavior change will more likely result. This may help reduce
the amount of enforcement proceedings that occur as a result
of involuntary compliance.

21

Involuntary compliance results from the following enforcement activities:
•
•
•
•
•

Warning letters
Re-inspections
Citations
Administrative fines and hearings
Permit suspensions

Although these enforcement activities are a necessary function in your regulatory work,
obtaining voluntary corrections by the operator has proven to be more effective in
achieving long-term compliance.

ON-SITE CORRECTION
On-site corrections are intended to achieve immediate corrective action of out-of-control
risk factors posing an immediate, serious danger to the consumer during the inspection.
Usually these violations are "operational" rather than structural and can be addressed
by management at the time of the inspection. For example –
•

Undercooking hamburger meat presents an
immediate danger to the consumer that can be
corrected on-site by additional cooking.

•

Preparing lettuce on the same work surface
previously used to cut raw chicken without having
washed, rinsed, and sanitized the surface
presents an immediate danger to the consumer
that can be corrected on-site by discarding the
contaminated lettuce.

Annex 6 provides a full list of suggested on-site corrections for out-of-control procedures
found during your inspections.
It is essential to consumer protection and to regulatory credibility for on-site
correction to be obtained for any out-of-control risk factors. Obtaining on-site
correction conveys the seriousness of the violation to management. Failure to require
on-site correction when an out-of-control risk factor has been identified implies that the
risk factor has little importance to food safety. If the operation is briefly stopped to
address the out-of-control risk factor, the operator may be more responsive to
addressing the practices resulting in the out-of-control risk factor in the future. A more
favorable impact on future behavior may result that might not have been achieved
through discussion alone.

22

When recommending on-site correction, effective communication regarding out-ofcontrol risk factors is essential and can often be accomplished by –
•
•

Discussing food safety concerns in words that can be easily understood by the
person in charge and the food service workers
Conveying the seriousness of the out-of-control risk factors in terms of increased
risk of illness or injury

Although the person in charge is ultimately
responsible for the conditions in the facility
and should therefore be informed of all out-ofcontrol risk factors, timely training of the food
service workers can in many cases have a
great impact on future behavior. A translator
and/or special training material may be
necessary when language or education
barriers exist. Remember that while it is
important for both the person in charge and
food service workers to know why they are
having to make a correction, the long-term
effectiveness of making the correction may be
lost if you are too technical or scientific in your rationale.
During the discussion of inspection findings with the person in charge, you should keep
the discussion focused on correction of violations that present an immediate danger to
the consumer. Discussion of lesser code violations should be deferred until outof-control risk factors are discussed and on-site correction is obtained. It is
important to point out to the operator that while most basic sanitation problems do not
pose a significant threat to the public, foodborne illness caused by out-of-control risk
factors often results in significant losses to consumers and the operator. Negligence
for not having a strong food safety management system in place to control risk factors
can result in financial ruin for even the largest of retail operations.

DETERMINING THE APPROPRIATE ON-SITE CORRECTION
To assist you in determining the appropriate on-site correction, you should reference
your existing regulatory policies and procedures. In the event that your jurisdiction does
not have such policies and procedures, your experience and professional judgment will
help you to offer the operator practical solutions for bringing the risk factors under
control.
In most cases, selecting the most appropriate on-site correction when out-of-control risk
factors are observed will be straightforward. For instance, if hamburgers are
inadequately cooked, the on-site correction is to continue cooking until the appropriate
cooking temperature is reached.
23

Determining the most appropriate on-site correction of out-of-control procedures such
as inadequate hot and cold holding can be very complicated. Since determining on-site
correction depends on a number of factors, you may need to conduct a hazard analysis
of the food in order to determine the appropriate course of action to take. Annex 6 of
this Manual lists the out-of-control procedures that may require a hazard analysis in
order to determine the appropriate on-site correction. More information on conducting a
hazard analysis is found in Annex 3.

Limitations of Reheating as an On-site Correction
One on-site correction used in the field is reheating. A common
misconception is that reheating is a “magic step” for eliminating hazards
resulting from improper holding or cooling. If a ready-to-eat, potentially
hazardous food is improperly held or cooled, the potential for spore- or
toxin-forming bacteria growth increases. Whether to recommend that
the food be reheated or discarded depends on a number of factors
including, but not limited to –
•
•
•
•

the hazards of significance
the nature of the food
its intended use
other important considerations discussed later in this section
including the degree of time and temperature abuse

Although reheating can eliminate vegetative bacterial cells resulting from post-cook
contamination (i.e. Salmonella) or from improper holding or cooling (i.e. Clostridium
perfringens), it has limitations that must be considered.
Some bacteria form spores that survive cooking. These spores can germinate and
grow if food is improperly held after cooking. Bacterial spores are likely to be present in
most foods. When a food is expected to contain spores of toxigenic bacteria such as
Clostridium botulinum or Bacillus cereus, reheating may be ineffective. The emetic
toxin of B. cereus, which has been largely associated with outbreaks in starchy foods, is
very stable to heat. While the toxin of C. botulinum may be destroyed with extended
reheating, the critical limit for reheating in the Food Code (165 ºF for 15 seconds) will
not be effective in ensuring the food’s safety.
Staphylococcus aureus does not produce spores, only a heat-stable toxin when present
in large numbers. Time- or temperature-abused, RTE, PHFs that are touched by bare
hands or otherwise contaminated with the organism are at risk.
Neither cooking nor reheating destroys chemical hazards such as ciguatera toxin or
scombrotoxin in fish; therefore, fish that are subject to these hazards and are received
from unapproved sources or at improper temperatures should be rejected.

24

Viruses are somewhat resistant to heat and given their low infectious dose may not be
reduced to safe levels using the reheating parameters in the Food Code. Therefore, if
ready-to-eat food is touched with bare hands, you will need to address several
questions in order to make the appropriate on-site correction recommendation,
including:
•

Does the facility have an employee
health policy to identify, restrict, and
exclude ill employees?

•

Did the employees working with the
food in question effectively wash their
hands and are handwashing facilities
adequate?

•

Is there an approved, alternate
procedure to no bare hand contact in
place and was it followed prior to the
bare hand contact?

•

Has there been an opportunity for the
employee’s hands to become
contaminated?

•

Was the bare hand contact with readyto-eat food limited or extensive?

Use these questions as the framework for making a recommendation for on-site
correction that is based on current science and your extensive knowledge of the
operation. Once you have answered these questions, you should have enough
information to determine the likelihood of occurrence of hazards transmitted by bare
hands. Remember that viruses may not be destroyed to safe levels by reheating, so if
you determine in your assessment that there is a high risk of viral contamination, then
discarding the affected food may be the most appropriate recommendation for on-site
correction.
When bare hand contact with ready-to-eat food is not observed or when bare hand
contact is observed but the risk of viral contamination is low, additional analysis is
needed before recommending reheating as an on-site correction for food found out of
temperature. In order to properly evaluate the degree of time and temperature abuse
and the proper disposition of the affected ready-to-eat food, the following questions
should be considered:
•
•

Are there any written procedures in place for using time alone as a public health
control and, if so, are they being followed properly?
What are the ingredients of the food and how was it made?

25

•
•
•
•
•
•
•
•
•
•
•
•

Is it likely that the food contains C. perfringens, C. botulinum, or B. cereus as
hazards (see Annex 3)?
Has there been an opportunity for post-cook contamination with raw animal foods
or contaminated equipment?
If there has been an opportunity for post-cook contamination, can
the hazards of concern be eliminated by reheating?
Are the food workers practicing good personal hygiene including
frequent and effective handwashing?
Was the food reheated or cooked to the proper temperature before
being placed out of temperature control?
What is the current temperature of the food when taken with a
probe thermometer?
How long has the food been out of temperature control (ask both
the manager and food employees)?
Are the answers of the food employees and the manager
consistent with one another when asked how long the food has
been out of temperature control?
Is it likely that food has cooled to its current temperature after
being out of temperature control for the alleged time?
Will the food be saved as leftovers?
How long before the food will be served?
Given what you know about the food, the food’s temperature, the handling of the
food, and the alleged time out of temperature, is it reasonably likely that the food
already contains hazards that cannot be destroyed by reheating?

The answers to these questions, in combination with observations you make during
your inspection, should provide you with enough information to make the appropriate
recommendation for on-site correction. If you are still unable to determine the most
appropriate disposition of the food after you have conducted your assessment, you may
want to consult your supervisor.
As you can see, there is no “catch-all” rule for determining the
appropriate on-site correction. Due to the economic hardship that may
be involved, it is important for you to base your recommendations on
sound science. It is crucial that you have a significant, working
knowledge of food microbiology. Your final decision should be based on
the best scientific analysis and professional judgment after considering
all the information that you have at hand. In some cases, you may even
need to consult with other food safety professionals to determine if a
food is safe to eat or whether a correction is needed.

26

LONG-TERM COMPLIANCE
While on-site correction of out-of-control risk factors is essential to consumer protection,
achieving long-term compliance is equally important. Overcoming several
misconceptions about long term compliance will help you in achieving a desirable
change of behavior. For example, in jurisdictions using a 44-item inspection report in
which only observed violations are marked, it is often taken for granted that if there are
no violations marked, the risk factors are being controlled. This is not necessarily true
since the observation of code violations is subject to many variables such as the time of
day or duration of the inspection. Another misconception is that training alone will result
in risk factors being controlled. While training may help, there is no guarantee that
knowledge acquired will equate to knowledge applied in the workplace. Another
assumption is that enforcement actions such as citations or administrative hearings or
on-site corrections will automatically result in future management control.
Unfortunately, there is no assurance that any of these actions will result in the long-term
control of risk factors.
Long-term compliance may best be achieved through voluntary actions by the operator.
If an operator supports the concept that a food safety management system is needed,
there is a better chance that long-term compliance will be achieved. The following
system components may be used alone or in combination by the operator to provide
voluntary active managerial control of risk factors:
Equipment and Layout – Critical limits are difficult to achieve when equipment does
not work properly. Proper calibration of equipment is vital to achieving food safety.
When calibration is unsuccessful or is not feasible, equipment should be replaced. In
addition to equipment malfunctioning, poor equipment layout can present opportunities
for cross contamination and must be considered. For example –
•

Hamburgers with uniform thickness and weight are not
all reaching a safe cooking temperature in a given time.
Upon examination, it is determined that the grill is
distributing heat unevenly. A new element is installed to
correct the problem.

•

Splash from a nearby handwashing sink is seen on a
prep table. A splash guard is installed to prevent cross
contamination from the handwashing sink to the prep
table.

27

Buyer Specifications – Written specifications for the goods and services purchased by
an establishment prevents many problems. For example –
•

Fish posing a parasite hazard and intended for raw consumption has not been
frozen for the specified time and temperature and no freezing equipment is onsite at the retail facility. Buyer specifications are established to place the
responsibility for freezing the fish on the supplier.

•

Lobster tails, hamburgers, or other products cooked with a set time parameter on
a conveyor are not reaching the proper temperature in the specified time
because they are larger than the size for which the conveyor is calibrated. Buyer
specifications are established to restrict the size of products received from the
supplier.

Recipe/Process Instructions – Simple control measures integrated into recipes and
processes can improve management control over risk factors. For example –
•

Process instructions that specify using color-coded
cutting boards for separating raw animal foods from
ready-to-eat products are developed to control the
potential for cross contamination.

•

Pasteurized eggs are substituted in recipes that call for
raw or undercooked eggs to reduce the risk of
foodborne illness.

•

Commercially, precooked chicken is used in recipes
calling for cooked chicken such as chicken salad to
reduce the risk of contaminating food contact surfaces
and ready-to-eat food with raw chicken.

First-In-First-Out (FIFO) – Product rotation is important for both quality and safety
reasons. “First-In-First-Out” means that the first batch of product prepared and placed
in storage should be the first one sold. Date marking foods as required by the Food
Code facilitates the use of a FIFO procedure. The FIFO concept limits the potential for
pathogen growth, encourages product rotation, and documents compliance with
time/temperature requirements.
Standard Operating Procedures (SOPs) – Following standardized, written procedures
for performing various tasks ensures that quality, efficiency, and safety criteria are met
each time the task is performed. Although every operation is unique, the following list
contains some common management areas that can be controlled with SOPs:

28

•
•
•
•
•

Personnel (disease control, cleanliness, training)
Facility maintenance
Sanitary conditions (general cleaning schedule, chemical storage, pest control,
sanitization of food contact surfaces)
Sanitary facilities (approved water supply and testing, if applicable, plumbing,
sewage disposal, handwashing and toilet facilities, trash removal)
Equipment and utensil maintenance

SOPs can also be developed to detail procedures for controlling risk factors:
•

Procedures are implemented for measuring temperatures at a given frequency
and for taking appropriate corrective actions to prevent hazards associated
inadequate cooking.

•

Adequate handwashing is achieved by following written procedures that dictate
frequency, proper technique, and monitoring.

Risk Control Plans (RCPs) – An RCP is a concisely
written management plan developed by the retail or food
service operator with input from the health inspector that
describes a management system for controlling specific
out-of-control risk factors. An RCP is intended to be a
voluntary strategy that you and the person in charge
jointly develop to promote long-term compliance for
specific out-of-control risk factors. For example, if food
is improperly cooled in the establishment, a system of
monitoring and record keeping outlined in an RCP can
ensure that new procedures are established to adequately cool the food in the future.
By implementing basic control systems over a period of time (e.g., 60 – 90 days), it is
likely that the new controls will become "habits" that continue.
An RCP should stress simple control measures that can be integrated into the daily
routine. It should be brief, no more than one or two pages for a single risk factor, and
address the following points in very specific terms:
•
•
•
•
•
•
•
•

What is the risk factor to be controlled?
How is the risk factor controlled?
Who is responsible for the control?
What monitoring and record keeping is required?
Who is responsible for monitoring and completing records?
What corrective actions should be taken when deviations are noted?
How long is the plan to continue?
How are the results of the RCP communicated to you?

29

By implementing an RCP, the retail or food service operator will have the opportunity to
determine the appropriate corrective action for the identified problem and design an
implementation strategy to best suit their facility and operation. Since the RCP is
tailored to meet the needs of the establishment, the operator takes complete ownership
of the plan and is ultimately responsible for its development and implementation. Your
role as the health inspector is to consult with the operator by suggesting ways that the
risk factor(s) might be controlled. By creating an RCP, the operator realizes that a
problem exists in their food safety management system and commits to a specific
correction plan rather than merely acknowledging a single violation. Follow up by
telephone or in person indicates to the operator your interest in seeing their plan
succeed. This also gives you an opportunity to answer any questions and offer
feedback to make the RCP more useful. An example of an RCP, along with a blank
template that you can use, is found in Annex 5 of this Manual.
Voluntary Food Safety Management Systems based on HACCP Principles: The
Food Code only requires HACCP plans for a few specific specialized processes;
however, the development of voluntary HACCP plans is always encouraged. The FDA
document "Managing Food Safety: A Manual for the Voluntary Use of HACCP
Principles for Operators of Food Service and Retail Establishments" is written for this
purpose. A retail or food service operator, in consultation with an appropriate regulatory
authority or other food safety professional, can use this document to establish an
effective food safety management system based on the principles of HACCP. The
document is available from FDA through the following website:
http://www.cfsan.fda.gov/~dms/hret2toc.html. Annex 2 contains tables that can be used
by industry to develop HACCP plans. The use of HACCP as a food safety management
system is discussed in more detail in Chapter 4 of this Manual.

SUMMARY
The regulatory inspection provides you with an opportunity to work with an operator to
strengthen the existing food safety management system. Regulatory programs can
integrate some, if not all, of these risk-based concepts into their compliance and
enforcement protocol. At a minimum, you can suggest some of these intervention
strategies to retail and food service operators as ways for them to take ownership of
food safety by reducing the recurrence of out-of-control risk factors identified during
your inspection. Integrating strategies designed to change long-term behavior will be
the most effective way to reduce the risk of foodborne illness in a facility.
A list of suggested intervention strategies to achieve on-site correction and long-term
compliance for out-of-control procedures is found in Annex 6 of this Manual. The list
illustrates the application of intervention strategies in an inspection program.

30

Chapter 4 – Reviewing Voluntary Food Safety
Management Systems
The FDA Food Code only requires a comprehensive HACCP plan when conducting
certain specialized processes that present a significant health risk if not conducted
under strict operational procedures. Examples include Reduced Oxygen Packaging
(ROP) and formulating a food to render it non potentially hazardous by adding acids or
preservatives. In most cases, however, the implementation of food safety management
systems based on HACCP principles is a completely voluntary effort by retail and food
service operators. As discussed in Chapter 3, a retail or food service establishment
may wish to develop and implement a food safety management system based on
HACCP principles as a way to control the occurrence of identified foodborne illness risk
factors. This manual does not apply to mandatory HACCP as required by the FDA Food
Code.
In order to provide feedback to an operator about their food safety management system
and its implementation, an operator may invite you to review their system. In this
capacity, you will act as an advisor or consultant to the operator by observing the
establishment’s actual practices and procedures. You may wish to make
recommendations to the operator based on your observations of how they are
implementing their system in comparison to what is written in their plan. This chapter
provides you with information that may assist you in conducting a review of a voluntary
food safety management system based on HACCP principles.

VOLUNTARY FOOD SAFETY MANAGEMENT SYSTEM BASED ON
HACCP PRINCIPLES
In Chapter 3, several intervention strategies that can be implemented by an operator to
achieve long-term compliance of risk factors were introduced. For example, an operator
may develop a risk control plan as an intervention strategy for controlling a specific outof-control process identified during an inspection.
The implementation of a comprehensive food safety management system to cover all
processes conducted in a facility offers possible advantages to an operator by providing
a mechanism for achieving active managerial control of multiple foodborne illness risk
factors associated with an entire operation. In other words, rather than the operator
“fixing” only the specific items that you identify as lacking active managerial control
during the inspection, the operator might choose to implement a comprehensive food
safety management system to ensure continuous control over all foodborne illness risk
factors of concern.

31

Other advantages of using HACCP principles may include the following:
•
•
•
•
•
•
•

Reduction in product loss
Increased product quality
Better control of product inventory
Consistency in product preparation and processing
Increased profit
Increased employee awareness and participation in food safety
ACTIVE, rather than PASSIVE, managerial control of risk factors

It is recommended that prior to reviewing a voluntary food safety management system
based on HACCP principles you read the FDA document entitled, Managing Food
Safety: A Manual for the Voluntary Use of HACCP Principles for Operators of Food
Service and Retail Establishment. Information on obtaining a copy is found in Annex 1.

VALIDATION
A voluntarily implemented food safety management
system using HACCP principles needs to be
“validated.” Validation, for the purposes of this
discussion, means to focus on scientific and
technical information to determine if the system in
place will effectively control the food safety hazards
once implemented. You may use observations,
measurements, and evaluations taken in the
establishment, as well as scientific studies and other
reference materials such as the Food Code or other
applicable regulations when validating food safety
management systems.
Since voluntarily implemented food safety management systems involve normal
processes and not high-risk specialized processes that might otherwise require a
HACCP plan, regulators or other food safety professionals should be able to validate a
voluntary plan without assistance. This is especially true since the critical limits listed in
the plan should either be the same or more stringent than those established by the
Food Code or other applicable regulations.
Reviewing a voluntary food safety management system to determine whether the
corrective actions and the monitoring, verification, and record keeping procedures are
sufficient to support the system may be time consuming. Because of this, it may be
helpful to seek expert advise from outside sources. Outside sources include, but are
not limited to, members of academia, private food safety consultants, and other federal
and state governmental officials.

32

The written plan for a voluntary food safety management system based on HACCP
principles may be relatively simple and therefore probably will not include complex
information that you might otherwise expect to see in a mandatory HACCP plan. You
should be very flexible in the application of HACCP principles during your review.
Generally, a written, voluntary food safety management system developed using the
FDA document entitled, Managing Food Safety: A Manual for the Voluntary Use of
HACCP Principles for Operators of Food Service and Retail Establishment, will include:
•
•
•
•
•
•

Types of food included in the plan by category or by food preparation process
Materials and equipment layout
Formulations or recipes
A flow diagram showing the preparation of the food
Training plans for managers and food employees
Scientific data or other information supporting the plan

The proposed food safety management system should also detail:
•
•
•
•
•
•
•

Significant food safety hazards
Each Critical Control Point (CCP)
Critical limits at each CCP
Methods, frequency, and responsible personnel for monitoring
Corrective actions to be taken if the critical limits at each CCP are not met
Methods, frequency, and responsible personnel for verifying that monitoring is
taking place and prerequisite programs are being followed
Records to be maintained

As you review the identified hazards in the plan, it is recommended that you check to
see that all control measures vital to food safety are somehow implemented in the
operation. You may use Annex 3 of this Manual to assist you. Due to the flexible
nature of voluntary food safety management systems, control measures, such as proper
refrigeration or cooling, may be implemented as part of the establishment’s Standard
Operating Procedures and not as critical control points. Remember that the goal of
voluntary food safety management systems is active managerial control of foodborne
illness risk factors. How the establishment achieves this goal is clearly their choice.
As you review the critical limits associated with each CCP, be sure to verify that the
critical limits are in compliance with the Food Code or other applicable regulation. If the
critical limits are not the same or more stringent than those in the Food Code or other
applicable regulation, it may be an oversight on the part of the operator or they could be
conducting a specialized process without even knowing it. If the former is true, you may
merely need to inform the operator of the applicable regulations for that food or process.
If the latter is true, this Manual does not apply.
Your regulations will dictate how specialized processes and deviations from your code
requirements are to be handled. In some jurisdictions, deviations from the requirements

33

stated in the regulations are not allowed. In other jurisdictions, including those that
have adopted the FDA Food Code, a variance and HACCP plan would be required.
In reviewing monitoring procedures at each CCP, it is recommended that the monitoring
procedures include answers to the following questions:
•
•
•
•

How will each CCP be monitored?
What will be monitored at each CCP?
When and how often will the monitoring take place?
Who will be responsible for the monitoring?

You should also look to see that the monitoring intervals are adequate enough to
ensure hazards are being controlled. For instance, if hot holding is designated as a
CCP and the plan states that the manager will check the product temperature only once
per day, the lack of frequent temperature checks may allow time for spore-forming or
toxin-forming bacteria to grow to dangerous levels without any ability to take corrective
action. It is clear to see how important adequate monitoring is to achieving active
managerial control.
In reviewing the corrective actions for each CCP, it is recommended that you use
Chapter 3 and Annex 6 of this Manual. As you look at the corrective actions the
establishment has listed for each CCP, ask yourself if the procedure listed will result in
safe food. If it will, then ask yourself if the procedure listed includes a mechanism for
making sure that the problem does not happen again. If the answer is no to either of
these questions, changes probably need to be made to the plan. The plan should also
list who is responsible for taking corrective actions.
In reviewing verification procedures, look to see that the plan contains who is
responsible for the verification and at what frequency. It is also suggested that
voluntarily implemented food safety management systems be reviewed periodically to
make sure all food safety hazards are still adequately controlled. Changes in menu
items, equipment, or buyer specifications often require a change in the system. In this
Manual, this review and subsequent change in the system is referred to as
“revalidation.”
Lastly, when record keeping procedures are reviewed, look to see that the procedures
are clearly outlined including what is to be recorded and who is responsible for
documenting the activities. It is recommended that you focus your review on helping
the establishment determine whether or not they are using the easiest record keeping
system for them, not on whether or not records should be kept for certain activities. If
you can think of a more efficient record keeping system than what is being
implemented, you may want to make a suggestion to the manager for his or her
consideration. You may propose something that the establishment did not consider
when it was developing the plan. The idea is that simple records, especially those that
are already part of the establishment’s normal operation, will most likely be maintained.

34

However, the facility may be completely comfortable with the record keeping that is
already specified in their plan.
If you see that records are not specified for certain CCPs but are for others, you may
want to bring it to the manager’s attention since records may be helpful in verifying that
monitoring and corrective actions are conducted properly. Keep in mind that the facility
has developed a voluntary food safety management system tailored to their needs and
available resources. If the facility does not want to keep records, your opinion of what
should be documented is irrelevant as long as active managerial control is achieved.
Clearly your role as a consultant becomes particularly important with regard to your
review of record keeping procedures.

FIELD VERIFICATION
The primary purpose of field verification is to determine whether the activities carried out
in support of a validated food safety management system are conducted according to
the written plan. In other words, “Is the firm accurately doing what it said it does and are
they operating according to the food safety management system they have in place?”
By conducting a verification inspection, you can help an operator identify strengths and
weaknesses in the system and offer suggestions for improvement.
Keep in mind that that there are many different types of food safety management
systems. Some may control foodborne illness risk factors using only some of the
principles of HACCP. Therefore, flexibility is an important component when providing
guidance for voluntarily implemented food safety management systems using HACCP
principles.

THE VERIFICATION PROCESS
The verification of food safety management systems involves three major activities:
•
•
•

Document Review
Record Review
On-site Verification

35

Step 1 - Document Review
The review of the documents related to the food safety management system should be
completed before you make on-site observations and can either be done at the office or
at the establishment prior to the inspection. In order for you to gain a better
understanding of the food safety management practices and procedures in place,
several documents may be reviewed, including the following:
•
•
•
•

Past inspection or verification reports
Prerequisite programs
Training protocols
The written system or plan in place

A preliminary review of the food safety management system and associated documents
may provide you with the following information:
•
•
•
•
•
•

Problems noted during past inspections
Type, frequency, and appropriateness of
training given in support of the plan
Types of potentially hazardous food and the
food preparation processes
Materials and layout of equipment used in
the preparation and processing of the food
Calibration procedures and frequency of any
equipment involved
Formulations or recipes for the food

It is also recommended that before conducting the on-site verification you become
familiar with the following:
•
•
•
•
•
•

Significant food safety hazards
Each CCP
Critical limits for each CCP
Method and frequency of monitoring
Corrective actions to be taken when critical limits are not met
In-house verification and record-keeping procedures

Step 2 - Record Review
The record review is a “spot check” to ensure that routine monitoring and in-house
verification by management is occurring as specified in the plan. As you conduct the
record review, ask yourself, “Do the records show that activities are being performed as
specified in the plan?”

36

The record review should take place after the document review because it will provide –
•

A better understanding of the strengths and weaknesses in the food safety
management system allowing you to concentrate on those areas needing
strengthening

•

An opportunity to become more familiar with the types of forms used in the
operation before actually reviewing them

There are at least 5 types of records or information generated to support the food safety
management system that may be spot-checked:
•
•
•
•
•

Prerequisite program records (i.e. training logs)
Monitoring records (i.e. time-temperature logs)
Corrective action records (i.e. shipment rejection logs)
Calibration records (i.e. logs of thermometer or pH meter calibrations)
Evidence of verification (i.e. management oversight of activities related to the
food safety management system)

To review the records, two approaches are suggested:
1.

Randomly select a variety of records, spot checking different time periods. Then
review each record to verify that all the CCPs, associated critical limits,
monitoring procedures and frequencies, corrective actions, verification and
calibration activities have taken place on those days.
For example: Pick one week from the previous month and identify the CCPs and
critical limits for the processes used. Check to see if the monitoring was done
properly and at the required frequency stated in the plan. If you note deviations
from the critical limits, check to see that the appropriate corrective actions were
documented. Additionally, check to make sure that the activities were verified
and that the equipment used was properly calibrated.

2.

Randomly select a few days of records, but focus only on the CCPs that appear
difficult to monitor or that have shown record-keeping or compliance problems in
the past. Use these records to review the associated critical limits, monitoring
procedures and frequencies, corrective actions, verification and calibration
activities for those days.
For example: Looking over past inspection reports, you see that hot holding has
historically been a problem in this establishment. You may select one week at
random from the past month and check to see if hot holding was monitored
properly and at the required frequency, as stated in the plan. If deviations from
the hot holding critical limit were noted, check to see that the appropriate
corrective actions were documented. Additionally, check to make sure that the
activities were verified and that the equipment used was properly calibrated.

37

It is also a good idea to include the current day’s records in your review. Seeing the
real-time activities of the plan will give you insight into the accuracy and consistency of
the monitoring prescribed in the plan.
Some questions to ask yourself as you review the records include:
•
•
•
•

Do the recorded critical limits meet or exceed those specified in the plan?
If deviations from critical limits are noted, do the records indicate that the
appropriate corrective actions were taken?
Do the records indicate the monitoring and verification frequencies and the
individuals performing these duties?
Do the records indicate that calibrations are being completed according to the
prescribed frequency and method?

At the conclusion of the record review, determine if there are any patterns to the
deviations. Multiple deviations at the same CCP can indicate that difficulties exist in
controlling or monitoring that CCP. Such observations may trigger a revalidation of the
system. Also, be sure to keep the group of records that you have reviewed with you so
that you can continue to evaluate the critical limits, monitoring,
corrective actions, etc. during the on-site verification portion of
your inspection.

Special Considerations Regarding Records
Remember that the maintenance of records is required in the
Food Code only in a limited number of cases. Records
generated in support of a voluntary food safety management
systems are not to be used to verify compliance with your
regulations unless the records are specifically required by your regulations.
An example of when records may be used to verify compliance with your regulations
would be the maintenance of shellstock tags. If there is a requirement in your
regulations for the operator to maintain shellstock tags in chronological order for at least
90 days, you could verify this requirement just as you would during a normal routine
inspection.
In contrast, if for instance you find documented cases of inadequately cooked or hot
held foods being sold to consumers, you cannot take regulatory action based on the
documentation. Documentation of hot holding and cooking, like most processes in your
regulations, is not required. The fact that the establishment is keeping records of these
processes means they are going above and beyond what is required by your
regulations to establish a system that will ensure food safety. You do not want to
discourage this effort by attempting to take regulatory action on voluntarily kept records.
Of course, you should point these discrepancies out to management and offer

38

recommendations to the establishment to prevent the problems from happening again.
Revalidation of the system may result from your recommendations.
To avoid any confusion, it is not recommended that you conduct an on-site verification
of a voluntary food safety management system at the same time as your regulatory
inspection. If, due to time and resource constraints, you must conduct an on-site
verification at the same time as your regulatory inspection, remember that items on your
inspection form can only be marked for violations of procedures or practices that you
observe during your inspection. Records may not be used to support a violation of the
code unless their maintenance is specifically required in your regulations
Another important consideration is that a food safety management system may have
critical limits that exceed those of your regulations. For example, many operators
choose to set their critical limits for cooking all foods at 180 ºF for 15 seconds. If you
discover during your record review or on-site verification that foods are only cooked to
165 ºF, then they are adhering to your regulations but not their written plan. This should
be pointed out to management so they can take whatever action they deem necessary.
Of course, if during your record review you find evidence that a product still in circulation
poses a serious health threat to the public, you should not only alert the operator but
you should also initiate an appropriate regulatory investigation as dictated by your
regulatory agency. If it is known by either party that a product still on the market poses
a health threat to consumers, both parties must play their respective roles to remove the
product immediately. This may involve voluntary recall of the suspected products.

Step 3 – On-site Verification
On-site verification is used in conjunction with the document review and record review
to determine whether the activities carried out in support of the food safety management
system are conducted according to the written plan. During the on-site verification,
remember to look at whether activities you observe are consistent with what is noted in
the records and supporting documents.
On-site verification involves observing activities of all the elements involved in the plan,
i.e. the employees, the person in charge, the equipment, etc. It is important to spend
sufficient time during the inspection to get a feeling for whether the activities in the plan
are really part of the operation’s daily routine. Be sure to ask the person in charge and
the food employees many open-ended questions to obtain information that you need
about the operation. For example, ask, “How often do you check the temperature?”
rather than, “Do you check the temperature every 2 hours?” The information you gather
from the person in charge and the food employees, along with your own observations,
should provide answers to the following questions:
•

Are required activities being performed according to established procedures as
outlined in the food safety management system?

39

•
•
•
•

Are activities checked or monitored according to the established methods, with
proper equipment, procedures, etc.?
Do the individuals performing the activity understand their duties?
Have the individuals performing the activity noted any problems that may be of
concern?
Are on-site observations consistent with the records kept and reviewed in the
record review portion of your verification inspection?

One key objective of on-site verification should be to confirm that the flow diagrams and
the equipment layout are still accurate. This can be done by selecting a sample of
menu items, with diverse preparation requirements, and “walking” through the food
preparation process from receipt to service.
During the on-site observation, place special emphasis on determining whether
corrective actions are taken when critical limits are not met. You should assume that
corrective actions were anticipated in the operation of the system.
For example, if you note that critical limits are not being met at a CCP, observe and
record the food worker’s response based on the following:
•
•
•

Was the deviation handled in a manner prescribed in the plan?
If not, how was the deviation handled?
How was the process brought back under control so that the deviation would not
recur?

Verification Report
At the conclusion of the on-site verification, a report similar to the one in Annex 7 of the
Manual may be completed. The report in Annex 7 contains a suggested checklist to
use when evaluating a food safety management system. It can be modified to the
particular needs of your jurisdiction or a particular establishment.

SUMMARY
FDA has provided guidance to operators of retail and food service establishments who
wish to implement voluntary food safety management systems based on HACCP
principles. Periodic review of these systems provides the operator with valuable
information that can be used to make improvements. As a food safety professional,
your knowledge and expertise make you qualified to conduct such reviews, but only at
the request of the operator. It should be noted, however, that you can sufficiently
determine if an operator has active managerial control of foodborne illness risk factors
by simply conducting a risk-based inspection. Validation and verification of voluntarily
implemented food safety management systems are services you can offer your industry
partners to provide them with feedback on how well their system is working.
40

Glossary

ACCEPTABLE LEVEL means the presence of a food safety hazard at levels low
enough not to cause an illness or injury.
ACTIVE MANAGERIAL CONTROL means the purposeful incorporation of specific
actions or procedures by industry management into the operation of their business to
attain control over foodborne illness risk factors.
COMPETITIVE MICROFLORA means the microorganisms naturally present in
potentially hazardous food that compete with pathogens for the available water,
nutrients, and oxygen.
CONTAMINATION means the unintended presence of potentially harmful substances,
including microorganisms, chemicals, and physical objects in food.
CONTROL MEASURE means any action or activity that can be used to prevent,
eliminate, or reduce an identified hazard. Control measures determined to be essential
for food safety are applied at critical control points in the flow of food.
CORRECTIVE ACTION means an activity that is conducted by a person when a critical
limit is not met.
CRITICAL CONTROL POINT (CCP) means an operational step in a food preparation
process at which control can be applied and is essential to prevent or eliminate a food
safety hazard or reduce it to an acceptable level.
CRITICAL LIMIT means one or more prescribed parameters that must be met to ensure
that food safety hazards are controlled at a CCP.
CROSS-CONTAMINATION means the transfer of harmful substances or diseasecausing microorganisms to food by hands, food-contact surfaces, sponges, cloth towels,
and utensils that touch raw food, are not cleaned, and then touch ready-to-eat foods.
Cross-contamination can also occur when raw food touches or drips onto cooked or
ready-to-eat foods.
DANGER ZONE means the temperature range between 5 ºC (41 ºF) and 57 ºC (135 ºF)
that favors the growth of pathogenic bacteria.
DEVIATION means a failure to meet a required critical limit for a critical control point.

41

EXCLUDE means to prevent a person from working as a food employee or entering a
food establishment except for those areas open to the general public.
EXTRINSIC FACTORS OF FOOD means the factors that people can readily control
involving food, such as temperature, acidity, and availability of oxygen.
FOOD PREPARATION PROCESS means the series of operational steps conducted to
produce a food ready to be consumed, i.e. Preparation of Ready-to-eat Food with No
Cook Step, Preparation for Same Day Service, and Complex Food Preparation.
FOODBORNE ILLNESS means illness resulting from the consumption of foods or
beverages contaminated with disease-causing microorganisms, chemicals, or other
harmful substances.
FOODBORNE OUTBREAK means the occurrence of two or more cases of a similar
illness resulting from the ingestion of a common food.
HAZARD means a biological, chemical, or physical property that may cause a food to
be unsafe for human consumption.
HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) means a
prevention-based food safety system that identifies and monitors specific food safety
hazards that can adversely affect the safety of food products.
HACCP PLAN means a written document that is based on the principles of HACCP and
that describes the procedures to be followed to ensure the control of a specific process
or procedure.
HACCP SYSTEM means the result of the implementation of the HACCP plan. A
HACCP system includes the HACCP plan and all the prerequisite programs.
HIGHLY SUSCEPTIBLE POPULATION (HSP) means persons who are more likely
than other populations to experience foodborne disease because they are either
immunocompromised, preschool age children (infants or toddlers), or older adults.
INFECTIOUS MICROORGANISMS means pathogenic bacteria, viruses, or parasites,
that when ingested, cause foodborne illness in humans.
INTRINSIC FACTORS OF FOOD means the factors that are inherent to the food and
are not readily controlled by people in a retail facility, such as water activity, nutrient
content, and competitive microflora.
MICROORGANISM means a form of life that can be seen only with a microscope
including bacteria, viruses, yeast, and single-celled animals.

42

MONITORING means the act of observing and making measurements to help
determine if critical limits are being met and maintained.
OPERATIONAL STEP means an activity or stage in the flow of food through a food
establishment such as receiving, storage, preparation, cooking, etc.
PARASITE means an organism that lives on or in another usually larger host organism
in a manner that harms or is of no advantage to the host. Parasites, like T. spiralis or
T. gondii, do not grow in food, only inside of the body once ingested.
PATHOGEN means a microorganism (bacterium, parasite, virus, or fungi) that causes
disease in humans.
PATHOGENIC LOAD means the expected amount of pathogens on a raw product, i.e.
amount of Salmonella on chicken.
PERSON IN CHARGE means the individual present at a food establishment who is
responsible for the operation at the time of inspection.
pH means the measure of the acidity of a product.
POTENTIALLY HAZARDOUS FOOD (PHF) means a natural or synthetic food that
requires temperature control because it is in a form capable of supporting:
•
•
•

The rapid and progressive growth of infectious or toxigenic microorganisms;
The growth and toxin formation of Clostridium botulinum; or
In raw shell eggs, the growth of Salmonella Enteritidis.

PHF includes:
ƒ
ƒ
ƒ
ƒ

animal food (a food of animal origin) that is raw or heat treated
a food of plant-origin that is heat-treated or consists of raw seed sprouts
cut melons
garlic-in-oil mixtures that are not modified in a way that results in mixtures that do
not support the growth of pathogenic microorganisms

PREREQUISITE PROGRAMS means procedures such as Standard Operating
Procedures (SOPs) that address basic operational and sanitation conditions in an
establishment.
READY-TO-EAT (RTE) FOOD means:
•
•
•
•

raw animal foods that have been properly cooked;
fish intended for raw consumption that has been frozen to destroy parasites;
raw fruits and vegetables that are washed;
fruits and vegetables that are cooked for hot holding;

43

•
•
•
•
•
•

plant food for which further washing, cooking, or other processing is not required
for food safety, and from which rinds, peels, husks, or shells, if naturally present,
are removed;
substances derived from plants such as spices, seasonings, and sugar
a bakery item such as bread, cakes, pies, fillings, or icing for which further
cooking is not required for food safety;
dry, fermented sausages, such as dry salami or pepperoni;
salt-cured meat and poultry products, such as prosciutto ham, country-cured
ham, and Parma ham; and
dried meat and poultry products, (such as jerky or beef sticks) and low acid foods
that have been thermally processed and packaged in hermetically sealed
containers.

RESTRICT means to limit the activities of a food employee so that there is no risk of
transmitting a disease that is transmittable through food and so that the food employee
does not work with exposed food, clean equipment, utensils, linens, or unwrapped
single-service or single-use articles.
RISK CONTROL PLAN (RCP) means a concisely written management plan developed
by the retail or food service operator with input from the health inspector that describes
a management system for controlling specific out-of-control risk factors.
RISK FACTOR means one of the broad categories of contributing factors to foodborne
illness outbreaks, as identified in the Centers for Disease Control and Prevention (CDC)
Surveillance Report for 1993-1997, that directly relates to foodborne safety concerns
within retail and food service establishments. The factors are Food from Unsafe
Sources, Inadequate Cooking Temperatures, Improper Holding Temperatures,
Contaminated Equipment, and Poor Personal Hygiene.
SEVERITY means the seriousness of the effect(s) of a hazard.
SPORE means a very tough, dormant form of certain bacterial cells that is very resistant
to desiccation, heat, and a variety of chemical and radiation treatments that are
otherwise lethal to vegetative cells.
SPORE-FORMER means a bacterium capable of producing spores under adverse
conditions..
Spore-formers in food include Clostridium botulinum, Bacillus cereus, and
Clostridium perfringens.
STANDARD OPERATING PROCEDURE (SOP) means a written method of controlling
a practice in accordance with predetermined specifications to obtain a desired outcome.

44

TOXIGENIC MICROORGANISM means pathogenic bacteria that causes foodborne
illness in humans due to the ingestion of toxins produced in food.
Toxigenic microorganisms in food include Staphylococcus aureus, Bacillus
cereus, and Clostridium botulinum.
VALIDATION means, for the purpose of this Manual, to focus on scientific and technical
information to determine if the food safety management system in place will effectively
control the food safety hazards once implemented.
VEGETATIVE CELL means a bacterial cell which is capable of actively growing.
VERIFICATION means those activities, other than monitoring, that determine the
validity of the HACCP plan and show that the system is operating according to the plan.
VIRUS means a submicroscopic parasite consisting of nucleic acid (DNA or RNA)
surrounded by a protein coat, and sometimes also encased in a lipid and glycoprotein
envelope. Viruses are completely dependent on a living host cell to survive and multiply,
and therefore can not multiply in or on food.
WATER ACTIVITY (Aw) means the quotient of the water vapor pressure of the
substance, divided by the vapor pressure of pure water at the same temperature.
Generally speaking, it is the amount of water available in the product to allow bacteria to
live and grow.

45

Annex 1 – References

The following is a partial list of references and sources of information that may be
helpful to you in evaluating food safety management systems that are developed by
operators in your jurisdiction. This list is not intended to be all-inclusive. FDA does not
endorse material that is not published by the federal government, though examples of
such material may be listed for your reference.

AGENCIES
United States Food and Drug Administration
•

Center for Food Safety and Applied Nutrition (CFSAN), Retail Food
Protection Branch

U.S. Food and Drug Administration
CFSAN, HFS-627
5100 Paint Branch Parkway
College Park, MD 20740-3835
•

Center for Food Safety and Applied Nutrition, Office of Field Programs

Dr. John E. Kvenberg, Deputy Director, OFP
U.S. Food and Drug Administration
CFSAN, HFS-600
5100 Paint Branch Parkway
College Park, MD 20740-3835
•

Regional Field Offices (Regional Retail Food Specialists)

Northeast (Connecticut, Maine, Massachusetts, New Hampshire, New York, Rhode
Island, and Vermont):
158-15 Liberty Avenue, HFR-NE4
Jamaica, NY 11433-1034
(718) 662-5621
FAX (718) 662-5434

46

One Montvale Avenue, HFR-NE250
Stoneham, MA 02180-3542
(781) 596-7700
FAX (781) 596-7896
Central - Mid Atlantic (Delaware, District of Columbia, Kentucky,
Maryland, New Jersey, Ohio, Pennsylvania, Virginia, and West
Virginia):
101 West Broad Street
Suite 400
Falls Church, VA 22046
(703) 235-8440 ext. 502
Central – Mid West (Illinois, Indiana, Michigan, Minnesota, North
Dakota, South Dakota, and Wisconsin):
20 North Michigan Ave., Suite 50
HFR-MW15
Chicago, IL 60602-4811
(312) 353-9400
FAX (312) 886-1682
240 Hennepin Avenue
Minneapolis, MN 55401
(612) 334-4100 ext. 115
FAX (612) 334-4134
Southeast (Alabama, Florida, Georgia, Louisiana, Mississippi,
North Carolina, Puerto Rico, South Carolina, Tennessee, and
Virgin Islands):
60 – 8th Street, N.E.
HFR-SE13
Atlanta, GA 30309-3959
(404) 253-1200 ext. 1265, 1267, 1268, 1273
FAX (404) 253-1207
Southwest (Arkansas, Colorado, Iowa, Kansas, Missouri,
Nebraska, New Mexico, Oklahoma, Texas, Utah, and Wyoming):
4040 N. Central Expressway, Suite 900
HFR-SW16
Dallas, TX 75204
(214) 253-4948, 4947, 4945
FAX (214) 253-4960

47

11510 W. 8th Street, HFR-SW36
Lenexa, KS 66285-5905
(913) 752-2401
FAX (913) 752-2487
Building 20, Denver Federal Center
P.O. Box 25087
Denver, CO 80225-0087
(303) 236-3026
FAX (303) 236-3551
Pacific (Alaska, American Samoa, Arizona, California, Guam,
Hawaii, Idaho, Guam, Montana, Nevada, Oregon, and
Washington):
Office of Regional Director - Pacific Region
Oakland Federal Bldg., HFR-PA16
1301 Clay Street, Suite 1180N
Oakland, CA 94612-5217
(510) 637-3960 ext. 27
FAX (510) 637-3976
51 West Third Street
Tempe, AZ 85281
(480) 829-7396 ext. 35
FAX (480) 829-7677
9780 SW Nimbus Avenue
Beaverton, OR 97008-7163
(503) 671-9711 ext. 16
(503) 671-9445
•

Division of Human Resource Development, State Training Team.

15000 Crabbs Branch Rd. HFC-60
Rockville, MD 20855
(301) 594-0959
FAX (301) 594-1966

48

United States Department of Agriculture
•

Food Safety and Inspection Services

Office of the Director
USDA FSIS PPID/HACCP
Room 6912, Suite 6900E
1099 - 14th Street, N.W.
Washington, DC 20250-3700
(202) 501-7319
FAX (202) 501-7639

ARTICLES
Bryan, Frank. “Hazard Analyses of Street Foods and
Considerations for Food Safety.” Dairy, Food and Environmental
Sanitation, February 1995, pp. 64-69.
Bryan, Frank. “HACCP: Present Status and Future in Contribution
to Food Safety.” Dairy, Food & Environmental Sanitation,
November 1994, pp. 650-655.
Bryan, Frank. “Procedures for Local Health Agencies to Institute a
Hazard Analysis Critical Control Point Program for Food Safety
Assurance in Food Service Operations.” Journal of Environmental
Health, March/April 1985, pp. 241-245.
Bryan, Frank. “Hazard Analysis of Food Service Operation.” Food
Technology, February 1981, pp. 78-87.
Bryan, Frank. “Hazard Analysis Critical Control Point Approach:
Epidemiologic Rationale and Application to Food Service
Operations.” Journal of Environmental Health, August 1981, pp. 714.
Bryan, Frank. “Factors that Contribute to Outbreaks of Foodborne
Disease.” Journal of Food Protection, October 1978, pp. 816-827.
Bryan, F.L. and Lyon, J.B. “Critical Control Points of Hospital Food
Service Operations. Journal of Food Protection, 1984.
Briley and Klaus. “Using Risk Assessment as a Method of
Determining Inspection Frequency.” Dairy and Food Sanitation,
December 1985, pp. 468-474.
Centers for Disease Control and Prevention.

49

Surveillance for Foodborne Disease Outbreaks –
United States, 1993-1997. Morbidity Mortality Weekly Report.
#49 (SS01), USPHS, March 17, 2000, pp. 1-51.
National Advisory Committee on Microbiological Criteria for Food
(NACMCF). 1997 Hazard Analysis and Critical Control Point
System, USDA - FSIS Information Office, 1997.
National Advisory Committee on Microbiological Criteria for Food
(NACMCF). 1992. Hazard Analysis and Critical Control Point
System, Int. J. Food Microbiology, 16:1-23.
National Food Processors Assoc. “HACCP Implementation: A
Generic Model for Chilled Foods.” Journal of Food Protection,
December, 1993, pp. 1077-1084.
Silliker, John, Ph.D. “Microbiological Testing and HACCP
Programs.” Dairy, Food and Environmental Sanitation, October
1995, pp. 606-610.
Stier, R.F., and Blumenthal, M.M., Ph.D. “Will HACCP be Carrot
or Stick.” Dairy,Food and Environmental Sanitation, October
1995, pp. 616 - 620.
Tisler, J.M. “The Food and Drug Administration’s Perspective on
HACCP,” Food Technology, June 1991, pp. 125-127.
Tompkin, R.B. “The Use of HACCP in the Production of Meat and
Poultry Products.” Journal of Food Protection, September 1990,
pp. 795-803.
Weingold, S.E. et al. “Use of Foodborne Disease Data for HACCP
Risk Assessment.” Journal of Food Protection, September 1994,
pp. 820-830.

BOOKS
Control of Communicable Diseases in Man, 16th ed., American
Public Health Association, 1995.
Corlett, D.A. and Pierson, M.D. HACCP, Principles & Applications,
ed., Chapman and Hall, New York, 1992.
Diseases Transmitted by Foods, 2nd ed., Centers for Disease
Control, USPHS, 1982.

50

Fellows, P.J. Food Processing Technology, Principles and
Practice, Ellis Horwood, New York, 1990.
Fennema, O.R. Food Chemistry, 2nd ed., Marcel Dekker, Inc.,
New York, 1985.
Foodborne Diseases, ed. D.O. Cliver, Academic Press, San Diego,
California, 1990.
HACCP Reference Book, National Restaurant Assoc., The
Educational Foundation, Chicago, 1994.
Jay, J.M. Modern Food Microbiology, 4th ed., Van Nostrand
Reinhold, New York, 1992.
Potter, N. Food Science, 4th ed., Van Nostrand Reinhold, New
York, 1986.
Procedures to Implement Hazard Analysis Critical Control Point
Systems, International Association of Milk, Food and
Environmental Sanitarians.

FDA PUBLICATIONS AND FEDERAL REGULATIONS
A Manual for the Voluntary Use of HACCP Principles for
Operators of Food Service and Retail Establishments,
available on FDA/CFSAN website at:
http://www.cfsan.fda.gov/~dms/hret2toc.html
FDA Food Code, current edition, may be purchased from the U.S.
Department of Commerce, National Technical Information Service,
via telephone: (703) 487-4650 or electronically via the FDA
website: http://www.cfsan.fda.gov/~dms/foodcode.html.
Fish and Fishery Products - Code of Federal Regulations, Title
21, Part 123 Fish and Fishery Products.
Fish and Fishery Products Hazards and Controls Guide, Third
Edition, June 2001. Food and Drug Administration, Washington,
D.C. May be purchased from:
National Technical Information Service,
U.S. Department of Commerce,
703-487-4650.

51

The Fish and Fishery Products Hazards and Controls Guide is also available
electronically at http://www.cfsan.fda.gov/~comm/haccpsea.html
Single copies may be obtained as long as supplies last from FDA
district offices and from:
U.S. Food and Drug Administration
Office of Seafood
5100 Paint Branch Parkway
College Park, MD 20740-3835
National Shellfish Sanitation Program Model Ordinance for
Molluscan Shellfish, available on the FDA/CFSAN website at:
http://www.cfsan.fda.gov/~ear/nsspotoc.html or may be purchased
from:
National Technical Information Service
U.S. Department of Commerce
703-487-4650.
Recommended National Retail Food Regulatory Program Standards, available
on the FDA/CFSAN website at: http://www.cfsan.fda.gov/~dms/ret-toc.html
Report of the FDA Retail Food Program Database of Foodborne Illness Risk
Factors, available on the FDA/CFSAN website at:
http://www.cfsan.fda.gov/~dms/retrsk.html
FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected
Institutional Foodservice, Restaurant, and Retail Food Store Facility Types
(2004), available on the FDA/CFSAN website at:
http://www.cfsan.fda.gov/~dms/retrsk2.html

52

Annex 2
Sample HACCP Tables
Table 1a. Process #1 – Food Preparation with No Cook Step
FOOD/MENU ITEMS:

HAZARD(S)

CRITICAL
CONTROL POINTS
CRITICAL LIMITS
(List Only the
Operational Steps
that are CCPs)

MONITORING

PREREQUISITE
PROGRAMS

53

CORRECTIVE
ACTIONS

VERIFICATION

RECORDS

Table 1b. Process #1 – Food Preparation with No Cook Step
FOOD/MENU ITEMS:
PROCESS
STEP

HAZARD(S)

CCP
CRITICAL LIMITS
(Y/N)

MONITORING

RECEIVE
STORE
PREPARE
HOLD
SERVE

Prerequisite
Programs

54

CORRECTIVE
VERIFICATION
ACTIONS

RECORDS

Table 2a. Process #2 – Preparation for Same Day Service
FOOD/MENU ITEMS:

HAZARD(S)

CRITICAL
CONTROL
POINTS
CRITICAL LIMITS
(List Only the
Operational Steps
that are CCPs)

MONITORING

PREREQUISITE
PROGRAMS

55

CORRECTIVE
VERIFICATION
ACTIONS

RECORDS

Table 2b. Process #2 – Preparation for Same Day Service
FOOD/MENU ITEMS:
PROCESS
STEP

HAZARD(S)

CCP
CRITICAL LIMITS
(Y/N)

MONITORING

RECEIVE
STORE
PREPARE
COOK
HOLD
SERVE
Prerequisite
Programs

56

CORRECTIVE
VERIFICATION
ACTIONS

RECORDS

Table 3a. Process #3 – Complex Food Preparation
FOOD/MENU ITEMS:

HAZARD(S)

CRITICAL
CONTROL POINTS
CRITICAL LIMITS
(List Only the
Operational Steps
that are CCPs)

MONITORING

PREREQUISITE
PROGRAMS

57

CORRECTIVE
VERIFICATION
ACTIONS

RECORDS

Table 3b. Process #3 – Complex Food Preparation
FOOD/MENU ITEMS:
PROCESS
STEP

HAZARD(S)

CCP
CRITICAL LIMITS
(Y/N)

MONITORING

RECEIVE
STORE
PREPARE
COOK
COOL
REHEAT
HOLD
SERVE
Prerequisite
Programs

58

CORRECTIVE
VERIFICATION
ACTIONS

RECORDS

Annex 3 - Hazard Analysis
This Annex provides guidance for determining food safety hazards in foods and/or food
preparation processes at retail.
HOW DO YOU CONDUCT A HAZARD ANALYSIS?
The purpose of hazard analysis is to develop a list of food safety hazards that are
reasonably likely to cause illness or injury if not effectively controlled. The process of
conducting a hazard analysis involves two stages:
1. Hazard Identification
2. Hazard Evaluation
Hazard identification can be thought of as a brain storming session. This stage focuses
on identifying the food safety hazards that might be present in the food given the food
preparation process used, the handling of the food, the facility, and general
characteristics of the food itself. During this stage, a review is made of the ingredients
used in the product, the activities conducted at each step in the process, the equipment
used, the final product and its method of storage and distribution, as well as the
intended use and consumers of the product. Based on this review, a list of potential
biological, chemical, or physical hazards is made at each stage in the food preparation
process.
In stage two, the hazard evaluation, each potential hazard is evaluated based on the
severity of the potential hazard and its likely occurrence. The purpose of this stage is to
determine which of the potential hazards listed in stage one of the hazard analysis
warrant control in the HACCP plan. Severity is the seriousness of the consequences of
exposure to the hazard. Considerations made when determining the severity of a
hazard include understanding the impact of the medical condition caused by the illness,
as well as the magnitude and duration of the illness or injury. Consideration of the likely
occurrence is usually based upon a combination of experience, epidemiological data,
and information in the technical literature. Hazards that are not reasonably likely to
occur are not considered in a HACCP plan. During the evaluation of each potential
hazard, the food, its method of preparation, transportation, storage, and persons likely
to consume the product should be considered to determine how each of these factors
may influence the likely occurrence and severity of the hazard being controlled.
Upon completion of the hazard analysis, a list of significant hazards that must be
considered in the HACCP plan is made, along with any measure(s) that can be used to
control the hazards. These measures, called control measures, are actions or activities

59

that can be used to prevent, eliminate, or reduce a hazard. Some control measures are
not essential to food safety, while others are.
Control measures essential to food safety like proper cooking, cooling, and refrigeration
of ready-to-eat, potentially hazardous foods are applied at critical control points (CCPs)
in the HACCP plan. The term control measure is used because not all hazards can be
prevented, but virtually all can be controlled. More than one control measure may be
required for a specific hazard. Likewise, more than one hazard may be addressed by a
specific control measure (e.g. proper cooking).
The physical characteristics and composition of the food during and after preparation
should be considered when determining the risk of a hazard. This means
understanding the intrinsic and extrinsic factors of the food that would allow conditions
that support the survival or growth of bacteria. Intrinsic factors are those that are
inherent to the food and are not readily controlled by people in a retail establishment,
such as water activity, nutrient content, and competitive microorganisms. Extrinsic
factors are those that people can readily control, such as temperature, acidity, and
availability of air.
Once the significant biological hazards are identified for a food, there are several issues
to consider when determining if conditions exist that would support their growth or
survival, including:
•

The nature of the food (ground or intact; plant or animal)

•

Whether the food is improperly cooled after cooking or improperly hot held,
(Clostridium perfringens or Bacillus cereus could grow because their spores
survive cooking and germinate)

•

Whether the food is improperly cold held (Listeria monocytogenes and Yersinia
will be a concern because they grow at refrigeration temperatures)

•

Whether foods have a high salt content (Vibrio and Staphylococcus aureus are
likely to grow because they are salt-tolerant)

•

Whether air is unavailable, such as in the interior of a cooked food or a sealed
modified-atmosphere package (Clostridium botulinum and C. perfringens will
thrive when air is not present)

•

Whether water activity is high (Staphylococcus aureus needs to have nutrients
readily available in order to thrive, but it can produce a potent toxin in a food with
a water activity that is lower than that needed by other organisms)

60

Several questions that you may ask yourself when assessing the food safety
hazards in food include the following:
•

Does the food permit survival or multiplication of pathogens and/or toxin
formation in the food before or during preparation?

•

Will the food permit survival or multiplication of pathogens and/or toxin formation
during subsequent steps of preparation?

•

What has been the safety record for the product in the marketplace? Is there an
epidemiological history associated with this food?

•

Is the food served to a highly susceptible population?

•

What is known about the time/temperature exposure of the food?

•

What is the water activity and pH of the food?

•

Have bare hands touched the food, or otherwise cross-contaminated it?

•

Is the food from a safe source?

•

Do food workers practice good personal hygiene, including frequent and effective
handwashing?

•

Has the food been exposed to unclean or unsanitized equipment?

•

Does the preparation procedure or process include a step that destroys
pathogens or their toxins? (Consider both vegetative cells and spores)

•

Is the product subject to recontamination after cooking?

Hazard identification, in conjunction with risk and severity estimation, provides a rational
basis for determining hazards of significance. There may be differences of opinion,
even among experts, as to the risk of a hazard and one may need to consult reliable
information published in peer-reviewed literature or recognized experts in the field. The
hazards must at least include those that are commonly associated with a specific
product.

61

A list of specific food safety hazards found in common products follows. As pointed out
in Recommended Procedural Step 3, each of these food safety hazards belong to more
general categories of hazards that may used as you develop your food safety
management system:
•
•
•
•
•
•
•
•

Salmonella and Campylobacter jejuni in raw poultry
Salmonella Enteriditis in undercooked eggs
E. coli O157:H7 in raw ground beef
Listeria monocytogenes in ready-to-eat foods, such as hot dogs and deli meat
Bacterial pathogens associated with unpasteurized juice or milk
Staphylococcus aureus toxin formation in ready-to-eat products that are
contaminated and later temperature-abused, such as cooked ham
Bacillus cereus spore survival and toxin formation in cooked rice
Clostridium perfringens and B. cereus spore survival and subsequent growth in
cooked meat/meat products

62

Table 1. Selected Biological and Chemical Hazards Found at Retail, Associated Foods,
and Control Measures.
HAZARD
Bacteria

ASSOCIATED FOODS

CONTROL MEASURES

Bacillus cereus
(intoxication caused by heatstable, preformed emetic toxin or
toxioinfection caused by heatlabile, diarrheal toxin)
Campylobacter jejuni

Meat, poultry, starchy foods (rice,
potatoes), puddings, soups, cooked
vegetables

Cooking, Cooling, Cold Holding, Hot
Holding

Poultry, raw milk

Clostridium botulinum
(intoxication cased by preformed
heat-labile toxin)

Vacuum-packed foods, reduced
oxygen packaged foods, underprocessed canned foods, garlic-in-oil
mixtures, time/temperature abused
baked potatoes/sautéed onions
Cooked meat and poultry, Cooked
meat and poultry products including
casseroles, gravies
Raw ground beef, raw seed sprouts,
raw milk, unpasteurized juice, foods
contaminated by infected food workers
via fecal-oral route

Cooking, Handwashing, Prevention
of Cross-contamination
Thermal Processing (Time +
Pressure), Cooling, Cold Holding,
Hot Holding, Acidification and Drying,
etc.

Clostridium perfringens
E. coli O157:H7 (other shiga
toxin-producing E. coli)

Listeria monocytogenes

Salmonella spp.

Shigella spp.

Staphylococcus aureus
(intoxication caused by
preformed heat-stable toxin)
Vibrio spp.
Parasites

Anisakis simplex

Viruses

Taenia spp.
Trichinella spiralis
Hepatitis A and E

Other Viruses (Rotaviruses,
Noroviruses, Reoviruses)

Raw meat and poultry, fresh soft
cheese, Pate, smoked seafood, deli
meats, deli salads
Meat and poultry, seafood, eggs, raw
seed sprouts, raw vegetables, raw
milk, unpasteurized juice
Raw vegetables and herbs, other
foods contaminated by infected
workers via fecal-oral route
RTE PHFs touched by bare hands
after cooking and further
time/temperature abused
Seafood, shellfish
Various fish (cod, haddock, fluke,
pacific salmon, herring, flounder,
monkfish)
Beef and pork
Pork, bear and seal meat
Shellfish, any food contaminated by
infected worker via fecal-oral route

Any food contaminated by infected
worker via fecal-oral route

63

Cooling, Cold Holding, Reheating,
Hot Holding
Cooking, No Bare Hand Contact with
RTE Foods, Employee Health Policy,
Handwashing, Prevention of Crosscontamination, Pasteurization or
Treatment of Juice
Cooking, Date Marking, Cold
Holding, Handwashing, Prevention of
Cross-contamination
Cooking, Use of Pasteurized Eggs,
Employee Health Policy, No Bare
Hand Contact with RTE foods,
Handwashing, Pasteurization or
Treatment of Juice
Cooking, No Bare Hand Contact with
RTE Foods, Employee Health Policy,
Handwashing
Cooling, Cold Holding, Hot Holding,
No Bare Hand Contact with RTE
Food, Handwashing
Cooking, Approved Source,
Prevention of Cross-contamination
Cooking, Freezing
Cooking
Cooking
Approved Source, No Bare Hand
Contact with RTE Food, Minimizing
Bare Hand Contact with Foods Not
RTE, Employee Health Policy,
Handwashing
No Bare Hand Contact with RTE
Food, Minimizing Bare Hand Contact
with Foods Not RTE, Employee
Health Policy, Handwashing

Table 2. Foods that might be served raw or undercooked.

Raw Animal
Food

Menu Items

Hazards

Beef

Steak Tartare
Carpaccio

Salmonella spp.
Escherichia coli O157:H7

Poultry

Duck

Salmonella spp.
Campylobacter jejuni

Eggs

Quiche, hollandaise sauce, Eggs Benedict,
homemade mayonnaise, meringue pie, some
puddings and custards, Monte Cristo sandwich,
mousse, tiramisu, chicken croquettes, rice balls,
stuffing, lasagna, french toast, crab cakes, egg
nog, fish stuffing, Caesar salad, ice cream

Salmonella Enteritidis

Raw Fish/Finfish

Lightly cooked fish, sushi, raw-marinated, coldsmoked fish, ceviche, tuna carpaccio

Anisakis simplex
Diphyllobothrium spp.
Pseudoterranova decipiens
Vibrio parahaemolyticus

Reef fish:
(barracuda, amberjack, horse-eye jack,
black/jack, other large species of jack, king
mackerel, large groupers, large snappers)

Ciguatera toxin

Shellfish

Oysters
Clams

Vibrio vulnificus
Vibrio spp.
Hepatitis A
Norovirus

Raw Dairy Products

Raw or unpasteurized milk, some soft cheeses
like Camembert, Brie, etc.

Listeria monocytogenes
Salmonella spp.
Campylobacter jejuni
E. coli O157:H7

64

Table 3. Natural Toxins1 in Seafood
Natural Toxins

Molluscan Shellfish
N.E. and N.W. coastal regions of
N. America

NSSP approved waters
2
(tags)
(FDA ICSSL listing)

Neurotoxic Shellfish Poisoning
(NSP)

Molluscan Shellfish harvested along coast
of Gulf of Mexico

NSSP approved waters
2
(tags)
(FDA ICSSL listing)

Molluscan Shellfish

NSSP approved waters
2
(tags)
(FDA ICSSL listing)

Amnesic Shellfish Poisoning (ASP)

Molluscan Shellfish
N.E. & N.W. coasts of N. America

NSSP approved waters
2
(tags)
(FDA ICSSL listing)

Ciguatera Fish Poisoning (CFP)

fin fish from extreme S.E. U.S., Hawaii,
Subtropical and Tropical areas:
barracuda
amberjack
horse-eye jack
black jack
other larger species of jack
king mackerel
large groupers
large snappers

Purchase from approved sources:
•
get fish from areas that are not
subject of an adverse advisory, or
•
get fish from a reef area known to
be monitored for toxicity and not
covered by an adverse advisory.

Gempylotoxin, a strong purgative oil
(can cause severe diarrhea)

Escolar

FDA recommendation: Escolar should
not be marketed in interstate commerce

Puffer Fish or Fugu, usually from IndoPacific ocean, however some noted from
Atlantic Ocean, Gulf of Mexico and Gulf of
California

Illegal to import or receive (exemption:
an agreement with one N.Y. importer)

Etrodotoxin

2

Control

Paralytic Shellfish Poisoning (PSP)

Diarrhetic Shellfish Poisoning (DSP)

1

Type of fish (species)

Fish and Fishery Products Hazards and Controls Guide, Third Edition, June 2001

The tags must contain a unique state issued "certification number" specific for each certified dealer. If the firm
is engaged in interstate commerce, this number appears in FDA’s Interstate Certified Shellfish Shippers List.

65

Table 4. Fish Considered to be Scombrotoxin-Forming Species1
Toxin Formation
Scombrotoxin formation as a
result of time/temperature abuse

1

Species - Market Names
Most scombroid poisonings from
tuna, mahi-mahi and bluefish.
Other species are:
Amberjack or yellowtail
Anchovy
Bluefish
Bonito
Escolar or Snake Mackerel
Gemfish
Herring (not River herring)
Jack
Jobfish
Kahawai
Mackerel (not Atka)
Mahi-Mahi
Marlin
Pilchard or Sardine
Sardine
Saury
Shad & roe
Shad, Gizzard
Snapper (Pristipomoides ssp)
Sprat or Bristling
Trevally
Tuna
Wahoo

Control
Buy from approved federally
inspected suppliers. They are
required to receive, hold, and
process using a HACCP system.
Check for an adequate quantity of
ice or other cooling media.
If not, a federally inspected
supplier or directly from a fishing
boat, check for the following at
receipt:
- an adequate quantity of ice or
other cooling media
- the time the fish were caught
(from the vessel or supplier)
- See * information below

Fish and Fishery Products Hazards and Controls Guide, Third Edition, June 2001

* FDA Recommended HACCP Controls for Histamine – Quick reference
Secondary Processor (Controls at receipt)
Transport records
OR
(< 40 ºF throughout transit)

Adequate Ice/cooling media
surrounding product at delivery

Processing/ Storage
Fresh (not previously frozen)
≤ 4 hrs @ > 40 ºF if any ≤ 8 hrs @ > 40 ºF if NO
exposure is > 70 ºF
exposure is > 70 ºF

Previously frozen
≤ 12 hrs @ > 40 ºF if
≤ 24 hrs @ > 40 ºF if
any exposure is > 70 ºF NO exposure is > 70 ºF

66

Table 5. Common Parasites in Seafood1
Parasites2

Nematodes or
roundworm
Cestodes or tapeworms
Trematodes or flukes

Type of fish/species likely
to be used in menu items
that will not be cooked
Sea bass
Capelin & roe
Cod
Flounder
- Dab
- Fluke
Grouper
Halibut
Herring
Jack
Jobfish
Kahawai
Mackerel
Monkfish
Mullet

Chilean Sea Bass
Ocean Perch
Plaice
Pollock
Rockfish
Sablefish
Salmon & roe
(aquacultured
and wild)
Seatrout
Sole
Sprat/Bristling
Trout/steelhead/
rainbow
Tuna, small
Turbot
Wolfish

Control

Purchase from a processor,
require the raw fish to have
been:
• Frozen and stored at -4
ºF (-20 ºC) or below for
7 days; or
•

Frozen at -31 ºF
(-35 ºC) or below and
stored at -31 ºF (-35 ºC)
for 15 hours; or

•

Frozen at -31 ºF
(-35 ºC) or below until
solid and stored at -4 ºF
(-20 ºC) for 24 hrs.

Freezing can be done in your
operation if it is done in
accordance with the Food Code,
Chapter 3.

1

Fish and Fishery Products Hazards and Controls Guide, Third Edition, June 2001

2

Some food products that have been implicated in human parasitic infection are:
ceviche
salmon roe
green herring
undercooked grilled fish
lomi lomi
sashimi
drunken crabs
poisson cru
sushi
cold smoke fish

67

Annex 4 - Food Safety Questions
In order to assure yourself that you are conducting comprehensive, risk-based
inspections, you may want to ask yourself the following sample list of questions before
leaving establishments. This list addresses the significant food safety concerns for
each operational step in the flow of food through the establishments. This sample list
can be used as a tool to help you focus your inspections on assessing the active
managerial control of foodborne risk factors. Assessment of whether establishments
are actively monitoring critical processes is especially important in your assessment of
establishments' active managerial control of foodborne illness risk factors. Note that
this list is not intended to be a questionnaire for operators, but rather a tool to help you
remember the critical processes to evaluate during your inspections.

RECEIVING
1.
2.
3.
4.
5.
6.
7.

Is their food from an approved source?
How do they verify that their food is from an approved source?
How do they know if the food is at the proper temperature upon receipt?
What kind of refusal policy do they have?
Do they keep receiving logs (not required)?
How do they verify the source of shellfish?
How do they maintain certification records for fish that must be frozen to destroy
parasites as specified in the Food Code?

COLD STORAGE/COLD HOLDING
1. How do they monitor their refrigeration units to ensure that they are maintaining
proper temperature?
2. Is their date marking procedure acceptable?
3. How do their employees know what food is to be used first?
4. Are their storage practices for RTE and raw food acceptable?
5. Where are their thermometers stored? Are they calibrated? How often?
6. What kind of monitoring procedures do they implement for ensuring food is at the
proper cold holding temperature?
7. Do they keep temperature logs (not required in most cases)?.

PREPARATION
1. What steps do they use to prevent cross-contamination?
2. What training is given for handwashing?
3. What is their handwashing policy?

68

4.
5.
6.
7.
8.

How do they clean and sanitize their equipment?
How do their employees eliminate bare hand contact with RTE food?
How do their employees minimize bare hand contact with food that is not RTE?
How do they process fruits and vegetables before service?
Do they serve a highly susceptible population?

COOKING
1.
2.
3.
4.

Does the staff know the correct cooking temperatures?
Do they have a consumer advisory?
Are cooking temperatures monitored?
What corrective actions are taken when food does not reach the proper
temperature?
5. Are cooking temperature logs maintained (not required)?

COOLING
1.
2.
3.
4.
5.

How is food cooled?
How are temperatures monitored?
How do they ensure that the prescribed time frames are met?
What corrective actions do they take if the time frames are not met?
Are cooling records maintained (not required)?

REHEATING
1.
2.
3.
4.
5.

What happens to leftovers?
How are food products reheated? Stove/oven, microwave, steam table, other?
How are temperatures monitored?
Are reheating records maintained (not required)?
What corrective actions are taken?

HOT HOLDING
1.
2.
3.
4.
5.
6.

How are cooked foods held until service?
How is temperature controlled? Steam table, stove/oven, hot box, other?
How are the temperatures monitored?
How are temperature records maintained (not required)?
What corrective actions are taken when food is found out of temperature?
Is temperature maintained during distribution if food is transported off-site?

TIME ALONE AS A PUBLIC HEALTH CONTROL
1. How long is PHF being held out of temperature before or after cooking?
2. How is the time out of temperature controlled?

69

3. How is time monitored?
4. How are time records maintained? As specified in the Food Code?

70

Annex 5 - Risk Control Plans

Example Risk Control Plan for Turkey Vegetable Soup
Establishment Name: ABC Establishment
Physical Address: 123 Any Street
City: Any City
State: Any State
Inspection
Inspection
Time In:
Time Out:
9:00 a.m.
12:30 p.m.
Agency: Your jurisdiction

Type of Facility: Full Service
Person in Charge: John Doe
Zip: 00000
County: Any
County
Inspector’s Name: Jane Doe

Date:
July 12, 2001

Specific observation noted during inspection:
Temperature of turkey vegetable soup in walk-in cooler was 65 ºF after cooling in the
walk-in all night (12 hours).

Applicable code violation(s):
Food Code Section 3-501.14 – Soup not cooled from 140 ºF – 41 ºF in 6 hours or less

Risk factor to be controlled:
Improper Holding Temperatures (Cooling)

What must be done to achieve compliance in the future:
Cool from 140 to 41 ºF within 6 hours provided that food is cooled from 140 to 70 ºF in <
2 hours.

71

How will active managerial control be achieved:
(Who is responsible for the control, what monitoring and record keeping is required,
who is responsible for monitoring and completing records, what corrective actions
should be taken when deviations are noted, how long is the plan to continue)
Conduct a Trial Run to Determine if Cooling Procedure Works
The head chef will portion soup at a temperature of 140 ºF in cleaned and sanitized 3inch metal pans, and place them uncovered in the coolest, protected area of the walk-in
cooler. He will record the time on the “Time-Temperature Log.” Two hours later, the
temperature of the soup will be checked and recorded. If the temperature of the soup is
not 70 ºF or less, the soup will be reheated to 165 ºF, and the trial run will be restarted in
an ice bath. When the temperature is 70 ºF or less within 2 hours, the time and
temperature will be recorded, and cooling will continue. Four hours later, the
temperature of the soup will again be checked and recorded. If the soup is 41 ºF or
less, the cooling procedure will be established. If the soup is not 41 ºF or less, it will be
discarded and other cooling options will be used (see below).
Procedure
When there is less than one gallon of soup left over at the end of the day, the head chef
will log the volume and disposition of the soup. When the volume is greater than one
gallon, the established procedure will be followed. The head chef will complete the
Temperature Log daily for 30 days. The general manager will review the log weekly for
completeness and adherence to the procedure.
Other options that may be suggested to the operator include: purchasing a data logger
to record cooling overnight; discarding any leftover soup at the end of the day; using
chill sticks/ice paddles; using a ice bath to cool leftovers prior to storage; and
purchasing a blast chiller).

How will the results of implementing the RCP be communicated back
to the inspector:
The log will be available for review by the regulatory authority upon request.
As the person in charge of the _______________ located at __________________,
I have voluntarily developed this risk control plan, in consultation with
______________________ and understand the provisions of this plan.
_______________________
(establishment manager)

____________________
(date)

________________________
(regulatory official)

____________________
(date)
72

Risk Control Plan
Establishment Name:

Type of Facility:

Physical Address:

Person in Charge:

City:
Inspection
Time In:

State:
Inspection
Time Out:

Zip:
Date:

County:

Inspector’s Name:

Agency:

Specific observation noted during inspection:
____________________________________________________________
____________________________________________________________
____________________________________________________________
Applicable code violation(s):
____________________________________________________________
____________________________________________________________
____________________________________________________________
Risk factor to be controlled:
____________________________________________________________
What must be achieved to gain compliance in the future:
____________________________________________________________
____________________________________________________________
____________________________________________________________

73

How will active managerial control be achieved:
(Who is responsible for the control, what monitoring and record keeping is required,
who is responsible for monitoring and completing records, what corrective actions
should be taken when deviations are noted, how long is the plan to continue)

How will the results of implementing the RCP be communicated back
to the inspector:

As the person in charge of the _______________ located at __________________,
I have voluntarily developed this risk control plan, in consultation with
______________________ and understand the provisions of this plan.
_______________________
(establishment manager)

____________________
(date)

________________________
(regulatory official)

____________________
(date)
74

Annex 6
Suggested Intervention Strategies
For Out-of-Control Procedures
Out-of-Control
Procedure
Bare Hand
Contact with
RTE Food
Cold Holding

Contaminated
Equipment
Cooking
Cooling

Associated Hazards
Bacteria, Parasites, and
Viruses via Fecal-oral
Route
Vegetative Bacteria,
Toxin-forming and Sporeforming Bacteria,
Scrombrotoxin (Finfish)
Bacteria, Parasites, and
Viruses
Vegetative Bacteria,
Parasites, and Possibly
Viruses
Toxin-forming and Sporeforming Bacteria

On-site correction
(COS)
Conduct Hazard
Analysis (See Chapter 3
and Annex 3).
Conduct Hazard
Analysis (See Chapter 3
and Annex 3).

Long-term Compliance

Clean and Sanitize
Equipment; Discard or
Reheat RTE Food.
Continue Cooking to
Proper Temperature.

Train Employees, Change
Equipment or Layout, Develop SOP

Conduct Hazard
Analysis (See Chapter 3
and Annex 3).
Discard or Reheat RTE
Food.

CrossContamination
of RTE Foods
with Raw
Animal Foods
Food Source/
Sound
Condition
Freezing to
Control
Parasites

Bacteria, Parasites, and
Possibly Viruses

Handwashing

Bacteria, Viruses, and
Parasites

Hot Holding

Toxin-forming and Sporeforming Bacteria

Receiving
Temperatures

Scombrotoxin, Bacteria

Wash Hands
Immediately; Conduct
Hazard Analysis (See
Chapter 3 and Annex 3).
Conduct Hazard
Analysis (See Chapter 3
and Annex 3).
Reject or Discard.

Reheating

Vegetative Bacteria;
Toxin-forming and Sporeforming Bacteria

Conduct Hazard
Analysis (See Chapter 3
and Annex 3).

Bacteria/Parasites/
Viruses/Scombrotoxin/
Ciguatera Toxin
Parasites

RCP, Train Employees,
SOP/HACCP Development
Change Equipment, RCP,
Train Employees, Develop
SOP/HACCP/Recipe

Change Equipment, RCP, Train
Employees, Develop
SOP/HACCP/Recipe
Change Equipment, RCP, Train
Employees, Develop
SOP/HACCP/Recipe
Change Equipment Layout, RCP,
Train Employees, Develop
SOP/HACCP/Recipe

Reject or Discard.

Change Buyer Specifications,
Train Employees

Freeze Immediately;
Discard; or Cook.

Change Buyer Specifications, RCP,
Develop SOP/HACCP/Recipe,
Change Equipment, Train
Employees
Change Equipment Layout, Train
Employees, RCP, Develop
SOP/HACCP

75

Change Equipment, RCP,
Train Employees, Develop
SOP/HACCP/Recipe
Change Buyer Specifications,
Train Employees, Develop
SOP/HACCP/Recipe
Change Equipment, RCP,
Train Employees, Develop
SOP/HACCP/Recipe

Annex 7
Verification Inspection Checklist
Date: _________Time: __________ Scheduled (S)/Unscheduled (U): _______
Establishment Name:______________________________________________
Est. Address:_____________________________________________________
Person in Charge: ________________ Health Inspector:_________________

Document Review
1. Documents provided for review:

Type of Document

Reviewed
(Y or N)

Prerequisite Programs (list them below)

Menu or Food List or Food Preparation Process
Flow Diagrams (Food Preparation)
Equipment Layout
Training Protocols
Hazard Analysis
Written Plan for Food Safety Management
System
Other

76

Comments/Strengths/
Weaknesses Noted

2. List Critical Control Points (CCPs) and Critical Limits identified by the
establishment’s HACCP plan.

Food Item or
Process

Critical Control
Point

Critical Limits

Comments/Problems
Noted

3. What monitoring records are required by the plan?

Type of Record
(Prerequisite Program
Activities, Monitoring,
Corrective Action, CCP
Verification, etc.)

Monitoring Frequency and
Procedure

Record Location
(Where kept?)

(How often?, Initialed and dated?, etc.)

4. Describe the strengths or weaknesses with the current monitoring or record keeping
regimen.
Comments:____________________________________________________________
______________________________________________________________________
______________________________________________________________________
5. Who is responsible for verification that the required records are being completed and
being properly maintained?
Comments:

77

6. Describe the training that has been provided to support the system?
Comments:

7. Describe examples
accomplished?

of

any

documentation

that

the

above

training

was

Comments:

______________________

Record Review and On-site Inspection
(Choose at random one week from the previous four)
8. Are monitoring actions performed according to the plan?
○ Full Compliance
○ Partial Compliance
○ Non-Compliance
Comments:

9. When critical limits established by the plan are not met, are immediate corrective
actions taken and recorded? ○Yes ○ No
Comments:

10. Do the corrective actions taken reflect the same actions described in the
establishment’s plan?
○ Yes ○ No
Comments:

78

11. Are routine calibrations required and performed according to the plan?
○ Yes ○ No
Comments:

(Examine the current day’s records, if possible)
12. Are the records for the present day accurate for the observed situation in the
facility?
○ Yes ○ No
Comments:

13. Do managers and employees demonstrate knowledge of the system?
Managers: ○ Yes ○ No
Employees: ○ Yes ○ No
Comments:

Continued Considerations
14. Have there been any changes to the menu or recipes since the last verification visit?
○ Yes ○ No
15. Was the system modified because of these menu or recipe changes?
○ Yes ○ No
Comments:
____________

79

Additional Comments or Recommendations:

80

Annex 8
Paperwork Reduction Act of 1995

This manual contains information collection provisions that are subject to review by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520).
The time required to complete this information collection is estimated to average 16
hours per response, including the time to review instructions, search existing data
sources, gather the data needed, and complete and review the information collection.
Send comments regarding this burden estimate or suggestions for reducing this burden
to:
Office of Compliance
Division of Cooperative Programs (HFS-625)
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
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. The
OMB control number for this information collection is 0910-0578 (expires 03/31/2009).

81