Seafood HACCP - Binder

Chap 1 - Introduction to Course and HACCP
Notes:
Chapter 1: Introduction to Course and HACCP
Overhead 1
Objective:
In this module, you will learn the:
Objective of the course,
Format of the course,
Expectations of the participant and
Meaning and importance of HACCP.
Course Objective
Food and Drug Administration Seafood regulations based on the principles of Hazard Analysis and Critical Control Point (HACCP) became
effective in the United States in December, 1997. The Food and Drug
Administration (FDA) issued these regulations to ensure safe processing
and importing of fish and fishery products. These regulations specify that
certain critical jobs in seafood processing be performed by someone
trained in HACCP. This person is responsible for developing and
modifying the HACCP plan and reviewing records. This course contains
the information necessary for you or a team to meet the HACCP-training
requirements. It is also designed to provide inspectors with the knowledge
they need to evaluate HACCP plans and practices.
Course Format
This seafood HACCP course is divided into three distinct segments:

HACCP fundamentals,
Relationship of HACCP and FDAs regulation to the seafood industry, and
Work session to develop a seafood HACCP plan.
The first segment defines the seven principles of HACCP. Learning these
principles will give a clear understanding of the fundamentals on which
HACCP is based. As each principle is discussed, the class will develop a
HACCP plan for cooked shrimp using the fictional ABC Shrimp Co. as a
model. This will help you understand HACCP principles and how they
interrelate.
The second segment explains the seafood HACCP regulations and
guidance materials that are available to help you develop a HACCP plan.
The manual also presents information about seafood-specific hazards.
The third segment demonstrates how to develop a seafood HACCP plan.
During this part of the course, the class will be divided into teams to write
a HACCP plan based on a narrative and flow chart.
Continued
1

Notes:
What is Expected of the Participant
HACCP is a common sense technique used to control food-safety hazards.

It is an important safety-management system and can be integrated into
any operation. However, HACCP can seem complicated and demanding
until its concepts are understood. Therefore, you are encouraged to ask
questions and to contribute first-hand experiences to discussions. This
manual includes exercises that require class participation throughout the
training. Keep in mind that the more you contribute to these exercises, the
less complicated the HACCP system will seem and the easier it will be to
implement a HACCP plan later.
How to Use This Manual
This manual is yours. Become familiar with it. Learn where the definitions are, where the forms are that will help you develop a HACCP plan,
and where to find other basic information. Make as many notes and marks
in the text as needed to assist in creating and understanding a HACCP
plan. Use the manual as a reference. This manual does not have a
copyright. Make as many copies of its forms as necessary or copy the
whole manual to share with others in your company.
Meaning and Importance of HACCP
Many people may not have heard the term HACCP until recently.
However, it is neither a new term nor a new concept.
Overhead 2
HACCP stands for:
Hazard Analysis and Critical Control Point
HACCP is merely an acronym that stands for Hazard Analysis and

Critical Control Point. But the concept behind this term is important.
Overhead 3
HACCP is:
Preventive, not reactive.
A management tool used to protect the food supply against
biological, chemical and physical hazards.

Notes:
HACCP is a preventive system of hazard control rather than a reactive

one. Food processors can use it to ensure safer food products for consumers. To ensure safer food, the HACCP system is designed to identify
hazards, establish controls and monitor these controls. Hazards can be
harmful microorganisms or chemical and/or physical contaminants.
Overhead 4
Origins of HACCP:
Pioneered in the 1960s.
First used when foods were developed for the space program.
Adopted by many food processors and the U.S. government.
The Pillsbury Co. pioneered the application of the HACCP concept to

food production during its efforts to supply food for the U.S. space
program in the early 1960s. Pillsbury decided that their existing qualitycontrol techniques did not provide adequate assurance against contamination during food production. The company found that end-product testing
necessary to provide such assurance would be so extensive that little food
would be available for space flights.
Overhead 5
HACCP is not a zero-risk system.
It is designed to minimize the risk of food-safety hazards.
The only way to ensure safety, Pillsbury concluded, would be to develop

a preventive system that kept hazards from occurring during production.
Since then, Pillsburys system has been recognized worldwide as the
state-of-the-art measure for food-safety control. It is not a zero-risk
system, but it is designed to minimize the risk of food-safety hazards.
The FDA first required HACCP controls for food processing in 1973
for canned foods to protect against Clostridium botulinum, which
causes botulism.
Overhead 6
Recommendation:
The HACCP approach be adopted by all regulatory agencies and
that it be mandatory for food processors.
1985 National Academy of Sciences
Continued
3

Notes:
In an assessment of the effectiveness of food regulation in the United

States, the National Academy of Sciences (NAS) recommended in 1985
that the HACCP approach be adopted by all regulatory agencies and that
it be mandatory for food processors.
Overhead 7
National Academy of Sciences recommendation
led to formation of the National Advisory Committee
on Microbiological Criteria for Foods (NACMCF).
This recommendation led to the formation of the National Advisory

Committee on Microbiological Criteria for Foods (NACMCF). This
committee standardized the HACCP principles used by industry and
regulatory authorities. The committees work is the basis of this core
curriculum.
Overhead 8
Instructors Note:
NACMCF is continuing to
refine the HACCP principles
in an effort to make them
more user friendly and
effective. In August 1997,
NACMCF adopted revised
HACCP guidelines. To the
extent possible, many of the
changes have been incorporated into this manual. Most
obviously, Principles 6 and 7
were switched, thereby
making recordkeeping
Principle 7. Additionally,
preventative measures was
changed to control measures.
Seven principles of HACCP:

1. Conduct hazard analysis.
2. Determine the critical control points (CCPs) in the process.
3. Establish critical limits.
4 Monitor each CCP.
5. Establish corrective actions.
6. Establish verification procedures.
7. Establish record-keeping and documentation procedures.
In 1992, NACMCF adopted the following seven HACCP principles.

They are:
In 1997, NACMCF adopted the following seven HACCP principles.
They are:
1. Conduct hazard analysis.
2. Determine the critical control points (CCPs) in the process.
3. Establish critical limits.
4. Monitor each CCP.
5. Establish corrective actions.
6. Establish verification procedures.
7. Establish record-keeping and documentation procedures.
Instructors and students

should be aware of the
dynamic nature of HACCP
and not be surprised or
confused as the principles
are refined.
These principles will be explained in more detail in the following

sessions. The seafood HACCP regulation and other domestic and
international HACCP control systems are based on these principles.
4

Notes:
Overhead 9
International use:
Codex
European Union
Canada
Australia
New Zealand
Japan
HACCP has been endorsed worldwide by organizations such as

Codex Alimentarius (a commission of the United Nations) and the
European Union and by several countries including Canada, Australia,
New Zealand and Japan.
Overhead 10
HACCP is not a stand-alone system.
HACCP
Good Manufacturing Practices
HACCP is a preventive system for ensuring food safety, but it is not a

stand-alone system. HACCP must be built upon current food-safety
programs such as Good Manufacturing Practices (GMPs) (e.g., sanitation
and personal hygiene programs) to make it work.
Overhead 11
Traditional Inspection Methods for Food-Safety Control
versus
The HACCP Approach
The HACCP concept is used by regulators during inspections of food

processors to focus their attention on the parts of the process that are most
likely to affect the safety of the product.
The inspection of plants operating under HACCP plans differs from
traditional inspection methods of food-safety control. Traditional methods
evaluate processing practices on the day or days of inspection. The
HACCP approach allows regulators to look at what happens in the plant
through time by examining the firms monitoring and corrective action
records.
Continued
5

Notes:
Overhead 12
HACCP inpections complement traditional inspection methods.
HACCP:
Emphasizes process control.
Concentrates on the points in the process that are critical to the
safety of the product.
Stresses communication between the regulator and industry.
With HACCP, the emphasis is to understand the process system. This

requires the regulator and industry to communicate and to work with one
another. The inspector will be verifying the HACCP plan by determining
that significant food-safety hazards have been properly identified and that
industry is consistently controlling these hazards. The inspector will
accomplish this by first surveying the plant and then reviewing the
HACCP plan and records. Regulatory inspections will continue to look
for compliance in areas such as sanitation, economic fraud, food
standards, etc.
In defining the roles of industry and the regulatory agencies in HACCP,
the NACMCF document indicates: It is the responsibility of the food
industry to develop and implement HACCP plans and for regulatory
agencies to facilitate this process." Or, in other words, the role of the
government is to ensure that industry adheres to their role.

Notes:
Overhead 13
It is the responsibility of the food industry to develop and implement
HACCP plans and for regulatory agencies to facilitate this process.
NACMCF, June 1993
As you learn more about HACCP, there will be many new definitions that
you will need to understand. To assist you, the most common HACCP
definitions are found in the following two pages. Refer back to these
pages as needed and add other terms as appropriate that will help you in
developing and implementing your own HACCP plan.
The next sessions will explain the basics of HACCP. We will start by first
defining the types of hazards.

Notes:
Definitions*
Continuous Monitoring: Uninterrupted collection and recording of
data such as temperature on a strip chart.
Control: (a) (verb) To manage the conditions of an operation to maintain
compliance with established criteria.

(b) (noun) The state in which correct procedures are being followed
and criteria are being met.
Control
Measure: Any action or activity that can be used to prevent,

eliminate or reduce a significant hazard (previously known as a
preventive measure and is still called a preventive measure in FDAs
Hazards and Controls Guide).
Control Point: Any point, step or procedure at which biological,
physical or chemical factors can be controlled.
Corrective Action: Procedures followed when a deviation occurs.
Critical
Control Point (CCP): A step at which control can be applied and is
essential to prevent or eliminate a food-safety hazard or reduce it to

an acceptable level.
CCP
Decision Tree: A sequence of questions asked to determine
whether a control point is a CCP.
Critical Limit: A maximum and/or minimum value to which a biological,
chemical or physical parameter must be controlled at a CCP to

prevent, eliminate or reduce to an acceptable level the occurrence
of a food-safety hazard.
Deviation: Failure to meet a critical limit.
HACCP: A systematic approach to the identification, evaluation and
control of food-safety hazards.

HACCP
Plan: The written document that is based upon principles of

HACCP and that delineates the procedures to be followed.
HACCP
System: The result of the implementation of the HACCP plan.
HACCP Team: The group of people who are responsible for developing,
implementing and maintaining the HACCP system.
Hazard: A biological, chemical or physical agent that is reasonably
likely to cause illness or injury in the absence of its control.
Monitor: To conduct a planned sequence of observations or
Notes:
measurements to assess whether a CCP is under control and to

produce an accurate record for future use in verification.
Operating Limits: Criteria that are more stringent than critical
limits and that are used by an operator to reduce the risk of

a deviation.
Prerequisite Programs: Procedures, including Good Manufacturing
Practices (GMPs), that address operational conditions providing the

foundation for the HACCP system.
Severity: The seriousness of a hazard (if not properly controlled).
Validation: The element of verification focused on collecting and
evaluating scientific and technical information to determine if the

HACCP plan, when properly implemented, will effectively control
the hazards.
Verification:
Those activities that determine the validity of the HACCP

plan and that the system is operating according to the plan.
* National Advisory Committee on Microbiological Criteria for Foods,
1997. Hazard Analysis and Critical Control Point Principles and

Application Guidelines.
9

Notes:
Acronyms
CCP:
CL:
Critical limit
FDA:
Critical control point
Food and Drug Administration
GMP: Good Manufacturing Practice
HACCP:
MIG: Mercury-in-glass thermometer
NAS:
National Academy of Science
NACMCF: National Advisory Committee on Microbiological Criteria

for Foods
PPM:
10
Hazard analysis and critical control point
Parts per million
SCP: Sanitation control procedures
SOP: Standard operating procedure
SSOP: Sanitation standard operating procedure
Chapter 1: Introduction
Status
This is the third edition of the Food and Drug
Administrationss (FDA) Fish and Fishery Products
Hazards and Controls Guidance. This Guide relates
to FDAs final regulations (21 CFR 123) that require
processors of fish and fishery products to develop
and implement Hazard Analysis Critical Control
Point (HACCP) systems for their operations. Those
final regulations were published in the Federal
Register on December 18, 1995 and became effective
on December 18, 1997. The codified portion of the
regulations is included in Appendix 8.
FDA intends to revise and reissue this guidance every
two to three years as the state of knowledge advances
relative to fish and fishery products hazards and
controls. The agency will accept public comment on
this third edition of the guidance for consideration in
drafting the fourth edition. Comments should be
submitted to:
U.S. Food and Drug Administration
Dockets Management Branch (HFA-305)
Room 1-23
12420 Parklawn Drive
Rockville, MD 20857
Comments should be identified with Docket Number
93N-0195.
This guidance is being issued as a companion

document to HACCP: Hazard Analysis Critical
Control Point Training Curriculum, which was
developed by the Seafood HACCP Alliance for
Training and Education. The Alliance is an organization of federal and state regulators, including FDA,
academia, and the seafood industry. FDA encourages
processors of fish and fishery products to use the two
documents together in the development of a HACCP
system. Copies of the training document may be
obtained from:
Florida Sea Grant
IFAS - Extension Bookstore
University of Florida
P.O. Box 110011
Gainesville, FL 32611-0011
1-800-226-1764
Purpose
The primary purpose of this guidance is to assist
processors of fish and fishery products in the development of their HACCP plans. Processors of fish
and fishery products will find information in this
guidance that will help them identify hazards that are
associated with their products, and help them formulate control strategies.
Another purpose of this guidance is to help consumers and the public generally to understand commercial seafood safety in terms of hazards and their
controls. This guidance does not specifically address
safe handling practices by consumers or by retail
establishments, although many of the concepts
contained in this guidance are applicable to both.
This guidance is also intended to serve as a tool to be
used by federal and State regulatory officials in the
evaluation of HACCP plans for fish and fishery
products.
1
Continued
Scope & Limitations

The controls and practices provided in this guidance
are recommendations and guidance to the fish and
fishery products industry. This guidance provides
information that would likely result in a HACCP plan
that is acceptable to FDA. However, it is not a
binding set of requirements. Processors may choose
to use other control measures, as long as they provide
an equivalent level of assurance of safety for the
product. However, processors that chose to use other
control measures (e.g. critical limits) are responsible
for scientifically establishing their adequacy.
The information contained in the tables in Chapter 3
and in Steps #10 and 11 in Chapters 4-21 provide
guidance for determining which hazards are reasonably likely to occur in particular fish and fishery
products under ordinary circumstances. The tables
should not be used separately for this purpose. The
tables list potential hazards for specific species and
finished product types. This information must be
combined with the information in the subsequent
chapters to determine the likelihood of occurrence.
This guidance is not a substitute for the performance
of a Hazard Analysis by a processor of fish and
fishery products, as required by FDAs regulations.
Hazards not covered by this guidance may be relevant to certain products under certain circumstances.
In particular, processors should be alert to new or
emerging problems (e.g., the occurrence of natural
toxins in fish not previously associated with that
toxin).
This guidance covers safety hazards associated with
fish and fishery products only. It does not cover most
hazards associated with non-fishery ingredients (e.g.,
Salmonella enteritidis in raw eggs). However, where
such hazards are presented by a fishery product that
contains non-fishery ingredients, control must be
included in the HACCP plan. Processors may use the
principles included in this guide for assistance in
developing appropriate controls for these hazards.
For example, the hazard of food allergens and food
intolerance substances that are part of or directly
added to the food can be controlled using the principles described in Chapter #19. As a further assis-
tance in this regard, Appendix 6 provides a list of the

most common food allergens that can pose a health
risk to certain sensitive individuals.
This guidance does not cover the hazard associated
with the formation of Clostridium botulinum toxin in
low acid canned foods (LACF) or shelf-stable
acidified foods. Mandatory controls for this hazard
are contained in the LACF regulation (21 CFR 113)
and the acidified foods regulation (21 CFR 114).
Such controls need not be included in HACCP plans
for these products.
This guidance does not cover the sanitation controls
required by the Seafood HACCP regulation. However, the maintenance of a sanitation monitoring
program is an essential prerequisite to the development of a HACCP program. If necessary sanitation
controls are not included in a prerequisite sanitation
monitoring program, they must be included in the
HACCP plan. It is the agencys intent to provide
guidance on the development of sanitation standard
operating processes and sanitation monitoring
programs in the future.
This guidance does not describe corrective action or
verification records, because these records are not
required to be listed in the HACCP plan. Nonetheless, such records must be maintained, where applicable. Likewise, it does not recount the specific
requirements for the content of records that are set
out in 123.9(a).
This guidance does not cover verification activities
such as reassessment of the HACCP plan and/or the
hazard analysis and review of consumer complaints,
that are mandated by 123.8.
The guidance also does not provide specific guidance
to importers of fish and fishery products for the
development of required importer verification
procedures. However, the information contained in
the text, and, in particular, in Appendix 5, should
prove useful for this purpose. Additionally, it is the
agencys intent to provide more specific guidance for
importers, either in future editions of this guidance,
or in a separate guidance document.
2
Changes in this Edition

Following is a summary of the most significant
changes in this edition of the guidance.
The information contained in Table 3-1 (Potential
Vertebrate Species Related Hazards) is modified as
follows:
Dace (Rhinichthys spp.) is now listed as having a

potential pesticides and environmental contaminants
hazard;
Alewife or river herring (Alosa pseudoharengus) is
now listed as having a potential scombrotoxin
(histamine) hazard;
Wild-caught freshwater salmon (Oncorhynchus
spp., Salmo salar) is no longer listed as having a
potential aquaculture drug hazard, an error in the
Second Edition;
Mackerel (Scomber scombrus) is no longer listed
as having a potential natural toxin (PSP) hazard.
The information contained in Table 3-3 (Potential
Process Related Hazards) is modified as follows:
Smoked fish is now listed as having a potential C.

botulinum hazard only when it is reduced oxygen
packaged and distributed or stored refrigerated;
A number of products are now listed in Table 3-3
as having potential glass inclusion hazards;
Dried fish is now listed as having a potential C.
botulinum hazard;
Fully cooked prepared foods are now listed as
having potential pathogen survival through pasteurization and pathogen contamination after pasteurization hazards.
The recommendations in Chapter 4 for the control of
pathogens from the harvest area are changed as
follows for consistency with 1998 and 1999 Interstate
Shellfish Sanitation Conference actions:
Raw consumption warnings on tags of molluscan

shellfish shellstock containers are now recommended
only if the shellstock is intended for raw consumption and the recommended language has been
modified;
Additional information is included about the

control of Vibrio parahaemolyticus in shellstock
intended for raw consumption, including information
about water sampling for Vibrio parahaemolyticus
performed by Shellfish Control Authorities under
certain conditions;
Specific controls are now recommended for the
control of Vibrio parahaemolyticus in oyster
shellstock intended for raw consumption if the
oysters are harvested in an area which has been
confirmed as the original source of oysters associated
with two or more V. parahaemolyticus illnesses in the
past three years. The new control strategy example
relies on the following critical limits for the time
from harvest to refrigeration, and is based on the
Average Monthly Maximum Air Temperature
(AMMAT):
- For AMMAT of less than 66F
(less than 19C): 36 hours
- For AMMAT of 66F to 80F
(19C to 27C): 12 hours
- For AMMAT greater than 80F
(greater than 27C): 10 hours;
For the control of Vibrio vulnificus, the critical
limits recommended for the time from harvest to
refrigeration for shellstock intended for raw consumption, based on Average Monthly Maximum
Water Temperature (AMMWT), are now:
- For AMMWT of less than 65F
(less than18C): 36 hours
- For AMMWT of 65 to 74F
(18 to 23C): 14 hours;
- For AMMWT of greater than 74 to 84F
(greater than 23 to 28C): 12 hours;
- For AMMWT of greater than 84F
(greater than 28C): 10 hours;
For the control of pathogens other than Vibrio
parahaemolyticus and Vibrio vulnificus, the critical
limits recommended for the time from harvest to
refrigeration for shellstock intended for raw consumption are now:
- For AMMAT of less than 66F
(less than 19C): 36 hours;
- For AMMAT of 66 to 80F
(19 to 27C): 24 hours;
- For AMMAT of greater than 80F
(greater than 27C): 20 hours.
3
Continued

pathogens from the harvest area are additionally
changed as follows:
The information on pathogens in molluscan

shellfish is now more clearly divided into two
categories:
- The control of pathogens of human or animal
origin;
- The control of naturally occurring pathogens;
The recommended goal of pasteurization for the
control of Vibrio vulnificus is now more clearly
defined as the reduction of the pathogen to
nondetectable levels [i.e., less than 3 MPN/gram, as
defined by the National Shellfish Sanitation Program
(NSSP)].
parasites are changed as follows:
The results of a survey of U.S. gastroenterologists

on U.S. seafood-borne parasitic infections are now
cited;
The recommended freezing times/temperatures are
now:
- Freezing and storing at -4F (-20C) or below
for 7 days (total time); or
- Freezing at -31F (-35C) or below until solid
and storing at -31F (-35C) or below for 15
hours; or
- Freezing at -31F (-35C) or below until solid
hours;
Because of the changes in the recommended
critical limits, the recommended control strategies
now refer only to external temperatures during
freezing and to the length of time that the fish is held
at the appropriate freezer temperature or the length of
time that the fish is held after it is solid frozen,
whichever is appropriate;
The parasite hazard is no longer considered
reasonably likely to occur if the finished product is
fish eggs that have been removed from the skein and
rinsed.
natural toxins are changed as follows:
PSP in lobster is no longer considered a significant

hazard because the levels found in lobster tomale are
not likely to pose a health hazard unless large quantities
are eaten from a heavily contaminated area.

scombrotoxin formation are changed as follows:
Information is now provided about the salt-tolerant

and facultative anaerobic nature of some of the
histamine-forming bacteria, raising concern for
scombrotoxin formation in some salted and smoked
fishery products and in fishery products packed in
reduced oxygen environments (e.g. vacuum
packaging);
The on-board chilling recommendations are
significantly modified as follows:
- Generally, fish should be placed in ice or in
refrigerated seawater or brine at 40F (4.4C) or
less within 12 hours of death, or placed in
refrigerated seawater or brine at 50F (10C) or
less within 9 hours of death;
- Fish exposed to air or water temperatures above
83F (28.3C), or large tuna (i.e., above 20 lbs.)
that are eviscerated before on-board chilling,
should be placed in ice (including packing the
belly cavity of large tuna with ice) or in
refrigerated seawater or brine at 40F (4.4C) or
less within 6 hours of death;
- Large tuna (i.e., above 20 lbs.) that are not
eviscerated before on-board chilling should be
chilled to an internal temperature of 50F (10C)
or less within 6 hours of death;
It is now recommended that, when refrigerated
brine or seawater is used for chilling fish on the
harvest vessel, the temperature of the cooling media
be monitored and recorded (harvest vessel control
strategy only);
It is now recommended that the critical limits at
receiving from the harvest vessel include a requirement that the chilling of fish on the harvest vessel be
continued to bring the internal temperature of the fish
to 40F (4.4C) or less (harvest vessel control strategy only);
It is now recognized that certain data previously
expected to be recorded by the harvester on harvest
vessel records may, under certain circumstances, be
more efficiently recorded by the primary (first)
processor on receiving records (harvest vessel control
strategy only), such as:
- Method of capture;
- Air and water temperature;
- Method of onboard cooling;
- Estimated date and time of death;
4
It is now recognized that, as an alternative to the

primary processor receiving harvest vessel records
that are maintained by the vessel operator, certain
harvest operations may lend themselves to monitoring and record keeping entirely by the primary
processor. This arrangement is suitable only if the
primary processor has direct knowledge about those
aspects of the harvesting practices that must be
controlled to ensure that the appropriate critical
limits are met. For example, if the harvest vessel
leaves from the processors facility and returns with
the iced or refrigerated catch to the processors
facility within the appropriate time limits for on
board icing or refrigeration of the catch, under
certain circumstances it may be possible for the
processor to perform all of the monitoring and record
keeping functions ordinarily performed by the
harvester;
It is now recommended that the critical limits at
receiving from the harvest vessel include a requirement that fish delivered in less than 12 hours after
death should exhibit evidence that chilling began on
the harvest vessel (e.g. at receipt the internal temperature of the fish is below ambient air and water
temperature);
It is now recommended that the date and time of
off-loading be recorded on receiving records maintained by the primary processor;
It is no longer recommended that primary (first)
processors check for the adequacy of ice, refrigerated
seawater, refrigerated brine, or other cooling media at
receipt from the harvest vessel;
It is no longer recommended that secondary
processors check the internal temperature of fish
received from other processors. However, it is now
recommended that the checks for the adequacy of ice
or other cooling media at receiving be verified
periodically by measuring the internal temperature of
the fish to ensure that it is at or below 40F (4.4C);
It is now recommended that the accuracy of time/
temperature data loggers or recorder thermometers
on vehicles delivering fish to secondary processors be
checked on all new suppliers vehicles and at least
quarterly thereafter;
The table of approximate safe shelf-life for
scombrotoxin-forming species which was previously
present is replaced with more generalized guidance
because the values contained in the table were
apparently being misused as binding limits;
The recommended critical limits for storage and

processing are significantly modified as follows:
- For fish that have not been previously frozen:
the fish are not exposed to ambient temperatures
above 40F (4.4C) for more than 4 hours,
cumulatively, if any portion of that time is at
temperatures above 70F (21C); or the fish are
not exposed to ambient temperatures above 40F
(4.4C) for more than 8 hours, cumulatively, as
long as no portion of that time is at temperatures
above 70F (21C);
- For fish that have been previously frozen: the
fish are not exposed to ambient temperatures
above 40F (4.4C) for more than 12 hours,
cumulatively, if any portion of that time is at
temperatures above 70F (21C); or the fish are
not exposed to ambient temperatures above
40F (4.4C) for more than 24 hours,
cumulatively, as long as no portion of that time is
at temperatures above 70F (21C);
There is no longer a minimum length of frozen
storage in the definition of previously frozen product;
It is now recommended that ambient air temperature
be monitored at the processing and packaging critical
control points;
A new concept is introduced to assist in the assessment of whether the hazard is significant at receiving
by the primary (first) processor: the hazard may not be
significant if the worst case environmental conditions
(i.e. air and water temperatures) during the harvest
season in a particular region would not permit the
formation of histamine during the time necessary to
harvest and transport the fish to the primary processor;
The recommendations previously provided for
refrigerated storage are now also recommended for
refrigerated processing;
For purposes of selecting fish for histamine analysis
and sensory examination it is now recommended that
lots be identified that contain only one species;
It is now recommended that the number of fish
tested for internal temperature at receipt by the
primary (first) processor be one per ton for lots of 10
tons or more, and one per 1000 lbs. for lots of under
10 tons, as long as at least 12 fish per lot are examined;
It is now recommended that no less than 18 fish per
lot be analyzed for histamine at receipt by the primary
(first) processor except where the lot is smaller than 18
fish (histamine testing control strategy only). The fish
5
Continued
collected for analysis may be composited for analysis

if the critical limit is reduced accordingly;
A sample size of 60 fish and a reject level of any
fish at or above 50 ppm histamine is now recommended as one option for corrective action when the
processing critical limits have been violated;
Another option is now provided for corrective
action when the sensory critical limit has been
violated (primary processor):
- Perform histamine analysis on the lot (i.e. fish of
common origin) by analyzing 60 fish (or the
entire lot for lots smaller than 60 fish) and
rejecting the lot if any are found with histamine
greater than or equal to 50 ppm. If found, the lot
may be subdivided and reanalyzed at the same
rate, rejecting those portions where a unit greater
than or equal to 50 ppm is found. The fish
collected for analysis may be composited for
analysis if the critical limit is reduced accordingly;
AND
- Perform a sensory examination of all fish in the lot;
It is now recognized that when refrigerated fish are
transported only short distances (4 hours or less) from
processor to processor, a suitable alternative to
requiring continuous monitoring during transit may
be for the secondary processor to check the internal
temperature of the fish upon receipt;
It is no longer recommended that maximum
indicating thermometers be used to monitor ambient
air temperature in storage coolers;
It is now recommended that high temperature
alarms used to monitor ambient air temperature in
storage coolers be connected to a 24-hour monitoring
service.
aquaculture drugs are changed as follows:
Additional information is now provided about the

labeling of approved conditions of use on aquaculture
drugs;
Information is now included about the newly
approved drug, chorionic gonadotropin;
Information is now included about additional
approved uses for formalin solution;
An additional approved manufacturer of tricaine
methansolfonate is now listed;
Thiamine hydrochloride is now listed as a low
regulatory priority drug for treatment of thiamine
deficiency in salmonids;
Discontinued use of the supplier until corrections

are made is now recommended as a corrective action
for all control strategy examples in which
aquacultured fish are received from the producer.
pathogen growth and toxin formation (other than
Clostridium botulinum) as a result of time/temperature
abuse are changed as follows:
A third set of recommended critical limits is now

provided for control during processing steps: If the
product is held at internal temperatures both above
and below 70F (21.1C), exposure times above 50F
(10C) should ordinarily be limited to 4 hours, as
long as no more than 2 of those hours are above 70F
(21.1C);
Additional information and guidance is now
provided to assist in the development of critical limits
during processing and storage, including:
- Examples of product time/temperature profiles;
- A recommendation that most microbiologically
sensitive products be stored at or below 40F
(4.4C), except where control of nonproteolytic
C. botulinum by refrigeration is necessary, in
which case storage at 38F (3.3C) is usually
appropriate;
Additional verification is now recommended, as follows:
- The accuracy of recorder thermometers and other
instruments used to monitor temperature in
transportation cargo areas should be checked on
new suppliers vehicles and at least quarterly for
each supplier thereafter;
- When visual checks of ice or cooling media are
used to monitor the adequacy of coolant, the
internal temperatures of the fish should be
periodically checked to ensure that the ice or
cooling media is sufficient to maintain product
temperatures at 40F (4.4C) or less;
There is now a specific acknowledgement that
frozen product storage and receipt of frozen raw
materials are not likely CCPs;
Background information on the pathogens of
concern now indicates that the infective doses of
Listeria monocytogenes and Vibrio parahaemolyticus
are unknown;
6
The example HACCP plans in Tables 12-1 and 122 are modified to correct an error in the Second Edition,
in which the cooked crab cooler step was inadvertently included as a CCP in the Gulf Coast blue crab
processing method (Table 12-1), rather than the East
Coast blue crab processing method (Table 12-2).
It is now recognized that when refrigerated fishery
products are transported only short distances (4 hours
or less) from processor to processor, a suitable
alternative to requiring continuous monitoring during
transit may be for the secondary processor to check
the internal temperature of the fish upon receipt;
It is now recommended that high temperature
alarms used to monitor ambient air temperature in
storage coolers be connected to a 24-hour monitoring
service.
C. botulinum toxin formation are changed as follows:
The introductory material is extensively reorganized and revised to provide greater clarity;
Information is now provided on a recommended
minimum oxygen transmission rate for oxygenpermeable packages (10,000 cc/m2/24 hrs);
Fishery products packaged in deep containers from
which the air is expressed are now identified as
presenting a C. botulinum toxin formation hazard;
Hot smoked product in aerobic packaging is no
longer identified as presenting a C. botulinum toxin
formation hazard sufficient to require preventive
controls in a HACCP plan. However, note that the
Association of Food and Drug Officials recommends
a minimum water phase salt content of 2.5% in
aerobically-packaged smoked fish;
Controls are no longer recommended specifically
for the control of C. botulinum toxin formation as a
result of time/temperature abuse during the processing of unpackaged product. Instead it is now recommended that the controls recommended for pathogens
other than C. botulinum be applied as appropriate.
The chapter also acknowledges that C. botulinum
toxin formation is possible in unpackaged or aerobically packaged product, but that, under those conditions, it requires the type of severe temperature abuse
that is not reasonably likely to occur in most food
processing environments;
It is now recognized that when refrigerated fishery

products are transported only short distances (4 hours
or less) from processor to processor, a suitable alternative to requiring continuous monitoring during transit
may be for the secondary processor to check the
internal temperature of the fish upon receipt;
It now states that 20% salt is the level needed to
ensure the safety of a shelf stable product relative to
all pathogens (based on the maximum salt level for
growth of S. aureus), rather than providing the apparently misleading statement that 10% salt is the level
needed in a shelf stable product for the control of C.
botulinum type A and proteolytic types B and F;
It now provides instruction to consult Chapter 12 for
information on refrigerated storage temperature
critical limits suitable for the control of pathogens
other than C. botulinum, rather than providing the
apparently misleading statement that 50F (10C) is an
appropriate critical limit for the control of C. botulinum type A and proteolytic types B and F. Refrigeration at or below 40F (4.4C) is recommended for the
control of all pathogens;
Specific guidance is now provided for control of
C. botulinum toxin formation in refrigerated, reduced
oxygen packaged, pasteurized fishery products,
including: 1) those that receive a nonproteolytic
C. botulinum pasteurization process in the final
container; and 2) those that receive a nonproteolytic
C. botulinum cook and are then hot filled into the final
container;
Specific guidance is now provided for control of C.
botulinum toxin formation in refrigerated, reduced
oxygen packaged pasteurized surimi-based products,
including a recommended control of 2.5% salt in
combination with a pasteurization process in the
finished product container of 185F (85C) (internal
temperature) for at least 15 minutes;
The use of recorder thermometers or digital time/
temperature data loggers throughout distribution and
retail storage and sales is no longer recommended as
an alternative to a second barrier to toxin formation by
C. botulinum type E and nonproteolytic types B and F;
It is now acknowledged that, for refrigerated
products that are packaged in oxygen-permeable
packaging, an oxygen-impermeable overwrap may be
used to extend shelf life while the product is under the
control of the processor, as long as the overwrap is
removed before the product leaves the processors
control;
7
Continued
It is now recommended that nitrite analysis accompany water phase salt analysis, as appropriate, when
such analysis is used as the means of monitoring the
brining, dry salting and/or drying steps;
It is now recommended that the accuracy of time/
temperature data loggers or recorder thermometers
on vehicles delivering fish to secondary processors be
checked on all new suppliers vehicles and at least
quarterly thereafter;
It is now recommended that high temperature alarms
used to monitor ambient air temperature in storage
coolers be connected to a 24-hour monitoring service.
pathogen growth and toxin formation as a result of
inadequate drying are changed as follows:
Controls are now provided for partial drying of

refrigerated, reduced oxygen packaged foods, where
drying is targeted for the control of C. botulinum type
E and nonproteolytic types B and F. The controls are
designed to ensure that the water activity of the
finished product is below 0.97;
The importance of packaging in preventing rehydration of dried products is now noted.
pathogen survival through cooking are changed as
follows:
The concept of exceptionally lethal cooking

processes is eliminated;
Information is now provided about the target
organism and degree of destruction for cooking
processes, including recommendations that:
- The target organism should ordinarily be
L. monocytogenes;
- The cook should ordinarily provide a 6D process;
Information is now provided about cooking processes that are designed to eliminate the spores of
Clostridium botulinum type E and nonproteolytic
types B and F, such as cooking of soups and sauces
that will be reduced oxygen packaged (e.g. vacuum
packaged) and distributed refrigerated. The information includes the recommendation that such products
be hot filled in a continuous filling system to minimize the risk of recontamination between cooking
and finished product packaging.

pathogen survival through pasteurization are changed
as follows:
Information is now provided about the target

organism and degree of destruction for pasteurization
processes, including recommendations that:
types B and F if the product is reduced oxygen
packaged (e.g. vacuum packaged), does not
contain other barriers that are sufficient to
prevent growth and toxin formation by this
pathogen, and is stored or distributed refrigerated
(not frozen);
L. monocytogenes for other products
(e.g. frozen products);
- The pasteurization process should ordinarily
provide a 6D reduction in the numbers of the
target pathogen.
pathogen introduction after pasteurization are changed
as follows:
Information is now provided on hot filling products

such as soups and sauces that are cooked to eliminate
the spores of Clostridium botulinum type E and
nonproteolytic types B and F, and then reduced
oxygen packaged (e.g. vacuum packaged) and then
distributed refrigerated (not frozen). The minimum
recommended hot fill temperature, 185F (85C), is
designed to minimize the risk of recontamination
between cooking and finished product packaging;
It is now recommended that cooling water flow rate
be controlled when UV treatment is used to treat
container cooling water.
allergens, food intolerance substances and prohibited
food and color additives are changed as follows:
Controls similar to those previously recommended

for use by primary processors are now recommended
for use by secondary processors, except that reliance
on raw material labeling or documents accompanying
the raw material shipment (in the case of unlabeled
product) are included as recommended control
strategies when the raw material is received from
another processor;
8
Undeclared sulfiting agents are now identified as a

potential hazard in cooked octopus;
General information is now provided on the control
of allergenic proteins in foods. Controls similar to
those previously recommended to ensure proper
labeling for certain food and color additives are now
recommended if foods that contain allergenic proteins
are part of or are directly added to a fishery product.
Additionally, reference is made to controlling inadvertent introduction of allergenic proteins, because of
cross-contact, through a rigorous sanitation regime,
either as part of a prerequisite program or as part of
HACCP itself.
metal inclusion are changed as follows:
The reference to the point at which FDAs Health

Hazard Evaluation Board has supported regulatory
action is corrected to indicate a metal fragment of
between 0.3 [7 mm] and 1.0 [25 mm];
The recommended corrective actions to regain
control over the operation after metal is detected in
the product now include:
- Locating and correcting the source of the metal
fragments; and
- Making adjustments to the materials, equipment,
and/or process, as needed, to prevent future
introduction of metal fragments;
Injection needles and metal ties are now identified
as additional sources of metal fragments in the
processing environment;
It is now recognized that visually inspecting
equipment for damage or missing parts may only be
feasible with relatively simple equipment, such as
band saws, small orbital blenders, and wire-mesh
belts.
Chapter 21 has been added to provide guidance on
the control of glass inclusion as a result of the use of
glass containers.
The recommendations in the Appendices are changed

as follows:
The maximum water phase salt level for growth of

Bacillus cereus is now given as 10 percent;
The maximum water phase salt level for growth of
Staphylococcus aureus is now given as 20 percent;
The minimum temperature for growth of pathogenic strains of Escherichia coli is now given as
43.7F (6.5C);
The maximum temperature for growth of Vibrio
parahaemolyticus is now given as 113.5F (45.3C);
Maximum cumulative exposure times are now
provided for Bacillus cereus, as follows: 5 days at
temperatures between 39.2 and 43F (4-6C); 17
hours at temperatures between 44 and 50F (7-10C);
6 hours at temperatures between 51 and 70F (1121C); and 3 hours at temperatures above 70F
(above 21C);
Maximum cumulative exposure times are now
provided for Clostridium perfringens, as follows:
21 days at temperatures between 50 and 54F (1012C); 1 day at temperatures between 55 and 57F
(13-14C); 6 hours at temperatures between 58 and
70F (15-21C); and 2 hours at temperatures above
70F (above 21C);
The maximum cumulative exposure times for
proteolytic Clostridium botulinum are now given as:
11 hours for temperatures between 50 and 70F
(10-21C); and 2 hours for temperatures above 70F
(above 21C);
nonproteolytic Clostridium botulinum are now given
as: 7 days for temperatures between 37.9 and 41F
(3.3 - 5C); 2 days for temperatures between 42 and
50F (6-10C); 11 hours for temperatures between
51 and 70F (11-21C); and 6 hours for temperatures
above 70F (above 21C);
Listeria monocytogenes are now given as: 7 days for
temperatures between 31.3 and 41F (-0.4 - 5C); and
2 days for temperatures between 42 and 50F (610C);
The maximum cumulative exposure time for
Shigella spp. is now given as 12 hours for temperatures between 51 and 70F (11-21C);
9
Tables of lethal rates and process times for 6D

cooks for a range of internal product temperatures are
now provided for Listeria monocytogenes and
nonproteolytic Clostridium botulinum type B (Tables
A-3 and A-4, respectively).
The FDA guideline for hard or sharp objects, found
in Compliance Policy Guide #555.425, is included in
the listing of FDA and EPA guidance levels generally 0.3 [7 mm] to 1.0 [25 mm] in length;
A listing of the most common food allergens is
included (Appendix 6).
Additional Copies
Numerous additional references are now included in

the Bibliography, and a number of the original references are corrected.
Multiple copies of this guidance may be obtained from:
Single copies of this guidance may be obtained as long

as supplies last from FDA district offices and from:
U.S. Food and Drug Administration
Office of Seafood
200 C St., S.W.
Washington, D.C. 20204
202-418-3133 (phone)
202-418-3196 (fax)
Florida Sea Grant

IFAS - Extension Bookstore
University of Florida
P.O. Box 110011
Gainesville, FL 32611-0011
1-800-226-1764
In addition to using the above listing to direct you to

relevant changes in this guidance, you should carefully review the chapters that are applicable to your
product and process.
This guidance is also available electronically at:

http://www.fda.gov
Select foods; then select seafood; then select HACCP.
10
Chapter 2: Steps in Developing Your HACCP Plan
The HACCP Plan Form
The Steps
This guidance is designed to walk you through a

series of eighteen steps that will yield a completed
HACCP plan. A blank HACCP Plan Form is contained in Appendix 1. Note that this is a two page
form, with the second page to be used if your process
has more critical control points than can be listed on
one page. The Seafood HACCP Regulation requires
that you prepare a HACCP plan for fish and fishery
products that you process (where significant safety
hazards exist). The regulation does not require that
you use the form included in Appendix 1. However,
using this standardized form will likely help you
develop an acceptable plan and will expedite regulatory review.
Following is a listing of the steps that this guidance

uses in HACCP plan development:
The Hazard Analysis Worksheet

In order to Complete the HACCP Plan Form you will
need to perform a process called hazard analysis.
FDA has found that the use of a standardized Hazard
Analysis Worksheet assists in this process. A blank
Hazard Analysis Worksheet is contained in Appendix
1. Note that this is also a two page form, with the
second page to be used if your process has more
processing steps than can be listed on one page.
While the Seafood HACCP Regulation requires that
processors perform a hazard analysis, it does not
require that it be kept in writing. However, FDA
expects that a written hazard analysis will be very
useful when you perform mandatory HACCP plan
reassessments, and when you are asked by regulators
to justify why certain hazards were or were not
included in your HACCP plan.
Preliminary Steps
- General information
- Describe the food
- Describe the method of distribution and storage
- Identify the intended use and consumer
- Develop a flow diagram
Hazard Analysis Worksheet
- Set up the Hazard Analysis Worksheet
- Identify the potential species-related hazards
- Identify the potential process-related hazards
- Complete the Hazard Analysis Worksheet
- Understand the potential hazard
- Determine if the potential hazard is significant
- Identify the critical control points (CCP)
HACCP Plan Form
- Complete the HACCP Plan Form
- Set the critical limits (CL)
- Establish monitoring procedures
What
How
Frequency
Who
- Establish corrective action procedures
- Establish a recordkeeping system
- Establish verification procedures
Chapter 2: HACCP Plan Steps

11
Continued
Preliminary Steps
STEP #3: DESCRIBE THE METHOD OF

DISTRIBUTION AND STORAGE.
STEP #1: GENERAL INFORMATION.

Record the name and address of your processing
facility in the spaces provided on the first page of the
Hazard Analysis Worksheet and the HACCP Plan
Form (Appendix 1).
Identify how the product is distributed and stored

after distribution (e.g. frozen, refrigerated, on ice, or
dry). Identify whether any special shipping methods,
such as mail order, are used.
Identify the market name or Latin name (species) of

the fishery component(s) of the product.
Examples:
stored and distributed frozen
distributed on ice and then stored under
refrigeration or on ice
distributed through mail order with chemical
refrigerant and then stored under refrigeration
Examples:
tuna
shrimp
jack mackerel
Record this information in the space provided on the

first page of the Hazard Analysis Worksheet and the
HACCP Plan Form.
STEP #2: DESCRIBE THE FOOD.
Fully describe the finished product food.

Examples:
individually quick frozen, cooked, peeled shrimp
fresh tuna steaks
frozen, surimi-based, imitation king crab legs
fresh, raw drum, in-the-round
raw shrimp, in-shell
raw, shucked soft clams
fresh seafood salad, with shrimp and
blue crab meat
frozen, breaded pollock sticks
frozen lobster cakes
Describe the packaging type.
STEP #4: IDENTIFY THE INTENDED USE

AND CONSUMER.
IDENTIFY HOW THE product will be used by the
end user or consumer.
Examples:
to be heated (but not fully cooked) and served
to be eaten with or without further cooking
to be eaten raw or lightly cooked
to be fully cooked before consumption
to be further processed into a heat and serve
product
Identify the intended consumer or user of the product. The intended consumer may be the general
public or a particular segment of the population, such
as infants or the elderly. The intended user may be
another processor, who will further process the
product.
Examples:
vacuum-packaged plastic bag
aluminum can
bulk, in wax-coated paperboard box
plastic container with snap lid
HACCP Plan Form.
Examples:
by the general public
by the general public, including some distribution
to hospitals and nursing homes
by another processing facility
HACCP Plan Form.

12
STEP #5: DEVELOP A FLOW DIAGRAM.
Figure # A-1 (Appendix 2) is an example of a flow

diagram.
You may already have effective controls in place for

a number of these hazards as part of your routine or
traditional handling practices. The presence of such
controls does not mean that the hazard is not significant. The likelihood of a hazard should be judged in
the absence of controls. For example, the fact that
histamine development in a particular species of fish
has not been noted, may be the result of: 1) the
inability of the fish to produce histamine; or 2) the
existence of controls that are already in place to
prevent its development (e.g. harvest vessel temperature controls). In the first case the hazard is not
reasonably likely to occur. In the second case the
controls should be included in the HACCP plan.
FDA plans to update Tables #3-1 and 3-2 as the

agency becomes aware of new information.
STEP #6: SET UP THE HAZARD ANALYSIS

WORKSHEET.
STEP #8: IDENTIFY THE POTENTIAL

PROCESS-RELATED HAZARDS.
Record each of the processing steps (from the flow

diagram) in Column 1 of the Hazard Analysis
Worksheet.
Find in Table #3-3 (Chapter 3) the finished product,

package type, and method of distribution and storage
that most closely matches the information that you
developed in Steps #2 and 3. Record the potential
hazard(s) listed in the table for that product into
Column 2 of the Hazard Analysis Worksheet at each
processing step.
The purpose of the diagram is to provide a clear,

simple description of the steps involved in the
processing of your fishery product and its associated
ingredients as they flow from receipt to distribution. The flow diagram should cover all of the steps
in the process which your firm performs. Receiving
and storage steps for each of the ingredients, including non-fishery ingredients, should be included. The
flow diagram should be verified on-site for accuracy.
STEP #7: IDENTIFY THE POTENTIAL

SPECIES-RELATED HAZARDS.
Find in Table #3-1 (Chapter 3) or Table #3-2 (Chapter 3) the market name (Column 1) or Latin name
(Column 2) of the product that you identified in Step
#2. Use Table #3-1 for vertebrates (animals with
backbones), such as finfish. Use Table #3-2 for
invertebrates (animals without backbones), such as
shrimp, oysters, crab, and lobster. Determine if it
has a potential species related hazard by looking for a
mark (or three letter code for a natural toxin) in
the right-hand columns of the table. If so, record the
potential hazard(s) in Column 2 of the Hazard
Analysis Worksheet, at each processing step.
You may need to include potential hazards for more

than one finished product food category in Table
#3-3. This will happen when your product fits more
than one description. For example if you process
shrimp salad using raw shrimp as a raw material, you
are processing both a cooked product (i.e. the intermediate cooked shrimp) and a salad (i.e. the finished
product shrimp salad). Potential hazards from both
finished product food categories apply to your
product and should be listed in Column 2 of the
Hazard Analysis Worksheet.
Tables #3-1 and 3-2 include the best information

currently available to FDA concerning hazards that
are specific to each species of fish. You should use
your own expertise, or that of outside experts, as
necessary, to identify any hazards that may not be
included in the table (e.g. those that may be new or
unique to your region).

13
Table #3-3 includes the best information currently

available to FDA concerning hazards that are related
to specific processing techniques. You should use
your own expertise, or that of outside experts as
necessary, to identify any hazards that may not be
included in the table (e.g. those that are new or
unique to your physical plant, equipment, or process). This is more likely with more complex or
innovative products.
FDA plans to update Table #3-3 as the agency
becomes aware of new information.
STEP #9: COMPLETE THE HAZARD
ANALYSIS WORKSHEET.
Consult the hazards and controls chapters of this
guidance (Chapters 4 through 21) for each of the
potential hazards that you entered in Column 2 of the
Hazard Analysis Worksheet. These chapters offer
guidance for completing your hazard analysis and
developing your HACCP plan.
Complete Steps #10 through 12 in the chapters
relating to each of the potential hazards. These steps
involve: understanding the potential hazard; determining if the potential hazard is significant; and
identifying the critical control points. When you
have finished these steps for all of the potential
hazards that relate to your product, you will have
completed the Hazard Analysis Worksheet. You may
then proceed to Step #13.
STEP #13: COMPLETE THE HACCP PLAN
FORM.
Find the processing steps which you have identified
as CCPs in Column 6 of the Hazard Analysis
Worksheet. Record the names of these processing
steps in Column 1 of the HACCP Plan Form. Enter
the hazard(s) for which these processing steps were
identified as CCPs in Column 2 of the HACCP Plan
Form. This information can be found in Column 2 of
the Hazard Analysis Worksheet.
Complete the HACCP Plan Form by consulting the
hazards and controls chapters of this guidance
(Chapters 4 through 21) for each of the significant
hazards that you entered in Column 2 of the HACCP
Plan Form. Complete Steps #14-18 in the chapters
relating to each of the significant hazards. These
steps involve: setting the critical limits; establishing
monitoring procedures; establishing corrective action
procedures; establishing a recordkeeping system; and
establishing verification procedures. When you have
finished these steps for all of the significant hazards
that relate to your product, you will have completed
the HACCP Plan Form.
You should then sign and date the first page of the
HACCP Plan Form. The signature must be that of
the most responsible individual on-site at your
processing facility or a higher level official. It
signifies that the HACCP plan has been accepted for
implementation by your firm.

14
Chapter 3: Potential Species-Related & Process-Related Hazards
Purpose
Table #3-3
Potential Process Related Hazards
This chapter contains three tables, which provide the

following information:
Table #3-1
contains a listing of potential hazards that are

associated with specific finished fishery products.
These hazards are referred to as process-related
hazards.
Potential Vertebrate Species Related Hazards

associated with specific species of vertebrate fish
(fish with backbones). These hazards are referred
to as species-related hazards;
Table #3-2
It is important to note that the tables provide listings

of potential hazards. You should use the tables
together with the information provided in chapters 4
through 21 in order to determine whether the hazard
is significant for your particular product, and, if so,
how it should be controlled.
Potential Invertebrate Species Related Hazards

associated with specific species of invertebrate fish
(fish without backbones). These hazards are also
referred to as species-related hazards;
Chapter 3: Hazard Tables

15
Continued
Table #3-1
Potential Vertebrate Species Related Hazards
Note: ASP = amnesic shellfish poison; CFP = ciguatera fish poison;
G = gempylotoxin; PSP = paralytic fish poison; T = tetrodotoxin.
Note: This table does not provide information about methyl mercury, which may be a potential
species related hazard in some species of vertebrate fish. FDA policy concerning this matter is under re-evaluation.
See Chapter 10 (Methyl Mercury) for further information.
Market Names
Latin Names
Hazards
Biological
Parasites
CHP 5
AHOLEHOLE
Kuhlia spp.
ALEWIFE or
RIVER HERRING
Alosa pseudoharengus
Chemical
Natural Toxins
CHP 6
Histamine
CHP 7
Chemical
CHP 9
CFP
ALFONSINO
Beryx spp.
Trachichthodes spp.
ALLIGATOR
Alligator
mississippiensis
Alligator sienensis
Alligator
mississippiensis
Alligator sienensis
ALLIGATOR
AQUACULTURED
AMBERJACK or
YELLOWTAIL
ANCHOVY
ANGELFISH
Seriola spp.
CFP
Anchoa spp.
Anchoviella spp.
Cetengraulis
mysticetus
Engraulis spp.
Stolephorus spp.
ASP6
ASP6
ASP6
ASP6
ASP6
Holacanthus spp.
Pomacanthus spp.
ARGENTINE
QUEENFISH
Argentina elongata
BARRACUDA
Sphyraena spp.
Drugs
CHP 11
CFP
6 This hazard only applies if the product is marketed uneviscerated.

16
Market Names
Latin Names
Hazards
Biological
Parasites
CHP 5
Chemical
Natural Toxins
CHP 6
Histamine
CHP 7
Chemical
CHP 9
BARRAMUNDI
Lates calcarifer
BASS
Ambloplites spp.
Micropterus spp.
Morone spp.
Stereolepis gigas
Synagrops bellus
Morone spp.
Centropristis spp.
BASS
AQUACULTURED
BASS, SEA
Acanthistius
brasilianus
Centropristis spp.
Dicentrarchus labrax
Lateolabrax japonicus
Paralabrax spp.
Paranthias furcifer
Polyprion americanus
Polyprion oxygeneios
Polyprion yanezi
BIGEYE
Priacanthus arenatus
Pristigenys alta
BLUEFISH
Pomatomus saltatrix
BLUEGILL
Lepomis macrochirus
BLUENOSE
Hyperoglyphe
antarctica
BOMBAY DUCK
Harpadon nehereus
BONITO
Cybiosarda elegans
Gymnosarda unicolor
Orcynopsis unicolor
Sarda spp.
BOWFIN and roe
Amia calva
BREAM
Abramis brama
Argyrops spp.
Sparus auratus
BREAM or BOGUE
Boops boops
4
4
4
4
4
4
4
4
4
4 This hazard does not apply if the product is intended to be cooked by the consumer or end-user.

17
Drugs
CHP 11
Market Names
Latin Names
Hazards
Biological
Parasites
CHP 5
Chemical
Natural Toxins
CHP 6
Histamine
CHP 7
Chemical
CHP 9
BREAM,
THREADFIN
Nemipterus japonicus
BUFFALOFISH
Ictiobus spp.
BULLHEAD
Ameiurus spp.
BURBOT
Lota lota
BUTTERFISH
Odax pullus
Peprilus spp.
Stromateus cinereus
CAPELIN and roe
Mallotus villosus
CARP
Cyprinus carpio
Hypophthalmichthys
molitrix
CARP
AQUACULTURED
CATFISH
CATFISH
AQUACULTURED
Cyprinus carpio
Hypophthalmichthys
molitrix
Ameiurus catus
Brachyplatystoma spp.
Ictalurus spp.
Pinirampus pirinampu
Platynematichthy
notatus
Pseudoplatystoma
tigrinum
Pylodictis oliveris
Ictalurus spp.
CATFISH, SEA
Ariopsis felis
Arius spp.
Bagre marinus
CHAR
Salvelinus alpinus
CHAR
AQUACULTURED
Salvelinus alpinus
CHIMAERA
Drugs
CHP 11
Harriota raleighana
Hydrolagus spp.

18
Market Names
Latin Names
Hazards
Biological
Parasites
CHP 5
CHUB
Chemical
Natural Toxins
CHP 6
Histamine
CHP 7
Chemical
CHP 9
Coregonus kiyi
Kyphosus spp.
Semotilus
atromaculatus
Coregonus alpenae
Coregonus reighardi
Coregonus zenithicus
CISCO or
TULLIBEE
Coregonus artedii
COBIA
Rachycentron canadum
COD
Arctogadus spp.
Boreogadus saida
Eleginus gracilis
Gadus spp.
Gadus macrocephalus
Lotella rhacina
Mora pacifica
Physiculus barbatus
Pseudophycis spp.
Cilus montii
Micropogonias
opercularis
CISCO or CHUB
COD or
ALASKA COD
COD, MORID
CORVINA
4
4
4
4
4
4
CRAPPIE
Pomoxis spp.
CROAKER
Argyrosomus spp.
Bairdiella spp.
Cheilotrema saturnum
Genyonemus lineatus
Micropogonias spp.
Nebris microps
Nibea spp.
Pachypops spp.
Pachyurus spp.
Paralonchurus spp.
Plagioscion spp.
Pseudotolithus spp.
Pterotolithus spp.
Roncador stearnsi
Umbrina roncador
Odontoscion dentex

19
Drugs
CHP 11
Market Names
Latin Names
Hazards
Biological
Parasites
CHP 5
Chemical
Natural Toxins
CHP 6
Histamine
CHP 7
Chemical
CHP 9
CROAKER or
CORVINA
Cynoscion spp.
CROAKER or
SHADEFISH
Argyrosomus regius
Pseudosciaena
manchurica
CROAKER or
YELLOWFISH
CUSK
Brosme brosme
CUSK-EEL
Lepophidium spp.
CUTLASSFISH
Aphanopus carbo
Lepidopus caudatus
Trichiurus spp.
DACE
Rhinichthys ssp.
DORY
Cyttus novaezealandiae
Zenopsis spp.
Zeus spp.
DRIFTFISH
Hyperoglyphe spp.
DRUM
Equetus punctatus
Larimus spp.
Pogonias cromis
Stellifer spp.
Totoaba macdonaldi
Umbrina coroides
DRUM or CUBBYU
Equetus umbrosus
DRUM,
FRESHWATER
Aplodinotus grunniens
DRUM or
LION FISH
Collichthys spp.
DRUM or
MEAGRE
Sciaena aquila
DRUM or
QUEENFISH
Seriphus politus

20
Drugs
CHP 11
Market Names
Latin Names
Hazards
Biological
Parasites
CHP 5
Chemical
Natural Toxins
CHP 6
Histamine
CHP 7
Chemical
CHP 9
Drugs
CHP 11
DRUM or
REDFISH
Sciaenops ocellatus
DRUM or REDFISH
AQUACULTURED
Sciaenops ocellatus
EEL
Anguilla spp.
Anguilla anguilla
Anguilla australis
Anguilla dieffenbachii
Anguilla japonicus
Ariosoma balearicum
Conger spp.
Gnathophis
catalinensis
Hildebrandia spp.
Paraconger
caudilimbatus
EEL,
FRESHWATER
Anguilla rostrata
EEL,
FRESHWATER
AQUACULTURED
Anguilla rostrata
EEL
AQUACULTURED
EEL, CONGER
EEL, MORAY
Gymnothorax funebris
Lycodontis javanicus
Muraena retifera
EEL, SPINY
Notacanthus chemnitzi
EELPOUT
Macrozoarces
americanus
Zoarces viviparus
Callorhynchus millii
EMPEROR
Lethrinus spp.
Lepidocybium
flavobrunneum
Ruvettus pretiosus
CFP
CFP
CFP
ELEPHANT FISH
ESCOLAR or
OILFISH
4
4
Note: ASP = amnesic shellfish poison; CFP = ciguatera fish poison; G = gempylotoxin; PSP = paralytic fish poison; T = tetrodotoxin.

21
Market Names
Latin Names
Hazards
Biological
Parasites
CHP 5
FLOUNDER
Ancylopsetta dilecta
Arnoglossus scapha
Atheresthes evermanni
Bothus spp.
Chascanopsetta
crumenalis
Cleisthenes pinetorum
Colistium spp.
Cyclopsetta chittendeni
Hippoglossoides
robustus
Limanda ferruginea
Liopsetta glacialis
Microstomus achne
Paralichthys albigutta
Paralichthys oblongus
Paralichthys olivaceus
Paralichthys
patagonicus
Paralichthys
squamilentus
Pelotretis flavilatus
Peltorhampus
novaezeelandiae
Platichthys spp.
Pseudorhombus spp.
Rhombosolea spp.
Samariscus triocellatus
Scophthalmus spp.
Chemical
Natural Toxins
CHP 6
Histamine
CHP 7
Chemical
CHP 9
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
Drugs
CHP 11
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1 This hazard does not apply to offshore catch (e.g. areas not subject to shoreside contaminant discharges).

22
Market Names
Latin Names
Hazards
Biological
Parasites
CHP 5
FLOUNDER
AQUACULTURED
FLOUNDER or DAB
FLOUNDER or
FLUKE
FLOUNDER,
ARROWTOOTH
Chemical
Natural Toxins
CHP 6
Histamine
CHP 7
Chemical
CHP 9
Drugs
CHP 11
4, 5
4, 5
4, 5
4, 5
Ancylopsetta dilecta
Arnoglossus scapha
Atheresthes evermanni
Bothus spp.
Chascanopsetta
crumenalis
Cleisthenes pinetorum
Colistium spp.
Cyclopsetta
chittendeni
Hippoglossoides
robustus
Limanda ferruginea
Liopsetta glacialis
Microstomus achne
Paralichthys spp.
Pelotretis flavilatus
Peltorhampus
novaezeelandiae
Pseudorhombus spp.
Rhombosolea spp.
Samariscus
triocellatus
Scophthalmus spp.
4, 5
4, 5
Pleuronectes limanda
Pleuronectes
proboscidea
Pleuronectes
punctatissimus
Paralichthys dentatus
Paralichthys
lethostigma
Paralichthys microps
Platylichthys flesus
Atheresthes stomias
4, 5
4, 5
4, 5
4, 5
4, 5
4, 5
4, 5
4, 5
4, 5
4, 5
4, 5
4, 5
4, 5
4
4
1
1
1 This hazard does not apply to offshore catch (e.g. areas not subject to shoreside contaminant discharges).
5 This hazard only applies if fresh fish or plankton is used as feed.
23
Market Names
Latin Names
Hazards
Biological
Parasites
CHP 5
FLYINGFISH
and roe
Chemical
Natural Toxins
CHP 6
Histamine
CHP 7
Chemical
CHP 9
Cypselurus spp.
Exocoetus spp.
Fodiator acutus
Hirundichthys spp.
Oxyporhamphus
micropterus
Parexocoetus
brachypterus
Prognichthys
gibbifrons
FROG
Rana spp.
GAR
Lepisosteus spp.
GEMFISH
Epinnula magistralis
Nesiarchus nasutus
Lepidocybium
flavobrunneum
GEMFISH or
BARRACOUTA
GEMFISH or
CABALLA
GOATFISH
Drugs
CHP 11
Rexea solandri
Thyrsites atun
Thyrsites lepidopoides
Mulloidichthys spp.
Mullus auratus
Parupeneus spp.
Pseudupeneus spp.
Upeneichthys lineatus
Upeneus spp.
CFP
CFP
CFP
GRAYLING
Thymallus arcticus
GREENBONE
Coridodax pullus
GREENLING
Hexagrammos spp.
GRENADIER
Coryphaenoides spp.
Lepidorhynchus
denticulatus
Macrourus spp.
Nezumia bairdi
Trachyrhynchus
murray

24
Market Names
Latin Names
Hazards
Biological
Parasites
CHP 5
Chemical
Natural Toxins
CHP 6
Caprodon schlegelii
Cephalopholis spp.
Diplectrum formosum
Epinephelus spp.
Mycteroperca spp.
Mycteroperca
microlepsis
CFP
GROUPER or HIND
Epinephelus guttatus
CFP
GROUPER or
JEWFISH
Epinephelus itajara
CFP
GRUNION
Leuresthes tenuis
GRUNT
Anisotremus
interruptus
Conodon nobilis
Haemulon spp.
Orthopristis
chrysoptera
Pomadasys crocro
GROUPER
GROUPER or GAG
GRUNT or
CATALINA
GRUNT or
MARGATE
GRUNT or
SWEETLIPS
4
4
4
Chemical
CHP 9
Drugs
CHP 11
CFP
CFP
CFP
CFP
CFP
Anisotremus taeniatus
Haemulon album
Haemulon
surinamensis
Plectorhynchus spp.
HADDOCK
Melanogrammus
aeglefinus
HAKE
Urophycis spp.
HALIBUT
Hippoglossus spp.
HALIBUT
AQUACULTURED
Hippoglossus spp.
Paralichthys
californicus
HALIBUT or
CALIFORNIA
HALIBUT
Histamine
CHP 7
4, 5
25
Market Names
Latin Names
Hazards
Biological
Parasites
CHP 5
HAMLET,
MUTTON
Natural Toxins
CHP 6
Histamine
CHP 7
HERRING or
SEA HERRING
or SILD and roe
Clupea spp.
HERRING,
THREAD
Opisthonema spp.
4
4
4
4
CFP
CFP
CFP
Lachnolaimus
maximus
CFP
Caranx spp.
Oligoplites saurus
Selene spp.
Seriola rivoliana
Urapsis secunda
CFP
CFP
CFP
CFP
CFP
JACK or
BLUE RUNNER
Caranx crysos
CFP
JACK or
CREVALLE
Alectis indica
CFP
JACK or
RAINBOW RUNNER
Elagatis bipinnulata
CFP
JACK or
ROOSTERFISH
Nematistius pectoralis
CFP
Aphareus spp.
Aprion virescens
Pristipomoides spp.
CFP
CFP
CFP
Epinephelus guttatus
Epinephelus
adscensionis
Epinephelus
drummondhayi
HOGFISH
JACK
JOBFISH
Drugs
CHP 11
4
4
4
4
4
4
HIND
Chemical
CHP 9
Epinephelus afer
Etrumeus teres
Harengula thrissina
Ilisha spp.
Opisthopterus tardoore
Pellona ditchela
Alosa spp.
HERRING
Chemical

26
Market Names
Latin Names
Hazards
Biological
Parasites
CHP 5
Chemical
Natural Toxins
CHP 6
Histamine
CHP 7
Gasterochisma
melampus
Grammatorcynus spp.
Rastrelliger kanagurta
Scomber scombrus
Pleurogrammus
monopterygius
MACKEREL, CHUB
Scomber spp.
MACKEREL, JACK
Trachurus spp.
Scomberomorus spp.
Scomberomorus cavalla
KAHAWAI
Arripis spp.
KINGFISH
Menticirrhus spp.
KINGKLIP
Genypterus spp.
LADYFISH
Elops spp.
LING
Molva spp.
LING,
MEDITERRANEAN
Molva macrophthalmus
LINGCOD
Ophiodon elongatus
LIZARDFISH
Synodus spp.
LUMPFISH roe
Cyclopterus lumpus
MACKEREL
MACKEREL, ATKA
MACKEREL,
SPANISH
CFP
Drugs
CHP 11
4
4
4
Chemical
CHP 9
CFP
MAHI-MAHI
Coryphaena spp.
MAHI-MAHI
AQUACULTURED
Coryphaena spp.
MARLIN
Makaira spp.
Tetrapturus spp.
MENHADEN
Brevoortia spp.
Ethmidium maculatum
MILKFISH
Chanos chanos

27
Market Names
Latin Names
Hazards
Biological
Parasites
CHP 5
MILKFISH
AQUACULTURED
Chanos chanos
MONKFISH
Lophius spp.
MORWONG
Aplodactylus
meandratus
Cheilodactylus spp.
Nemadactylus spp.
MULLET
Agonostomus
monticola
Aldrichetta forsteri
Crenimugil crenilabis
Mugil spp.
Mullus spp.
Neomyxus chaptalii
Xenomugil thoburni
Chemical
Natural Toxins
CHP 6
Histamine
CHP 7
Chemical
CHP 9
Drugs
CHP 11
4
4
4
4
4
4
MUSKELLUNGE
Esox masquinongy
OPAH
Lampris guttatus
OPALEYE
Girella nigricans
OREO DORY
Allocyttus niger
Pseudocyttus
maculatus
OSCAR
Astronotus ocellatus
OSCAR
AQUACULTURED
Astronotus ocellatus
PACU
Myleus pacu
PADDLEFISH
and roe
Polyodon spp.
PADDLEFISH
and roe
AQUACULTURED
Polyodon spp.
PARROTFISH
Scarus spp.
PATAGONIAN
TOOTHFISH or
CHILEAN SEA BASS
Dissotichus eleginoides
CFP2
2 Indicates that the cigutera hazard is only associated with this species in the tropical Pacific Ocean.
28
Market Names
Latin Names
Hazards
Biological
Parasites
CHP 5
Chemical
Natural Toxins
CHP 6
Histamine
CHP 7
Chemical
CHP 9
Hermosilla azurea
Perca fluviatilis
PERCH, LAKE or
YELLOW
Perca flavescens
PERCH, NILE
Lates niloticus
PERCH, NILE
AQUACULTURED
Lates niloticus
PERCH, OCEAN
Sebastes spp.
PERCH, PILE
Rhacochilus vacca
PERCH, SILVER
Bairdiella chrysoura
PERCH, WHITE
Morone americana
PICAREL
Spicara maena
PICKEREL
Esox spp.
PIKE
Esox lucius
PERCH
PILCHARD or
SARDINE
PLAICE
POLLOCK or
ALASKA POLLOCK
Sardina pilchardus
Sardinops spp.
Hippoglossoides
platessoides
Pleuronectes platessa
Pleuronectes
quadrituberculatus
POLLOCK
Drugs
CHP 11
Pollachius pollachius
Pollachius virens
Theragra
chalcogramma
POMFRET
Brama spp.
Taracetes rubescens
POMPANO
Alectis ciliaris
Parastromateus niger
Trachinotus spp.
CFP

29
Market Names
Latin Names
Hazards
Biological
Parasites
CHP 5
POMPANO or
PERMIT
POMPANO or
POMPANITO
Natural Toxins
CHP 6
Histamine
CHP 7
Chemical
CHP 9
Drugs
CHP 11
Trachinotus kennedyi
Trachinotus falcatus
Trachinotus rhodopus
PORGY
Calamus spp.
Chrysophrys auratus
Dentex spp.
Diplodus spp.
Lagodon rhomboides
Pagrus spp.
Pterogymnus laniarus
Stenotomus caprinus
PORGY or SCUP
Stenotomus chrysops
PUFFER
Arothron spp.
Fugu spp.
Lagocephalus spp.
Sphoeroides maculatus
RACEHORSE
Congiopodus
leucopaecilus
ROCKFISH
Helicolenus papillosus
Scorpaena cardinalis
Sebastes spp.
T
T
ROCKLING
Ciliata spp.
Enchelyopus cimbrius
ROSEFISH
Helicolenus
dactylopterus
ROUGHY
Paratrachichthys
trailli
ROUGHY, ORANGE
Hoplostethus atlanticus
ROUGHY, SILVER
Hoplostethus
mediterraneus
SABLEFISH
Anoplopoma fimbria
Oncorhynchus spp.
Salmo salar
SALMON and roe,

AQUACULTURED
Chemical
4
4
4, 5
4, 5
30
Market Names
Latin Names
Hazards
Biological
Parasites
CHP 5
SALMON and roe

(WILD)
(FRESHWATER)
SALMON and roe,
(WILD) (OCEAN)
Chemical
Natural Toxins
CHP 6
Histamine
CHP 7
Chemical
CHP 9
Oncorhynchus spp.
Salmo salar
Oncorhynchus spp.
Salmo salar
SANDDAB
Citharichthys sordidus
SANDPERCH
Mugiloides chilensis
Parapercis spp.
SARDINE
Harengula spp.
Sardinella spp.
SAUGER
Stizostedion canadense
SAURY
Cololabis saira
Scomberesox saurus
SCAD
Caranx mate
Decapterus spp.
Selar
crumenophthalmus
Trachurus spp.
4
4
SCULPIN
Hemitripterus
americanus
Myoxocephalus
polyacanthocephalus
Scorpaenichthys
marmoratus
SEA BREAM
Archosargus
rhomboidalis
Chrysophrys unicolor
Pagellus spp.
SEAROBIN
Chelidonichthys spp.
Peristedion miniatum
Prionotus carolinus
Pterygotrigla picta
SEATROUT
Cynoscion spp.
SHAD and roe
Alosa spp.

31
Drugs
CHP 11
Market Names
Latin Names
Hazards
Biological
Parasites
CHP 5
SHAD, GIZZARD
Dorosoma spp.
Nematalosa vlaminghi
SHARK
Carcharhinus spp.
Cetorhinus maximus
Galeocerdo cuviere
Galeorhinus spp.
Hexanchus griseus
Lamna ditropis
Negaprion brevirostris
Notorynchus
cepedianus
Prionace glauca
Sphyrna spp.
Triaenodon obesus
Triakis semifasciata
SHARK or
PORBEAGLE
Lamna nasus
SHARK or
SMOOTHHOUND
Mustelus spp.
SHARK, ANGEL
Squatina spp.
SHARK, DOGFISH
or CAPE SHARK
Chemical
Natural Toxins
CHP 6
Histamine
CHP 7
Chemical
CHP 9
Centrophorus spp.
Mustelus spp.
Scyliorhinus spp.
Squalus spp.
SHARK, MAKO
Isurus spp.
SHARK, THRESHER
Alopias spp.
SHEEPHEAD
Semicossyphus pulcher
Archosargus
probatocephalus
SHINER
Notropis spp.
SILVERSIDE
Atherinops spp.
Basilichthys australis
Menidia menidia
SKATE
Bathyraja spp.
Raja spp.

32
Drugs
CHP 11
Market Names
Latin Names
Hazards
Biological
Parasites
CHP 5
SKILLFISH
Erilepis zonifer
SMELT
Allosmerus elongatus
Argentina spp.
Hypomesus spp.
Osmerus spp.
Plecoglossus altivelis
Retropinna retropinna
Spirinchus spp.
Thaleichthys pacificus
SNAKEHEAD
Channa striata
Ophicephalus
obscurus
SNAPPER
Apsilus dentatus
Etelis spp.
Lutjanus spp.
Macolor spp.
Ocyurus chrysurus
Pristipomoides spp.
Rhomboplites
aurorubens
Symphorichthys
spilurus
Chemical
Natural Toxins
CHP 6
Histamine
CHP 7
Chemical
CHP 9
Drugs
CHP 11
CFP
CFP
CFP
SNOOK
Centropomus spp.
SOLE or FLOUNDER
Aseraggodes spp.
Austroglossus spp.
Buglossidium luteum
Clidoderma
asperrimum
Embassichthys
bathybius
Eopsetta exilis
Eopsetta jordani
Errex zachirus
Glyptocephalus spp.
Gymnachirus melas
Hippoglossina spp.
Lepidopsetta bilineata
Microchirus spp.
Microstomus kitt
Microstomus pacificus
Pleuronectes
americanus
Pleuronectes vetulus
Psettichthys
melanostictus
Solea vulgaris
Synaptura orientalis
Trinectes spp.
Xystreurys liolepis
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4

33
Market Names
Latin Names
Hazards
Biological
Parasites
CHP 5
SOLE or
FLOUNDER
AQUACULTURED
Aseraggodes spp.
Austroglossus spp.
Buglossidium luteum
Clidoderma
asperrimum
Embassichthys
bathybius
Eopsetta exilis
Eopsetta jordani
Errex zachirus
Glyptocephalus spp.
Gymnachirus melas
Hippoglossina spp.
Lepidopsetta bilineata
Microchirus spp.
Pleuronectes
americanus
Pleuronectes vetulus
Psettichthys
melanostictus
Solea vulgaris
Synaptura orientalis
Trinectes spp.
Xystreurys liolepis
SPADEFISH
Chaetodipterus spp.
SPEARFISH
Tetrapturus spp.
SPOT
Leiostomus xanthurus
SPRAT or
BRISTLING
Sprattus spp.
Holocentrus spp.
Myripristis spp.
Sargocentron spp.
STURGEON and roe
Acipenser spp.
Huso huso
Pseudoscaphirhynchus
spp.
Scaphirhynchus spp.
STURGEON and roe

AQUACULTURED
Natural Toxins
CHP 6
Histamine
CHP 7
Chemical
CHP 9
Drugs
CHP 11
4, 5
4, 5
4, 5
4, 5
4, 5
4, 5
4, 5
4, 5
4, 5
4, 5
4, 5
4, 5
4, 5
4, 5
4, 5
4, 5
4, 5
4, 5
4, 5
4, 5
SQUIRRELFISH
Chemical
CFP
Acipenser spp.
Huso huso
Pseudoscaphirhynchus
spp.
Scaphirhynchus spp.
34
Market Names
Latin Names
Hazards
Biological
Parasites
CHP 5
SUCKER
SUCKER or
REDHORSE
SUNFISH
(not Mola mola)
SURFPERCH
Chemical
Natural Toxins
CHP 6
Histamine
CHP 7
Chemical
CHP 9
Carpiodes spp.
Catostomus
commersoni
Cycleptus elongatus
Moxostoma
macrolepidotum
Archoplites interruptus
Lepomis spp.
Amphistichus spp.
Cymatogaster
aggregata
Embiotoca spp.
Hyperprosopon
argenteum
Rhacochilus toxotes
SWORDFISH
Xiphias gladius
TANG
Acanthurus spp.
Ctenochaetus spp.
Tenthis spp.
Zebrasoma spp.
TARPON
Megalops atlanticus
TAUTOG
Tautoga onitis
Drugs
CHP 11
CFP3
CFP3
CFP3
CFP3
THORNYHEAD
Sebastolobus spp.
THREADFIN
Eleutheronema
tetradactylum
Galeoides decadactylus
Polydactylus spp.
TILAPIA
Tilapia spp.
TILAPIA
AQUACULTURED
Tilapia spp.
TILEFISH
Caulolatilus spp.
Lopholatilus
chamaeleonticeps
Malacanthus plumieri
Prolatilus jugularis
TOMCOD
Microgadus spp.
3 Indicates that the cigutera hazard is only associated with this species in the tropical Pacific Ocean.
35
Market Names
Latin Names
Hazards
Biological
Parasites
CHP 5
TONGUESOLE
Cynoglossus spp.
TREVALLY
Caranx sexfasciatus
TRIGGERFISH
Balistes spp.
Canthidermis
sufflamen
Melichthys niger
Navodon spp.
TRIPLETAIL
TROUT
(AQUACULTURE)
TROUT,
RAINBOW or
STEELHEAD
Natural Toxins
CHP 6
CFP
Histamine
CHP 7
Chemical
CHP 9
Drugs
CHP 11
CFP
CFP
CFP
Datnioides
quadrifasciatus
Lobotes spp.
Oncorhynchus
aguabonita
Oncorhynchus clarki
Oncorhynchus gilae
Oncorhynchus mykiss
Salmo trutta
Salvelinus fontalis
Salvelinus malma
Salvelinus namaycush
Stenodus leucichthys
Oncorhynchus mykiss
TRUMPETER
Latridopis spp.
Latris lineata
TUNA (small)
Allothunnus fallai
Auxis spp.
Euthynnus spp.
Katsuwonus pelamis
Thunnus tonggol
TUNA (large)
Chemical
4
4
4
4
4
Thunnus alalunga
Thunnus albacares
Thunnus atlanticus
Thunnus maccoyii
Thunnus obesus
Thunnus thynnus

36
Market Names
Latin Names
Hazards
Biological
Parasites
CHP 5
TURBOT
WAHOO
Hypsopsetta guttulata
Pleuronichthys spp.
Psettodes spp.
Reinhardtius
hippoglossoides
Scophthalmus
maximum
Chemical
Natural Toxins
CHP 6
Chemical
CHP 9
Drugs
CHP 11
4
4
Acanthocybium
solandri
WALLEYE
Stizostedion spp.
WAREHOU
Seriolella spp.
WEAKFISH
Cynoscion spp.
Macrodon ancylodon
WHITEFISH
Coregonus spp.
Prosopium
cylindraceum
WHITING
Merluccius gayi
Merluccius hubbsi
Merluccius merluccius
WHITING, BLUE
Micromesistius spp.
WHITING or
PACIFIC WHITING
Merluccius productus
WHITING,
NEW ZEALAND
Histamine
CHP 7
Macruronus
novaezelandiae
WOLFFISH
Anarhichas spp.
YELLOWTAIL or
AMBERJACK
Seriola lalandei
ZANDER
Stizostedion lucioperca
CFP
37
Table #3-2
Potential Invertebrate Species Related Hazards
Market Names
Latin Names
Hazards
Biological
Pathogens
CHP 4
ABALONE
AQUACULTURED
INVERTEBRATES
Parasites
CHP 5
Chemical
Natural Toxins
CHP 6
Chemical
CHP 9
Haliotis spp.
Marinauris roei
Notohaliotis ruber
Schismotis laevigata
ALL SPECIES
ARKSHELL
Anadara subcrenata
Arca spp.
CLAM, BENTNOSE
Macoma nasuta
CLAM BUTTER
Saxidomus spp.
CLAM, CALICO
Macrocallista maculata
CLAM, GEODUCK
Panopea abrupta
Panopea bitruncata
CLAM, HARD
Arctica islandica
Meretricinae spp.
Meretrix spp.
Venus mortoni
Protothaca thaca
Mercenaria spp.
Protothaca staminea
Protothaca tenerrima
Tapes aureus
Tapes decussatus
Tapes semidecussata
Tapes variegata
Tapes virginea
Venerupis
philippinarum
CLAM, MARSH
Corbicula japonica
CLAM, PISMO
Tivela stultorum
CLAM,
HARDSHELL or
QUAHOG
CLAM,
LITTLENECK
Drugs
CHP 11

38
Market Names
Hazards
Latin Names
Biological
Pathogens
CHP 4
Parasites
CHP 5
Chemical
Natural Toxins
CHP 6
Chemical
CHP 9
CLAM, RAZOR
Ensis spp.
Siliqua spp.
Solen spp.
Tagelus spp.
CLAM, SANGUIN
Sanguinolaria spp.
CLAM, SOFTSHELL
Mya arenaria
Mactra spp.
Mactrellona alata
Mactromeris spp.
Mactrotomas spp.
Simomactra spp.
Spisula spp.
Tresus spp.
Mactra schalinensis
CLAM, VENUS
Chione spp.
Macrocallista nimbosa
CLAM, WEDGE
Paphies spp.
COCKLE
Cardium spp.
Clinocardium spp.
Dinocardium robustum
Serripes groenlandicus
CONCH
Strombus spp.
COQUINA
Donax spp.
COQUINA, FALSE
Iphigenia brasiliana
CRAB, BLUE
Callinectes sapidus
CRAB, BROWN
Geryon fenneri
CRAB,
BROWN KING
Lithodes aequispina
CLAM, SURF
SURFCLAM
CLAM, SURF
AQUACULTURED
CRAB, CENTOLLA
Lithodes antarcticus
Lithodes murrayi
CRAB, DEEPSEA
Paralomis granulosa

39
Drugs
CHP 11
Market Names
Hazards
Latin Names
Biological
Pathogens
CHP 4
Parasites
CHP 5
Chemical
Natural Toxins
CHP 6
CRAB, DUNGENESS
Cancer magister
CRAB, JONAH
Cancer borealis
CRAB, KING
Paralithodes
camtschaticus
Paralithodes platypus
Chemical
CHP 9
CRAB, KING or
HANASAKI
Paralithodes brevipes
CRAB, KOREAN
or KEGANI
Erimacrus isenbeckii
CRAB, LITHODES
Neolithodes brodiei
CRAB, RED
Geryon quinquedens
CRAB, RED ROCK
Cancer productus
CRAB, ROCK
Cancer irroratus
Cancer pagurus
CRAB, SNOW
Chionoecetes angulatus
Chionoecetes bairdi
Chionoecetes opilio
Chionoecetes tanneri
CRAB, SPIDER
Jacquinotia edwardsii
Maja squinado
CRAB, STONE
Menippi spp.
CRAB, SWIMMING
Callinectes arcuatus
Callinectes toxotes
Portunus spp.
Cambarus spp.
Cherax spp.
Euastacus armatus
Pacifastacus spp.
Paranephrops spp.
Procambarus spp.
Astacus spp.
CRAWFISH or
CRAYFISH

40
Drugs
CHP 11
Market Names
Hazards
Latin Names
Biological
Pathogens
CHP 4
CRAWFISH or
CRAYFISH
AQUACULTURED
JELLYFISH
Rhopilema spp.
KRILL
Euphausia spp.
Meganyctiphanes
norvegica
Thysandoessa inermis
LANGOSTINO
Cervimunida johni
Munida gregaria
Pleuroncodes monodon
LIMPET
Acmaea testitudinalis
Cellana denticulata
Diodora aspera
Fissurella maxima
Lottia gigantea
Patella caerulea
LOBSTER
Homarus spp.
LOBSTER,
NORWAY
Nephrops norvegicus
LOBSTER, ROCK
Jasus spp.
LOBSTERETTE
Chemical
CHP 9
Sepia spp.
LOBSTER,
SLIPPER
Natural Toxins
CHP 6
Cambarus spp.
Cherax spp.
Euastacus armatus
Pacifastacus spp.
Paranephrops spp.
Procambarus spp.
Astacus spp.
CUTTLEFISH
LOBSTER, ROCK
or SPINY
Parasites
CHP 5
Chemical
Drugs
CHP 11
Palinurus spp.
Panulirus spp.
Ibacus ciliatus
Scyllarides spp.
Thenus orientalis
Metanephrops spp.
Nephropsis aculeata
7 This hazard only applies if the lobster are held in pounds.

41
Market Names
Hazards
Latin Names
Biological
Pathogens
CHP 4
MUSSEL
Modiolus spp.
Mytilus spp.
Perna canaliculus
OCTOPUS
Eledone spp.
Octopus spp.
Chemical
Parasites
CHP 5
Natural Toxins
CHP 6
Chemical
CHP 9
1
1
OYSTER
Crassostrea spp.
Ostrea spp.
Tiostrea spp.
PEN SHELL
Atrina pectinata
PERIWINKLE
Littorina littorea
Lunatatia spp.
SCALLOP
Aequipecten spp.
Amusium spp.
Argopecten nucleus
Chlamys spp.
Patinopecten
yessoensis
Pecten spp.
Placopectin
magellanicus
2
2
2
2
2
2
2
2
2
2
2
2
Aequipecten spp.
Amusium spp.
Argopecten nucleus
Chlamys spp.
Patinopecten
yessoensis
Pecten spp.
Placopectin
magellanicus
2
2
2
2
2
2
2
2
2
2
2
2
SCALLOP or
BAY SCALLOP
Argopecten irradians
SCALLOP, CALICO
Argopecten gibbus
SCALLOP or
WEATHERVANE
Patinopecten caurinus
SCALLOP
AQUACULTURED
SEA CUCUMBER
Cucumaria spp.
Holothuria spp.
Parastichopus spp.
Stichopus spp.
1 This hazard only applies if the product is intended to be consumed raw or partially cooked.
42
Drugs
CHP 11
Market Names
Hazards
Latin Names
Biological
Pathogens
CHP 4
SEA URCHIN roe
Echinus esculentus
Evechinus chloroticus
Heliocidaris spp.
Loxechimus spp.
Paracentrotus spp.
Pseudocentrotus spp.
Strongylocentrotus spp.
SEABOB
Xiphopenaeus kroyeri
SHRIMP
Crangon spp.
Metapenaeus affinis
Palaemon serratus
Palaemonetes vulgaris
Pandalopsis dispar
Pandalus spp.
Penaeus spp.
Plesionika martia
SHRIMP
AQUACULTURED
Crangon spp.
Exopalaemon styliferus
Macrobrachium spp.
Metapenaeus spp.
Palaemon serratus
Palaemonetes vulgaris
Pandalopsis dispar
Pandalus spp.
Penaeus spp.
Plesionika martia
SHRIMP,
FRESHWATER
Macrobrachium spp.
SHRIMP,
FRESHWATER
AQUACULTURED
Macrobrachium spp.
SHRIMP, ROCK
Sicyonia brevirostris
SHRIMP, ROYAL
Pleoticus robustus
SHRIMP or
PINK SHRIMP
Parasites
CHP 5
Pandalus borealis
Pandalus jordani

43
Chemical
Natural Toxins
CHP 6
Chemical
CHP 9
Drugs
CHP 11
Market Names
Hazards
Latin Names
Biological
Pathogens
CHP 4
SHRIMP or
PRAWN
SNAIL or
ESCARGOT
SQUID
TOP SHELL
WHELK or
SEA SNAIL
Chemical
Parasites
CHP 5
Natural Toxins
CHP 6
Chemical
CHP 9
Hymenopenaeus
sibogae
Otala spp.
Helix pomatia
Achatina fulica
Alloteuthis media
Berryteuthis magister
Dosidicus gigas
Illex spp.
Loligo spp.
Lolliguncula spp.
Nototodarus spp.
Ommastrephes spp.
Rossia macrosoma
Sepiola rondeleti
Sepioteuthis spp.
Todarodes sagittatus
1
1
1
1
1
1
1
1
1
1
1
1
Turbo cornutus
Nonodonta turbinata
Buccinum spp.
Busycon spp.
Neptunea spp.
1 This hazard only applies if the product is intended to be consumed raw or partially cooked.
44
Drugs
CHP 11

45
Vacuum packaged
(e.g. mechanical
vacuum, steam
sweep, hot fill),
MAP, CAP,
hermetically sealed
or packed in oil
Vacuum packaged
(e.g. mechanical
vacuum, steam
sweep, hot fill),
MAP, CAP,
hermetically sealed
or packed in oil
Other than vacuum
packaged, MAP,
CAP, hermetically
sealed or packed
in oil
Vacuum packaged
(e.g. mechanical
vacuum, steam
sweep, hot fill),
MAP, CAP,
hermetically sealed
or packed in oil
Cooked shrimp, crab,

lobster, and other fish,
including cooked meat,
sections, and whole fish,
and including surimibased analog products


Pasteurized crab, lobster,

and other fish, including
pasteurized surimi-based
analog products
Frozen
All
Other than
frozen
Frozen
Method of
Distribution
and Storage
Pathogen
growthtemperature
abuse
CHP 12
CHP 13
C. botulinum
growth
Toxin
formationinadequate
drying
CHP 14
CHP 15
S. aureus
toxin batter
Biological
Pathogen
survival
through
cooking
CHP 16
Pathogen
Pathogen
survival
contamination
through
after
pasteurization pasteurization
CHP 17
CHP 18
Hazards
Note: MAP = modified atmosphere packaging; CAP = controlled atmosphere packaging
Package Type
Finished Product Food
Potential Process Related Hazards
Table #3-3
CHP 19
Allergens/
Additives
Chemical
CHP 20
CHP 21
Glass
inclusion
Physical
Metal
inclusion

46
Frozen
Other than
frozen
All
Vacuum packaged
(e.g. mechanical
vacuum, steam
sweep, hot fill),
MAP, CAP,
hermetically sealed
or packed in oil
Vacuum packaged
(e.g. mechanical
vacuum, steam
sweep, hot fill),
MAP, CAP,
hermetically sealed
or packed in oil
Other than vacuum
packaged, MAP,
CAP, hermetically
sealed or packed in
oil
Smoked fish
Smoked fish
Smoked fish
All
CHP 19
Allergens/
Additives
Chemical
Other than vacuum

packaged, MAP,
CAP, hermetically
sealed or packed
in oil

analog products
Pathogen
Pathogen
survival
contamination
through
after
CHP 17
CHP 18
Pathogen
survival
through
cooking
CHP 16
CHP 15
S. aureus
toxin batter
Biological
Other
than frozen
Vacuum packaged
(e.g. mechanical
vacuum, steam
sweep, hot fill),
MAP, CAP,
hermetically sealed
or packed in oil

analog products
Toxin
formationinadequate
drying
CHP 14
CHP 13
C. botulinum
growth
Hazards
Pathogen
growthtemperature
abuse
CHP 12
Method of
Distribution
and Storage
Package Type
CHP 20
CHP 21
Glass
inclusion
Physical
Metal
inclusion

47
Vacuum packaged
(e.g. mechanical
vacuum, steam
sweep, hot fill),
MAP, CAP,
hermetically sealed
or packed in oil
Vacuum packaged
(e.g. mechanical
vacuum, steam
sweep, hot fill),
MAP, CAP,
hermetically sealed
or packed in oil
Other than vacuum
packaged, MAP,
CAP, hermetically
sealed or packed
in oil
All
All
All
Salads and cocktails

prepared from
ready-to-eat fishery
products

prepared from
products

prepared from
products
Raw, breaded shrimp,

finfish, oysters, clams,
squid, and other fish
Stuffed crab, shrimp,

finfish, and other fish
Dried fish
All
All
All
All
Other than
frozen
Frozen
Method of
Distribution
and Storage
CHP 19
Allergens/
Additives
Pathogen
Pathogen
survival
contamination
through
after
CHP 17
CHP 18
Pathogen
survival
through
cooking
CHP 16
CHP 15
S. aureus
toxin batter
Toxin
formationinadequate
drying
CHP 14
CHP 13
C. botulinum
growth
Chemical
Pathogen
growthtemperature
abuse
CHP 12
Biological
Hazards
Package Type
CHP 20
Metal
inclusion
CHP 21
Glass
inclusion
Physical

48
Other than
frozen
All
Frozen
Vacuum packaged
(e.g. mechanical
vacuum, steam
sweep, hot fill),
MAP, CAP,
hermetically sealed
or packed n oil
Other than vacuum
packaged, MAP,
CAP, hermetically
sealed or packed
in oil
Vacuum packaged
(e.g. mechanical
vacuum, steam
sweep, hot fill),
MAP, CAP,
hermetically sealed
or packed in oil
Raw oysters, clams

and mussels
Raw oysters, clams

and mussels
Raw fish other than

oysters, clams and
mussels (includes
non-finfish species)
Pathogen
survival
through
cooking
CHP 16
Pathogen
Pathogen
survival
contamination
through
after
CHP 17
CHP 18
CHP 19
Allergens/
Additives
Chemical
CHP 20
CHP 21
Glass
inclusion
Physical
Metal
inclusion
CHP 15
S. aureus
toxin batter
Biological
Toxin
formationinadequate
drying
CHP 14
CHP 13
C. botulinum
growth
Pathogen
growthtemperature
abuse
CHP 12
Hazards
Frozen
Vacuum packaged
(e.g. mechanical
vacuum, steam
sweep, hot fill),
MAP, CAP,
hermetically sealed
or packed in oil
Raw oysters, clams

and mussels
Method of
Distribution
and Storage
Package Type

49
All
Frozen
Other than
frozen
All
Vacuum packaged
(e.g. mechanical
vacuum, steam
sweep, hot fill),
MAP, CAP,
hermetically sealed
or packed in oil
Vacuum packaged
(e.g. mechanical
vacuum, steam
sweep, hot fill),
MAP, CAP,
hermetically sealed
or packed in oil
Other than vacuum
packaged, MAP,
CAP, hermetically
sealed or packed
in oil
Partially cooked or
uncooked prepared
foods
Partially cooked or
uncooked prepared
foods
Partially cooked or
uncooked prepared
foods
CHP 20
CHP 21
Glass
inclusion
Physical
Metal
inclusion
CHP 19
Allergens/
Additives
Other than vacuum

packaged, MAP,
CAP, hermetically
sealed or packed
in oil
Pathogen
Pathogen
survival
contamination
through
after
CHP 17
CHP 18
Raw fish other than

oysters, clams and
mussels (includes nonfinfish species)
Pathogen
survival
through
cooking
CHP 16
Other than
frozen
CHP 15
S. aureus
toxin batter
Vacuum packaged
(e.g. mechanical
vacuum, steam
sweep, hot fill),
MAP, CAP,
hermetically sealed
or packed in oil
Toxin
formationinadequate
drying
CHP 14
Chemical
Raw fish other than

oysters, clams and
mussels (includes nonfinfish species)
CHP 13
C. botulinum
growth
Pathogen
growthtemperature
abuse
CHP 12
Biological
Hazards
Method of
Distribution
and Storage
Package Type

50
All
All
Fermented, acidified,
pickled, salted, and low
acid canned foods
CHP 19
Allergens/
Additives
Chemical

* Note: Controls for this hazard need not be included in HACCP plans for shelf-stable, acidified and low acid canned foods.
See 21 CFR 113 and 114 for mandatory controls.
All
Other than vacuum

packaged, MAP,
CAP, hermetically
sealed or packed in
oil
Fully cooked prepared

foods
Other than
frozen
Pathogen
Pathogen
survival
contamination
through
after
CHP 17
CHP 18
Hazards
Pathogen
survival
through
cooking
CHP 16
Vacuum packaged
(e.g. mechanical
vacuum, steam
sweep, hot fill),
MAP, CAP,
hermetically sealed
or packed in oil
CHP 15
S. aureus
toxin batter

foods
Toxin
formationinadequate
drying
CHP 14
CHP 13
C. botulinum
growth
Pathogen
growthtemperature
abuse
CHP 12
Biological
Frozen
Method of
Distribution
and Storage
Vacuum packaged
(e.g. mechanical
vacuum, steam
sweep, hot fill),
MAP, CAP,
hermetically sealed
or packed in oil
Package Type

foods
CHP 20
Metal
inclusion
CHP 21
Glass
inclusion
Physical
Chapter 5: Parasites (A Biological Hazard)

STEP #10: UNDERSTAND THE POTENTIAL
HAZARD.
Parasites (in the larval stage) consumed in uncooked,
or undercooked, unfrozen seafood can present a
human health hazard. Among parasites, the nematodes or roundworms (Anisakis spp., Pseudoterranova
spp., Eustrongylides spp. and Gnathostoma spp.),
cestodes or tapeworms (Diphyllobothrium spp.)
and trematodes or flukes (Chlonorchis sinensis,
Opisthorchis spp., Heterophyes spp., Metagonimus
spp., Nanophyetes salminicola and Paragonimus
spp.) are of most concern in seafood. Some products
that have been implicated in human infection are:
ceviche (fish and spices marinated in lime juice);
lomi lomi (salmon marinated in lemon juice, onion
and tomato); poisson cru (fish marinated in citrus
juice, onion, tomato and coconut milk); herring roe;
sashimi (slices of raw fish); sushi (pieces of raw fish
with rice and other ingredients); green herring
(lightly brined herring); drunken crabs (crabs marinated in wine and pepper); cold-smoked fish; and,
undercooked grilled fish. A recent survey of U.S.
gastroenterologists has confirmed that seafood-borne
parasitic infections occur in the U.S. with sufficient
frequency to make preventive controls necessary
during the processing of parasite-containing species
of fish that are intended for raw consumption.
Controlling parasites
The process of heating raw fish sufficiently to kill

bacterial pathogens is also sufficient to kill parasites.
Guidance concerning cooking and pasteurizing to kill
pathogens is provided in Chapters 16 and 17. Regulatory requirements for retorting (low acid canned
foods) are contained in 21 CFR 113. This Guide
does not provide further guidance on retorting.
The effectiveness of freezing to kill parasites depends

on several factors, including the temperature of the
freezing process, the length of time needed to freeze
the fish tissue, the length of time the fish is held
frozen, the fat content of the fish, and the type of
parasite present. The temperature of the freezing
process, the length of time the fish is held frozen, and
the type of parasite appear to be the most important
factors. For example, tapeworms are more susceptible to freezing than are roundworms. Flukes appear
to be more resistant than roundworms.
Freezing and storing at -4F (-20C) or below for 7
days (total time), or freezing at -31F (-35C) or
below until solid and storing at -31F (-35C) or
below for 15 hours, or freezing at -31F (-35C) or
below until solid and storing at -4F (-20C) or below
for 24 hours is sufficient to kill parasites. FDAs Food
Code recommends these freezing conditions to
retailers who provide fish intended for raw consumption.
Note: these conditions may not be suitable for freezing
particularly large fish (e.g. thicker than six inches).
The effectiveness of hydrostatic pressure in the
elimination of parasites from fish flesh is being
studied.
Brining and pickling may reduce the parasite hazard
in a fish, but they do not eliminate it, nor do they
minimize it to an acceptable level. Nematode
larvae have been shown to survive 28 days in an
80 salinometer brine (21% salt by weight).
Fish that contain parasites in their flesh may also
contain parasites within their egg skeins, but generally not within the eggs themselves. For this reason,
eggs that have been removed from the skein and
rinsed are not likely to contain parasites.
Trimming away the belly flaps of fish or candling and
physically removing parasites are effective methods
for reducing the numbers of parasites. However, they
do not completely eliminate the hazard, nor do they
minimize it to an acceptable level.
Chapter 5: Parasites
65
Continued
STEP #11: DETERMINE IF THE HAZARD IS

SIGNIFICANT.
2. Can the parasite hazard be eliminated or reduced to

an acceptable level here? (Note: If you are not certain
Determine if parasites is a significant hazard at

each processing step.
of the answer to this question at this time, you may

answer No. However, you may need to change this
answer when you assign critical control points in
Step #12.)
1. Is it reasonably likely that parasites will be introduced at the receiving step (e.g. do they come in with
the raw material)?
Tables #3-1 and 3-2 (Chapter 3) list those species for

which FDA has information that a potential parasite
hazard exists. Ordinarily, you should identify the
receiving step for these species as having a significant
parasite hazard if you will market the fish for consumption without cooking by the end user (e.g. raw).
Species that normally have parasites as a result of
consuming infected prey, apparently do not have the
same parasite hazard when raised on pelleted food in
an aquaculture operation. You need not consider
such aquacultured fish as having a parasite hazard.
On the other hand, aquacultured fish that are fed
processing waste and by-catch fish may have a
parasite hazard, even when wild caught fish of that
species do not normally have a parasite hazard.
Species of fish other than those identified in Tables
#3-1 and 3-2 may have a parasite hazard in certain
localized areas. You should consider this possibility
in your hazard analysis.
If the finished product is fish eggs that have been
removed from the skein and rinsed, it is not reasonably likely that it will contain parasites. You need not
consider such product as having a parasite hazard.
However, unrinsed fish eggs or fish eggs that remain
in the skein ordinarily will have a parasite hazard if
the species is identified in Tables #3-1 or 3-2 as
having a parasite hazard.
It is not reasonably likely that parasites will enter the
process at other processing steps.
Parasites should also be considered a significant

hazard at any processing step where a preventive
measure is or can be used to eliminate (or reduce the
likelihood of occurrence to an acceptable level)
parasites that are reasonably likely to come in with
the raw material. Preventive measures for parasites
can include:
Retorting (covered in 21 CFR 113);
Cooking (covered in Chapter 16);
Pasteurizing (covered in Chapter 17);
Freezing (covered in this chapter);
Brining or pickling (not a complete control);
Candling and physical removal
(not a complete control);
Trimming away the belly flap
(not a complete control).
List such preventive measures in Column 5 of the
Hazard Analysis Worksheet, at the appropriate
processing step(s).
If the answer to either question 1 or 2 is Yes the
potential hazard is significant at that step in the
process and you should answer Yes in Column 3 of
the Hazard Analysis Worksheet. If neither criterion
is met you should answer No. You should record
the reason for your Yes or No answer in Column
4. You need not complete Steps #12 through 18 for
this hazard for those processing steps where you have
recorded a No.
You should also consider the likelihood that, without
proper controls, parasites would survive your cooking process. Some cooking processes (e.g. retorting)
may be exceptionally lethal to parasites, because the
process is designed to kill more heat-stable bacterial
pathogens. In such cases, even significant underprocessing would not jeopardize the safety of the
product relative to parasites, and it may not be
necessary to identify parasites as a significant
hazard.
66
It is important to note that identifying this hazard as

significant at a processing step does not mean that it
must be controlled at that processing step. The next
step will help you determine where the critical control
point is located.
Intended use
In determining whether a hazard is significant, you

should also consider the intended use of the product,
which you developed in Step #4. If the fish is intended to be cooked by the consumer before consumption, then you do not need to consider the hazard
significant even if the species is listed as having a
potential parasite hazard in Table #3-1 or 3-2. Similarly, if you have assurance that the fish will be
processed by a subsequent processor, restauranteur or
institutional user (e.g. prison, nursing home) in a way
that will kill the parasites, you do not need to identify
parasites as a significant hazard.
Example:
A primary processor receives whole salmon from the
harvest vessel and re-ices the fish for shipment to a
second processor. The primary processor has assurance that the second processor butchers the fish and
freezes it for the sushi market. The primary processor
would not need to identify parasites as a significant
hazard.
It is important to note that, at certain levels in certain
species of fish, parasites constitute filth, and, as a
result, cause the fish to be adulterated. See Compliance Policy Guide section 540.590. However, since
these defect action levels relate to a filth issue,
preventive controls to assure that they are not exceeded need not be included in your HACCP plan.
mining whether a processing step is a CCP for

parasites:
1. Does the process contain a heating step, such as
retorting, cooking, or pasteurizing, that is designed to
kill pathogens?
a. If it does, you may identify the heating step as

the CCP.
In this case, you should enter Yes in Column
6 of the Hazard Analysis Worksheet for the
heating step, and enter No for the receiving
step. In addition, for the No entry, note in
Column 5 that the hazard is controlled by the
heating step. (Note: if you have not previously
identified parasites as a significant hazard at
the heating step in Column 3 of the Hazard
Analysis Worksheet, you should change the
entry in Column 3 to Yes.) See Chapters 16
(cooking) and 17 (pasteurizing) for further
guidance on this control strategy.
Example:
A hot-smoked salmon processor could set the
critical control point for parasites at the hotsmoking step, and would not need to identify
the receiving step as a critical control point for
this hazard.
b. If the process does not contain a heating step,
you should identify a freezing step as the CCP.
STEP #12: IDENTIFY THE CRITICAL

CONTROL POINTS (CCP).
For each processing step where parasites is identified in Column 3 of the Hazard Analysis Worksheet as
a significant hazard, determine whether it is necessary
to exercise control at that step in order to control the
hazard. Figure #A-2 (Appendix 3) is a CCP decision
tree that can be used to aid you in your determination.
In this case you should enter Yes in Column

6 of the Hazard Analysis Worksheet for the
freezing step, and enter No for the receiving
step. In addition, for the No entry, note in
Column 5 that the hazard is controlled by the
freezing step. (Note: if you have not previously
identified parasites as a significant hazard at
the freezing step in Column 3 of the Hazard
Analysis Worksheet, you should change the
entry in Column 3 to Yes.) This control
approach will be referred to as Control
Strategy Example 1 in Steps #14 through 18.
The following guidance will also assist you in deterChapter 5: Parasites

67
Continued
Example:
A salmon processor that sells the finished
product for raw consumption should identify a
freezing step as the CCP for parasites. The
processor would not need to identify the
receiving step as a critical control point for
this hazard.
It is important to note that you may select a
control strategy that is different from that
which is suggested above, provided that it
assures an equivalent degree of safety of the
product.
Proceed to Step #13 (Chapter 2) or to Step #10 of the
next potential hazard.
CONTROL STRATEGY EXAMPLE 1 - FREEZING

Critical Limit: Freezing and storing at -4F (-20C) or
below for 7 days (total time);

OR
Freezing at -31F (-35C) or below until solid
hours;
OR
Freezing at -31F (-35C) or below until solid
and storing at -4F (-20C) or below for 24 hours.
Enter the critical limit(s) in Column 3 of the HACCP
Plan Form.
STEP #15: ESTABLISH MONITORING
PROCEDURES.
HACCP Plan Form

STEP #14: SET THE CRITICAL LIMITS (CL).
For each processing step where parasites is identified as a significant hazard on the HACCP Plan Form
identify the maximum or minimum value to which a
feature of the process must be controlled in order to
control the hazard.
You should set the CL at the point that if not met the
safety of the product will be questionable. If you set
a more restrictive CL you could, as a result, be
required to take corrective action when no safety
concern actually exists. On the other hand, if you set
a CL that is too loose you could, as a result, allow
unsafe product to reach the consumer.
As a practical matter it may be advisable to set an
operating limit that is more restrictive than the CL.
In this way you can adjust the process when the
operating limit is triggered, but before a triggering of
the CL would require you to take corrective action.
You should set operating limits based on your
experience with the variability of your operation and
with the closeness of typical operating values to the
CL.
For each processing step where parasites is identified as a significant hazard on the HACCP Plan
Form, describe monitoring procedures that will
ensure that the critical limits are consistently met.
To fully describe your monitoring program you
should answer four questions: 1) What will be
monitored? 2) How will it be monitored? 3) How
often will it be monitored (frequency)? 4) Who will
perform the monitoring?
It is important for you to keep in mind that the
feature of the process that you monitor and the
method of monitoring should enable you to determine whether the CL is being met. That is, the
monitoring process should directly measure the
feature for which you have established a CL.
You should monitor often enough so that the normal
variability in the values you are measuring will be
detected. This is especially true if these values are
typically close to the CL. Additionally, the greater
the time span between measurements the more
product you are putting at risk should a measurement
show that a CL has been violated.
Following is guidance on setting critical limits for the

control strategy example discussed in Step #12.
68
Following is guidance on establishing monitoring

procedures for the control strategy example discussed
in Step #12. Note that the monitoring frequencies
that are provided are intended to be considered as
minimum recommendations, and may not be adequate in all cases.
What Will Be Monitored?
Who Will Perform the Monitoring?

Who: Monitoring may be performed by the freezer
operator, a production supervisor, a member of

the quality control staff, or any other person who
has an understanding of the monitoring device
and the critical limit.
STEP #16: ESTABLISH CORRECTIVE
ACTION PROCEDURES.

What: Freezer temperature;
AND
Length of time fish is held at freezer temperature
or held frozen, as appropriate.
How Will Monitoring Be Done?
How: Use a recording thermometer, digital
time/temperature data logger, or similar device;

AND
Visual check on time and solid frozen condition,
as appropriate.
Form, describe the procedures that you will use when
your monitoring indicates that the CL has not been
met.
These procedures should: 1) ensure that unsafe
product does not reach the consumer; and, 2) correct
the problem that caused the CL deviation. Remember that deviations from operating limits do not need
to result in formal corrective actions.
Following is guidance on establishing corrective
action procedures for the control strategy example
discussed in Step #12.
How Often Will Monitoring Be Done

(Frequency)?
Corrective Action: Take one or more of the
For temperature:
Frequency: Continuous monitoring, with visual
check at least once during the cycle, but no less

than once per day.
For time:
Frequency: Start and end of each freezing cycle;
OR
Time when fish is solid frozen and end of
freezing cycle for each freezing cycle.
following actions as necessary to regain control

over the operation after a critical limit deviation:
Make repairs or adjustments to the freezer;
OR
Move some or all of the product in the freezer
to another freezer;
AND
Refreeze and store the product at -4F (-20C)
or below for 7 days (total time), or refreeze
at -31F (-35C) or below until solid and store
at -31F (-35C) or below for 15 hours, or
refreeze at -31F (-35C) or below until solid and
store at -4F (-20C) or below for 24 hours.
69
Continued
STEP #17: ESTABLISH A RECORDKEEPING

SYSTEM.
STEP #18: ESTABLISH VERIFICATION

PROCEDURES.
Form, list the records that will be used to document
the monitoring procedures discussed in Step #15.
The records should clearly demonstrate that the
monitoring procedures have been followed, and
should contain the actual values and observations
obtained during monitoring.
Form, establish verification procedures that will
ensure that the HACCP plan is: 1) adequate to
address the hazard of parasites; and, 2) consistently
being followed.
Following is guidance on establishing verification
in Step #12.
Following is guidance on establishing a record

keeping system for the control strategy example
Verification: When digital time/temperature data
Records: Temperature recorder chart, digital time/
temperature data logger printout, with notations

for start and end of freezing cycle or time when
fish is solid frozen and end of freezing cycle, as
appropriate.
loggers, or recorder thermometers are used for

monitoring, check for accuracy against a known
accurate thermometer (NIST-traceable) at least
once per day;
AND
Review monitoring, corrective action and
verification records within one week of
preparation.
Enter the verification procedures in Column 10 of the
HACCP Plan Form.
70
71
Freezing
(1)
Critical Control
Point (CCP)
Parasites
(2)
Significant
Hazard(s)
Recorder
themometers
Visual check of
when first
fish is solid
frozen and at end
of freezing cycle
Length of time
held frozen
How
What
(6)
Continuous,
with visual
check at end of
each freezing
cycle
Frequency
Monitoring
Temperature of
blast freezer and
storage freezer
(5)
(4)
Freezer operator
Who
(7)
Adjust freezer
(8)
Corrective
Action(s)
When fish is
solid frozen and
at end of each
freezing cycle
Freezer operator
Same
Refreeze product
Se
eT
ex
t f Exa
or mp
Fu le
ll R O
eco nly
mm
en
da
tio
ns
Freeze at -31F or
below until solid and hold
at -4F or below for
24 hours
(3)
Critical Limits
for each Preventive
Measure
Recorder chart
with notations
for solid frozen
and end of
each cycle
(9)
Records
Check the
accuracy of
the temperature
recording
devices daily
Review
monitoring,
corrective
action and
verification
records within
one week of
preparation
(10)
Verification
This table is an example of a portion of a HACCP plan relating to the control of parasites for a processor of
frozen salmon fillets with pin bones removed, where the finished product is distributed to other processors for the production
of lox, using Control Strategy Example 1 - Freezing. It is provided for illustrative purposes only. Parasites may be only one
of several significant hazards for this product. Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3) for other potential hazards
(e.g. chemical contaminants, aquaculture drugs, food and color additives, and metal fragments).
Control Strategy Example 1 - Freezing
TABLE #5-1
Notes:
72
Chap 5 - Principle 1: Hazard Analysis
Chapter 5: Principle 1: Hazard Analysis
Overhead 1
Explanatory Note:
HACCP traditionally deals
only with food-safety hazards. Participants may realize
that issues associated with
GMPs sanitation, economic fraud and wholesomeness are important and
must be properly handled by
the processor. However,
unless these issues specifically
affect food safety, they should
not be part of a companys
HACCP program.
Objective:
In this module you will learn:
What hazard analysis is.
How to conduct a hazard analysis.
How to identify significant hazards.
What control measures are.
How to identify control measures.
The hazard-analysis step is fundamental to the HACCP system. To establish a plan that effectively prevents food-safety hazards, it is crucial that all
significant safety hazards and the measures to control them be identified.
Overhead 2
Principle 1:
Conduct a hazard analysis.
Likekihood of occurrence
Severity
As previously stated, a hazard is a biological, chemical or physical agent

that is reasonably likely to cause illness or injury in the absence of its
control. The term hazard, when used in the context of HACCP, is limited
to safety.
Considerations for the HACCP Team
Explanatory Note:
During the hazard analysis, the potential significance of each hazard

should be assessed by considering the likelihood of occurrence and severity. This is usually based upon a combination of experience, epidemiological data and information in the technical literature. Severity is the seriousness of a hazard.
Smoked fish offers an

example of considering
factors beyond the immediate
control of the processor.
Due to the possibility of
temperature abuse during
distribution and/or retail
sales of smoked fish, the
potential exists for germination, growth and toxin
production of Clostridium
botulinum type E. The hazard
is controlled by brining fish to
achieve salt concentrations at
some specified level (e.g.,
3.5 percent water-phase salt
in the finished product).
During the hazard analysis, factors that may be beyond the immediate
control of the processor must be considered. For example, product distribution may be beyond the direct control of your firm, but information on how
the food will be distributed could influence how the food will be processed
and/or packaged.
For some processors, the expertise necessary to properly assess the likelihood of occurrence and severity of the various hazards is available within
the company. However, others may need to seek outside assistance to
address this issue correctly.
Continued
51

Notes:
The HACCP team has the initial responsibility to decide which hazards
are significant and must be addressed by the HACCP plan. Keep in mind
that there may be differences of opinion, even among experts, as to the
significance of a hazard. The HACCP team may rely on available guidance materials and the opinions of experts who assist in the development
of HACCP plans. During the hazard analysis, safety concerns must be
differentiated from quality concerns.
Overhead 3
Safety concerns must be differentiated
from quality concerns
Hazard Analysis
One approach to hazard analysis divides it into two activities hazard

identification and hazard evaluation. Hazard identification should result in
a list of potential hazards at each operational step (use flow diagram) in
the process from the receipt of raw materials to the release of the finished
product. During hazard identification, the team need not be confined by
the hazards likelihood of occurrence or its potential for causing disease.
Explanatory Note:
The list of hazards and FDAs
Fish and Fishery Products
Hazards and Controls Guide
can be very useful, especially
for firms that do not have
strong technical expertise.
These firms may also need to
seek technical assistance in
developing their HACCP
programs.
All potentially significant hazards must be considered. To assist in this,

the following list of hazards will be valuable.
Overhead 4
Hazards List
Biological Hazards:
Pathogenic microorganisms (e.g., bacteria, viruses)
Parasites
Chemical Hazards:
Natural toxins
Chemicals
Pesticides
Drug residues
Unapproved food and color additives
Decomposition (safety only, e.g., histamine)
Physical Hazards:
Metal, glass, etc.
52
After hazard identification, the team conducts a hazard evaluation: a

three-step process in which the list of potential hazards developed during
the hazard identification is narrowed to those hazards that are significant
to the product and process in question. The steps in hazard evaluation are:
1. Assess severity of health consequences if potential hazard is not
properly controlled;

Explanatory Note:
2. Determine the likelihood of occurrence of potential hazard if not

properly controlled; and
3. Determine, using information from steps 1 and 2, if the potential
hazard is to be addressed in the HACCP plan.
First-time HACCP writers

often identify too many
hazards! This is a problem
because the potential exists to
dilute a processors ability to
focus efforts and control the
truly significant hazards. The
dilemma is deciding what is
significant. A hazard must be
controlled if it is: 1) reasonably likely to occur AND
2) if not properly controlled,
it is likely to result as an
unacceptable health risk to
consumers. In the case of
hazards for which regulatory
action levels, tolerances or
other limits have been
established for safety
concerns (e.g., pesticides,
animal drugs), an unacceptable health risk is the risk that
the limit has been exceeded,
not the mere presence of the
substance at a detectable
level. Therefore, if violation of
an action level in that type of
food is reasonably likely to
occur, then the processors
hazard analysis should
identify that hazard as one to
be controlled through its
HACCP system.
HACCP focuses solely on hazards that are reasonably likely to occur

and likely to result in an unacceptable health risk to consumers if not
controlled. Without this focus, it would be tempting to try to control too
much and thus lose sight of the truly relevant hazards.
Overhead 5
Hazard Analysis
A hazard must be controlled if it is
reasonably likely to occur, and
likely to result in an unacceptable risk to consumers.
Hazard-Analysis Worksheet
A hazard-analysis worksheet can be used to organize and document the
considerations in identifying food-safety hazards. Although there is no
specific or required form, the worksheet should document specific
information (see HACCP Worksheets, Appendix II). In the cooked-shrimp
example, each step in the process flow diagram should be first listed in
Column 1. The results of the hazards identification are recorded in
Column 2. The results of the hazard evaluation should be recorded in
Column 3, with the justification for accepting or rejecting the listed
potential hazards stated in Column 4.
Control Measures
Control measures are actions and activities that can be used to prevent or
eliminate a food-safety hazard or reduce it to an acceptable level. In
practice, control measures encompass a wide array of activities.
Explanatory Note:
On the hazard-analysis worksheet, please note the hazards that are

identified for IQF cooked shrimp. At the receiving step, bacterial pathogens and chemicals have been identified as significant hazards for the two
raw material forms (fresh and frozen) used by this company. Bacterial
pathogens (e.g., Vibrios) are known to be associated with raw (fresh and
frozen) shrimp, hence they must be identified as significant hazards.
Additionally, sulfiting agents used to inhibit the development of blackspot
are considered significant hazards.
Verification procedures will

be discussed later, but ABC
Shrimp Co. may verify the
results of the supplier testing
by randomly conducting its
own tests.
As ABC Shrimp Co. analyzed its process, it did not identify any control
measures that are taken at the receiving step for bacterial pathogens on
incoming product. However, it did determine control measures for
chemicals. Previously sulfited product will be labeled. For raw product
received from boats, the company will test for sulfiting agents. For frozen
Continued
53

Notes:
shrimp received from other suppliers, ABC Shrimp Co. will rely on
supplier declarations. ABC Shrimp Co. also has identified sulfites as a
significant hazard at the weigh/pack/label stage because of the need to
identify the presence of any sulfite residual. ABC Shrimp Co. resolved
this hazard by training weigh/pack/label personnel to identify and use the
correct label.
Cold storage is identified in the hazard analysis as potentially important in
terms of food safety. Unless temperatures are properly maintained,
bacterial pathogens can increase. Therefore, maintaining refrigerated
storage conditions is a control measure.
ABC Shrimp Co. also noted a significant hazard at the cooking step. At
this step, where it is most concerned about the survival of pathogens that
may contaminate the finished product, ABC Shrimp Co. has determined
three measures that are important in controlling this hazard. First, an
adequate cook time and temperature will be established that ensures the
destruction of bacterial pathogens. Second, cook time and temperature
are monitored to ensure that they meet the requirements of the established
process. Third, cooker personnel will be trained to operate all cooking
equipment, including monitoring devices (timers and temperature
recorders).
Examples of Control Measures
The following are examples of control measures that could be used to

control the three types of hazards.
A. Biological Hazards
Bacteria
1. Time/temperature control (e.g., proper control of refrigeration
and storage time minimizes the growth of pathogens).
2. Heating and cooking processes (e.g., thermal processing).
3. Cooling and freezing (e.g., cooling and freezing retard the growth
of pathogenic bacteria).
4. Fermentation and/or pH control (e.g., lactic acid-producing
bacteria in yogurt inhibit the growth of some pathogenic bacteria
that do not grow well in acidic conditions).
5. Addition of salt or other preservatives (e.g., salt and other
preservatives inhibit growth of some pathogenic bacteria).
6. Drying (e.g., the drying process may use enough heat to kill
pathogenic bacteria, but even when drying is conducted at lower
temperatures, it may remove enough water from the food to
prevent some pathogens from growing).
7. Source control (e.g., the presence or amount of pathogens in raw
materials may be controlled by obtaining them from noncontaminated sources).
54

Notes:
Viruses
1. Cooking methods (e.g., adequate cooking will destroy viruses).
Parasites
1. Dietary control (e.g., preventing the parasite from having access
to the food. For example, infection from Trichinella spiralis in
pork has decreased due to better control of pigs diets and
environments. However, this control method is not always
practical for all species of animals used for food. The diet and
environment of wild fish cannot be controlled, for instance).
2. Inactivation/removal (e.g., some parasites are resistant to chemical disinfection but can be inactivated by heating, drying or
freezing. In some foods, visual examination may detect parasites.
A procedure called candling enables processors to examine
fish on a brightly lit table. Over the light, worms, if present, are
easy to see and remove. This procedure cannot ensure 100
percent detection. Therefore, it should be combined with other
means of control, such as freezing.)
B. Chemical Hazards
1. Source control (e.g., vendor certification and raw-material
testing).
2. Production control (e.g., proper use and application of food
additives).
3. Labeling control (e.g., finished product properly labeled with
ingredients and known allergens).

C. Physical Hazards
1. Source control (e.g., vendor certification and raw-material
testing).
2. Production control (e.g., use of magnets, metal detectors, sifter
screens, destoners, clarifiers, air tumblers, x-ray equipment, and

visual inspection).
NOTE: Control measures for each significant hazard should be recorded
in column 5 of the hazard-analysis worksheet.
Continued
55
Hazard-Analysis Worksheet
ABC Shrimp Co.
IQF Cooked Shrimp Production
Example: For Illustrative Purposes Only*

Note: The ABC Shrimp Co. will serve as our model seafood processing firm. Following the
discussion of each HACCP principle, that principle will be applied to the ABC Shrimp Co. Please
become familiar with the process flow diagram and process narrative associated with the model.
(1)
Ingredient/processing step
(2)
Identify potential hazards
introduced, controlled or
enhanced at this step.
(3)
Are any
potential
food-safety
hazards
significant?
(4)
Justify your decision for
column 3.
(5)
What control measure(s)
can be applied to prevent
significant hazards?
(6)
Is this step
a critical
control
point ?
(Yes/No)
(Yes/No)
Receiving Fresh Shrimp
BIOLOGICAL
Bacterial pathogens
Yes
Raw seafoods can be natural

reservoirs for marine vibrios
and, depending on the quality
of the harvest, can harbor
terrestrial pathogens such
as Salmonella.
A cook step follows that

assumes a high bacterial
load.
Note: If this product were marketed raw, the answer in column 3 would be no because the product is highly unlikely
to be used by a consumer without adequate cooking. In this case, this would not be a significant hazard.
CHEMICAL
Sulfiting agent
Yes
Sulfiting agents may cause

an allergic-type reaction.
Labeling control based

on product screening.
Note: If shrimp were aquacultured, hazards could include chemicals such as pesticides, herbicides and heavy metals.
Additionally, drugs used to prevent disease, control parasites, and affect growth should be considered.
PHYSICAL
None
Cold Storage
BIOLOGICAL
Bacterial pathogen growth
Yes
Without controlled temperature, bacterial pathogens

may increase in numbers.

load.
CHEMICAL
None
PHYSICAL
None
Firm Name:
Product Description:
Firm Address:
Method of Storage and Distribution:
Signature:
Intended Use and Consumer:
Date:
*Models may not be fully consistent with guidance contained in FDAs Fish and Fishery Products Hazards and Control Guide.
56
IQF Cooked Shrimp

(1)
(2)
introduced, controlled, or
enhanced at this step?
(3)
Are any
potential
food-safety
hazards
significant?
(4)
column 3.
(5)
can be applied to prevent the
significant hazard?
(Yes/No)
(Yes/No)
Receiving Frozen Shrimp
BIOLOGICAL
Bacterial pathogens
Yes
Frozen seafoods can be

natural reservoirs for marine
vibrios and, depending on the
quality of the harvest, can
harbor terrestrial pathogens
such as Salmonella.

load.
CHEMICAL
Sulfiting agent
Yes
Sulfiting agents may cause

an allergic-type reaction.
Labeling control based

on supplier declaration.
BIOLOGICAL
Bacterial pathogen
contamination
No
Not likely to occur
CHEMICAL
Chemical contaminants
No
Not likely to occur

No history of occurrence
BIOLOGICAL
Yes
If not properly controlled,

bacterial pathogens can
grow during thawing.
Bacterial pathogen
contamination
No
Controlled by SSOP
PHYSICAL
None
Frozen Storage
BIOLOGICAL
None
CHEMICAL
None
PHYSICAL
None
Receiving Packaging
Material
PHYSICAL
None
Dry Storage
BIOLOGICAL
None
CHEMICAL
None
PHYSICAL
None
Thawing
(6)
Is this step
a critical
control
point?

load.
CHEMICAL
None
PHYSICAL
None
57
IQF Cooked Shrimp

(1)
(2)
(3)
Are any
potential
food-safety
hazards
significant?
(4)
column 3.
BIOLOGICAL
No
Not likely to occur because

of the continuous process.
Bacterial pathogen
contamination
No
Controlled by SSOP
CHEMICAL
Sanitizer residues
No
Controlled by SSOP
BIOLOGICAL
No
Not likely to occur

(See size grading)
Bacterial pathogen
contamination
No
(See size grading)
CHEMICAL
Sanitizer residues
No
Controlled by SSOP
BIOLOGICAL
No
Not likely to occur

(See size grading)
Bacterial pathogen
contamination
No
(See size grading)
CHEMICAL
Sanitizer residues
No
Controlled by SSOP
PHYSICAL
Metal fragments
No
Subsequent processing
removes any fragments.
No historical problem.
BIOLOGICAL
No
Not likely to occur

(See size grading)
Bacterial pathogen
contamination
No
(See size grading)
CHEMICAL
Sanitizer residues
No
Controlled by SSOP
BIOLOGICAL
No
Not likely to occur

(See size grading)
Bacterial pathogen
contamination
No
(See size grading)
CHEMICAL
Sanitizer residues
No
Controlled by SSOP
PHYSICAL
None
Peeling
PHYSICAL
None
Razor Slide
Tumbler/Deveiner
PHYSICAL
None
Cull Table
PHYSICAL
None
58
(6)
Is this step
a critical
control
point?
(Yes/No)
(Yes/No)
Size Grading
(5)
significant hazard?
IQF Cooked Shrimp

(1)
(2)
enhanced at this step.
(3)
Are any
potential
food-safety
hazards
significant?
(4)
Justify your decision in
column 3.
(5)
significant hazards?
(Yes/No)
(Yes/No)
Cold Storage
BIOLOGICAL
Yes
Without controlled
temperatures, bacterial
pathogens may increase
in numbers.
CHEMICAL
Sanitizer residues
No
Controlled by SSOP
BIOLOGICAL
Bacterial pathogen survival
Yes
Without proper processing

time and temperature,
bacterial pathogens such as
Listeria monocytogenes,
Salmonella spp. and
Vibrio spp. may survive.
CHEMICAL
Sanitizer residues
No
Controlled by SSOP
No
Controlled by SSOP

load.
PHYSICAL
None
Cooker
Adequate cooking time

and temperature
PHYSICAL
None
Shuffler
BIOLOGICAL
Recontamination with
bacterial pathogens
Note: Companies that DO NOT have SSOPs in place would need to control post-processing contamination with appropriate HACCP sanitation CCPs.
No

of the continuous process
Note: Under different conditions where time and temperature abuse may occur, controls must be sufficient to minimize the growth
of bacterial pathogens in the product. Remember, this product does not have to be heated by the consumer.
CHEMICAL
Sanitizer residues
No
Controlled by SSOP
BIOLOGICAL
bacterial pathogens
No
Controlled by SSOP
No
(See remarks for shuffler)
CHEMICAL
Sanitizer residues
No
Controlled by SSOP
No
Not likely to occur due to

rapid freezing rate
No
Controlled by SSOP
PHYSICAL
None
Cull
PHYSICAL
None identified
Spiral Freezer
BIOLOGICAL
CHEMICAL
Sanitizer residues
(6)
Is this step
a critical
control
point?
PHYSICAL
None identified
59
IQF Cooked Shrimp

(1)
(2)
introduced, controlled or
(3)
Are any
potential
food-safety
hazards
significant?
(4)
column 3.
(5)
significant hazard?
(Yes/No)
(Yes/No)
Glaze Station
BIOLOGICAL
bacterial pathogens
No
Use potable water and

equipment cleaned
per SSOP.
No
(See shuffler)
CHEMICAL
Sanitizer residues
No
Controlled by SSOP
BIOLOGICAL
bacterial pathogens
No
(See shuffler)
No
(See shuffler)
CHEMICAL
Sulfiting agent
Yes
Potential allergic-type
reaction (accurate label
declaration)
Sanitizer residues
No
Controlled by SSOP
No

frozen
No

frozen
PHYSICAL
None
Weigh/Pack/Label
PHYSICAL
None identified
Mastercase/Palletize
BIOLOGICAL
CHEMICAL
None
PHYSICAL
None
Freezer Storage
BIOLOGICAL
CHEMICAL
None
PHYSICAL
None
60
(6)
Is this step
a critical
control
point?
Accurate label declaration
Chapter 6: Natural Toxins (A Chemical Hazard)

HAZARD.
Contamination of fish with natural toxins from the
harvest area can cause consumer illness. Most of
these toxins are produced by species of naturally
occurring marine algae (phytoplankton). They
accumulate in fish when they feed on the algae or
on other fish that have fed on the algae. There are
also a few natural toxins which are naturally occurring in certain species of fish.
There are five recognized fish poisoning syndromes
in the United States: paralytic shellfish poisoning
(PSP), neurotoxic shellfish poisoning (NSP),
diarrhetic shellfish poisoning (DSP), amnesic shellfish poisoning (ASP), and ciguatera fish poisoning
(CFP). Scombrotoxin formation, the subject of
Chapter 7, is not considered a natural toxin.
Species involved
This section will provide information about species

and geographic areas which have been linked to one
of the five fish poisoning syndromes by historical
occurrence of the syndrome. However, it is important to note that historical occurrence may be an
inadequate guide to future occurrence in the case of
natural toxins, since the source algae vary in their
distribution. Processors need to be alert to the
potential for emerging problems.
Paralytic shellfish poisoning in the U.S. is generally
associated with the consumption of molluscan
shellfish from the northeast and northwest coastal
regions of the U.S. PSP in other parts of the world
has been associated with molluscan shellfish from
environments ranging from tropical to temperate
waters. In addition, in the U.S., PSP toxin has
recently been reported from the viscera of mackerel,
lobster, Dungeness crabs, tanner crabs, and red rock
crabs. While the viscera of mackerel are not normally
eaten, the viscera of lobster and crabs are. However, the

levels of PSP toxin that are found in lobster tomale are
not likely to pose a health hazard unless large quantities
are eaten from a heavily contaminated area.
Neurotoxic shellfish poisoning in the U.S. is generally associated with the consumption of molluscan
shellfish harvested along the coast of the Gulf of
Mexico, and, sporadically, along the southern Atlantic coast. There has been a significant occurrence of
toxins similar to NSP in New Zealand, and some
suggestions of occurrence elsewhere.
Diarrhetic shellfish poisoning is generally associated
with the consumption of molluscan shellfish. There
has been no documented occurrence to date in the
U.S. However, instances have been documented in
Japan, southeast Asia, Scandinavia, western Europe,
Chile, New Zealand, and eastern Canada.
Amnesic shellfish poisoning is generally associated
with the consumption of molluscan shellfish from the
northeast and northwest coasts of North America. It
has not yet been a problem in the Gulf of Mexico,
although the algae that produces the toxin has been
found there. ASP toxin has recently been identified
as a problem in the viscera of Dungeness crab, tanner
crab, red rock crab, and anchovies along the west
coast of the United States. The viscera of anchovies
are also eaten.
Marine toxins are not ordinarily a problem in scallops if only the adductor muscle is consumed.
However, products such as roe-on scallops and whole
scallops do present a potential hazard for natural
toxins.
Ciguatera toxin is carried to humans by contaminated
fin fish from the extreme southeastern U.S., Hawaii,
and subtropical and tropical areas worldwide. In the
south Florida, Bahamian, and Caribbean regions,
barracuda, amberjack, horse-eye jack, black jack,
other large species of jack, king mackerel, large
groupers, and snappers are particularly likely to
contain ciguatoxin. These species are not generally
Chapter 6: Natural Toxins

73
Continued
associated with ciguatera in the northern Gulf of

Mexico. Many other species of large fish-eating
fishes may be suspect. In Hawaii and throughout the
central Pacific, barracuda, amberjack, and snapper
are frequently ciguatoxic, and many other species
both large and small are suspect. Mackerel and
barracuda are frequently ciguatoxic from mid to
northeastern Australian waters.
Natural toxin detection
FDA has established action levels for all of the
natural toxins except CFP.
PSP- 0.8 ppm (80ug/100g) saxitoxin equivalent;
NSP- 0.8 ppm (20 mouse units/100g) brevetoxin-2
equivalent;
DSP- 0.2 ppm okadaic acid plus 35-methyl okadaic
acid (DXT 1);
ASP- 20 ppm domoic acid, except in the viscera of
Dungeness crab, where 30 ppm is permitted.
There are no validated, rapid methods that are
suitable for shipboard, dockside, or commercial
testing of lots of fish for any of these toxins.
Natural toxin control
Natural toxins cannot be reliably eliminated by heat.
However, severe heating processes, such as retorting,
may be effective at reducing the levels of some
natural toxins.
To minimize the risk of molluscan shellfish containing natural toxins from the harvest area, State and
foreign government agencies, called Shellfish
Control Authorities, classify waters in which molluscan shellfish are found, based, in part, on the presence of natural toxins. As a result of these classifications, molluscan shellfish harvesting is allowed from
some waters, not from others, and only at certain
times, or under certain conditions, from others.
Shellfish Control Authorities then exercise control
over the molluscan shellfish harvesters to ensure that
harvesting takes place only when and where it has
been permitted. Molluscan shellfish include oysters,
clams, mussels, and scallops, except where the
scallop product contains the shucked adductor
muscle only.
Significant elements of Shellfish Control Authorities

efforts to control the harvesting of molluscan shellfish include: 1) a requirement that containers of inshell molluscan shellfish (shellstock) bear a tag that
identifies the type and quantity of shellfish, harvester,
harvest location, and date of harvest; 2) a requirement
that molluscan shellfish harvesters be licensed; 3) a
requirement that processors that shuck molluscan
shellfish or ship, reship, or repack the shucked product
be certified; and, 4) a requirement that containers of
shucked molluscan shellfish bear a label with the
processors name, address, and certification number.
An established water classification system similar to
the molluscan shellfish system is not in place for
controlling CFP in fin fish. However, some states
issue advisories regarding reefs that are known to be
toxic. In areas where there is no such advisory
system, fishermen and processors must depend on
first-hand knowledge about the safety of the reefs
from which they obtain fish.
Where PSP or ASP have become a problem in fin fish
or crustaceans, states generally have closed or restricted
the appropriate fisheries. In addition, removal and
destruction of the viscera will eliminate the hazard.
Escolar, puffer fish, and whelk
There are naturally occurring toxins in some species
that do not involve marine algae. Escolar or oilfish
(i.e. Lepidocybium flavobrunneum, Ruvettus pretiosus)
contains a strong purgative oil, called gempylotoxin,
that may cause diarrhea when consumed. FDA
advises against importation and interstate marketing
of these fish.
Puffer fish, or fugu, may contain tetrodotoxin.
Poisonings from tetrodotoxin have usually been
associated with the consumption of puffer fish from
waters of the Indo-Pacific ocean regions. However,
several reported cases of poisonings, including
fatalities, involved puffer fish from the Atlantic
Ocean, Gulf of Mexico, and Gulf of California.
There have been no confirmed cases of poisonings
from Spheroides maculatus but there is still reason
for concern.

74
Tetramine is a toxin that is found in the salivary

glands of Neptunia spp., a type of whelk. The hazard
can be controlled by removing the glands.
FDA makes no recommendations in this Guide and
has no specific expectations with regard to controls
for tetrodotoxin or tetramine in processors HACCP
plans.
STEP #11: DETERMINE IF THE
POTENTIAL HAZARD IS SIGNIFICANT.
At each processing step, determine whether natural
toxins is a significant hazard. The criteria are:
1. Is it reasonably likely that unsafe levels of
natural toxins will be introduced here (e.g. does it
come in on the raw material at an unsafe level)?
Tables #3-1 and 3-2 (Chapter 3) identify the species

of fish for which natural toxins is known to be a
potential hazard. Under ordinary circumstances, it
would be reasonably likely to expect that, without
proper controls, natural toxins from the harvest area
could enter the process at unsafe levels at the receiving step from those species. There may be circumstances in your geographic area that would allow you
to conclude that it is not reasonably likely for a
particular natural toxin to occur at unsafe levels in
fish from your area. You should be guided by the
historical occurrence of the toxin, at levels above the
established guidance levels, in your geographic area.
However, you should remain alert to the potential for
emerging problems.
If you are receiving fish, other than molluscan
shellfish, from another processor you should not need
to identify natural toxins as a significant hazard.
This hazard should have been fully controlled by the
primary (first) processor.
Natural toxins should also be considered a significant hazard at any processing step where a preventive
measure is or can be used to eliminate (or is adequate
to reduce the likelihood of occurrence to an acceptable level) unsafe levels of natural toxins that are
reasonably likely to come in with the raw material.
Preventive measures for natural toxins can include:
Making sure that incoming fish have not been
caught in an area that has been closed because of a
natural toxin problem;
Making sure that incoming fin fish have not been
caught in an area for which there is a CFP advisory
or for which you have knowledge there is a CFP
problem;
Checking incoming molluscan shellfish to ensure
that they are properly tagged or labeled;
Making sure that incoming molluscan shellfish are
supplied by a licensed harvester (where licensing is
required by law) or by a certified dealer.
Hazard Analysis Worksheet at the appropriate
processing step(s).
potential hazard is significant at the receiving step
and you should answer Yes in Column 3 of the
Hazard Analysis Worksheet. If neither criterion is
met you should answer No. You should record the
reason for your Yes or No answer in Column 4.
You need not complete Steps #12 through 18 for this
hazard for those processing steps where you have
recorded a No.
step will help you determine where in the process the
critical control point is located.
2. Can natural toxins which were introduced at unsafe

levels at an earlier step be eliminated or reduced to an
acceptable level here? (Note: If you are not certain of
the answer to this question at this time, you may

Step #12).

75
Continued
Intended use
In determining whether a hazard is significant you
which you developed in Step #4. However, in most
cases, it is not likely that the significance of this
hazard will be affected by the intended use of the
product. One exception is with products in which
only the muscle tissue will be consumed. For example, where the finished product is only the shucked
adductor muscle of the scallop, or the muscle tissue
of a crab or finfish, it is reasonable to assume that the
product as consumed will not contain natural toxins.
Similarly, in species, such as mackerel, in which the
viscera is not normally consumed, it is reasonable to
assume that the product as consumed will not contain
natural toxins. In either case you should then enter
No in Column 3 of the Hazard Analysis Worksheet
for each of the processing steps. For each No entry
briefly explain in Column 4 that the product is
consumed without the viscera. In this case, you need
not complete Steps #12 through 18 for this hazard.
For each processing step where natural toxins is
identified in Column 3 of the Hazard Analysis
Worksheet as a significant hazard, determine whether
it is necessary to exercise control at that step in order
to control the hazard. Figure #A-2 (Appendix 3) is a
CCP decision tree that can be used to aid you in your
determination.
The following guidance will also assist you in
determining whether a processing step is a CCP for
natural toxins:
1. Where preventive measures, such as those described
in Step #11 are available to you, the hazard of
natural toxins can best be controlled at the receiving
step.
In these cases, you should enter Yes in Column 6

of the Hazard Analysis Worksheet for the receiving
step. This control approach will be referred to as
Control Strategy Example 1 in Steps #14 through
18. Note that this control strategy is identical to

Control Strategy Example 1 for pathogens from the
harvest area (Chapter 4) and Control Strategy
Example 6 for environmental chemical contaminants
and pesticides (Chapter 9). If you choose an identical control strategy for two or more of these hazards,
you may combine the hazards in the HACCP Plan
Form.
It is important to note that you may select a control
strategy that is different from that which is suggested
above, provided that it assures an equivalent degree of
safety of the product.
HACCP Plan Form
identified as a significant hazard on the HACCP Plan
Form identify the maximum or minimum value to
which a feature of the process must be controlled in
order to control the hazard.
safety of the product will be questionable. If you set a
more restrictive CL you could, as a result, be required
to take corrective action when no safety concern
actually exists. On the other hand, if you set a CL that
is too loose you could, as a result, allow unsafe
product to reach the consumer.
operating limit that is more restrictive than the CL. In
this way you can adjust the process when the operating limit is triggered, but before a triggering of the CL
would require you to take corrective action. You
should set operating limits based on your experience
with the variability of your operation and with the
closeness of typical operating values to the CL.
control strategy example discussed in Step #12.

76
CONTROL STRATEGY EXAMPLE 1 SOURCE CONTROL

Critical Limit: No fish may be harvested from:
An area that is closed to fishing by foreign,

federal, state, or local authorities;
OR
An area that is the subject of a CFP advisory;
OR
An area for which you have knowledge that
there is a CFP problem;
AND
All shellstock (in-shell molluscan shellfish) must
bear a tag that discloses the date and place they
were harvested (by State and site), type and
quantity of shellfish, and by whom they were
harvested (i.e., the identification number
assigned to the harvester by the shellfish control
authority, where applicable or, if such
identification numbers are not assigned, the name
of the harvester or the name or registration
number of the harvesters vessel). For bulk
shipments of shellstock (loose shellstock), the
shellstock must be accompanied by a bill of
lading or other similar shipping document that
contains the same information.
AND
All molluscan shellfish must have been harvested
from waters authorized for harvesting by a
shellfish control authority. For U.S. Federal
waters, no molluscan shellfish may be harvested
from waters that are closed to harvesting by an
agency of the federal government.
AND
All containers of shucked molluscan shellfish
must bear a label that identifies the name,
address, and certification number of the packer
or repacker of the product.
AND
All molluscan shellfish must be from a harvester
that is licensed as required (note that licensing
may not be required in all jurisdictions) or from a
processor that is certified by a shellfish control
authority.
(Note: only the primary processor [the processor

that takes possession of the molluscan shellfish
from the harvester] need apply controls relative
to the identification of the harvester, the
harvesters license, or the approval status of the
harvest waters.)
Plan Form.
PROCEDURES.
procedures for the control strategy example discussed in Step #12. Note that the monitoring frequencies that are provided are intended to be considered as minimum recommendations, and may not be
adequate in all cases.

77
Continued

(Frequency)?

For molluscan shellfish:

For Molluscan Shellfish:
What:
The tags on containers of shellstock. The Bill

of Lading or other similar shipping document
accompanying bulk shipments of shellstock;
AND
The harvest site listed on the tag or on the Bill
of Lading or other similar shipping document;
AND
The labels on containers of shucked molluscan
shellfish;
AND
The license of fishermen, where applicable;
AND
The certification number of suppliers (other
than fishermen) of shellstock or shucked
molluscan shellfish;
Frequency:
For checking tags: every container;

AND
For checking harvest site: every lot;
AND
For checking labels: at least three containers
randomly selected from throughout every lot;
AND
For checking licenses: every delivery;
AND
For checking certification numbers: every
delivery.
For other fish:
Frequency: Every lot of fish received.
For other fish:

What: The harvest area location.
Who: Monitoring may be performed by a receiving
or production employee or supervisor, a member

of the quality control staff, or any other person
who has an understanding of the nature of the
controls.

How: Make visual checks;
For other fish:

How: Ask the harvester for the harvest site at the time
of receipt, or obtain the information from the

harvesters catch record, where applicable.

that takes possession of the molluscan shellfish
from the harvester] need apply controls relative
to the identification of the harvester, the
harvesters license, or the approval status of the
harvest waters.)
Enter the What, How, Frequency, and Who
monitoring information in Columns 4, 5, 6, and 7,
respectively, of the HACCP Plan Form.

78

ACTION PROCEDURES.
your monitoring indicates that the CL has not been met.
action procedures for the control strategy example
Note: If an incoming lot that fails to meet a receiving

critical limit is mistakenly accepted, and the error is
later detected, the following actions should be taken:
1) the lot and any products processed from that lot
should be destroyed, diverted to a nonfood use or to a
use in which the critical limit is not applicable, or
placed on hold until a food safety evaluation can be
completed; and 2) any products processed from that
lot that have already been distributed should be
recalled and subjected to the actions described above.
that takes possession of the molluscan shellfish from
the harvester] need apply controls relative to the
identification of the harvester, the harvesters license,
or the approval status of the harvest waters.)
For other fish that fail to meet the CL:
Corrective Action: Reject the lot;
AND
Discontinue use of supplier until evidence is
obtained that harvesting practices have
changed.

Corrective Action:
Reject shellstock that is not properly tagged or

is not accompanied by a proper shipping
document;
AND
Reject shucked molluscan shellfish that is not
properly labeled;
AND
Reject molluscan shellfish that has been
harvested from unapproved waters;
AND
Reject molluscan shellfish that is not from a
licensed harvester or certified processor;
AND
obtained that harvesting, tagging, and/or
labeling practices have changed.
Enter the corrective action procedures in Column 8 of

SYSTEM.
the accomplishment of the monitoring procedures
discussed in Step #15. The records should clearly
demonstrate that the monitoring procedures have
been followed, and should contain the actual values
and observations obtained during monitoring.
Following is guidance on establishing a
recordkeeping system for the control strategy example discussed in Step #12.

79
CONTROL STRATEGY EXAMPLE 1 SOURCE CONTROLS

PROCEDURES.
For molluscan shellfish shellstock:
For each processing step where natural toxins are

address the hazard of natural toxins; and, 2)
consistently being followed.
Records: A receiving record that documents:
Date of harvest;
AND
Location of harvest by State and site;
AND
Quantity and type of shellfish;
AND
Name of the harvester, name or registration
number of the harvesters vessel, or an
identification number issued to the harvester
by the shellfish control authority;
AND
Number and date of expiration of the
harvesters license, where applicable;
AND
Certification number of the shipper, where
applicable.

in Step #12.
Verification: Review monitoring and corrective
action records within one week of preparation.

HACCP Plan Form.

that takes possession of the molluscan shellfish from
the harvester] need apply controls relative to the
identification of the harvester, the harvesters license,
or the approval status of the harvest waters.)
For shucked molluscan shellfish:
Records: Receiving record that documents:
Date of receipt;
AND
Quantity and type of shellfish;
AND
Name and certification number of the packer or
repacker.
For other fish:
Records: Receiving record that documents the harvest
area.
Enter the names of the HACCP records in Column 9
of the HACCP Plan Form.

80

81
Receiving fresh fish
(1)
Critical Control
Point (CCP)
Natural toxins - CFP
(2)
Significant
Hazard(s)
(6)
Every lot
Frequency
Monitoring
Ask fishermen
for the harvest
location
How
What
Identify harvest
area
(5)
(4)
Receiving
employee
Who
(7)
Reject lot
(8)
Corrective
Action(s)
Discontinue use
of supplier until
evidence is obtained
that harvesting
practices have
changed
Se
eT
ex
t f Exa
or mp
Fu le
ll R O
eco nly
mm
en
da
tio
ns
No fish may be harvested

from an area that is
covered by a State CFP
advisory, or for which
there is information from
fishermen, news media,
academia, or other
sources that there is a
current CFP problem.
(3)
Critical Limits
for each Preventive
Measure
Receiving record
(9)
Records
Review
monitoring
and corrective
action records
within one week
of preparation
(10)
Verification
This table is an example of a portion of a HACCP plan relating to the control of natural toxins for a fish processor
in Hawaii that receives locally harvested barracuda, using Control Strategy Example 1 - Source control.
It is provided for illustrative purposes only. Natural toxins may be only one of several significant hazards for this product.
Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3) for other potential hazards (e.g. chemical contaminants).
Table #4-1 (Chapter 4) provides guidance for source controls for molluscan shellfish.
Control Strategy Example 1 - Source control
TABLE #6-1
Notes:

82
Chap 7 - Principle 3: Establish Critical Limits

Notes:
Chapter 7: Principle 3: Establish Critical Limits
Overhead 1
Objective:
In this module, you will learn:
How to define critical limits.
How to set critical limits for a CCP.
How to find sources of critical limit information.
How to determine the relationship between critical limits
and operating limits.
Critical limits must be established for each CCP identified in the hazard
analysis.
Overhead 2
Principle 3:
Establish critical limits.
Overhead 3
Definition:
Critical Limit: A maximum and/or minimum value to which a
biological, chemical or physical parameter must be controlled at a
CCP to prevent, eliminate or reduce to an acceptable level the
occurrence of a food-safety hazard.
A critical limit represents the boundaries that are used to ensure that an
operation produces safe products. Each CCP must have one or more
critical limits for each food-safety hazard. When the process deviates
from the critical limit, a corrective action must be taken to ensure food
safety. Examples of critical limits are listed in Table 1.
Establishing Critical Limits
In many cases, the appropriate critical limit may not be readily apparent
or available. Tests may need to be conducted or information gathered
from sources such as scientific publications, regulatory guidelines, experts
or experimental studies (Table 2).
Continued
73
Overhead 4
Table 1. Examples of Critical Limits
Hazard
CCP
Critical Limit
bacterial pathogens
(biological)
pasteurizer
161 F for 15 seconds for elimination of pathogens from milk
bacterial pathogens
(biological)
drying oven
Drying schedule oven temperature: 200 F, drying time:

120 min., air flow rate: 2 cuft/min, product thickness: 0.5
inches (to achieve aw to 0.85 to control pathogens in dried foods)
bacterial pathogens
(biological)
acidification
Batch schedule product weight: 100 lbs., soak time: 8 hrs.,

acetic acid concentration: 3.5 percent, volume 50 gal. (to achieve
maximum pH of 4.6 to control Clostridium botulinum in pickled foods)
Overhead 5
Explanatory Note:
Table 2. Sources of Information on Critical Limits
These critical limits are for

illustrative purposes only. They
do not relate to any specific
product but demonstrate how
critical limits could apply at
CCPs utilizing different control
parameters for bacterial
pathogens. In actual practice,
critical limits must be scientifically based.
General Source
Examples
scientific publications
journal articles, food science texts,

microbiology texts
regulatory guidelines
state and local guidelines, tolerances and

action levels; USDA guidelines, tolerances and
action levels; FDA guidelines, tolerances and
action levels
FDA
FDA Fish and Fisheries Products Hazards and

Controls Guidance Manual (referenced in
Chapter 13)
experts
NACMCF (National Advisory Committee on

Microbiological Criteria for Foods), thermal
process authorities; consultants, food
scientists/microbiologists, equipment
manufacturers, sanitarians, university
extension, trade associations
experimental studies
in-house experiments; contract labs
If the information needed to define the critical limit is not available,

a conservative value should be selected. The rationale and reference
material used to establish a critical limit should become part of the
support documentation for the HACCP plan.
Often a variety of options exist for controlling a particular hazard. The
control options usually necessitate the establishment of different critical
74

Notes:
limits. The selection of the best control option and the best critical limit
is often driven by practicality and experience. The following examples
suggest control options and critical limits that could be applied at the
fryer step to control bacterial pathogens in fried fish patties.
Overhead 6
Option No. 1
Monitoring for Pathogens
Hazard presence of pathogens (microbiological)
CCP fryer
Critical limit no pathogens detected
(Not typically the best option)
Setting a microbial limit as a critical limit for an in-process CCP is rarely

practical. Microbiological limits are difficult to monitor, and testing to
determine critical limit deviations may require several days. Therefore,
microbiological limits cannot be monitored on a timely basis. Microbiological contamination is often sporadic, and samples may need to be large
to be meaningful. In this example, sampling and microbiological tests of
the fish patties are unlikely to be sensitive enough or practical.
Overhead 7
Option No. 2
Controlling Internal Temperature
CCP fryer
Critical limit minimum internal temperature of 150 F for one minute
Setting a microbial critical limit is not necessary in this example as long

as an appropriate critical limit can be set that is based on the conditions
needed to inactivate the microorganisms of concern. Pathogens of concern
in fish patties are destroyed by cooking the patties to an internal temperature of 150 F for one minute. In this option, the product temperature at the
end of frying is used as a critical limit. This option is typically more
practical and sensitive than finished-product pathogen testing.
Continued
75
Overhead 8
Notes:
Option No. 3
Controlling Factors that Affect Internal Temperature
CCP fryer
Critical limit minimum fryer oil temperature of 350 F
Critical limit maximum patty thickness of 1/4 inch
Critical limit minimum cook time in the oil of one minute
In many cases, it is not practical to continually monitor the internal

temperature of the food product to ensure conformance with a critical
limit. As an alternative, critical limits may be set that establish conditions
necessary to ensure that the cooking process achieves the necessary
minimum product temperature. In this option, the oil temperature, the fish
patty thickness and the time that the patty stays in the hot oil are all
factors that affect the final patty temperature. Tests must be performed to
ensure that controlling these factors within the critical limits will always
result in an internal product temperature that will inactivate the microorganisms of concern. Typically, this option is easier to control and to
monitor than the previous two. In addition, the cooker temperature and
cooking time can be monitored continually, which gives greater confidence that every item has been adequately cooked.
The process should be capable of operating within the bounds set by the
critical limit. The parameters for the fryer minimum fryer-oil temperature, maximum patty thickness and minimum cook time become the
critical limits for the CCP. The critical limits should not be confused with
the operating parameters of the equipment.
Establishing Operating Limits
Overhead 9
Definition:
Operating Limits: Criteria that are more stringent than critical limits
and that are used by an operator to reduce the risk of a deviation.
If monitoring shows a trend toward lack of control at a CCP, operators

should take action to bring the CCP under control before the critical limit
is exceeded. The point where operators take such an action is called the
operating limit. Operating limits should not be confused with critical
limits. Operating limits are established at a level that would be reached
before the critical limit is violated.
76

Notes:
Overhead 10
Definition:
Process Adjustment: An action taken by the firm to bring the process
back within operating limits.
The process should be adjusted when the operating limit is reached to

avoid violating critical limits. These actions are called process adjustments. A processor may use these adjustments to avoid loss of control and
the need to take corrective action. Spotting a trend toward loss of control
early and acting on it can save product rework, or worse yet, product
destruction. Corrective action is only required when the critical limit is
exceeded.
Operating limits may be selected for various reasons:
For quality reasons (e.g., higher cooking temperatures for flavor
development or to control organisms that can cause spoilage).
To avoid exceeding a critical limit (e.g., a cooking temperature higher
than the critical limit could be used as an alarm point to warn the
operator that the temperature is approaching the critical limit and
needs adjusting).
To account for normal variability (e.g., a fryer with a 5 F variability
should be set at least 5 F above the critical limit to avoid violating it).
Figures 1 and 2 are graphical representations of several important points:
1) operating limits and process adjustments, 2) critical limits and
corrective actions, and 3) implications of lot size. In this example of a
generalized cooking process, an operating limit is established at 200 F
and a critical limit at 190 F. Somewhere in the 10 F range between these
two points, wise processors will make a process adjustment to bring the
cook temperature back above 200 F. Because an adjustment is made
before the temperature drops below the critical limit of 190 F, no HACCP
record is required. However, if an adjustment is not taken until after the
temperature drops below the critical limit, as shown in Figures 1 and 2,
appropriate corrective actions must be taken and a corrective action report
must be placed in the HACCP records file (corrective actions and records
will be discussed in subsequent chapters).
When a corrective action is necessary, processors must be able to identify
and segregate the affected lots. If lot sizes are big, large quantities of
product may require segregation and corrective action despite the fact that
only a small amount of product was produced when critical limits were
exceeded. Coding production into smaller lots means far less product may
be involved when violation of a critical limit occurs. Therefore, wise
processors should change codes often during the production day and
match monitoring frequency with code changes.
77
Overhead 11
Notes:
Figure 1
205
Cooker Temperature
Operating
Limit
Process
Adjustment
Needed
195
Critical
Limit
190
Degrees F
200
185
Corrective Action
Required
LOT 1
180
Time
Figure 2
205
Cooker Temperature
Operating
Limit
Process
Adjustment
Needed
195
185
LOT 1
LOT 2
LOT 3
180
Time
78
Critical
Limit
190
Degrees F
200
Corrective Action
Required
LOT 4
LOT 5

Critical Limits for ABC Shrimp Co.
Notes:
The hazard-analysis worksheet for the IQF cooked-shrimp example

identifies two CCPs: cooker and weigh-pack-label. The following table
lists examples of critical limits for these CCPs.
Explanatory Note:
Overhead 12
For the purpose of this

example, we have assumed
that a study was performed to
determine the worst case
(e.g., largest shrimp, lowest
initial temperature). The
shrimp would be heated to an
internal temperature of 145 F
for 15 seconds by cooking
for at least three minutes at
212 F or greater. In practice,
processors may choose to
vary process times depending
on shrimp size. Therefore,
shrimp size grading would
likely become a CCP.
Table 4. Establishment of Critical Limits

Critical Control Point
Critical Limit
CCP Cooker
Cook at 212 F for three minutes

(to achieve minimum internal temperature of 145 F for 15 sec.)
CCP Weigh/Pack/Label
All product containing sulfiting agent

must declare presence
Overhead 13
HACCP Plan Form
Critical Limits:
Explanatory Note:
1.
2.
3.
CCP Hazard Critical

Limits
4.
5.
6.
7.
Monitoring
What How Frequency Who
8.
9.
10.
Since residuals of sulfiting

agents may trigger allergictype reactions, labeling is
required on product with
detectable residues. Detection
levels range above 10ppm.
Corrective Verification Records

Action(s)
The CCP, hazards and critical limits should be recorded in columns 1, 2 and 3
on the HACCP plan form.
79
80
Date:
Signature:
Firm Address: Anywhere, USA
All product
containing residual
sulfiting agent must
declare presence
Cook at 212 F for

three minutes (to
achieve minimum
internal temperature
of 145 F for 15
seconds)
(3)
Critical Limits
for each Control
Measure
How
What
(6)
Frequency
Monitoring
Who
(7)
(8)
Corrective
Action(s)
Intended Use and Consumer: Thaw and serve, general public
Method of Storage and Distribution: Frozen
Product Description: Cooked and frozen, headless, peeled and deveined shrimp
(5)
(4)
Allergic-type reaction
for undeclared
sulfiting agent
Weigh/Pack/
Label
Firm Name: ABC Shrimp Co.
Survival of bacterial
pathogens
(2)
Significant Hazards
Cooker
(1)
Critical Control
Point (CCP)
ABC Shrimp Co.

Cooked Shrimp
EXAMPLE: For Illustrative Purposes Only* - HACCP Plan Form
(9)
Verification
(10)
Records
Chap 9 - Principle 5: Corrective Actions
Chapter 9: Principle 5: Corrective Actions
Overhead 1
Explanatory Note:
Corrective actions are
implemented when
monitoring results indicate
a deviation from critical
limits. Effective corrective
actions depend heavily on
an adequate monitoring
program.
Objective:
The definition of corrective actions,
Procedures for corrective action and
Record-keeping requirements for corrective actions.
Overhead 2
Principle 5:
Establish corrective actions.
Corrective actions must be taken when critical limits at a CCP have been
compromised. When possible, these actions should be predetermined
when developing the HACCP plan.
Overhead 3
Definition:
Corrective Action: Procedures to be followed when a deviation occurs.
When critical limits are violated at a CCP, the predetermined, documented

corrective actions should be instituted. These corrective actions should
state procedures to restore process control and determine the safe
disposition of the affected product. It may be possible, and is always
desirable, to correct the problem on the spot.
Corrective action options include:
isolating and holding product for safety evaluation.
diverting the affected product or ingredients to another line where
deviation would not be considered critical.
reprocessing.
destroying product.
Continued
91

Notes:
The primary objective is to establish a HACCP program that permits rapid

identification of deviations from a critical limit. The sooner the deviation
is identified, the more easily corrective actions can be taken and the
greater the potential for minimizing the amount of noncompliant product.
An individual who has a thorough understanding of the process, product
and HACCP plan and who has the authority to make decisions needs to be
assigned the responsibility of making corrective actions.
Effective corrective action plans must:
Correct and eliminate the cause of the noncompliance to assure that the
CCP is brought back under control.
Segregate, assess and determine the disposition of the noncompliant
product.
All corrective actions taken must be documented. Documentation will
assist the firm in identifying recurring problems so that the HACCP plan
can be modified. Additionally, corrective action records provide proof of
product disposition.
Components of Corrective Actions
There are two components of corrective actions: 1) to correct and

eliminate the cause of the deviation and restore process control and
2) to identify the product that was produced during the process deviation
and determine its disposition.
Overhead 4
Corrective Action Components:
To correct and eliminate the cause of the deviation and restore
process control.
To identify the product that was produced during the process
deviation and determine its disposition.
Correct and Eliminate the Cause of the Deviation and Restore

Process Control
Corrective actions must bring the CCP back under control. A corrective
action should take care of the immediate (short-term) problem as well as
provide long-term solutions. The objective is to implement a short-term
fix so that control can be re-established and the process started again as
soon as possible without further process deviation.
92

Notes:
It may be necessary to determine the cause of the deviation to prevent

future recurrence. A critical limit failure that was not anticipated or
reoccurs should result in an adjustment to the product or process or a
re-evaluation of the HACCP plan.
One outcome of the re-evaluation may be a decision to modify the
HACCP plan. A permanent solution to eliminating or minimizing the
initial cause or causes for the process deviation should be implemented if
necessary. Specific instructions for corrective actions must be available to
plant workers and should be part of the documented HACCP plan.
Explanatory Note:
Identify the Product that was Produced During the Process Deviation
and Determine the Disposition
If a product is to be tested
and released, the sampling
method is highly important.
The use of a faulty sampling
protocol can result in
accepting, rather than
rejecting, an undesirable
product. The limits of
sampling plans must be
understood. It may be
prudent to consult an expert.
When a deviation occurs, identify nonconforming product. There are four

steps that may be used for determining product disposition and developing a corrective action plan.
Overhead 5
Four Steps:
A. Step One: Determine if the product presents a safety hazard:
a. Based on expert evaluation.
b. Based on physical, chemical or microbiological testing.
B. Step Two: If no hazard exists based on the evaluations in
Step 1, the product may be released.
C. Step Three: If a potential hazard exists (based on the
evaluations in Step 1), determine if the product can be:
a. Reworked/reprocessed.
b. Diverted for a safe use.
D. Step Four: If potentially hazardous product cannot be handled
as described in Step 3, the product must be destroyed. This is
usually the most expensive option and is usually regarded as
the last resort.
Explanatory Note:
It is important to ensure that
any reworking does not result
in the creation of a new
hazard. Of primary concern
are toxic materials, including
heat-stable biological toxins.
It must be realized that
reworked product is still
subject to regulatory scrutiny
and that reworking must
result in a safe product.
Continued
93

Notes:
Corrective Action Format Examples
Corrective actions are usually written in an if/then format. The if

part of the corrective action describes the condition and the then part
describes the action taken. For example:
Overhead 6
IF deviation:
Temperature of milk at pasteurizer

drops below critical limit.
THEN corrective action:
Milk flow is diverted until temperature

recovers. Diverted product is
repasteurized. Check the operation of
the heating/cooling units to determine
the reason for the temperature
deviation that caused the flow
diversion. Repair if necessary,
re-establish control and resume
production.
Overhead 7
Explanatory Note:
During the process, it is
possible to extend the cook
time until the desired internal
temperature is reached for
the required time. However,
this would be a process
adjustment rather than a
corrective action.
IF deviation:
Product (e.g., hot smoked fish)

does not reach required internal
temperature for the required time.
Recook or destroy product.
Overhead 8
94
IF deviation:
Mahi-mahi held at elevated

temperature for excess time period
(temperature limit exceeded, possible
elevated histamine level).
Bury product in ice, place on hold

and conduct sensory analysis and
histamine test. Determine the reason
for the process delay. Prevent future
occurrences.

Corrective Action Records
Explanatory Note:
Predetermined corrective actions are written into the HACCP plan. When
critical limits are exceeded and a corrective action occurs, it is recorded.
A corrective-action report form is helpful.
The corrective action

recording should be closely
linked with the corresponding
monitoring that recorded a
deviation. Recommended
approaches include recording
the monitoring and corrective
actions on the same form,
piece of paper, or electronic
record.
The corrective-action report should contain the following:

a. Product identification (e.g., product description, amount of product
on hold).
b. Description of the deviation.
c. Corrective action taken including final disposition of the affected
product.
d. Name of the individual responsible for taking the corrective action.
e. Results of the evaluation when necessary.
HACCP plan records could contain a separate file in which all deviations
and corresponding corrective actions are maintained in an organized
fashion. Corrective actions are recorded in column 8 of the HACCP
plan form. Following is the corrective actions for the IQF cooked-shrimp
example.
Overhead 9
HACCP Plan Form
Corrective Actions:
1.
2.
3.
CCP Hazard Critical

Limits
4.
5.
6.
7.
Monitoring
8.
9.
10.

Action(s)
Specify the corrective-action procedures for each CCP.
Continued
95
96
Date:
Signature:
Cook at 212 F for

three minutes (to
achieve minimum
of 145 F for 15
seconds)
(3)
Critical Limits
for each Control
Measure
Monitor cook
time by
timing the
movement of
a block placed
on belt through
cooker.
Cook time
Cook time
monitored
hourly.
Temperature
monitored
continuously
with hourly
visual checks.
Frequency
(6)
Cook will
perform the
hourly checks.
Quality-control
supervisor will
program the
continuousrecording
thermometer.
Who
(7)
If temperature or
time parameters
are not met, then
processing line
will be stopped
and required
adjustments
made. All product
produced during
the deviation
will be recooked
or destroyed.
(8)
Corrective
Action(s)
Intended Use and Consumer: Thaw and serve, general public
Monitor temperature with

a continuous
temperature
recorder
How
What
Monitoring
Cook
temperature
(5)
(4)
pathogens
(2)
Significant Hazards
Cooker
(1)
Critical Control
Point (CCP)
ABC Shrimp Co.

Cooked Shrimp
(9)
Verification
(10)
Records
from undeclared
sulfiting agent
Weigh/Pack
Label
All product containing
residual sulfiting agent
must declare
presence
(3)
Critical Limits
for each Control
Measures
Examine all
labels issued
at packing line
and match
declaration
with product
identity.
Rapid sulfite
test
Observation
of supplier
declaration
At receiving,
sample each
vessel of fresh
shrimp to test
for presence
of sulfites.
At receiving,
supplier
declaration for
absence of
sulfites for
frozen shrimp.
How
What
(6)
Frozen shrimp,
check every
shipment
Fresh shrimp,
three-grab
samples per
vessel
One label each

time a label
roll is replaced
Frequency
Monitoring
At weigh/pack/
label stage,
check for "contains sulfite"
declaration.
(5)
(4)
Dock master
Dock master
Packing
supervisor
Who
(7)
If this product is
mislabeled, then
appropriately
label.
(8)
Corrective
Action(s)
(9)
Verification
97
Note: In this example, results from product screening at the receiving step are a portion of the monitoring necessary to assure compliance with weigh/pack/label critical limits.
(2)
Significant Hazards
(1)
Critical Control
Point (CCP)
ABC Shrimp Co.

Cooked Shrimp
(10)
Records

Notes:
98
Chapter 10: Methyl Mercury (A Chemical Hazard)
The draft Fish and Fishery Products Hazards and

Controls Guide (February 16, 1994) listed methyl
mercury as a potential safety hazard for bonito,
halibut, Spanish mackerel, king mackerel, marlin,
shark, swordfish, and bluefin tuna. The selection of
these species was based on historical data on levels
of methyl mercury found in fish consumed in the
U.S. The selection was also based on an FDA action
level of 1.0 ppm in the edible portion of fish.
While FDA has not changed the 1.0 ppm action level,
the agency is re-evaluating it in light of significant
new data on the health effects of methyl mercury
from consumption of fish. These data have become
available since the action level was developed.
When the action level re-evaluation is completed,
FDA will, among other things, update this Guide by
including advice on how to assess the significance of
a potential methyl mercury hazard in fish, and what
controls, if any, are necessary to ensure the safety of
fish in this regard.
Chapter 10: Mercury

125
Notes:
Chapter 10: Mercury

126
Chap 10 - Principle 6: Verification Procedures
Chapter 10: Principle 6: Verification Procedures
Overhead 1
Explanatory Note:
Routine monitoring activities
for critical limits should not
be confused with verification
methods, procedures or
activities. This could be a
point of confusion, and the
instructor should keep this in
mind while addressing this
chapter.
Objective:
How to define verification.
What functions are part of HACCP plan verification.
What functions are part of validation.
Overhead 2
Principle 6:
Establish verification procedures.
Overhead 3
Definition:
Verification: Those activities, other than monitoring, that determine
the validity of the HACCP plan and that verify the system is
operating according to the plan.
Verification
One of the more complex HACCP principles is verification. Although it is

complex, the proper development and implementation of the verification
principle is fundamental to the successful execution of the HACCP plan.
HACCP has spawned the use of a new adage trust what you verify,
which speaks to the heart of the verification principle. The purpose of the
HACCP plan is to prevent food-safety hazards, and the purpose of
verification is to provide a level of confidence that the plan is based on
solid scientific principles, is adequate to control the hazards associated
with the product and process, and is being followed.
Continued
99
Overhead 4
Notes:
Trust What You Verify

Verification provides a level of confidence that the HACCP plan is
based on solid scientific principles, is adequate to control the
hazards associated with the product and process, and is being
followed.
Perhaps one of the reasons verification has been difficult to understand is

because there are several elements associated with this principle, including validation and reviews. Confusion also arises because the HACCP
plan must include verification procedures for individual CCPs and for the
overall plan. To facilitate understanding, each of these elements will be
discussed.
Overhead 5
Elements of Verification:
Validation
CCP verification activities
Calibration of monitoring devices
Calibration record review
Targeted sampling and testing
CCP record review
HACCP system verification
Observations and reviews
Microbiological end-product testing
Regulatory agencies
Validation
Overhead 6
Definition:
Validation: The element of verification focused on collecting and
evaluating scientific and technical information to determine if the
HACCP plan, when properly implemented, will effectively control the
hazards.
Validation is an essential component of verification and requires substantiation that the HACCP plan, if implemented effectively, is sufficient to
control the food-safety hazards that are likely to occur. Validation of the
plan occurs before the plan is actually implemented. The purpose of
100

Notes:
validation is to provide objective evidence that all essential elements of

the plan have a scientific basis and represent a valid approach to
controlling the food-safety hazards associated with the specific product
and process. There are several approaches to validating the HACCP plan,
among them are: incorporation of fundamental scientific principles, use of
scientific data, reliance on expert opinion or conducting in-plant observations or tests.
Overhead 7
Validation of the HACCP plan, who does it?
HACCP team
Individual qualified by training or experience
What does validation involve?
A scientific and technical review of the rationale behind each part
of the HACCP plan from hazard analysis through each CCP
verification strategy.
Validation can be performed by the HACCP team or by an individual

qualified by training or experience. Validation activities may be similar in
scope and time commitment to the original HACCP plan development. An
in-plant validation should be performed initially before actual reliance on
the HACCP plan and when factors warrant. These factors could include:
changes to the raw materials, product or process; adverse review findings;
recurring deviations; new scientific information about potential hazards or
control measures; on-line observations; or new distribution or consumerhandling practices. Validation involves a scientific and technical review of
the rationale behind each part of the HACCP plan from hazard analysis
through each CCP verification strategy.
Overhead 8
Validation Frequency:
Initially
When factors warrant. The following may warrant validation of
the plan:
changes in raw materials,
changes in product or process,
adverse review findings,
recurring deviations,
new information on hazards or control measures,
on-line observations, and
new distribution or consumer handling practices.
Continued
101

Notes:
Examples of Validation Activities:

1. One approach to controlling vegetative pathogens as a hazard in
cooked hamburgers is to ensure that the hamburgers are cooked to

an internal temperature that destroys pathogens. In the HACCP
plan, parameters for maximum patty thickness, maximum belt
speed and minimum oven temperature could be the critical limits to
ensure that an adequate temperature is reached at the cook step.
These criteria would be established after collecting enough data online to ensure that controlling those points would also control the
minimum internal temperature of every hamburger patty as it is
cooked.
2. An internal temperature of 145 F was determined as critical to
destroy pathogens in cooked shrimp. The firm uses a process of
212 F for three minutes to provide an internal temperature of at
least 145 F. The ability of the process time and temperature to
achieve the internal temperature of the cooked shrimp should be
validated by measuring the center temperature of a representative
number of cooked shrimp. The cooking equipment should also be
validated using temperature distribution tests to determine that
adequate temperatures are delivered throughout the cooker during
processing.
Verification of CCPs
Overhead 9
CCP Verification Activities:
Calibration
Calibration record review
Targeted sampling and testing
CCP record review
Verification activities developed for CCPs are essential to ensure that the
control procedures used are properly functioning and that they are operating and calibrated within appropriate ranges for food-safety control.
Additionally, CCP verification includes supervisory review of CCP
calibration, monitoring and corrective action records to confirm compliance with the HACCP plan. CCP verification may also include targeted
sampling and testing.
Calibration
Verification activities at CCPs include calibration of monitoring devices
to assure the accuracy of the measurements taken. Calibration is conducted to verify that monitoring results are accurate.
102
Calibration of CCP monitoring equipment is fundamental to the successful implementation and operation of the HACCP plan. If the equipment is
out of calibration, then monitoring results will be unreliable. If this
happens, the CCP should be considered out of control since the last
documented acceptable calibration. This situation should be given ample
consideration when establishing the frequency of calibration. Frequency
of calibration should also be influenced by equipment sensitivity.
Overhead 10
Calibrations are performed:
On equipment and instruments used in monitoring or verification.
At a frequency to ensure accuracy of measurements.
By checking accuracy against a recognized standard at or near
the condition that the instrument or equipment will be used.
Examples of calibration activities:

1. A thermometer used to monitor temperature at a cook CCP
may be checked for accuracy by comparing it against a certified

thermometer in a hot-water bath.
2. The continuous temperature chart recorder on a pasteurizer may
be compared during each batch against a certified accurate
thermometer.
3. A pH meter is calibrated against pH buffer standards of 7.0 and 4.0
when it is used to test products with a final pH of 3.8 to 4.2.
Calibration Record Review

Reviewing the equipment calibration records involves checking the dates
and methods of calibration and the test results (e.g., equipment passing or
failing). Calibration records are kept and reviewed. This review may be
conducted as part of an audit (audits are discussed later in this chapter).
Example of calibration record review:
1. A review of the thermometer records indicates that the
thermometer was checked for accuracy against a certified

thermometer at a frequency specified in the HACCP plan. The
records also indicate that the thermometer performed within
established limits and did not need adjustment. This review
disclosed no problems in the MIG calibrations.
Targeted Sampling and Testing

Verification may also include targeted sampling, testing and other periodic activities. Vendor compliance may be checked by targeted sampling
when receipt of material is a CCP and purchase specifications are relied
Continued
103

Notes:
on as critical limits. Typically, when a monitoring procedure is not as

stringent as desired, it should be coupled with a strong verification
strategy.
Examples of targeted sampling and testing:
1. In the cooked-shrimp example, the firm may purchase frozen
shrimp under a suppliers guarantee for a sulfite-free product. A

quarterly sample is collected for laboratory analysis to verify that
the product being tested is sulfite-free.
2. In the cooked-shrimp example, verification of sulfite residual
control at receiving of fresh shrimp may involve quarterly analysis
of samples to ensure that the results obtained through the original
monitoring procedure are accurate. Records should indicate any
deviations.
3. Egg white is used as an ingredient in meringue-pie topping.
Historically, egg whites have been associated with a risk of
Salmonella. Since the meringue is not cooked or otherwise treated
to kill Salmonella, the preventive measure could be to ensure that
all egg whites received are Salmonella-free. The CCP would be
egg-white receiving, and the critical limit would be every lot has a
guarantee ensuring it is pasteurized and Salmonella-free. The
adequacy of the suppliers certificate could be periodically verified
by collecting samples from a lot and testing for Salmonella.
When critical limits are set for equipment operation, product samples may
be taken to ensure that the equipment settings are appropriate for product
safety. For example, the firm processing cooked shrimp may collect inline samples of selected product after cooking to measure internal temperature.
CCP Record Review

At least two types of records are generated at each CCP: monitoring and
corrective action. These records are valuable management tools, providing documentation that CCPs are operating within established safety
parameters and that deviations are handled in a safe and appropriate
manner. However, records alone are meaningless unless someone in a
supervisory capacity reviews them on a periodic basis to verify that the
HACCP plan is being followed. Current seafood HACCP regulations
mandate a second review of monitoring records within one week after the
initial records were taken.
HACCP System Verification
In addition to the verification activities for CCPs, strategies should be

developed for scheduled verification of the complete HACCP system. The
frequency of the system-wide verification should be yearly (at a mini-
104

Explanatory Note:
mum) or whenever there is a system failure or a significant change in the

product or process. The HACCP team is responsible for ensuring that this
verification function is performed. Often, the HACCP team will contract
an independent third party to conduct the system-wide verification
activities.
The frequency of verification

activities will likely change
over time. A history of review
findings that indicate that the
processes are consistently in
control may justify safely
reducing the frequency. On
the other hand, adverse
findings, such as inconsistent
monitoring activities, inconsistent record keeping and
improper corrective actions
warrant correcting the
problems and more frequent
verification reviews. Adverse
findings may indicate a need
for subsequent validation of
the HACCP plan. FDAs
seafood HACCP regulation
requires reassessment of
the HACCP plan on an
annual basis. This is a
process that includes a
technical review of the
hazard analysis and each
element of the HACCP plan
as well as on-site review of
all flow diagrams and
appropriate records from the
operation of the plan. The
purpose of the reassessment
is to ensure that the HACCP
plan accurately identifies and
controls relevant hazards.
Overhead 11
HACCP System Verification Frequency:
Annually
Occurrence of a system failure or significant change in product
or process
System Verification Activities

Systematic verification activities include on-site observations and record
reviews. Reviews are usually performed by an unbiased person who is not
responsible for performing the monitoring activities.
System verification should occur at a frequency that ensures the HACCP
plan is being followed continuously. This frequency depends on a number
of conditions, such as the variability of the process and product.
Overhead 12
Verification Activities of the HACCP System:
Check the accuracy of the product description and flow chart.
Check that CCPs are monitored as required by the HACCP plan.
Check that processes are operating within established critical limits.
Check that records are completed accurately and at the time
intervals required.
Overhead 13
Record Review:
Monitoring activities have been performed at the locations
specified in the HACCP plan.
Monitoring activities have been performed at the frequencies
specified in the HACCP plan.
Corrective actions have been performed whenever monitoring
indicated deviation from critical limits.
Equipment has been calibrated at the frequencies specified in the
HACCP plan.
Continued
105

Notes:
End-Product Microbiological Testing in HACCP Verification

As explained in Chapter 2, microbiological testing is ineffective for
routine monitoring but can be used as a verification tool. Microbiological
testing can be used to determine (e.g., during verification audits or on
periodic basis that the overall operation is under control.
Example of microbiological testing:
1. Several years ago, NACMCF recommended a microbiological
criteria for Staphylococcus aureus in cooked, ready-to-eat

crabmeat. The recommended criteria for plants operating under a
HACCP plan and following GMPs are as follows: for every five
sample units (n=5), no more than two units (c = 2) can exceed 100
organisms per gram (m = 100/g), and no unit can exceed 1,000
organisms per gram (M = 1,000/g). Obviously, analysis for this
organism would not be useful for routine CCP monitoring.
However, it may be useful for periodically verifying the
effectiveness of the HACCP system.
Company Verification Schedule

Table 1 is an example of company-established HACCP verification
schedule.
Table 1 and Overhead 14
Example of a Company-Established
HACCP Verification Schedule
106
Activity
Frequency
Initial validation of HACCP plan
Prior to and during initial

implementation of plan
Subsequent validation
of HACCP plan
When critical limits changed,

significant changes in process
occurred, equipment failed,
system failed, etc.
Verification of CCP monitoring

as described in the plan
(e.g., monitoring of shrimp
cook time and temperature)
According to HACCP plan

(e.g., daily record review)
Review of monitoring and

corrective action records to
show compliance with the plan
Weekly
Reassessment of HACCP plan
Yearly

Notes:
The Role of Regulatory Agencies

in HACCP Plan Verification
The major role of regulatory agencies in a HACCP system is to verify that

HACCP plans are effective and are being followed. Verification normally
will occur at the inspected facility; however, some aspects of verification
may be conducted at other appropriate locations.
HACCP plans are unique documents prepared by a processor to ensure
the control of a specific process or procedure. The plans may contain
proprietary information and must be appropriately protected by the
regulatory agency. Agency personnel must have access to records that
pertain to CCPs, deviations, corrective actions and other information
pertinent to the HACCP plan that may be required for verification.
Overhead 15
Verification procedures by an agency include:
Review of the HACCP plan and any modification.
Review of CCP monitoring records.
Review of corrective action records.
Review of the verification records.
Visual inspections of operations to determine if the HACCP plan
is followed and records are properly maintained.
Random sample collection and analysis.
107
108
Date:
Signature:
Cook at 212 F for

15 minutes (to
achieve minimum
of 145 F for 15
seconds)
(3)
Critical Limits
for each Control
Measure

a continuous
temperature
recorder
Monitor cook
time by timing
the movement of
a block placed
on belt through
cooker.
Cook time
How
What
(6)
Cook time
monitored
hourly.
Temperature
monitored
continuously
with hourly
visual checks.
Frequency
Monitoring
Cook
temperature
(5)
(4)
Cook will
perform the
hourly checks.
Quality-control
supervisor will
program the
continuousrecording
thermometer.
Who
(7)
If temperature or
time parameters
are not met, then
processing line
will be stopped
and required
adjustments
made. All product
produced during
the deviation
will be recooked
or destroyed.
(8)
Corrective
Action(s)
Cooking equipment
validation study
(on file)
Process validation study

of time and temperature
of cook and its effect on
the final internal temperature of various sizes of
shrimp and initial temperature (on file)
Semi-annual finishedproduct microbial testing
Quarterly calibration of
thermometer
Daily record review
(9)
Verification
Intended Use and Consumer: Thaw and serve
pathogens
(2)
Significant Hazards
Cooker
(1)
Critical Control
Point (CCP)
ABC Shrimp Co.

Cooked Shrimp
EXAMPLE: For Illustrative Purposes Only - HACCP Plan Form
(10)
Records
from undeclared
sulfiting agent
Weigh/Pack
Label
must declare
presence
(3)
Critical Limits
for each Control
Measure
Examine all
labels issued
at packing line
and match
declaration
with product
identity.
Rapid sulfite
test
Observation
of supplier
declaration
At receiving,
sample each
vessel of fresh
shrimp to test
for presence
of sulfites.
At receiving,
supplier
declaration for
absence of
sulfites for
frozen shrimp.
How
What
(6)
Frozen shrimp,
check every
shipment
Fresh shrimp,
three-grab
samples per
vessel
One label each

time a label
roll is replaced
Frequency
Monitoring
At weigh/pack/
label stage,
declaration.
(5)
(4)
Dock master
Dock master
Packing
supervisor
Who
(7)
If this product is
mislabeled, then
appropriately
label.
(8)
Corrective
Action(s)
Quarterly lab report

for sulfite (frozen shrimp)
Daily record review

for sulfite (fresh shrimp)
Daily record review
Daily record review
(9)
Verification
109
(2)
Significant Hazards
(1)
Critical Control
Point (CCP)
ABC Shrimp Co.

Cooked Shrimp
(10)
Records

Notes:
110
Chapter 11: Aquaculture Drugs (A Chemical Hazard)
STEP #11: DETERMINE IF THIS


HAZARD.
Unregulated/unapproved drugs administered to
aquacultured fish pose a potential human health
hazard. These substances may be carcinogenic,
allergenic, and/or may cause antibiotic resistance in
man. To control this hazard in food animals, all
drugs, whether for direct medication or for addition
to feed, must be approved by FDA. Under certain
conditions authorized by FDA, unapproved new
animal drugs may be used in conformance with the
terms of an Investigational New Animal Drug
(INAD) application.
Incentives for the use of animal drugs in aquatic
animal species include the need to: 1) treat and
prevent disease; 2) control parasites; 3) affect reproduction and growth; and, 4) tranquilization (e.g.
during transit). Relatively few drugs have been
approved for aquaculture. As a result, aquaculture
growers may use unapproved drugs, general purpose
chemicals that are not labeled for drug use, and
approved drugs in a manner that deviates from the
labeled instructions.
When a drug is approved by FDAs Center for
Veterinary Medicine, the conditions of the approval
are listed on its label. These conditions include: the
species for which the drug is approved; the approved
dosage; the approved route of administration; the
approved frequency of use; and the approved indications for use. Only a licensed veterinarian may
legally prescribe or use a drug under conditions that
are not listed on the label. This restriction is more
fully explained in 21 CFR 530.
Labels of approved drugs list mandatory withdrawal
times, where applicable. These withdrawal times
must be observed to ensure that the edible tissue is
safe when it is offered for sale. Tissue residue
tolerances have been established for some drugs.
At each processing step, determine whether aquaculture drugs is a significant hazard. The criteria are:
1. Is it reasonably likely that unsafe levels of aquaculture drugs will be introduced at this processing step
(e.g. do raw materials come in with unsafe levels of
aquaculture drugs, or are they used at this step)?
Under ordinary circumstances, it would be reasonably likely to expect that unsafe levels of aquaculture
drugs could enter the process during the receiving of
any type of aquacultured fish, including:
Fin fish;
Crustaceans;
Aquatic animals, such as alligator.
Under ordinary circumstances it would also be
reasonably likely to expect that unsafe levels of
aquaculture drugs could enter the process during the
holding of live lobster (e.g. lobster pounds).
Under ordinary circumstances it would not be
reasonably likely to expect that aquaculture drugs
could enter the process during the receiving of wildcaught fish. Currently, FDA is not aware of drug use
in the grow-out of molluscan shellfish. If the agency
becomes aware of such use, this Guide, and, in
particular, Table #3-2 (Chapter 3) will be updated
accordingly. On a regional basis, it may be reasonable for you to conclude that aquaculture drug use is
not a significant hazard for other species, because
they are not used by producers in your region.
2. Can the presence of unsafe levels of aquaculture
drugs, which are reasonably likely to occur, be eliminated or reduced to an acceptable level here? (Note:
If you are not certain of the answer to this question at

this time, you may answer No. However, you may
need to change this answer when you assign critical
control points in Step #12)
Chapter 11: Drugs

127
Continued
Aquaculture drugs should also be considered a

significant hazard at any processing step where a
preventive measure is, or can be, used to eliminate
the hazard (or reduce the likelihood of its occurrence
to an acceptable level), if it reasonably likely to occur.
Preventive measures for the control of aquaculture
drugs used in aquaculture operations can include:
On-farm visits to review drug usage (other than
INADs) before receipt of the product, coupled
with a suppliers lot-by-lot certificate that any
INADs used were used in conformance with the
application requirements;
Receipt of suppliers lot-by-lot certification of
proper drug usage, coupled with appropriate
verification (See Step #18 - Verification);
Review of drug usage records (other than INADs)
at receipt of the product, coupled with a suppliers
lot-by-lot certificate that any INADs used were
used in conformance with the application
requirements;
Drug residue testing;
Receipt of evidence (e.g. third party certificate)
that the producer operates under a third partyaudited Quality Assurance Program for aquaculture
drug use.
(Note: The use of Investigational New Animal Drugs
(INAD) is confidential unless an exception is made
by the sponsor of the drug research. Thus, review of
INAD drug usage records by the processor may not
be practical in certain situations. Written certification from the grower to the processor stating that any
INAD drug usage is in accordance with authorizations from FDA/Center for Veterinary Medicine, will
be acceptable on a lot-by-lot basis.)
Preventive measures for the control of aquaculture
drugs used during the holding of live fish (e.g. lobster
pounds) can include controlled application of animal
drugs in a manner consistent with:
The established withdrawal times;
The labeled instructions for use;
Extralabel use of FDA-approved drugs, under a
veterinarians supervision in accordance with FDA
regulations and guidelines;
The conditions specified in the FDA low
regulatory priority aquaculture drug list;
The conditions of an INAD application.

processing step(s). Ordinarily this will be either the
receiving step or the preharvest step. However, in the
case of an integrated operation, where fish processing
and grow-out, and, perhaps feed manufacture, are
performed by the same firm, it may be possible and
desirable to exercise preventive measures early in the
process (ideally at feed manufacture), rather than at
receipt of the fish at the processing plant. Such
preventive measures will not be covered in this
chapter. For the holding of live fish (e.g. lobster
pounds) the preventive measure will usually be
applied at the holding step.
If the answer to either question 1 or 2 is Yes, the
the Hazard Analysis Worksheet. Except in the case
of an integrated aquaculture operation, this will
usually be the receiving step. If none of the criteria
are met you should answer No. You should record
recorded a No.
Intended use
which you developed in Step #4. However, for
aquaculture drugs, it is unlikely that the intended use
will affect the significance of the hazard.
Chapter 11: Drugs

128

For each processing step where aquaculture drugs
is identified in Column 3 of the Hazard Analysis
determination.
aquaculture drugs:
Is the hazard the result of the use of aquaculture
drugs during the raising of fish (i.e. aquaculture) or
during the holding of live fish (e.g. lobster pounds)?
1. If it is the result of aquaculture, is your relationship
with the grower one that enables you to visit the farm
before receipt of the fish?
a.If you have such a relationship with the grower,
then you may identify a pre-harvest step as the
CCP for aquaculture drugs. The preventive
measure for this type of control is on-farm visits to
review drug usage, coupled with a suppliers lotby-lot certificate that any INADs used were used in
conformance with the application requirements.
Example:
A processor of aquacultured catfish that
regularly purchases from the same growers
would visit the grower before the fish are
harvested and review the growers drug usage
practices and records. The processor could also
receive a guarantee that any INADs used were
requirements. The processor could then set the
critical control point for aquaculture drugs at the
pre-harvest step.
In this case, you should enter Yes in Column 6 of

the Hazard Analysis Worksheet for the pre-harvest
Control Strategy Example 1 in Steps #14 through
18. (Note: if you have not previously identified
aquaculture drugs as a significant hazard at the preharvest step in Column 3 of the Hazard Analysis
Worksheet, you should change the entry in Column 3
to Yes.)
b. If you have no such relationship with the grower,
then you may identify the receiving step as the CCP
for aquaculture drugs. At the receiving step you
may exercise one of the following preventive
measures:
Suppliers lot-by-lot certification of proper drug

usage, coupled with appropriate verification
(See Step #18 - Verification).
Example:
A processor of aquacultured shrimp that
purchases raw material shrimp through various
brokers could receive lot-by-lot certificates from
the growers. The certificates would state that all
drugs were used in conformance with applicable
regulations and labeled instructions. The
processor combines this monitoring procedure
with quarterly raw material testing for verification.
the Hazard Analysis Worksheet for the receiving step.
This control approach will be referred to as Control
Review of drug usage records (other than INADs)
at receipt of the product, coupled with a suppliers
lot-by-lot certificate that any INADs used were
requirements.
Example:
brokers could receive records of drug use (other
than INADs) from the growers when the product
is delivered. Additionally, the processor could
receive a lot-by-lot certificate that would state
that any INADs were used in conformance with
the application requirements.
Continued
Chapter 11: Drugs

129

Drug screening on all lots at receipt. This
screening can be performed by rapid analytical
methods which may indicate the presence of a
family of drugs, rather than any specific drug. If
the rapid screening test indicates that a family of
drugs is present, further testing and/or follow-up
with the supplier would be necessary.
Note: A limited number of drug screening tests for
aquaculture are available. Tests are not available to
assay for all drugs that might be used in all
aquacultured species. Processors should be cautioned that tests that have not been validated may be
unreliable. These tests may fail to detect a residue or
may give a false positive. FDA has not validated any
of the aquaculture screening tests; nor has the
Association of Official Analytical Chemists (AOAC).
Processors should assure themselves that the tests
that they intend to use have otherwise been validated
and are appropriate for the species and tissue to be
tested.
Example:
brokers could screen all incoming lots of shrimp
with a bank of validated rapid tests that target
the families of drugs likely to be used during
grow-out.
Receipt of evidence (e.g. continuing or lot-by-lot
third party certificate) that the producer operates
under a third party-audited Quality Assurance
program for aquaculture drug use.
Example:
A processor of aquacultured trout that regularly
purchases raw material trout from the same
grower could obtain a third party certificate,
valid for one year, that attests that the grower
operates under a Quality Assurance Program
which covers aquaculture drug usage.
2. If the hazard is the result of live fish holding (e.g.
lobster pounds), then you may identify the holding step
as the CCP for aquaculture drugs. The preventive
measure for this type of control is the controlled
application of animal drugs (e.g. oxytetracycline) in a
manner consistent with: the established withdrawal
times; the labeled instructions for use; extralabel use of
an FDA-approved drug, under a veterinarians supervision in accordance with FDA regulations and guidelines; the conditions specified in the FDA low regulatory priority aquaculture drug list; and, the conditions
of an INAD application.
Example:
A processor that uses oxytetracycline in the
holding of live lobster in a lobster pound would
use the drug in accordance with the established
withdrawal time and any other labeled
instructions.
the Hazard Analysis Worksheet for the holding step.
strategy that is different from those which are
suggested above, provided that it assures an equivalent degree of safety of the product.
Chapter 11: Drugs

130
HACCP Plan Form

is identified as a significant hazard on the HACCP
Plan Form, identify the maximum or minimum value
to which a feature of the process must be controlled
in order to control the hazard.
You should set the critical limit at the point that if not
met the safety of the product may be questionable. If
you set a more restrictive critical limit you could, as a
result, be required to take corrective action when no
safety concern actually exists. On the other hand, if
you set a critical limit that is too loose you could, as
a result, allow unsafe product to reach the consumer.
operating limit that is more restrictive than the
critical limit. In this way you can adjust the process
when the operating limit is triggered, but before a
triggering of the critical limit would require you to
take corrective action. You should set operating
limits based on your experience with the variability
of your operation and with the closeness of typical
operating values to the critical limit.
control strategy examples discussed in Step #12.
CONTROL STRATEGY EXAMPLE 1 ON-FARM VISITS
Critical Limit: Animal drugs are used on fish only if
the drugs have been:

Approved by FDA and used in accordance with
proper withdrawal times and other labeled
conditions;
OR
Approved by FDA and used in an extra-label
manner under a veterinarians supervision in
accordance with FDA regulations and guide
lines. The regulations and guidelines are
available from the FDA Center for Veterinary
Medicine, HFV-230, 7500 Standish Place,
Rockville, MD 20855;
OR
Listed on the FDA low regulatory priority
aquaculture drug list;
OR
Permitted by FDA for use in food fish under
the conditions of an INAD (as evidenced by a
lot-by-lot written certificate from the grower).
CONTROL STRATEGY EXAMPLE 2 SUPPLIERS CERTIFICATION
Critical Limit: Certificate indicating proper drug
usage accompanying each lot of incoming

aquacultured fish.
CONTROL STRATEGY EXAMPLE 3 RECORDS OF DRUG USE
Critical Limit: Animal drugs used on fish only if the
drugs have been:

conditions;
OR
accordance with FDA regulations and guide
lines. The regulations and guidelines are
OR
Listed on the low regulatory priority
OR
the conditions of an INAD (as evidenced by a
lot-by-lot written certificate from the grower).
CONTROL STRATEGY EXAMPLE 4 RESIDUE DRUG TESTING
Critical Limit: No fish will be accepted that contains
unapproved drug residues (other than those used

within the provisions of an INAD application or
used in accordance with the criteria specified in
the low regulatory priority aquaculture
drug list).
Chapter 11: Drugs

131
Continued
CONTROL STRATEGY EXAMPLE 5 - QA PROGRAM

Critical Limit: Third party certificate indicating that
the producer operates under a third party-audited

Quality Assurance program for aquaculture drug
use, either for each lot of incoming aquacultured
fish or for each producer of incoming
aquacultured fish.
CONTROL STRATEGY EXAMPLE 6 CONTROL DURING HOLDING
Critical Limit: Animal drugs are used on fish only if
the drugs have been:

conditions;
OR
accordance with FDA regulations and
guidelines. The regulations and guidelines are
OR
Listed on the FDA low regulatory priority
OR
the conditions of an INAD.
FDA-approved aquaculture drugs
FDA approved aquaculture drugs with their approved
sources, species and withdrawal times are listed
below. Additional details on conditions of use (e.g.
disease conditions and dosage levels) can be obtained
from: the Code of Federal Regulations as cited
below; the labeling for the drug; the FDA Center for
Veterinary Medicine (www.fda.gov/cvm/index/
aquaculture); or Guide to Drug, Vaccine, and
Pesticide Use in Aquaculture, Texas Agricultural
Extension Service, Publication B-5085.
Chorionic Gonadotropin
Supplied by Intervet, Inc., Millsboro, DE, may be
used as an aid in improving spawning function in
male and female brood finfish, (21 CFR 522.1081);
Formalin solution
Supplied by Natchez Animal Supply Co., Natchez,
MS or Argent Laboratories, Redmond, WA, may
only be used in salmon, trout, catfish, largemouth
bass, and bluegill for the control of protozoa and
monogenetic tremetodes, and on the eggs of
salmon, trout and pike (esocids) for control of
fungi of the family Saprolegniacea,
(21 CFR 529.1030);
Formalin solution
Supplied by Western Chemical, Inc., Ferndale, WA,
may be used to control: external protozoa and
monogenetic tremetodes on all fin fish species;
external protozoan parasites on shrimp; and fungi
of the family Saprolegniaceae on the eggs of all fin
fish species, (21 CFR 529.1030);
Tricaine methanesulfonate (MS-222)
Supplied by Argent Laboratories, Redmond, WA,
and Western Chemical, Inc., Ferndale, WA, may
only be used in the families Ictaluridae (catfish),
Salmonidae (salmon and trout), Esocidae (pike),
and Percidae (perch) when the fish is intended to
be used for food. It may not be used within 21 days
of harvesting fish for food. In other fish and in
cold-blooded animals, the drug should be limited to
hatchery or laboratory use, (21 CFR 529.2503);
Oxytetracycline
For feed use, supplied by Pfizer, Inc., may only be
used in salmonids, catfish, and lobster. Withdrawal
times are: marking in pacific salmon, 7 days;
disease control in salmonids, 21 days; catfish,
21 days; lobster, 30 days (21 CFR 558.450).
Oxytetracycline tolerance in the flesh is 2.0 ppm,
(21 CFR 556.500).
Sulfamerazine
Supplied by Roche Vitamins, Inc., may only be
used in trout. It may not be used within 21 days of
harvest (21 CFR 558.582). Sulfamerazine tolerance
in the flesh is zero, (21 CFR 556.660). Note: this
product is currently not marketed.
Sulfadimethoxine/ormetoprim combination
Supplied by Roche Vitamins, Inc., may only be
used in salmonids and catfish. Withdrawal times
are: salmonids, 42 days; catfish, 3 days (21 CFR
558.575). Sulfadimethoxine/ormetoprim
combination tolerance in the flesh is 0.1 ppm for
both drugs, (21 CFR 556.640).
Chapter 11: Drugs

132
FDA low regulatory priority aquaculture drugs

FDAs Center for Veterinary Medicine has identified a
number of low regulatory priority aquaculture drugs.
The following list identifies these compounds and
provides their indicated use and usage levels. These
compounds have undergone review by the Food and
Drug Administration and have been determined to be
new animal drugs of low regulatory priority. Additional
information on this subject can be obtained from: the
FDA Center for Veterinary Medicine (www.fda.gov/
cvm/index/aquaculture); or Guide to Drug, Vaccine,
and Pesticide Use in Aquaculture, Texas Agricultural
Extension Service, Publication B-5085.
Acetic Acid
Used in a 1000 to 2000 ppm dip for 1 to 10
minutes as a parasitide for fish.
Calcium Chloride
Used to increase water calcium concentration to
insure proper egg hardening. Dosages used would
be those necessary to raise calcium concentration
to 1-20 ppm CaCO3. Used up to 150 ppm
indefinitely to increase the hardness of water for
holding and transporting fish in order to enable fish
to maintain osmotic balance.
Calcium Oxide
Used as an external protozoacide for fingerlings to
adult fish at a concentration of 2000 mg/L for 5
seconds.
Carbon Dioxide Gas
Used for anesthetic purposes in cold, cool, and
warm water fish.
Fullers Earth
Used to reduce the adhesiveness of fish eggs to
improve hatchability.
Garlic (whole form)
Used for control of helminth and sea lice
infestations of marine salmonids at all life stages.
Hydrogen Peroxide
Used at 250-500 mg/L to control fungi on all
species and life states of fish, including eggs.
Ice
Used to reduce metabolic rate of fish during transport.
Magnesium Sulfate
Used to treat external monogenic trematode
infestations and external crustacean infestations in
fish at all life stages. Used in all freshwater
species. Fish are immersed in a 30,000 mg
MgSO4/L and 7000 mg NaCl/L solutions for 5 to
10 minutes.
Onion (whole form)

Used to treat external crustacean parasites, and to
deter sea lice from infesting external surface of
salmonids at all life stages.
Papain
Used in a 0.2% solution to remove the gelatinous
matrix of fish egg masses in order to improve
hatchability and decrease the incidence of disease.
Potassium Chloride
Used as an aid in osmoregulation; relieves stress
and prevents shock. Dosages used would be those
necessary to increase chloride ion concentration to
10-2000 mg/L.
Povidone Iodine
Used in a 100 ppm solution for 10 minutes as an
egg surface disinfectant during and after water
hardening.
Sodium Bicarbonate
Used at 142 to 642 ppm for 5 minutes as a means
of introducing carbon dioxide into the water to
anesthetize fish.
Sodium Chloride
Used in a 0.5% to 1.0% solution for an indefinite
period as an osmoregulatory aid for the relief of
stress and prevention of shock; and 3% solution for
10 to 30 minutes as a parasitide.
Sodium Sulfite
Used in a 15% solution for 5 to 8 minutes to treat
eggs in order to improve their hatchability.
Thiamine Hydrochloride
Used to prevent or treat thiamine deficiency in
salmonids. Eggs are immersed in an aqueous
solution of up to 100 ppm for up to four hours
during water hardening. Sac fry are immersed in
an aqueous solution of up to 1,000 ppm for up to
one hour.
Urea & Tannic Acid
Used to denature the adhesive component of fish
eggs at concentrations of 15g urea and 20g NaCl/5
liters of water for approximately 6 minutes, followed
by a separate solution of 0.75 g tannic acid/5 liters
of water for an additional 6 minutes. These
amounts will treat approximately 400,000 eggs.
Chapter 11: Drugs

133
Continued
The Agency is unlikely to object to the use of low

regulatory priority substances if the following
conditions are met: 1) the substances are used for the
stated indications; 2) the substances are used at the
prescribed levels; 3) the substances are used according to good management practices; 4) the product is
of an appropriate grade for use in food animals; and,
5) there is not likely to be an adverse effect on the
environment.
The Agencys enforcement position on the use of
these substances should not be considered an approval, nor an affirmation of their safety and effectiveness. The Agency reserves the right to take a
different position on the use of any or all of these
substances at some time in the future.

typically close to the critical limit. Additionally, the
greater the time span between measurements the
more product you are putting at risk should a measurement show that a critical limit has been violated.
procedures for the control strategy examples discussed in Step #12. Note that the monitoring frequencies that are provided are intended to be considered as minimum recommendations, and may not be
Classification of these substances as new animal

drugs of low regulatory priority does not exempt
facilities from complying with other Federal, State,
and local environmental requirements. For, example,
facilities using these substances would still be
required to comply with National Pollutant Discharge
Elimination System (NPDES) requirements.
Plan Form.

What: On-farm drug usage procedures;
AND
Producer certificate indicating proper INAD
usage.

PROCEDURES.
What: Producer certificate indicating proper drug

Plan Form, describe monitoring procedures that will
method of monitoring should enable you to determine whether the critical limit is being met. That is,
the monitoring process should directly measure the
feature for which you have established a critical
limit.
usage.
What: On farm drug usage procedures;
AND
Producer certificate indicating proper INAD
usage.
What: Fish flesh for drug residues.

What: Third party certificate indicating operation
under third-party audited QA program.
Chapter 11: Drugs

134
CONTROL STRATEGY EXAMPLE 6 -
Note: A limited number of drug screening tests for

aquaculture are available, and these have not been
validated by FDA or AOAC. This topic is further
CONTROL DURING HOLDING

What: Type of aquaculture drug used;
AND
Date and quantity of drug use;
AND
Any other conditions of drug use that are
relevant to: the established withdrawal times; the
labeled instructions for use; the extralabel use of
an FDA-approved drug used under a
veterinarianss supervision in accordance with
FDA regulations and guidelines; the conditions
specified in the FDA low regulatory priority
aquaculture drug list; or, the conditions of the
INAD application;
AND
Date of distribution of the finished product.

How: Visual for presence of third party certificate.

How: Visually observe drug use and distribution.
(Frequency)?

Frequency: At least once per year for each
aquaculture site.
ON-FARM VISITS
CONTROL STRATEGY EXAMPLE 2 How: Survey farm husbandry procedures, ask
SUPPLIERS CERTIFICATION
questions, and review drug usage records;

AND
Visual for presence of INAD certificate.
Frequency: Each lot received.

How: Visual for presence of lot-by-lot certificate.
CONTROL STRATEGY EXAMPLE 4 CONTROL STRATEGY EXAMPLE 3 -
RESIDUE DRUG TESTING
RECORDS OF DRUG USE

How: Review drug records;
AND
Visual for presence of INAD certificate.
Frequency: Each lot received checked for presence
of certificates. Certificates may be issued on a

lot-by-lot or continuing basis, but at least
annually.

How: Obtain samples and analyze for drugs, using
rapid screening methods.
Continued
Chapter 11: Drugs
135
Frequency: Every time aquaculture drugs are used
during holding;
AND
Every time the product is distributed.
Who: Production employee or supervisor, member
of the quality control staff, or any other

personnel who has an understanding of drug
usage and limits.
CONTROL STRATEGY EXAMPLE 1 STEP #16: ESTABLISH CORRECTIVE

ACTION PROCEDURES.
ON-FARM VISITS
Who: Field agent (employee or contractor) or any
other person who has an understanding of animal

drug usage and limits.
Who: Receiving employee or supervisor, production
supervisor, member of the quality control staff,

or any other person who has an understanding of
the control procedure.

Plan Form, describe the procedures that you will use
when your monitoring indicates that the critical limit
has not been met.
the problem that caused the critical limit deviation.
Remember that deviations from operating limits do
not need to result in formal corrective actions.

action procedures for the control strategy examples
Who: Production supervisor, member of the
quality control staff, or any other personnel who

has an understanding of animal drug usage and
limits.

Corrective Action: Reject product, if the CL is

Who: Member of the quality control staff or contract
laboratory.
not met;
AND
obtained that drug treatment practices have
changed.

CONTROL STRATEGY EXAMPLE 2 Who: Receiving employee or supervisor, production
supervisor, a member of the quality control staff,

or any other person who has an understanding of
the control procedure.
Corrective Action: Reject lot, if the CL is not met;
AND
Discontinue use of supplier until a commitment is
obtained that a certificate will accompany each lot.
Chapter 11: Drugs

136

RECORDS OF DRUG USE


AND
changed.

SYSTEM.

AND
changed.

Plan Form, list the records that will be used to
document the accomplishment of the monitoring
procedures discussed in Step #15. The records should
clearly demonstrate that the monitoring procedures
have been followed, and should contain the actual
values and observations obtained during monitoring.

AND
Discontinue use of supplier until a certificate is
provided.

recordkeeping system for the control strategy examples discussed in Step #12.

Corrective Action: Hold the product until the drug
residue is at or below tolerance. This may be

accomplished by collecting and analyzing a
representative sample of the product, using an
approved method;
OR
Destroy the product;
OR
Divert the product to non-food use.
AND
Modify drug use practices
Records: On-site audit report;

AND
INAD certificate.

Records: Certificate;
AND
Receiving record showing lots received and
presence/absence of certificate.

Records: Growers drug records;

AND
INAD certificate;
AND
Chapter 11: Drugs

137
Continued
Records: Analytical results.
Verification: Visit all new aquacultured fish

RECORDS: Third party certificate;
AND
Records: Drug use records;
suppliers within the year and all existing fish

suppliers at a predetermined frequency to review
the growers drug usage procedures;
OR
Collect a representative sample of the raw
material, in-process product, or finished product
at least quarterly and analyze for drug residues.
AND
verification records within one week of preparation.
AND
Records indicating date of distribution of drugtreated product.
RECORDS OF DRUG USE



PROCEDURES.

Plan Form, establish verification procedures that will
address the hazard of aquaculture drugs; and, 2)
consistently being followed.



procedures for the control strategy examples discussed in Step #12.



HACCP Plan Form.
Chapter 11: Drugs

138
Chapter 11: Drugs

139
Pre-harvest
(1)
Critical Control
Point (CCP)
Aquaculture drugs
(2)
Significant
Hazard(s)
Survey farm
husbandry
procedures, ask
questions, and
review drug
records
Visual
Certificate
indicating proper
INAD usage
How
What
(6)
Who
(7)
Once per year for Field agent

each aquaculture
site
Frequency
Monitoring
On farm drug
usage procedures
(5)
(4)
AND
Reject
(8)
Corrective
Action(s)
Same
Same
Reject
Discontinue use
of supplier until
evidence is
obtained that
drug treatment
practices have
changed
Se
eT
ex
t f Exa
or mp
Fu le
ll R O
eco nly
mm
en
da
tio
ns
Animal drugs used on fish

only if the drugs have
been: a) approved by FDA
and used in accordance
with proper withdrawal
times and other labeled
conditions; b) approved
by FDA and used in an
extra-label manner under
a veterinarians
supervision in accordance
with FDA regulations and
guidelines; c) listed on the
low regulatory priority
aquaculture drug list; or,
d) permitted by FDA for
use in food fish under the
conditions of an INAD
(as evidenced by a lot-bylot written certificate
from the grower)
(3)
Critical Limits
for each Preventive
Measure
Certificate of
INAD usage
On-site audit
report
(9)
Records
Review
monitoring
and corrective
action records
within one week
of preparation
(10)
Verification
This table is an example of a portion of a HACCP plan relating to the control of aquaculture drugs in farm-raised catfish,
using Control Strategy Example 1 - On-farm visits. It is provided for illustrative purposes only.
Aquaculture drugs may be only one of several significant hazards in this product. Refer to Tables 3-1, 3-2, and 3-3
(Chapter 3) for other potential hazards (e.g. chemical contaminants and metal fragments).
Control Strategy Example 1 - On-farm visits
TABLE #11-1
Chapter 11: Drugs

140
Receiving
(1)
Critical Control
Point (CCP)
Aquaculture Drugs
(2)
Significant
Hazard(s)
Visual
How
What
Presence of a
certificate
indicating proper
drug usage
(5)
(4)
(6)
Each lot received
Frequency
Monitoring
Receiving dock
employee
Who
(7)
AND
Reject lot
(8)
Corrective
Action(s)
Discontinue use
until supplier
agrees to provide
certificate for
each lot
Se
eT
ex
t f Exa
or mp
Fu le
ll R O
eco nly
mm
en
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tio
ns
Certificate indicating
proper drug usage
accompanying all lots of
incoming pond-raised
shrimp
(3)
Critical Limits
for each Preventive
Measure
Receiving record
Growers drug
usage certificate
(9)
Records
Review
monitoring,
corrective
action, and
verification
records within
one week of
preparation
Visit all new

pond-raised
shrimp
suppliers within
the year and
all existing
suppliers at
25% per year on
a rotating basis
to review the
growers drug
usage
procedures
(10)
Verification
This table is an example of a portion of a HACCP plan relating to the control of aquaculture drugs in pond-raised shrimp,
using Control Strategy Example 2 - Suppliers certification. It is provided for illustrative purposes only.
(Chapter 3) for other potential hazards (e.g. chemical contaminants, food and color additives, and metal fragments).
Control Strategy Example 2 - Suppliers certification
TABLE #11-2
Chapter 11: Drugs

141
Receiving
(1)
Critical Control
Point (CCP)
Aquaculture Drugs
(2)
Significant
Hazard(s)
Review drug
records at
receipt
Visual
Certificate
indicating
proper INAD
usage
How
What
(6)
Each lot
received
Frequency
Monitoring
On-farm drug
usage procedures
(5)
(4)
Production
supervisor
Who
(7)
AND
Reject lot
(8)
Corrective
Action(s)
Same
Same
Same
Discontinue use
of supplier until
evidence is
obtained that
drug treatment
practices have
changed
Se
eT
ex
t f Exa
or mp
Fu le
ll R O
eco nly
mm
en
da
tio
ns
Animal drugs used on fish

only if the drugs have
been: a) approved by FDA
and used in accordance
with proper withdrawal
times and other labeled
conditions; b) approved
by FDA and used in an
extra-label manner
under a veterinarians
supervision in accordance
with FDA regulations and
guidelines; c) listed on the
low regulatory priority
aquaculture drug list; or
d) permitted by FDA for
use in food fish under the
conditions of an INAD
(as evidence by a lot-bylot written certificate)
(3)
Critical Limits
for each Preventive
Measure
Certificate of
INAD usage
Receiving record
Growers drug
usage records
(9)
Records
Review
monitoring
and corrective
action records
within one week
of preparation
(10)
Verification
This table is an example of a portion of a HACCP plan relating to the control of aquaculture drugs in pond-raised shrimp,
using Control Strategy Example 3 - Records of drug use. It is provided for illustrative purposes only.
(Chapter 3) for other potential hazards (e.g. chemical contaminants, food and color additives, and metal fragments).
Control Strategy Example 3 - Records of drug use
TABLE #11-3
Chapter 11: Drugs

142
Receiving
(1)
Critical Control
Point (CCP)
Aquaculture Drugs
(2)
Significant
Hazard(s)
(6)
Each lot received
Frequency
Monitoring
Obtain samples
and analyze for
drugs using rapid
screening methods
How
What
Fish flesh for drug
residues
(5)
(4)
Quality assurance
personnel
Who
(7)
AND
Reject lot
(8)
Corrective
Action(s)
Note: A limited
number of drug
screening tests for
aquaculture are
available, and these
have not been
validated by FDA
or AOAC. This
topic is further
discussed in Step
#12.
Discontinue use
of supplier until
evidence is
obtained that
drug treatment
practices have
changed
Se
eT
ex
t f Exa
or mp
Fu le
ll R O
eco nly
mm
en
da
tio
ns
No fish will be accepted

that contains unapproved
drug residues (other than
those used under an INAD
application or included on
the low regulatory
priority aquaculture drug
list)
(3)
Critical Limits
for each Preventive
Measure
Analytical
results
(9)
Records
Review
monitoring and
corrective action
records within
one week of
preparation
(10)
Verification
This table is an example of a portion of a HACCP plan relating to the control of aquaculture drugs in farm-raised catfish,
using Control Strategy Example 4 - Residue drug testing. It is provided for illustrative purposes only.
Control Strategy Example 4 - Residue drug testing
TABLE #11-4
Chapter 11: Drugs

143
Receiving
(1)
Critical Control
Point (CCP)
Aquaculture Drugs
(2)
Significant
Hazard(s)
Visual, for
presence of
certificate
How
What
Presence of third
party certificate
(5)
(4)
(6)
Who
(7)
Each lot checked to Receiving dock

see if covered by
employee
certificate, which
is renewed
annually
Frequency
Monitoring
Receiving record
Discontinue use
until a certificate
is obtained
AND
Third party
certificate of
operation
(9)
Records
Reject lot
(8)
Corrective
Action(s)
Se
eT
ex
t f Exa
or mp
Fu le
ll R O
eco nly
mm
en
da
tio
ns
Third party certificate

indicating that the
producer operates under
a third party audited
Quality Assurance
Program that covers
aquaculture drug usage
(3)
Critical Limits
for each Preventive
Measure
Review
monitoring and
corrective action
records within
one week of
preparation
(10)
Verification
This table is an example of a portion of a HACCP plan relating to the control of aquaculture drugs for an aquacultured trout
processor, using Control Strategy Example 5 - QA program. It is provided for illustrative purposes only.
Aquaculture drugs may be only one of several significant hazards for this product. Refer to Tables 3-1, 3-2, and 3-3
Control Strategy Example 5 - QA program
TABLE #11-5
Chapter 11: Drugs

144
Holding
(1)
Critical Control
Point (CCP)
Aquaculture Drugs
(2)
Significant
Hazard(s)
How
What
(6)
Every time
aquaculture
drugs are used
Every time
aquaculture
drugs are used
Every time
aquaculture
drugs are used
Date and quantity Visual

of drug use
observation of
drug use
Date of finished
product
distribution
Frequency
Monitoring
Visual
observation of
drug use
Type of
aquaculture drug
used
(5)
(4)
Production
employee
Who
(7)
AND
Hold the product
(8)
Corrective
Action(s)
No other aquaculture
drugs will be used
Visual
observation of
drug use
Shipping
supervisor
Production
employee
Drug use record
(9)
Records
modify drug use

practices
AND
Destroy the lot

when
unapproved
drugs are used
AND
Collect a sample Drug use record

of the finished
product and have
analyzed for
Shipping record
oxytetracycline
residue by contact
laboratory. If 2.0
ppm or less,
release. If higher
than 2.0 ppm,
hold product an
additional 5 days
and then retest
Se
eT
ex
t f Exa
or mp
Fu le
ll R O
eco nly
mm
en
da
tio
ns
Lobster will be withheld

from distribution for 30
days after treatment
with oxytetracycline in
accordance with the
labeled directions for
use
(3)
Critical Limits
for each Preventive
Measure
Review
monitoring and
corrective action
records within
one week of
preparation
(10)
Verification
This table is an example of a portion of a HACCP plan relating to the control of aquaculture drugs for a processor that holds live
lobster in a lobster pound, using Control Strategy Example 6 - Control during holding. It is provided for illustrative purposes only.
Aquaculture drugs may be only one of several significant hazards for this product. Refer to Tables 3-1, 3-2, and 3-3
(Chapter 3) for other potential hazards (e.g. natural toxins and food and color additives).
Control Strategy Example 6 - Control during holding
TABLE #11-6
Chap 11 - Principle 7: Record-Keeping Procedures

Notes:
Chapter 11: Principle 7: Record-Keeping Procedures
Overhead 1
Objective:
What kinds of records are needed in a HACCP system.
When to record monitoring information.
How computerized records can be used.
How to conduct a record review.
Accurate record keeping is an essential part of a successful HACCP

program. Records provide documentation that the critical limits have been
met or that appropriate corrective actions were taken when the limits were
exceeded. Likewise, they provide a means of monitoring so that process
adjustments can be made to prevent a loss of control.
Overhead 2
Principle 7:
Establish record-keeping and documentation procedures.
Types of Records Needed
Overhead 3
Four kinds of categories are kept as part of the HACCP
system.
1. HACCP plan and support documentation used in developing
the plan
2. Records of CCP monitoring
3. Records of corrective action
4. Records of verification activities
Continued
111

Explanatory Note:
1. HACCP-Plan Support Documents
Although not required by the

seafood HACCP regulation,
it is advisable to maintain
HACCP-plan support
documentation described
in this chapter.
HACCP-support documents include the information and data used to

develop the HACCP plan. This includes the written hazard-analysis
worksheet (Chapter 5) and records of any information used in performing
the hazard analysis and establishing the critical limits.
Support documents may include: sufficient data used to establish the
adequacy of any barriers to bacterial pathogen growth, to establish the
safe shelf life of the product (if age of the product can affect safety), and
to establish the adequacy of a heating process in destroying bacterial
pathogens. In addition to data, support documents may also include
correspondence with consultants or other experts.
Support documents should also include:
A list of the HACCP team and their responsibilities.
A summary of the preliminary steps taken in the development of the
HACCP plan.
Prerequisite programs.
2. Monitoring Records
HACCP monitoring records are primarily kept to demonstrate control at
CCPs. HACCP records provide a useful way to determine if critical limits
have been violated. Timely record review by a management representative
ensures that the CCPs are being controlled in accordance with the
HACCP plan. This was discussed in Chapter 10. Monitoring records also
provide a means by which regulators can determine whether a firm is in
compliance with its HACCP plan.
By tracking the values recorded on monitoring records, an operator or
manager can determine if a process is approaching its critical limit.
Trends can be identified through record review to make necessary process
adjustments. If timely adjustments are made before the critical limit is
violated, processors can reduce or eliminate the labor and material costs
associated with corrective actions.
112
Overhead 4
All HACCP monitoring records should be on forms
that contain the following information:
Form title,
Firm name and location,
Time and date,
Product identification (including product type, package size,
processing line and product code, where applicable),
Actual observation or measurement,
Critical limits,
Operators signature or initials,
Reviewers signature or initials, and
Date of review.
Examples of CCP monitoring records may include:

Storage temperature records for temperature-sensitive ingredients,
in-process materials and finished products where temperature control is
necesssary to ensure product safety.
Container-seal examination records where the hermetic seal affects
product safety.
Salometer-measurement records where salt brine is used to establish a
barrier to bacterial pathogen growth in the finished product
3. Corrective Action Records
Corrective action records were discussed in Chapter 9.
4. Verification Records
Verification records (Chapter 10) should include:
Modifications to the HACCP plan (e.g., changes in ingredients,
formulations, processing, packaging and distribution);
Processor audit records verifying supplier compliance with guarantees
or certifications;
Verification of the accuracy and calibration of all monitoring
equipment;
Results of microbiological challenge tests, environmental
microbiological tests, and periodic in-line and finished-product
microbiological, chemical and physical tests if applicable;
Results of in-house, on-site inspections; and
Results of equipment-evaluation tests.
Examples of verification records include:
Temperature distribution studies for thermal processes.
Metal detector challenges.
Continued
113

Notes:
Record-Monitoring Information
Monitoring information should be recorded at the time the observation is

made. False or inaccurate records filled out before the operation takes
place or ones that are completed later are inappropriate for a HACCP
system.
Computerized Records
Computerized records are an option to manual record keeping. When

using computerized records, include controls to ensure that records are
authentic, accurate and protected from unauthorized changes.
Record Review
Monitoring records for CCPs and critical-limit deviations must be

reviewed in a timely manner by a representative of plant management.
All records should be signed or initialed and dated by the reviewer.
This subject is discussed more in Chapter 10.
ABC Shrimp Company IQF Cooked-Shrimp Example
Monitoring Records
Sample records are included for each of the monitoring activities
identified in columns 4 to 7 of the HACCP plan for IQF cooked shrimp.
The names of these forms should be entered in column 10 of the HACCP
plan form. These records include:
Figure 1. Raw material evaluation sheet.
This form records the presence or absence of sulfiting agents detected in
incoming raw shrimp at the receiving-raw-shrimp step. It is also
used to record the vendors name and the presence or absence of a
suppliers certificate for incoming frozen shrimp at the receivingfrozen-shrimp step.
Figure 2. Suppliers guarantee.
This document indicates that the shrimp from this vendor does not contain
sulfiting agents.
Figure 3. Shrimp cooker log.
This form is used to record the time and temperature of cooking at the
cooker step.
Figure 4. Pack-room inspection record.
The form is used to note that shrimp treated with sulfiting agents are
appropriately labeled.
114

Notes:
Additional Records
Figure 5. Laboratory results - sulfite residuals.
This document indicates the results of a laboratory analysis for sulfite
residual, which is used as a quarterly verification of the suppliers
certification.
Figure 6. Cooking process validation letter.
This document confirms that the cooking critical limits are scientifically
sound.
Figure 7. Cooking equipment validation letter.
This document confirms that the temperature throughout the cooking
equipment is at or above the critical limit when the equipment is properly
operated.
Figure 8. Equipment calibration log.
This form records the results of the quarterly calibration of the MIG
thermometers used on the cookers.
Figure 9. Laboratory report - product microbiology.
This document indicates the results of finished product laboratory
analyses for total plate count (TPC), coliform bacteria, Escherichia coli,
Staphylococcus aureus and Salmonella.
Figure 10. Sample corrective action record.
This record relates to the cooking process records that have been
previously discussed. This form is used to document the action taken
when a critical limit is exceeded.
Figure 11. Employee Training Record.
This document indicates the training courses completed by each
employee.
Overhead 5
HACCP Plan Form
Records:
1.
2.
3.
CCP Hazard Critical

Limits
4.
5.
6.
7.
Monitoring
8.
9.
10.

Action(s)
Specify the record-keeping procedures for each CCP.
Continued
115

Explanatory Note:
Figure 1 and Overhead 6
Figure 1 also includes

information for a variety of
nonsafety attributes in
addition to the sulfiting agent
information. It exemplifies the
use of existing forms for
HACCP purposes. Some firms
may choose to separate their
HACCP records from
nonsafety control records.
Note the critical limits at the
bottom of the form.
Raw-Material Evaluation Sheet

ABC Shrimp Co., Smithville, GA
Date:
Lot Number:
Time of Examination:
Declared Wt:
Actual Wt:
Country of Origin:
Shrimp Type:
Process Type:
Brand:
Packer:
Vendor:
Sample No.
Actual Color
Frozen Wt.
Drained Wt.
No./Pkg.
Ct./Lb.
% Peel
% Pieces
% Shell Spots
Foreign Mat.
% Meat Spots
Dehydrated
% Swimmerets
% Missing Tail
Sulfites
Veins
Phosphate
% Spines
Bleaching
% Discolored
Salt
Bilge Odor
Stale
Certificate for Sulfite Use (Yes/No):

Operator:
Reviewed By:
Date:
(Items in bold are part of HACCP record.)
116

Notes:

Suppliers Guarantee
East Bay Fishing Co., Yourtown, LA
December 25, 1995
ABC Shrimp Co.
P.O. Box 54
Smithville, GA 43898
Dear Mr. Smith,
This certifies that, in accordance with your purchasing
specification, this shipment of frozen shrimp has not been treated with
any sulfite compounds East Bay Lot Number 12345.
Yours truly,
Ira M. Honest
QC Director, East Bay Fishing Co.
Explanatory Note:
Figure 3: Continuous
temperature monitoring is
performed by a recording
thermometer. Manual time and
temperature checks are
performed every hour, and the
operator confirms that the
critical limit was continually
met since the last reading.
Time checks are performed by
determining how long it takes
a block to move through the
steam tunnel using a stopwatch. A comparison between
the standard thermometer and
the recording thermometer is
made daily. A deviation
occurred at 4:28 p.m.,
triggering a corrective action
that is documented in Figure
10. Note that during the 5:01
p.m. temperature check, the
recording thermometer was
reading lower than the
standard thermometer. This
condition is acceptable as long
as the two instruments are as
close as reasonably possible.
However, it would not be
acceptable for the recording
thermometer to read higher
than the standard thermometer.

Shrimp Cooker Log
Date: 3/4/96
Critical Limits: 212 F for 3 minutes
Line: Number 1
Product: IQF cooked shrimp
Operator: Jamie Good

Line
Number
Lot
Number
Time
of Day
034
Steam
Temp.
(F)
Temp.
from
Recorder
(F)
Cook
Time
(Min.)
Critical
Limits
Met
2:34 p.m.
214
3.2
Yes
043
3:30 p.m.
214
3.2
Yes
053
4:28 p.m.
210
3.1
No
053
4:29 p.m.
212
053
5:01 p.m.
213
212
Yes
3.1
Comments
See corrective actions
Steam valve
adjusted
Yes
Temperature/time to be checked hourly during operation.

Reviewer:
Date:
If critical limits are exceeded, notify the shift supervisor,

and separate and identify the batch involved.
117

Notes:

Pack-Room Inspection Record
Date: 3/4/95
Line: Number 1
Product: IQF cooked shrimp
Label Room Supervisor: Betty Smith

Lot
Number
Time
of Day
Presence of
Sulfiting Agents
Yes/No
Sulfite Statement
on Label
Yes/No
Label Type
& Comments
043
3:45 p.m.
Yes
Yes
ABC 8 oz.
044
4:45 p.m.
Yes
Yes
Smith Brothers
12 oz.
Reviewer:
Date of Review:
Critical Limits: All shrimp treated with sulfiting agents must be

accurately labeled.

A-One Laboratory Report for:
Date: 3/5/95
Sample Number: ABC Shrimp lot# 002
Vendor: East Bay
Sulfites, ppm: < 10 ppm
Examined by: Sheila Good

Remarks:
The above sample was analyzed for the presence of
sulfites using official AOAC recognized methods.
Irvine R. Wright
Laboratory Director
A-One Laboratories
Jonestown, PA 25418
118

Notes:

Cooking-Process Validation Letter
Seafood Processing Research and Extension Unit
Your State University
January 5, 1996
ABC Shrimp Co.
P.O. Box 54
Dear Mr. Smith:
Various published studies document that a process which
provides an internal temperature of 145 F in shrimp is adequate
for pasteurization. This supports our studies revealing that
pathogenic organisms are destroyed by processing the shrimp at
212 F for three minutes. This process provides an internal
temperature above 145 F for a minimum of 15 seconds.
Sincerely,
I.M. Helpful
119

Explanatory Note:
Figure 7: Emphasize that all

thermal-processing equipment should be tested to
verify that it will perform the
required process.
Cooking-Equipment Validation Letter

January 5, 1996
ABC Shrimp Co.
P.O. Box 54
Dear Mr. Smith:
On Dec. 20, 1995, during a visit to your firm, temperature
distribution tests were performed in your shrimp steam cooker on line
number one using a portable data logger and 12 thermocouple leads.
Test results from three production runs indicated that the temperature
distribution in your steam cooker, when operated at a mercury-in-glass
reading of 212 F, ranges from 212 F to 214 F. These studies indicate
that your steam cooker continues to operate as designed.
On this same date, the internal temperature of six shrimp from
individual lots of large (3.5 to 5.0 shrimp per oz.), medium (5.0 to 9.0
shrimp per oz.) and small (9.0 to 17.0 shrimp per oz.) shrimp were
measured in the cooker during production runs at 212 F for three
minutes. The internal temperature of the large shrimp exceeded 150 F;
the medium shrimp, 160 F; and the small shrimp, 165 F. The internal
temperatures noted during these tests exceed your firms HACCP
critical limits of an internal temperature of 145 F for 15 seconds.
Sincerely,
I.M. Helpful
120

Explanatory Note:
Figure 8: Emphasize that all

monitoring equipment such as
thermometers and scales
should be checked against a
standard. In some cases, this
standard may be a boilingwater bath, an ice slush or a
known weight, depending
upon the instrument and the
accuracy requirements for the
critical limit being monitored.
Note that on the 6/12/89
calibration, the thermometer
was 1 F above the standard.
This could have an impact on
the previously produced
product and could have
resulted in critical limit
deviations. These should be
evaluated, and appropriate
corrective action should be
taken and recorded.
Equipment-Calibration Log
Temperature Measurement
Instrument/Equipment
Instrument/Equipment: Standard thermometer

Location in Plant: Shrimp Cooker Line Number One
Serial Number: B546
Model Number: Always Right 140 F to 260 F
Date Received in Plant: 3/2/95
Date
Calibrated
Calibration
Results
Method
of Calibration
Employee
Reviewer
Date
3/15/95
Thermometer
was in calibration.
Tested in steam
flow 215 F using
certified thermometer S.N. 07569
Sam Smith
Becky Allen
3/18/95
6/12/95
Thermometer scale
adjusted 1 F down
to match standard
thermometer.
Tested in steam
flow 215 F using
Stan Jones
Becky Allen
6/15/95
9/10/95
Thermometer was
in calibration.
Tested in steam
flow 215 F using
Sam Smith
Joe Noble
9/15/95
12/2/95
Thermometer was
reading 5 F below
the standard thermometer scale.
Adjusted.
Tested in steam
flow 215 F using
Sam Smith
Becky Allen
12/6/95
2/29/96
Thermometer was
in calibration.
Tested in oil bath

215 F by laboratory
using certified
thermometer S.N.
56432
Jean Jones
Joe Noble
3/3/96
121

Explanatory Note:
There are situations when the

results of a verification
activity would necessitate a
corrective action. For example, with the positive
Salmonella result in Batch 1,
it would be appropriate for
the processor to hold any of
the affected lot still in storage
and recall any of the product
that was no longer under the
processors control. Then the
processor could recook or
destroy the lot. It would also
be appropriate to re-evaluate
the HACCP plan and its
implementation to determine
how the defect could have
occurred.
A-One Laboratory Report

Date: 4/5/96
Sample No.: ABC Shrimp Lot # 0112
Vendor: East Bay
Analyst: Sheila Good
The results of the analyses of sample 0112 consisting of 6/8 oz.

samples of shrimp identified as batch 1 to 6 are as follows:
Explanatory Note:
Figure 9: Finished product
analyses may often be
included as part of a firms
periodic verification efforts.
Firms should establish
specifications for the microbiological tests that are
performed as part of
verification.
Batch
T.P.C./
g
Coliforms/
10g
E. Coli/
10g
Staph/
g
Salmonella/
sample
40
Negative
Positive
48
Negative
Negative
20
Negative
Negative
56
Negative
Negative
40
Negative
Negative
20
Negative
Negative
Remarks:
The above sample was analyzed using methods found in the FDA
Bacteriological Analytic Manual, 7th Edition.
Irvine R. Wright
Laboratory Director
A-One Laboratories
Jonestown, PA 25418
122

Explanatary Note:
See Figure 3 for corresponding monitoring record

showing process deviation.
Corrective-Action Report
Date: 3/4/96
Explanatory Note:
Lot I.D.: 053
Figure 10: The critical limit

failure in the first corrective
action report would not likely
have been noted without the
continuous monitoring
provided by the recording
thermometer. In a continuous
cooker, when a temperature
drop occurs, the product in
the cooker at the time of the
deviation must be held and
evaluated, recooked,
destroyed or shifted to some
other acceptable use unless
the line can be stopped to
give a still cook.
Description of Problem:
At 4:28 p.m., the temperature dropped to 210 F for 30 seconds
according to the recorder.
Action Taken:
Temperature drop was noted immediately. Steam valve was
adjusted and the product exiting the cooker for the next five
minutes was destroyed.
Date Problem Solved: 3/4/96

Current Status:
Remainder of lot is acceptable.
Supervisor: Ollie K. Fellows

Reviewer: Seymour Samples
Date: 3/4/96
123

Notes:

Employee-Training Record
ABC Shrimp Co.
Employee: Richard J. Smith

Training Course
124
Date of Course
Sanitation in the processing plant,

4-hour course, state inspection service.
July 6, 1994
Computer operation of the pasteurizer,

Best Yet Pasteurizer Co.,
John Jones, customer representative.
three days on-the-job training.
Feb. 2-5, 1995
Sanitation in the processing plant,

4-hour course, state inspection service, update.
Aug. 3, 1995
pathogens
Cooker
125
Signature:
Date:
Cook at 212 F for

three minutes (to
achieve minimum
of 145 F for 15
seconds)
(3)
Critical Limits
for each Control
Measure
a continuous
temperature
recorder
Monitor cook
time by
timing the
movement of
a block placed
on belt through
cooker.
Cook time
How
What
(6)
Cook time
monitored
hourly.
Temperature
monitored
continuously
with hourly
visual checks.
Frequency
Monitoring
Cook
temperature
(5)
(4)
Cook will
perform the
hourly checks.
Quality-control
supervisor will
program the
continuousrecording
thermometer.
Who
(7)
If temperature or
time parameters
are not met, then
processing line
will be stopped
and required
adjustments
made. All product
produced during
the deviation
will be recooked
or destroyed.
(8)
Corrective
Action(s)
Cooking equipment
validation study
(on file)
Process validation study

of time and temperature
of cook and its effect on
the final internal temperature of various sizes of
shrimp and initial temperature (on file)
Semi-annual finishedproduct microbial testing
Quarterly calibration of
thermometer
Daily record review
(9)
Verification
Intended Use and Consumer: Thaw and serve
(2)
Significant Hazards
(1)
Critical Control
Point (CCP)
ABC Shrimp Co.

Cooked Shrimp
Recording
charts
Cooker log
(10)
Records
126
from undeclared
sulfiting agent
Weigh/Pack
Label
must declare
presence
(3)
Critical Limits
for each Control
Measure
Examine all
labels issued
at packing line
and match
declaration
with product
identity.
Rapid sulfite
test
Observation
of supplier
declaration
At receiving,
sample each
vessel of fresh
shrimp to test
for presence
of sulfites.
At receiving,
supplier
declaration for
absence of
sulfites for
frozen shrimp.
How
What
(6)
Frozen shrimp,
check every
shipment
Fresh shrimp,
three-grab
samples per
vessel
One label each

time a label
roll is replaced
Frequency
Monitoring
At weigh/pack/
label stage,
declaration.
(5)
(4)
Dock master
Dock master
Packing
supervisor
Who
(7)
If this product is
mislabeled, then
appropriately
label.
(8)
Corrective
Action(s)

for sulfite (frozen shrimp)
Daily record review

for sulfite (fresh shrimp)
Daily record review
Daily record review
(9)
Verification
(2)
Significant Hazards
(1)
Critical Control
Point (CCP)
ABC Shrimp Co.

Cooked Shrimp
Supplier
guarantees
Raw-material
evaluation
sheets
Pack-room
inspection
sheet
(10)
Records
Chap 12 - The Seafood HACCP Regulation

Notes:
Chapter 12: The Seafood HACCP Regulation
Overhead 1
Objective:
What are the requirements of the seafood HACCP regulation.
How to reference the specific requirements.
In December 1997, the FDA initiated a seafood regulation based on the

seven principles of HACCP called Procedures for the Safe and Sanitary
Processing and Importing of Fish and Fishery Products. This regulation
has become known as the seafood HACCP regulation. It will be
referred to in this chapter as the regulation. A copy of the regulation
is provided in Appendix I.
Regulation Format
The regulation is part of Title 21 of the Code of Federal Regulations
(CFR), Part 123, and is subdivided into three subparts and 13 sections.
Overhead 2
Regulation Format
Subpart A General provisions
123.3
Definitions
123.5
Current GMPs
123.6
HACCP plan
123.7
Corrective actions
123.8
Verification
123.9
Records
123.10
Training
123.11
Sanitation control procedures
123.12
Special requirements for imported products
Subpart B Smoked and smoke-flavored fishery products
123.15
General
123.16
Process controls
Subpart C Raw molluscan shellfish
123.20
General
123.28
Source controls
Continued
127

Explanatory Note:
Definitions 123.3
The terms "fish" and "fishery

product" together define the
products that are subject to
this regulation.
Twenty important terms are used throughout the regulation. They are:
Overhead 3
Definitions 123.3
certification number
critical control point
critical limit
fish
fishery product
hazard
importer
molluscan shellfish
preventive measure
process-monitoring instrument
processing
processor
scombroid toxin-forming species
shall
shellfish-control authority
shellstock
should
shucked shellfish
smoked or smoke-flavored
fishery products
tag
Of the terms listed above, a few definitions need to be emphasized.

Fish means freshwater or saltwater finfish, crustaceans, aquatic animal life
(including alligators, frogs, aquatic turtles, jellyfish, sea cucumbers,

sea urchins and roe) other than birds or mammals, and all mollusks,
where such animal life is intended for human consumption.
Fishery product means any human food product where fish is a character-
izing ingredient. [Note: This definition exempts products from the

mandatory HACCP requirements that contain inconsequential
amounts of fish. For example, Worcestershire sauce contains some
anchovy paste but is not characterized by that ingredient.]
Overhead 4
Who must comply?
Importer
Processor domestic and foreign
128

Importer means either the U.S. owner/consignee or the U.S. agent/
Explanatory Note:
representative of the foreign owner/consignee at the time of the

products entry into the United States. This person is responsible for
ensuring that goods being offered for entry are in compliance with all
laws affecting the importation. Ordinarily, the importer is not the
custom-house broker, freight forwarder, carrier or steamship
representative. [Note: The ownership of an imported product can
change many times in a short period of time after entry into the
United States. However, the person who is the owner or consignee at
the time that the product is offered for entry is identified as the
importer because: 1) that person has the ability to decide whether to
offer the product for entry, and 2) that person is in a position to ensure
that the product is processed under appropriate controls and to
demonstrate this to FDA.]
The terms importer, processor

and processing together
define who is subject to this
regulation.
Processor means any person engaged in commercial, custom or institu-
tional processing of fish or fishery products either in the United States

or in a foreign country.
Processing means handling, storing, preparing, heading, eviscerating,
Explanatory Note:
shucking, freezing, changing into different market forms, manufacturing, preserving, packing, labeling, dockside unloading or holding fish
or fishery products. [Note: Eviscerating done by an aquaculture
grower before delivery to a processing plant would make it necessary
for the grower to comply with the requirements of this regulation.
Fishing vessels and carriers may be affected by this regulation
indirectly through the controls that processors may impose on them to
meet HACCP obligations. However, vessels are not directly affected
by the regulation, except for factory trawlers and similar vessels.
Retail establishments must follow state and local government
regulations. The Food Code (FDAs model food ordinance that many
state and local regulatory authorities use in developing their food laws
and regulations) requires that raw materials for retail establishments
come from approved sources.]
Products that do not move in

interstate commerce are not
subject to the regulation.
However, products are
considered to have entered
into interstate commerce if
raw materials, ingredients,
packaging, etc. have originated outside the state.
Explanatory Note:
The use of the term should
in the FDA regulation may
differ from its use in Chapters
5 through 11 of this manual.
Chapters 5 through 11 are
designed to teach the principles of HACCP, including
certain activities that need to
be carried out to properly
implement HACCP plans.
Identifying these activities
as those that should be
enacted means they are
important for the HACCP
program to be effective.
Many of these activities
may be mandatory elements
of the regulation.
Overhead 5
This regulation does not apply to:
The harvest or transport of fish or fishery products.
Practices such as heading, eviscerating or freezing intended
solely to prepare a fish for holding on a harvest vessel.
The operation of a retail establishment.
Shall is used to state mandatory requirements.

Should is used to state recommended or advisory procedures or to identify
recommended equipment.
Continued
129

Notes:
Current Good Manufacturing Practices (CGMPs) 123.5

Overhead 6
Current Good Manufacturing Practices 123.5
Regulations found in Title 21, Part 110 of the Code of Federal
Regulations
Proper practices for the safe and sanitary handling of all foods
The Food Drug and Cosmetic Act deems food to be adulterated if

processed under insanitary conditions. The Current Good Manufacturing
Practices describe the conditions and practices that must be followed to
avoid producing adulterated food product. Part 110 applies to the
processing of all FDA-regulated food products including fish and fishery
products because it is the basis for determining whether the facilities,
methods, practices and controls used to process these products are safe
and whether the products have been processed under sanitary conditions.
The purpose of the seafood HACCP regulation is to set out requirements
specific to the processing of fish and fishery products.
Hazard Analysis 123.6(a)
Overhead 7
Hazard Analysis 123.6(a)
Every processor shall conduct or have conducted a hazard analysis.
The regulation requires that every processor perform a hazard analysis. It

outlines two major steps in a hazard analysis:
Determine whether there are hazards that are reasonably likely to occur.
Identify preventive measures to control the identified hazards.
Overhead 8
Hazards that are "reasonably likely to occur:"
Those "for which a prudent processor would establish controls"
This means a prudent processor would establish controls because there is

a reasonable possibility that a hazard will occur. To make this decision,
examine:
130
Notes:
Experience,
Illness data,
Scientific reports and
Other information
(e.g., FDAs Fish and Fishery Products Hazards and Control Guide).
The criteria for including a food-safety hazard in a processors HACCP

plan should be the likelihood that the hazard will occur or develop in that
product without proper controls (e.g., based on the processing technique,
the harvest location, the species).
An example of a hazard that is reasonably likely to occur is histamine in
certain fish species. Histamine reaction is one of the most frequently
reported illnesses from seafood. The relationship between time and
temperature abuse after harvest and the formation of the toxin is wellestablished.
It is the end product of the hazard analysis the HACCP plan and its
implementation that will be judged by the regulator and not the hazard
analysis itself. For this reason, the regulation does not require that the
hazard analysis be performed in any particular way or that it be documented in writing for regulatory review. However, a written hazard
analysis will help the processor remember the thought process used to
identify the hazards and develop the HACCP plan. This will be useful
when periodic plan reassessments are conducted and when the plan is
reviewed by regulators.
HACCP Plan 123.6(b)
Overhead 9
HACCP Plan 123.6(b)
Every processor shall have and implement a written HACCP plan
whenever a hazard analysis reveals one or more food-safety
hazards that are reasonably likely to occur.
Overhead 10
A HACCP plan shall be specific to:
Each processing location.
Each species of fish and type of fishery product.
When HACCP plan components are similar, some fish and fishery
products may be grouped under a single HACCP plan.
Continued
131

Notes:
HACCP Plan Contents 123.6(c)

Overhead 11
The HACCP plan shall:
List the food-safety hazards that are reasonably likely to occur.

List the CCPs.
List the critical limits.
List the monitoring procedures.
List predetermined corrective-action plans.*
List the verification measures.
Provide for a system of monitoring records.
* Processors are not required to predetermine corrective actions.
Food-safety hazards can include: natural toxins, microbiological contamination, chemical contamination, pesticides, drug residues, decomposition
that is related to safety (e.g., scombroid toxin-forming species), parasites
that are related to safety (e.g., fish used for raw consumption), unapproved food and color additives, and physical hazards. They can be
hazards that are introduced inside the processing plant or hazards that
occur before, during or after harvest.
The frequencies of the monitoring and verification procedures must be
included in the HACCP plan. Monitoring records must provide the actual
values or observations noted during monitoring.
Signing and Dating the HACCP Plan 123.6(d)
Overhead 12
The HACCP plan shall be signed and dated by:
The most responsible individual at the processing facility
or a higher level official of the processor.
This signature shall signify that the HACCP plan has been accepted
for implementation by the firm.
132
Overhead 13
Notes:
The HACCP plan shall be signed and dated:
Upon initial acceptance.

Upon any modification.*
At least annually.*
* This is a verification requirement.
Low Acid Canned Foods and Acidified Foods 123.6(e)

Processors who must comply with the requirements of part 113 or 114
(acidified and low-acid canned foods) of the CFR do not need to address
the hazard of Clostridium botulinum in their HACCP plans. Their HACCP
plans do not need to include controls to prevent that hazard, but they must
continue to comply with 113 or 114. Other hazards may be reasonably
likely to occur in an acidified or low-acid canned fishery product (e.g.,
histamine in canned tuna), and these must be addressed in the HACCP
plan as appropriate.
Sanitation Controls and the HACCP Plan 123.6(f)
Explanatory Note:
FDA recognizes that sanitation controls may be troublesome to manage in

a HACCP plan. It is often difficult to determine appropriate critical limits
and corrective actions for sanitation controls, particularly those relating to
personnel hygiene (e.g., hand washing). For this reason, the regulation
does not require that sanitation controls be included in the HACCP plan.
However, sanitation controls that are not in the plan must be monitored
according to the sanitation provisions of the regulation. Sanitation is
discussed in section 123.11.
HACCP plans will not be

preapproved by FDA before
they are implemented by the
processor. They should not be
submitted to the agency for
review. FDA reached this
decision because:
HACCP plans should be
evaluated on-site, a process
best accomplished during
inspections of processing
facilities.
FDA does not have sufficient resources to review
HACCP plans from all
domestic and foreign seafood
processors in advance of
HACCP implementation by
processors.
Legal Basis 123.6(g)

FDAs application of HACCP is primarily based on the Federal Food
Drug and Cosmetic Act. This section of the act makes it unlawful to
process food under conditions that may render it injurious to health. Any
fish or fishery products processed or imported in violation of this
regulation can be considered adulterated and subject to regulatory action.
Continued
133

Notes:
Corrective Action 123.7

Overhead 14
Corrective Action 123.7
Whenever a deviation from a critical limit occurs, a processor shall
take corrective action.
The regulation requires that a corrective action take place whenever a

critical limit is not met at a CCP.
Overhead 15
Corrective Actions Two Choices
Predetermined
Alternate Procedure
Segregate and hold product.
Determine product acceptability.
Apply corrective action to product and process.
Reassess the HACCP plan.
Processors have a choice of developing a predetermined corrective-action

plan in advance as part of their HACCP plans or of following the alternate
procedure for corrective actions provided in the regulation. When a
processor develops a plan in advance, he/she follows the plan that is
appropriate when the deviation occurs. These corrective-action plans
become part of their HACCP plans as previously described in section
123.6(c).
A predetermined corrective-action plan provides a processor with benefits
such as faster action when a deviation occurs and less need to justify to
management the appropriateness of the corrective action after it has been
taken. But unusual situations may arise that may not be addressed in
predetermined corrective-action plans. Processors may choose not to
predetermine their corrective actions. In these cases, the alternate
corrective-action procedure must be followed.
A proper corrective-action plan describes the steps that are to be taken and
assigns responsibility for taking those steps. It is designed to ensure that:
No product enters commerce that is either injurious to health or is
otherwise adulterated as a result of the deviation.
The cause of the deviation is corrected.
134

Notes:
The alternate corrective-action procedure involves:

Segregating and holding the affected product until the next two
requirements are met.
Determining whether the product is safe for distribution. This
decision must be made by someone who has suitable training
or experience. This training or experience must be in the field(s) of
science that is necessary for the person to understand the public
health consequences of the critical-limit deviation.
Take corrective action, as necessary, to ensure no unsafe product
enters commerce.
Take corrective action, as necessary, to fix the problem that caused
the deviation.
Determine whether the HACCP plan needs to be modified to reduce
the risk that the deviation will happen again and modify the HACCP
plan as necessary. This decision must be made by someone who has
met the training requirements covered in section 123.10.
All corrective actions must be fully documented in records.
Verification 123.8
Overhead 16
Every processor shall verify:
That the HACCP plan is adequate to control the food-safety

hazards that are reasonably likely to occur.
That the HACCP plan is implemented effectively.
Every processor must verify that the HACCP plan is adequate to control
food safety hazards that are reasonably likely to occur, and that the plan is
being effectively implemented. Verification must include, at a minimum,
reassessment of the HACCP plan, ongoing verification activities, and
record reviews.
The HACCP plan must be reassessed at least once per year and whenever
any changes occur that could affect the hazard analysis or the HACCP
plan in any way. This could include changes in:
Raw materials or source of raw materials.
Product formulation.
Processing methods or systems.
Finished product distribution systems.
The intended use or consumers of the finished product.
The purpose of the reassessment is to ensure that the HACCP plan is
adequate to control the food-safety hazards which are reasonably likely to
occur. It must be performed by an individual who meets the training
requirements described in section 123.10. If a processor has no HACCP
plan because no significant hazards were identified, then the hazard
analysis must be reassessed whenever any changes occur that could affect
the hazard analysis.
Continued
135

Notes:
The regulation requires ongoing verification activities in addition to

periodic reassessment. These ongoing activities are in keeping with the
HACCP principle that verification must ensure that the HACCP plan is
being implemented on a day-to-day basis. These ongoing verification
procedures must be listed in the HACCP plan.
Overhead 17
Ongoing verification:
Consumer complaint review.
Calibration of process-monitoring instruments.
Periodic end-product and in-process testing (processors option).
Records must be kept of the calibration procedures and end-product or inprocess testing that is performed as part of a processors HACCP
activities.
Consumer complaints must be reviewed by the processor to determine
whether they relate to problems at a CCP. The regulation does not give
regulators access to consumer complaints but does give them access to
corrective action records that relate to problems identified by consumer
complaints.
Overhead 18
Review of records:
CCP monitoring records.
Corrective-action records.
Calibration records.
In-process and end-product testing records.
Explanatory Note:
The regulation requires that processors review certain records as part of

verification. The purpose of these reviews is to ensure that the records
are complete and that the activities occurred in accordance with the
processors written procedures. The records must be reviewed by
someone who meets the training requirements described in section
123.10.
Importer and sanitation

records are not required to
be reviewed.
Monitoring and corrective-action records must be reviewed within one

week of when the record was made. Calibration and in-process or endproduct testing records must be reviewed in a timely manner.
Sometimes the review of a consumer complaint or the performance of
verification procedure will indicate a potential public-health problem.
When this happens, the processor must follow the corrective-action
procedures described in section 123.7.
136

Notes:
Records 123.9
Overhead 19
Records required by the regulation:
Monitoring records.
Corrective-action records.
Verification records.
Sanitation-control records.
Importer-verification records.
The records required by the regulation must:

Contain certain information.
Be completed at the time of the activity.
Be signed or initialed by the operator or observer.
Be retained for specified periods of time.
Be available for review and copying by regulatory authorities.
Overhead 20
Required information on each record:
Name and location of the processor or importer.
Date and time of the activity being recorded.
Signature or initials of the person making the record.
Identity of the product and the production code where appropriate.
Overhead 21
Record retention:
One year for refrigerated products.
Two years for frozen or preserved products.
If permanent storage at the processing facility is not practical (e.g.,

a remote processing site or a processing vessel), the records may be
transferred to some other facility at the end of the season. But the
records must be able to be promptly returned when requested by a
regulatory agency.
Continued
137

Notes:
A key feature of the HACCP verification process is access by government

inspectors to the the HACCP plan, monitoring records and correctiveaction records. Examination of HACCP records enables an inspector to
see how the processing facility operates over time rather than just on the
day of the inspection. Additionally, it enables the inspector to review the
adequacy of the processors preventive-control system.
FDA has concluded that records and plans should be protected to the
extent possible to promote the implementation of HACCP across the
seafood industry. The regulation generally states that HACCP plans and
records which come into FDAs possession will be treated as either trade
secrets or commercial confidential materials.
Training 123.10
The regulation requires that certain activities and functions be performed
by an individual trained in HACCP.
Overhead 22
The HACCP-trained individual shall:
Develop the HACCP plan.
Reassess and modify the HACCP plan and hazard analysis.
Review HACCP records.
Processors can use a trained employee or a trained third party to perform

these functions. The jobs may be done by one person or by several as long
as they have been properly trained. The regulation defines a HACCPtrained individual as one who has successfully completed training in the
application of HACCP principles to fish and fishery product processing
that is at least equivalent to that received under a standardized curriculum
recognized as adequate by the U.S. Food and Drug Administration or who
is otherwise qualified through job experience to perform these functions.
Job experience will qualify if it has provided knowledge at least equivalent to that provided through the standardized curriculum. This course
material, developed by the National Seafood HACCP Alliance, is the
standardized curriculum that has been recognized by FDA.
Sanitation Control Procedures (SCP) 123.11
Sanitation is a prerequisite program that is necessary for the effective
implementation of HACCP. In writing the seafood HACCP regulation,
FDA concluded that the GMP regulations (21 CFR 110) had not proven
fully effective in encouraging seafood processors to take full responsibility for ensuring that sanitation in their plants consistently met minimum
standards. For these reasons, the regulation requires that processors take
certain actions to control sanitation conditions and practices.
138

Notes:
These actions must be taken even if a processor determines there is no

need for a HACCP plan. The sanitation requirements of the regulation
may be made part of the processors HACCP plan or may be managed
separately. Some processors may choose to use a combination of these
approaches.
Overhead 23
General Requirement
Current GMP regulations are the standard for proper sanitation
conditions and practices.
Eight key sanitation conditions and practices.
Mandatory sanitation monitoring with record keeping.
Mandatory corrections with record keeping.
Recommended SSOP.
The SCP regulation encourages, but does not require, that each processor
develops a Sanitation Standard Operating Procedures (SSOP). The SSOP
should describe how the processor will ensure that certain key sanitation
conditions and practices will be met. It should also describe how the plant
operations will be monitored to ensure that the conditions and practices
will be met.
Whether or not a processor chooses to write an SSOP, the key sanitation
conditions and practices that are relevant to the plant must be monitored.
Overhead 24
Eight key sanitation conditions and practices:
Safety of water.
Condition and cleanliness of food-contact surfaces.
Prevention of cross-contamination.
Maintenance of hand-washing, hand-sanitizing and toilet facilities.
Protection from adulterants.
Labeling, storage and use of toxic compounds.
Employee health conditions.
Exclusion of pests.
The purpose of the monitoring is to ensure that the requirements of the

current GMP regulations are met. Monitoring frequencies are not
specified but must be sufficient to ensure that the current GMP requirements are met.
Continued
139

Notes:
When the conditions and practices contained in the current GMP

regulations are not met, they must be corrected in a timely manner.
Records must be kept of the monitoring and the corrections. These
records are subject to the same requirements as the HACCP records,
except plant-verification review.
Imported Products 123.12
It has always been the importers responsibility to offer for entry into this
country products that are not adulterated under U.S. law. FDAs surveillance system for imports has traditionally consisted of: reviews of
customs entry forms for fish and fishery products being offered for entry
into the United States, sensory analyses (wharf examinations) and sample
collections for laboratory anlysis of products awaiting entry, and automatic detention of products with a history of problems. As with traditional
processing-plant inspections, this method is a snapshot approach that is
not preventive.
Under the seafood HACCP regulation, HACCP controls are required for
imported fish and fishery products as well as for domestic products. The
definition of processor explicitly includes those who process seafood in
foreign countries. Additionally, the regulation requires that importers take
certain steps to verify that their foreign suppliers meet the requirements of
the regulation.
Overhead 25
Importer Verification:
Import from countries with a memorandum of understanding (MOU)
or
Implement verification procedures.
Importers may meet their obligation in one of two ways. They may
import fish and fishery products that are covered by memorandums of
understanding between the United States and a foreign country. In this
case, they do not need to take any other action to meet the requirements
of the regulation.
Otherwise, the importer must have and implement written verification
procedures for ensuring that the fish and fishery products offered for
import into the United States were processed in accordance with the
requirements of the regulation.
140

Notes:
Overhead 26
Importer Verification Procedures:
Product specifications and
Affirmative steps.
Product specifications should cover those characteristics of the product

that would be useful in providing assurance that the product is not
adulterated under section 402 of the Federal Food, Drug and Cosmetic
Act. This section relates to contaminants that may render the food
injurious to health and to insanitary processing conditions. It may be
appropriate for a specification for frozen tuna steaks to include a
maximum limit for histamine of 50 ppm.
Overhead 27
Importer Verification Procedures
Affirmative steps may include any of the following:
Obtain foreign processors HACCP and sanitation monitoring
records for the lot being entered.
Obtain continuing or lot-by-lot certificate from competent
third party.
Regularly inspect foreign processor.
Obtain foreign processors HACCP plan and written guarantee
that regulation is being met.
Test the product and obtain written guarantee that regulation
is being met.
Perform other verification procedures that provide equivalent
level of assurance.
An importer may hire a competent third party to perform verification

activities. However, the importer remains responsible for demonstrating
to FDA that the requirements have been met.
The importer must keep records in English that document that the
affirmative steps have been performed. The records must describe the
results of the steps. These records are subject to the records requirements
described in section 123.9. Importers that also process fish or fishery
products must also meet the HACCP and sanitation requirements of the
regulation for their processing operations.
Continued
141

Notes:
Smoked and Smoke-Flavored Fishery Products 123.15 and 123.16

Overhead 28
Smoked and Smoke-Flavored Fishery Products
HACCP plan must include controls for Clostridium botulinum
toxin formation for the shelf life of the product under normal and
moderate abuse conditions.
Where product is subject to 21 CFR 113 or 114, the HACCP
plan need not include such controls.
Smoked fish has been linked to a few cases of botulism. Clostridium

botulinum, the bacteria that causes botulism, is prevented from growing in
properly smoked fish by a combination of barriers, including salt, smoke,
nitrite and, in the case of hot-smoked fish, heat. Careful control of these
parameters is necessary to ensure the safety of the finished product. Such
controls must be included in the HACCP plans of these products, unless
the product is preserved by the addition of acid or heat under the controls
required by the acidified or low-acid canned food regulations (21 CFR
113 and 114).
It is important to note that if there are other significant hazards, they must
be included in the HACCP plan.
Raw Molluscan Shellfish 123.20 and 123.28
and Control of Communicable Diseases 1240.60
Overhead 29
Raw Molluscan Shellfish 123.20
HACCP plans must include a means for controlling the origin of
the raw molluscan shellfish.
Where processing includes a treatment that ensures the destruction
of vegetative cells of microorganisms of public health concern,
the HACCP plan need not include controls on sources of origin.
The largest number of reported illnesses from consumption of seafood is

caused by raw molluscan shellfish (oysters, clams and mussels). These
hazards are primarily introduced before the molluscan shellfish are
harvested. The risk of occurrence of these hazards is reduced by ensuring
that the molluscan shellfish come from sanitary growing waters. In most
cases, the sanitary quality of molluscan-shellfish growing waters is
determined by a state or national agency called a shellfish-control
authority.
142

Notes:
The regulation provides very specific requirements for controlling the

source of origin for raw molluscan shellfish. It is important to note,
however, that other hazards may also be reasonably likely to occur in
these products, and they must be identified in the HACCP plan.
Overhead 30
Processors shall only process molluscan shellfish from:
Growing waters approved by a shellfish-control authority.
Federal growing waters not closed by an agency of the federal
government.
Overhead 31
Shellstock Receiving
If source is a harvester, harvester must be in compliance with any
license requirement.
If source is another processor, processor must be certified by a
shellfish-control authority.
Containers of shellstock must be properly tagged.
Overhead 32
Required information on tag:
Date and place shellfish were harvested (state and site).
Type and quantity of shellfish.
Harvester identification number, name of harvester or name or
registration number of harvesters vessel.
Continued
143
Overhead 33
Notes:

Records for shellstock receiving must document:
Date of harvest.
Location of harvest by state and site.
Quantity and type of shellfish.
Date of receipt by the processor.
Name of harvester, name or registration number of the
harvesters vessel or harvesters identification number.
Overhead 34
Shucked molluscan shellfish containers must bear a label that
contains:
Name of packer or repacker.
Address of packer or repacker.
Certification number of packer or repacker.
Overhead 35
Records for shucked product must document:
Date of receipt.
Quantity and type of shellfish.
Name and certification number of the packer or repacker.
144
Chapter 14: Pathogen Growth & Toxin Formation

as a Result of Inadequate Drying (A Biological Hazard)

HAZARD.
Pathogen growth in the finished product as a result of
inadequate drying of fishery products can cause
consumer illness. Examples of dried fish products
are: salmon jerky; octopus chips; dried shrimp; and,
stock fish.
Control of drying
Dried products are usually considered shelf stable
and are, therefore, often stored and distributed
unrefrigerated. The characteristic of dried foods that
makes them shelf stable is their low water activity
(Aw). Water activity is the measure of the amount of
water in a food that is available for the growth of
microorganisms, including pathogens. A water
activity of 0.85 or below will prevent the growth and
toxin production of all pathogens, including Staphylococcus aureus and Clostridium botulinum, and is
necessary for a shelf-stable dried product. S. aureus
grows at a lower water activity than other pathogens,
and should, therefore, be considered the target
pathogen for drying for shelf-stable products.
Some dried products that are reduced oxygen packaged (e.g. vacuum packaged, modified atmosphere
packaged) are dried only enough to control growth
and toxin production by C. botulinum type E and
nonproteolytic types B and F, and are then refrigerated to control growth and toxin formation by
C. botulinum type A and proteolytic types B and F,
and other pathogens that may be present in the
product, including S. aureus. A water activity of
below 0.97 will prevent the growth of C. botulinum
type E and nonproteolytic types B and F, and is
necessary for these refrigerated, partially dried
products. More information on C. botulinum and
reduced oxygen packaging is contained in Chapter 13.
This chapter covers the control of the drying process

to prevent the growth and toxin production of pathogens, including S. aureus and C. botulinum in the
finished product. Such control is critical to product
safety.
This chapter does not cover the growth of pathogens,
including S. aureus, that may occur as a result of
time/temperature abuse during processing, including
before or during the drying process. That hazard is
covered in Chapter 12. It also does not cover the
control of C. botulinum type A and proteolytic types
B and F, and other pathogens that may be present,
including S. aureus, during refrigerated storage of
reduced oxygen packaged, partially dried products.
That hazard is covered in Chapters 12 and 13.
Controlling pathogen growth and toxin formation by
drying is best accomplished by:
Scientifically establishing a drying process that
reduces the water activity to 0.85 or below, if the
product will be stored and distributed unrefrigerated
(shelf-stable);
Scientifically establishing a drying process that
reduces the water activity to below 0.97, if the
product will be stored refrigerated (not frozen) in
reduced oxygen packaging;
Designing and operating the drying equipment so
that every unit of product receives at least the established minimum process;
Packaging the finished product in a container that
will prevent rehydration.
You should select a packaging material that will
prevent rehydration of the product under the expected
conditions of storage and distribution. Additionally,
finished product package closures should be free of
gross defects that could expose the product to
moisture during storage and distribution.
Chapter 14: Drying

191
Continued
Pathogen growth is not a concern in dried products

that are stored, distributed, displayed and sold frozen,
and are so labeled. These products need not meet the
control measures outlined in this chapter since drying
in this case is not critical to product safety. Similarly,
drying may not be critical to the safety of dried
products that are stored refrigerated, unless they are
reduced oxygen packaged, since refrigeration may be
sufficient to prevent pathogen growth in aerobically
packaged products.
The drying operation used in the production of
smoked or smoke-flavored fish is not designed to
result in a finished product water activity of 0.85 or
below. Drying controls for these products are described in Chapter 13.
Because spores of Clostridium botulinum are known
to be present in the viscera of fish, any product that
will be preserved by salting, drying, pickling, or
fermentation must be eviscerated prior to processing
(see Compliance Policy Guide sec. 540.650). Without evisceration, toxin formation is possible during
the process even with strict control of temperature.
Evisceration must be thorough and performed to
minimize contamination of the fish flesh. If even a
portion of the viscera or its contents is left behind, the
risk of toxin formation by C. botulinum remains.
Small fish, less than 5 inches in length, that are
processed in a manner that prevents toxin formation,
and that reach a water phase salt content of 10 percent
in refrigerated products, or a water activity of below
0.85 (Note: this value is based on the minimum water
activity for growth of S. aureus) or a pH of 4.6 or less
in shelf-stable products, are exempt from the evisceration requirement.
Strategies for controlling pathogen growth
Pathogens can enter the process on raw materials.
They can also be introduced into foods during processing from the air, unclean hands, insanitary
utensils and equipment, unsafe water, and sewage.
There are a number of strategies for the control of
pathogens in fish and fishery products. They include:
Controlling the amount of moisture that is available
for pathogen growth, water activity, in the product by
drying (covered in this chapter);

formulation (covered in Chapter 13);
Controlling the amount of salt or preservatives,
such as sodium nitrite, in the product (covered in
Chapter 13);
Controlling the level of acidity, pH, in the product
(covered by the acidified foods regulations, 21 CFR
114 for shelf-stable acidified products; and for
refrigerated acidified products in Chapter 13);
Managing the amount of time that food is exposed
to temperatures that are favorable for pathogen
growth and toxin production (covered in Chapter 12;
for C. botulinum, in Chapter 13; and for S. aureus in
hydrated batter mixes, in Chapter 15);
Killing pathogens by cooking (covered in Chapter
16), pasteurizing (covered in Chapter 17), or retorting
(covered by the low acid canned foods regulations,
21 CFR 113).
At each processing step, determine whether pathogen growth and toxin formation as a result of inadequate drying is a significant hazard. The criteria are:
1. For shelf-stable products, is it reasonably likely that
S. aureus will grow and form toxin in the finished
product if the product is inadequately dried?
Table #A-1 (Appendix 4) provides information on the

conditions under which S. aureus will grow. If your
food meets these conditions before drying, then
drying will usually be important to the safety of the
product, because it provides the barrier to S. aureus
growth. Under ordinary circumstances, it would be
reasonably likely that S. aureus will grow and form
toxin in such products during finished product
storage and distribution, if drying is not properly
performed. However, see also the information
contained in Intended use and method of distribution and storage, below.
Chapter 14: Drying

192
2. For shelf-stable products, can S. aureus toxin

formation, which is reasonably likely to occur, be
eliminated or reduced to an acceptable level at this
processing step? (Note: If you are not certain of the
answer to this question at this time, you may answer

No. However, you may need to change this answer
when you assign critical control points in Step #12.)
Pathogen growth and toxin formation as a result of
inadequate drying should also be considered a
preventive measure is, or can be, used to eliminate
(or reduce the likelihood of occurrence to an acceptable level) the hazard, if it is reasonably likely to occur.
3. For refrigerated (not frozen), reduced oxygen
packaged products, is it reasonably likely that
C. botulinum type E and nonproteolytic types B and F
will grow and form toxin in the finished product if the
product is inadequately dried?
Table #A-1 (Appendix 4) provides information on the

conditions under which C. botulinum type E and
nonproteolytic types B and F will grow. If your
refrigerated (not frozen), reduced oxygen packaged
food meets these conditions before drying, then
drying will usually be important to the safety of the
product, because it provides the barrier to growth
and toxin formation by C. botulinum type E and
nonproteolytic types B and F. Under ordinary
circumstances, it would be reasonably likely that
C. botulinum type E and nonproteolytic types B and
F will grow and form toxin in such products during
finished product storage and distribution, if drying
is not properly performed. However, see also the
information contained in intended use and method
of distribution and storage, below.
4. For refrigerated (not frozen), reduced oxygen
packaged products, can C. botulinum type E and
nonproteolytic types B and F toxin formation, which is
reasonably likely to occur, be eliminated or reduced to
an acceptable level at this processing step? (Note: If
you are not certain of the answer to this question at

this time, you may answer no. However, you may
need to change this answer when you assign critical
control points in Step #12.)
Pathogen growth and toxin formation as a result of

inadequate drying should be considered a significant
hazard at any processing step where a preventive
measure is, or can be, used to eliminate (or reduce to
the likelihood of occurrence to an acceptable level)
the hazard, if it is reasonably likely to occur.
Step #10 discusses a number of pathogen control
strategies. This chapter covers control of pathogens
by drying. Delivering a properly designed drying
process can be an effective preventive measure for
the control of pathogens. If this preventive measure
is applied list it in Column 5 of the Hazard Analysis
Worksheet at the drying step.
If the answer to question 1, 2, 3 or 4 is Yes the
potential hazard is significant at the drying step in the
recorded a No.
Intended use and method of distribution and storage
should also consider the intended use and method of
distribution and storage of the product, which you
developed in Steps #4 and 3, respectively. Because
of the highly stable nature of S. aureus toxin and the
extremely toxic nature of C. botulinum toxin, it is
unlikely that the intended use will affect the significance of the hazard.
However, the hazard may not be significant if: 1) the
product is immediately frozen after processing,
maintained frozen throughout distribution, and
labeled to be held frozen and to be thawed under
refrigeration immediately before use (e.g. Important, keep frozen until used, thaw under refrigeration
immediatley before use); or 2) the product is
Chapter 14: Drying

193
Continued
unpackaged or aerobically packaged, and is distributed refrigerated throughout the chain of commerce,
and is labeled to be kept refrigerated. In both of
these cases, the hazard of pathogen growth is controlled by the control of temperature, rather than by
the drying of the product. In these cases, you may
enter No in Column 3 of the Hazard Analysis
Worksheet for each of the processing steps. In
addition, for each No entry briefly explain in
Column 4 that the hazard is controlled by freezing or
refrigeration. In this case, you need not complete
Steps #12 through 18 for this hazard. However, refer
to Chapter 12 for the control of pathogen growth by
refrigeration.
A salmon jerky processor could set the critical

control point for controlling the hazard of pathogen
growth and toxin formation as a result of inadequate
drying at the drying step. The processor would not
need to identify the processing steps prior to drying
as critical control points for that hazard. However,
these steps may be CCPs for the control of other
hazards, such as the growth of pathogens as a result
of time/temperature abuse during processing, covered
by Chapter 12.

HACCP Plan Form
For each processing step where pathogen growth

and toxin formation as a result of inadequate drying
determination.
For the drying step, identify the maximum or minimum value to which a feature of the process must be
controlled in order to control the hazard.

You should identify the drying step as the critical

control point for this hazard. Therefore, you should
answer Yes in Column 6 of the Hazard Analysis
Worksheet at the drying step and No in that column
for the other processing steps for which the hazard
was identified as a significant hazard. In addition,
for each No entry make sure that Column 5 indicates that the hazard is controlled at the drying step.
(Note: if you have not previously identified pathogen growth and toxin formation as a result of inadequate drying as a significant hazard at the drying
step in Column 3 of the Hazard Analysis Worksheet,
you should change the entry in Column 3 to Yes.)
safety of the product is questionable. If you set a
more restrictive CL you could, as a result, be required to take corrective action when no safety
with the closeness of typical operating values to the CL.
drying step.
This control approach is referred to as Control

Strategy Example 1 in Steps #14-18. It is important
to note that you may select a control strategy that is
different from that which is suggested above, provided that it assures an equivalent degree of safety of
the product.
Example:
Chapter 14: Drying
194
CONTROL STRATEGY EXAMPLE 1 CONTROL OF DRYING

Critical Limit: The minimum or maximum values for
the critical factors established by a scientific

study (i.e. for shelf-stable products, those which
must be met in order to ensure that the finished
product has a water activity of 0.85 or less; for
refrigerated [not frozen], reduced oxygen
packaged products, those which must be met in
order to ensure that the finished product has a
water activity of less than 0.97). These will
likely include drying time, input/output air
temperature, humidity, and velocity, and flesh
thickness. Other critical factors that affect the
rate of drying of the product may also be
established by the study;
OR
The minimum percent weight loss established by
a scientific study (i.e. for shelf-stable products,
those which must be met in order to ensure that
the finished product has a water activity of 0.85
or less; for refrigerated [not frozen], reduced
oxygen packaged products, those which must be
met in order to ensure that the finished product
has a water activity of less than 0.97);
OR
For shelf-stable products: Maximum finished
product water activity of 0.85 or less;
OR
For refrigerated (not frozen), reduced oxygen
packaged products: Maximum finished product
water activity of less than 0.97.
Plan Form.
PROCEDURES.
It is important for you to keep in mind that the feature

of the process that you monitor and the method of
monitoring should enable you to determine whether
the CL is being met. That is, the monitoring process
should directly measure the feature for which you
have established a CL.
procedures for the drying step. Note that the monitoring frequencies that are provided are intended to
be considered as minimum recommendations, and
may not be adequate in all cases.
What: Critical factors of the established drying
process that affect the ability of the process to

ensure the desired finished product water activity
(i.e. 0.85 or below for shelf stable products, less
than 0.97 for refrigerated [not frozen], reduced
oxygen packaged products). These may include
drying time, air temperature, humidity, and
velocity, and flesh thickness;
OR
Percent weight loss;
OR
Water activity.
For the drying step, describe monitoring procedures

that will ensure that the critical limits are consistently
met.
Chapter 14: Drying

195
Continued
OR
Using all or a portion of the lot, determine
the percent weight loss by weighing the product
before and after drying;
OR
Collect a representative sample of finished
product and conduct water activity analysis.
For batch drying equipment:

How: Monitor the drying time and the input/output
air temperature (as specified by the study) with a

temperature recording device or digital time/
temperature data logger. The device should be
installed where it can be easily read and the
sensor for the device should be installed to
ensure that it accurately measures the air input/
output temperature;
AND
Monitor all other critical factors specified by the
study with equipment appropriate for the
measurement;
OR
Using all or a portion of the batch, determine
the percent weight loss by weighing the product
before and after drying;
OR
Collect a representative sample of finished
product and conduct water activity analysis.

(Frequency)?

Frequency: Temperature requirements of the drying
process should be monitored continuously by the

instrument itself, with visual check of the
monitoring instrument at least once per batch;
AND
Time requirements of the drying process should
be monitored for each batch;
AND
study as often as necessary to maintain control;
OR
For continuous drying equipment:
Percent weight loss should be determined for

each batch of finished product;
How: Monitor the input/output air temperature (as
specified by the study) with a temperature

recording device or digital time/temperature data
logger. The device should be installed where it
can be easily read and the sensor for the device
should be installed to ensure that it accurately
measures the air input/output temperature;
AND
Monitor the time by measuring either:
The RPM of the belt drive wheel, using a stop
watch or tachometer;
OR
The time necessary for a test unit or belt
marking to pass through the equipment, using a
stop watch;
AND
study with equipment appropriate for the
measurement;
OR
Water activity should be determined for each
batch of finished product.
Frequency: Temperature requirements of the drying
process should be monitored continuously by the

instrument itself, with visual check of the
monitoring instrument at least once per day;
AND
Time requirements of the drying process should
be monitored at least once per day, and whenever
any changes in belt speed are made;
AND
Monitoring of all other critical factors specified
by the study as often as necessary to maintain
control;
Chapter 14: Drying

196
OR
Percent weight loss should be determined for
each lot of finished product;
OR
Water activity should be determined for each lot
of finished product.
an understanding of the operation of the

equipment and the critical limit. In assigning
responsibility for monitoring you should
consider the complexity of the monitoring
equipment. For example, accurately performing
water activity analyses requires considerable
training.
CONTROL OF DRYING

ACTION PROCEDURES.

Who: Time and temperature monitoring is
performed by the equipment itself. However, a

visual check should be made of the recorded data
at least once at the end of each cycle in order to
ensure that the critical limits have consistently
been met. These checks, as well as the monitoring
of the other critical factors in the drying process,
the percent weight loss, or the water activity may
be performed by the equipment operator, a
production supervisor, a member of the quality
control staff, a member of the maintenance or
engineering staff, or any other person who has an
understanding of the operation of the equipment
and the critical limit. In assigning responsibility
for monitoring you should consider the complexity
of the monitoring equipment. For example,
accurately performing water activity analyses
requires considerable training.
Who: Temperature monitoring is performed by the
equipment itself. However, a visual check

should be made of the recorded data at least daily
in order to ensure that the critical limits have
consistently been met. These checks, as well as
the monitoring of the drying time and the other
critical factors in the drying process, the percent
weight loss, or the water activity may be
performed by the equipment operator, a
control staff, a member of the maintenance or
engineering staff, or any other person who has
For the drying step, describe the procedures that you

will use when your monitoring indicates that the CL
has not been met. These procedures should: 1)
ensure that unsafe product does not reach the consumer; and, 2) correct the problem that caused the
CL deviation. Remember that deviations from
operating limits do not need to result in formal corrective actions.
action procedures for the drying step.
following actions as necessary to regain control

over the operation after a CL deviation:
Adjust the air temperature or velocity;
OR
Adjust the length of the drying cycle to
compensate for a temperature or velocity drop,
humidity increase, or inadequate percent
weight loss;
OR
Adjust the belt speed to increase the length of
the drying cycle;
AND
When there has been a failure to maintain
specified critical factors of the drying process, or
when the prescribed minimum percent weight
loss is not met, take one of the following actions
to the product involved in the deviation:
Chapter 14: Drying

197
Continued
OR
Redry the product (provided that redrying does
not present an unacceptable opportunity for
pathogen growth);
OR
Segregate and hold the product (under
refrigerated conditions) for an evaluation of
the adequacy of the drying process. The
evaluation may involve water activity determi
nation on a representative sample of the finished
product. If the evaluation shows that the
product has not received an adequate drying
process the product should be destroyed,
diverted to a non-food use, or redried;
OR
Divert the product to a use in which the critical
limit is not applicable because pathogen growth
in the finished product will be controlled by
means other than drying (e.g. divert inadequately
dried fish to a frozen fish operation);
OR
Divert the product to a non-food use.
AND
When finished product testing shows that the
water activity is above 0.85, take one of the
following actions to the product involved in the
deviation:
OR
Re-dry the product (where re-drying does not
create a hazard for pathogen growth);
OR
limit is not applicable because pathogen
growth in the finished product will be
controlled by means other than drying (e.g.
divert inadequately dried fish to a frozen fish
operation);
OR
Divert the product to a non-food use.

SYSTEM.

OR
For the drying step, list the records that will be used
to document the accomplishment of the monitoring
procedures discussed in Step #15. The records
should clearly demonstrate that the monitoring
procedures have been followed, and should contain
the actual values and observations obtained during
monitoring. Following is guidance on establishing a
recordkeeping system for the drying step.

Records: Temperature recorder charts or digital
time/temperature data logger printout;

AND
Records that are appropriate for the other critical
factors (e.g. drying log that indicates input/output
air humidity and/or velocity);
OR
Records of weight before and after drying;
OR
Records of water activity analysis for each lot
of product.
Records: Temperature recorder charts or digital
time/temperature data logger printout;

AND
Drying log that indicates the RPM of the belt
drive wheel or the time necessary for a test unit
or belt marking to pass through the drier;
AND
Records that are appropriate for the other critical
factors (e.g. drying log that indicates input/output
air humidity and/or velocity);
Records of weight before and after drying;
OR
Records of water activity analysis for each lot
of product.
Chapter 14: Drying

198

PROCEDURES.
For the drying step, establish verification procedures
that will ensure that the HACCP plan is: 1) adequate
to address the hazard of pathogen growth and toxin
formation as a result of inadequate drying; and, 2)
consistently being followed. Following is guidance
on establishing verification procedures for the drying
step.
Verification: Process establishment (except where
finished product water activity analysis is the

monitoring procedure): The adequacy of the
drying process should be established by a
scientific study. For shelf-stable products, it
should be designed to ensure the production of a
shelf stable product with a water activity of 0.85.
For refrigerated (not frozen), reduced oxygen
packaged products, it should be designed to
ensure a finished water activity of less than 0.97.
Expert knowledge of drying process calculations
and the dynamics of mass transfer in processing
equipment is required to establish such a drying
process. Such knowledge can be obtained by
education or experience or both. Establishment
of drying processes requires access to adequate
facilities and the application of recognized
methods. The drying equipment must be
designed, operated and maintained to deliver the

established drying process to every unit of
product. In some instances, drying studies will
be required to establish the minimum process.
In other instances, existing literature which
establish minimum processes or adequacy of
equipment, are available. Characteristics of the
process, product and/or equipment that affect the
ability of the established minimum drying
process should be taken into consideration in the
process establishment. A record of the process
establishment should be maintained;
AND
Finished product sampling and analysis to
determine water activity at least once every three
months (except where such testing is performed
as part of monitoring);
AND
Check the accuracy of the temperature recording
device or digital time/temperature data loggers
against a known accurate thermometer
(NIST-traceable) at least once per day;
AND
Calibrate other instruments as necessary to
ensure their accuracy;
AND
Review monitoring, corrective action, and
preparation.
HACCP Plan Form.
Chapter 14: Drying

199
Chapter 14: Drying

200
Pathogen growth and

toxin formation
Drying (forced
convection oven)
Digital time/
temperature
data logger
Digital time/
temperature
data logger
Drying time
Oven air input

temperature
Minimum drying time

5 hours
Minimum oven
temperature 140oF
Once per day

before
operations
Frequency
(6)
Slicer operator
Who
(7)
Readjust slicer
(8)
Corrective
Action(s)
To achieve a final water

activity of 0.85 or less
Continuous,
with visual
check each
batch
Continuous,
with visual
check each
batch
Oven operator
Oven operator
Segregate
product and hold
for evaluation.
Evaluate by
performing
water activity
analysis on
finished product.
Re-dry if more
than 0.85
Extend drying
process
Continue drying
Se
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mm
en
da
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Preset slicer to
just less than
1/4"
How
What
Monitoring
Product
thickness
(5)
(4)
Maximum product
thickness 1/4"
(3)
Critical Limits
for each Preventive
Measure
Data logger
printout
Data logger
printout
Processing log
(9)
Records
Note: The critical limits in this example are for illustrative purposes only, and are not related to any recommended process.
(2)
Significant
Hazard(s)
(1)
Critical Control
Point (CCP)
Analyze
finished product
sample once
every 3 months
for water
activity
Check the
accuracy of the
data logger
daily.
Review
monitoring,
verification and
corrective
action records
within one
week of
preparation
Documentation
of drying
process
establishment
(10)
Verification
This table is an example of a portion of a HACCP plan relating to the control of pathogen growth and toxin formation
as a result of inadequate drying for a processor of shelf-stable salmon jerky, using Control Strategy Example 1 - Control of drying.
It is provided for illustrative purposes only. Pathogen growth and toxin formation as a result of inadequate drying may be
only one of several significant hazards for this product. Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3)
for other potential hazards (e.g. aquaculture drugs, chemical contaminants, parasites, and metal fragments).
Control Strategy Example 1 - Control of drying
TABLE #14-1
Chapter 15: Staphylococcus aureus Toxin Formation

in Hydrated Batter Mixes (A Biological Hazard)

HAZARD.

Staphylococcus aureus toxin formation in hydrated

batter mixes can cause consumer illness. This toxin
in particular is a concern because the toxin cannot be
destroyed by heating steps that may be performed by
the processor or the consumer. Pathogens other than
S. aureus, such as those described in Chapter 12, are,
in many cases, less likely to grow in hydrated batter
mixes, and are likely to be killed by the heating steps
that follow.

growth and toxin production (covered in this chapter
for S. aureus in hydrated batter mix; Chapter 13 for
C. botulinum; and Chapter 12 for other pathogens
and conditions);
Control of Staphylococcus aureus in batter mixes

S. aureus can enter the process on raw materials. It
can also be introduced into foods during processing
from unclean hands and insanitary utensils and
equipment.
The hazard develops when a batter mix is exposed to
temperatures favorable for S. aureus growth for
sufficient time to permit toxin development. S. aureus
toxin does not normally reach levels that will cause
food poisoning until the numbers of the pathogen
reach 100,000 to 1,000,000/gram. S. aureus will
grow at temperatures as low as 41-43F (5.0-6.1C)
and at a water activity as low as .85 (additional
information on conditions favorable to
S. aureus growth are provided in Table #A-1 (Appendix 4). However, toxin formation is not likely at
temperatures lower than 50F (10C). For this
reason, toxin formation can be controlled by minimizing exposure of hydrated batter mixes to temperatures above 50F (10C). Exposure times greater
than 12 hours for temperatures between 50F (10C)
and 70F (21.1C) could result in toxin formation.
Exposure times greater than 3 hours for temperatures
above 70F (21.1C) could also result in toxin
formation.

21 CFR 113);
drying (covered in Chapter 14);
formulation (covered in Chapter 13);
Chapter 13);
refrigerated acidified products in Chapter 13).
Chapter 15: Batter

201
Continued

At each processing step, determine whether
S. aureus toxin formation in hydrated batter mixes
is a significant hazard. The criteria are:
1. Is it reasonably likely that S. aureus will grow and
form toxin in the hydrated batter mix at the hydrated
batter mix storage/recirculation step?
Remember that you should consider the potential for

time/temperature abuse in the absence of controls.
You may already have controls at the hydrated batter
mix storage/recirculation step that minimize the
potential for time/temperature abuse that could result
in S. aureus growth and toxin formation. This and
the following steps will help you determine whether
those or other controls should be included in your
HACCP plan.
Step #10 provides information to help you decide if
the time/temperature conditions of your hydrated
batter mix storage/recirculation step are significant
for this hazard.
2.Can S. aureus growth and toxin formation, which is
reasonably likely to occur, be eliminated or reduced to
an acceptable level at this processing step?
(Note: If you are not certain of the answer to this

question at this time, you may answer No. However, you may need to change this answer when you
assign critical control points in Step #12.)
S. aureus toxin formation in hydrated batter mixes
should also be considered a significant hazard at any
processing step where a preventive measure is, or can
be, used to eliminate (or reduce the likelihood of
occurrence to an acceptable level) the hazard, if it is
reasonably likely to occur.

strategies. This chapter covers control of S. aureus
toxin formation that occurs as a result of time/
temperature abuse at the hydrated batter mix storage/
recirculation step. A preventive measure for toxin
formation can include controlling the amount of time
that batter mixes are exposed to temperatures above
50F (10C).
List this preventive measure in Column 5 of the
Hazard Analysis Worksheet at the batter mix storage/
recirculation step.
the Hazard Analysis Worksheet. If none of the
criteria is met you should answer No. You should
record the reason for your Yes or No answer in
Column 4. You need not complete Steps #12 through
18 for this hazard for those processing steps where
you have recorded a No.
step will help you determine where the critical
control point is located.
Intended use
which you developed in Step #4. However, because
of the highly stable nature of S. aureus toxin, it is
Chapter 15: Batter

202
STEP #12: IDENTIFY CRITICAL CONTROL

POINTS (CCP).
HACCP Plan Form

For each processing step where S. aureus growth

and toxin formation in hydrated batter mixes is
determination.
You should identify the hydrated batter mix storage/
recirculation step as the critical control point for this
hazard. For hand battering operations, where hydrated batter mix is stored at each hand battering
station, each station should be identified as a CCP.
the product.
You should answer Yes in Column 6 of the Hazard
Analysis Worksheet at the hydrated batter mix
storage/recirculation step and No in that column
for the other processing steps for which the hazard
was identified as a significant hazard. In addition,
for each No entry make sure that Column 5 indicates that the hazard is controlled at the hydrated
batter mix storage/recirculation step. (Note: if you
have not previously identified S. aureus growth and
toxin formation in hydrated batter mixes as a
significant hazard at the hydrated batter mix storage/
recirculation step in Column 3 of the Hazard Analysis Worksheet, you should change the entry in
Column 3 to Yes.)
Example:
A breaded fish processor could set the critical control
point for controlling the hazard of S. aureus growth
and toxin formation in hydrated batter mixes at the
hydrated batter mix storage/recirculation step. The
processor would not need to identify other processing
steps as critical control points for that hazard.
For the hydrated batter mix storage/recirculation step,

identify the maximum or minimum value to which a
feature of the process must be controlled in order to
control the hazard.
safety of the product may be questionable. If you set
hydrated batter mix storage/recirculation step.
CONTROL STRATEGY EXAMPLE 1 HYDRATED BATTER MIX CONTROL
Critical Limit: Hydrated batter mix temperatures
should not exceed 50F (10C) for more than

twelve hours, cumulatively;
AND
Hydrated batter mix temperatures should not
exceed 70F (21.1C) for more than three hours,
cumulatively.
Plan Form.

Chapter 15: Batter
203
Continued

PROCEDURES.


describe monitoring procedures that will ensure that
the critical limits are consistently met.
HYDRATED BATTER MIX CONTROL

How: Use a digital time/temperature data logger;
OR
Use a recorder thermometer;
OR
Use a maximum indicating thermometer;
OR
Use a high temperature alarm;
OR
Use an indicating thermometer.
(Frequency)?

procedures for the hydrated batter mix storage/
recirculation step. Note that the monitoring frequencies that are provided are intended to be considered
as minimum recommendations, and may not be

Frequency: Continuous monitoring, with visual
check at least once per day;

OR
For indicating thermometers: at least every two
hours.
Who: With recorder thermometers, high temperature

What: The temperature of the hydrated batter mix.
alarms, maximum indicating thermometers, and

digital data loggers, monitoring is performed by
the equipment itself. However, when such
instruments are used, a visual check should be
made at least once per day in order to ensure that
the critical limits have consistently been met.
These checks, as well as indicating thermometer
checks, may be performed by a production
employee, a production supervisor, a member of
has an understanding of the process and the
monitoring procedure.
Chapter 15: Batter

204


SYSTEM.

ACTION PROCEDURES.
describe the procedures that you will use when your
monitoring indicates that the CL has not been met.
action procedures for the hydrated batter mix storage/
recirculation step.

list the records that will be used to document the
accomplishment of the monitoring procedures
recordkeeping system for the hydrated batter mix
storage/recirculation step.
CONTROL STRATEGY EXAMPLE 1 Records: Printout from digital time/temperature

following actions to regain control over the

operation after a CL deviation:
Add ice to the hydrated batter mix storage/
recirculation tank;
OR
Make repairs or adjustments to the hydrated
batter mix refrigeration equipment;
AND
Take one of the following actions to product
involved in the critical limit deviation:
Destroy the product and the remaining
hydrated batter mix;
OR
Divert the product and the remaining hydrated
batter mix to a non-food use;
OR
Hold the product and hydrated batter until it
can be evaluated based on its total time/
temperature exposure;
OR
Hold the product and hydrated batter
mix until the hydrated batter mix can be
sampled and analyzed for the presence of
staphylococcal enterotoxin.
data logger;
OR
Recorder thermometer chart;
OR
Record showing the results of the maximum
indicating thermometer checks;
OR
Record showing the results of the high
temperature alarm checks;
OR
Record showing the results of the indicating
thermometer checks.
Chapter 15: Batter

205
Continued

PROCEDURES.

Verification: Review monitoring, corrective action,

establish verification procedures that will ensure that
the HACCP plan is: 1) adequate to address the hazard
of S. aureus growth and toxin formation in hydrated
batter mixes; and, 2) consistently being followed.
procedures for the hydrated batter mix storage/
recirculation step.
and verification records within one week of

preparation;
AND
When digital time/temperature data loggers,
recorder thermometers, or high temperature
alarms are used, check for accuracy against a
known accurate thermometer (NIST-traceable) at
least once per day;
AND
When indicating thermometers or maximum
indicating thermometers are used, check for
accuracy against a known accurate thermometer
(NIST-traceable) when first used and at least
once per year thereafter. (Note: optimal
calibration frequency is dependent upon the
type, condition, and past performance of the
monitoring instrument.)
HACCP Plan Form.
Chapter 15: Batter

206
Chapter 15: Batter

207
Batter mix
recirculation
(1)
Critical Control
Point (CCP)
Recorder
thermometer
How
What
Hydrated batter
mix temperature
(5)
(4)
(6)
Continuous with
visual check once
per day
Frequency
Monitoring
Production
employee
Who
(7)
Adjust hydrated
batter mix
refrigeration
equipment
(8)
Corrective
Action(s)
Destroy
hydrated batter
mix and any
product
produced during
deviant period
Se
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Fu le
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mm
en
da
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ns
Hydrated batter mix

temperature not to
exceed 50oF for more
than 12 hrs, nor 70oF for
more than 3 hrs,
cumulative
(3)
Critical Limits
for each Preventive
Measure
Recorder
thermometer
chart
(9)
Records
S. aureus growth and

toxin formation
(2)
Significant
Hazard(s)
Review
monitoring,
corrective
action and
verification
records within
one week of
preparation
Check accuracy
of recorder
thermometer
once per day;
(10)
Verification
This table is an example of a portion of a HACCP plan relating to the control of S. aureus toxin formation in hydrated batter
mixes for a breaded fish processor, using Control Strategy Example 1 - Hydrated batter mix control. It is provided for illustrative
purposes only. S. aureus toxin formation in the hydrated batter mix may be only one of several significant hazards for this product.
Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3) for other potential hazards (e.g. chemical contaminants and metal fragments).
Control Strategy Example 1 - Hydrated batter mix control
TABLE #15-1
Notes:
Chapter 15: Batter

208
Chapter 18: Introduction of Pathogens After Pasteurization

and Specialized Cooking Processes (A Biological Hazard)

HAZARD.
The introduction of pathogens after pasteurization and
certain cooking processes can cause consumer illness.
Pasteurization is a mild or moderate heat treatment,
usually performed on fishery products after the
product is placed in the hermetically sealed finished
product container. The purpose of pasteurization is to
either: 1) make the product safe for an extended
refrigerated shelf-life, which, in most cases, involves
eliminating the spores of Clostridium botulinum type
E and nonproteolytic B and F (the types of C. botulinum most commonly found in fish); or 2) eliminate or
reduce the numbers of other target pathogens (e.g.
Listeria monocytogenes, Vibrio vulnificus, Vibrio
parahaemolyticus).
In addition to eliminating pathogens, the pasteurization process also greatly reduces the number of
spoilage bacteria present in the fishery product.
These bacteria normally restrict the growth of pathogens through competition. Rapid growth of pathogens that may be introduced after pasteurization is,
therefore, a concern. This chapter covers control of
recontamination after pasteurization.
For some products that are marketed refrigerated,
cooking is performed immediately before reduced
oxygen packaging (e.g. vacuum packaging, modified
atmosphere packaging). For these products, the
cooking process is targeted to eliminate the spores of
types B and F, particularly when the product does not
contain other barriers that are sufficient to prevent
growth and toxin formation by this pathogen (e.g.
many refrigerated, vacuum packaged hot-filled soups
and sauces). These cooking processes, which are
discussed in Chapter 16, have much in common with
pasteurization processes, which are discussed in

Chapter 17. For example, control of recontamination
after they are placed in the finished product container
is critical to the safety of these products. Additionally, because these products are cooked before they
are packaged, they are at risk for recontamination
between cooking and packaging. The risk of this
recontamination is minimized by filling the container
in a continuous filling operation while the product is
still hot (i.e. hot filling), another critical step for the
safety of these products. This control strategy is
suitable for products that are filled directly from the
cooking kettle, where the risk of recontamination is
minimized. It is not ordinarily suitable for products
such as crabmeat, lobster meat, or crayfish meat, or
other products that are handled between cooking and
filling. Hot filling is covered in this chapter.
Control of pathogen introduction after pasteurization
and after cooking that is performed immediately before
reduced oxygen packaging
There are three primary causes of recontamination

after pasteurization and after cooking that is performed immediately before reduced oxygen packaging. They are:
Defective container closures;
Contaminated container cooling water;
Recontamination between cooking and reduced
oxygen packaging.
Poorly formed or defective container closures can
increase the risk of pathogens entering the container,
especially during container cooling performed in a
water bath. Contaminated cooling water can enter
through the container closure, especially when the
closure is defective. Container closure can be
controlled by adherence to seal guidelines that are
provided by the container or sealing machine manufacturer. Control is accomplished through periodic
seal inspection.
Chapter 18: Post-pasteurization

227
Continued
Contamination of cooling water can be controlled by

ensuring that a measurable residual of chlorine, or
other approved water treatment chemical, is present
in the cooling water, or by ensuring that ultraviolet
(UV) treatment systems are operating properly.
Recontamination between cooking and reduced
oxygen packaging in continuous filling systems
where the product is packaged directly from the
kettle can be controlled by hot filling at temperatures
at or above 185F (85C). FDA is interested in
information on the value of adding a time component
(e.g. 3 minutes) to this hot filling temperature
recommendation, to provide limited lethality for any
nonproteolytic C. botulinum spores present on the
packaging material.
It may also be prudent to use packaging that has been
manufactured or treated to inactivate spores of C.
botulinum type E and nonproteolytic types B and F
(e.g. gamma irradiation, hot extrusion). FDA is
interested in comment on the utility of such measures.
Controlling the amount of moisture that is available for pathogen growth, water activity, in the
product by formulation (covered in Chapter 13);
Chapter 13);
growth and toxin production (covered in Chapter 12;
for C. botulinum, in Chapter 13; and for S. aureus in
batter mix, in Chapter 15).
At each processing step determine whether introduction of pathogens after pasteurization is a
significant hazard. The criteria are:
1. Is it reasonably likely that pathogens will be introduced at this processing step (consider post-pasteurization processing steps, only)?

Controlling the introduction of pathogens after the
pasteurization process and after cooking process
performed immediately before reduced oxygen
packaging (covered in this chapter);
21 CFR 113);
refrigerated acidified products in Chapter 13);
It is reasonable to assume that, in the absence of

controls, pathogens of various types may enter the
finished product container during a water bath
cooling process or between cooking and reduced
oxygen packaging.
2. Can the introduction of pathogens after pasteurization be eliminated or reduced to an acceptable level
here? (Note: If you are not certain of the answer to
this question at this time, you may answer No.

However, you may need to change this answer when
you assign critical control points in Step #12)
Introduction of pathogens after pasteurization
should also be considered a significant hazard at any
processing step where a preventive measure is, or
can be, used to eliminate (or reduce the likelihood of
occurrence to an acceptable level) the hazard, if it is
reasonably likely to occur.

drying (covered in Chapter 14);

228

strategies. This section covers control of pathogen
introduction that can occur after the pasteurization
process and between cooking and reduced oxygen
packaging. Preventive measures for the introduction
of pathogens at these times can include:
Controlling container sealing;
Controlling the residual of chlorine, or other
approved water treatment chemical, in container
cooling water;
Controlling UV light intensity of bulbs used for
treating container cooling water and the flow rate
of the cooling water moving through the UV
treatment system;
Hot filling the product into the final container in a
continuous filling system.
processing step(s).
recorded a No.
Intended use and method of storage and distribution
which you developed in Step #4. However, for those
fishery products which are currently pasteurized, it is
However, if your product is immediately frozen after

processing, maintained frozen throughout distribution, and labeled to be held frozen and to be thawed
under refrigeration immediately before use (e.g.
Important, keep frozen until used, thaw under
refrigeration immediately before use), then formation of C. botulinum toxin may not be a significant
hazard.
For each processing step where introduction of
pathogens after pasteurization is identified in
Column 3 of the Hazard Analysis Worksheet as a
significant hazard, determine whether it is necessary
to exercise control at that step in order to control the
hazard. Figure #A-2 (Appendix 3) is a CCP decision
tree that can be used to aid you in your determination.
You should identify the container sealing step, the
water bath container cooling step, and the hot filling
step (where applicable) as the critical control points
for this hazard. Therefore, you should answer Yes
in Column 6 of the Hazard Analysis Worksheet for
the container sealing, water bath container cooling,
and hot filling steps. (Note: if you have not previously identified pathogen introduction after pasteurization as a significant hazard at the container
sealing, water bath container cooling, and hot filling
steps in Column 3 of the Hazard Analysis Worksheet,
you should change the entries in Column 3 to Yes).
This control approach is referred to as Control
the product.

229
Continued
HACCP Plan Form
For hot filling:
Critical Limit: Product temperature of 185F (85C) or
higher as the product enters the final container.

At each processing step where introduction of
pathogens after pasteurization is identified as a
significant hazard on the HACCP Plan Form (e.g.
container sealing, water bath container cooling and
hot filling) identify the maximum or minimum value
with the closeness of typical operating values to the
CL.
control strategy example identified in Step #12.
CONTROL STRATEGY EXAMPLE 1 CONTROL OF RECONTAMINATION
For container sealing:

Plan Form.
PROCEDURES.
For each processing step where introduction of
significant hazard on the HACCP Plan Form (e.g.
container sealing, container cooling tank and hot
filling), describe monitoring procedures that will
Critical Limit: Container or sealing machine
manufacturers seal guidelines.

For container cooling:
Critical Limit: Measurable residual of chlorine, or
other approved water treatment chemical, at the

discharge point of the container cooling tank;
OR
Equipment manufacturers UV light intensity and
flow rate guidelines.

procedures for the control option discussed in Step
#12. Note that the monitoring frequencies that are
provided are intended to be considered as minimum
recommendations, and may not be adequate in all
cases.

230


What: Container integrity

What: Residual chlorine, or other approved water
treatment chemical, in the cooling water;

OR
Intensity of UV light;
AND
Cooling water flow rate.
For hot filling:
What: Product temperature as the product enters the
final container.

How: Visual examination of containers
(non-destructive):
Recommendations for visual examinations that
ensure a reliable hermetic seal should be
obtained from the container or sealing machine
manufacturer. They should include:
- For double seamed metal and plastic cans:
The external features of the double seam
should be examined for gross closure defects,
including: cutovers, seam sharpness, false
seams, deadheading, droop, damage to the
countersink wall indicating a broken chuck,
cable cuts, and product overlapping the
flange. In addition, visual examination
should include examination of the entire
container for product leakage or other
obvious defects;
OR
- For pouches: Visual examination should be
sufficient to detect gross closure defects,
including: cuts, fractures, non-bonding,
malformation, puncture, abrasion, blister,
contaminated seal, delamination, seal creep,
wrinkle, flex cracks, crushed package or other
obvious defects;
OR
- For glass containers, visual examination
should be sufficient to detect gross closure
and glass defects, including: cap tilt, cocked
cap, crushed lug, stripped cap, cut through,
and chipped and cracked glass finish;
AND
Detailed examination of containers (destructive):
Recommendations for seal evaluation
measurements that ensure a reliable hermetic
seal should be obtained from the container or
sealing machine manufacturer. They should
include:
- For double seamed metal and plastic cans:
The examination should include a teardown
examination of the can. If the micrometer
method is used, three (3) measurements,
approximately 120 apart around the double
seam, should be made. Measurements should
include: cover hook, body hook, width,
tightness, and thickness. If the optical
method (seamscope or projector) is used, cuts
should be made at at least two (2) different
locations, excluding the side seam juncture.
Measurements should include body hook,
overlap, tightness, and thickness;
OR
- For pouches: The examination should
include: burst testing or vacuum or bubble
testing. It may also include: drop testing, peel
testing (tensile strength), residual gas testing,
electroconductivity testing, and dye testing;
OR
- For glass containers: The examination should
include cold water vacuum testing.
Additional examinations can include: security
values (lug-tension) for lug-type caps; and,
pull-up (lug position) for lug-type, twist caps.

231
Continued
OR
For UV light meter and flow rate meter:
at least daily.

How: Measure residual of chlorine, or other
approved water treatment chemical, at the

discharge point of the container cooling tank;
OR
Use a UV light meter;
AND
Use a flow rate meter.
For hot filling:

Frequency: Continuous monitoring by the instrument
itself, with visual check of the instrument at least

once per batch of cooked product.
For hot filling:

How: Use a digital time/temperature data logger;
OR
Use a recorder thermometer.
CONTROL OF RECONTAMINATION

(Frequency)?
Who: Monitoring may be performed by the sealing
machine operator, a production supervisor, a

member of the quality control staff, or any
person who is trained and qualified to conduct
container examinations.

Frequency: Visual examination of containers: At
least one container from each sealing head at least

every 30 minutes of sealing machine operation.
At a minimum this should include visual
examinations made at the beginning of
production, and immediately following a jam in
the sealing machine, or machine adjustment,
repair, or prolonged shut down;
AND
Detailed examination of containers: At least one
container from each sealing head at least every
four hours of sealing machine operation. At a
minimum this should include examinations made
at the beginning of production and immediately
following a jam in the sealing machine, or
machine adjustment, repair, or prolonged shut
down.
Frequency: For residual water treatment chemical:
Who: Monitoring may be performed by the
equipment operator, a production supervisor, a

member of the quality control staff or any other
person who has an understanding of the testing
procedure and the critical limits.
For hot filling:
Who: With recorder thermometers and digital data
loggers, monitoring is performed by the

equipment itself. However, when such
instruments are used a visual check should be
performed at least once per batch of cooked
product in order to ensure that the critical limits
have consistently been met. These checks may
be performed by a production employee, a
control staff, or any other person who has an
understanding of the process and the monitoring
procedure.
Sufficient frequency to assure control, but no less

frequently than once every four hours of use;

232

ACTION PROCEDURES.
At each processing step in which introduction of
significant hazard in the HACCP Plan Form (e.g.
container sealing, water bath container cooling and
hot filling), describe the procedures that you will use
when your monitoring indicates that the CL has not
been met.

Corrective Action: If no measurable residual
chlorine, or other approved water treatment

chemical, is detected, add chlorine or adjust the
chlorine metering system and recheck for
chlorine residual;
OR
If UV intensity is inadequate, replace or clean the
bulbs or shields;
AND
If flow exceeds the critical limit, adjust or
replace the pump.
For hot filling:

action procedures for the control option discussed in
Step #12.

Corrective Action: Identify and correct the source
of the defect after a CL deviation;

AND
Evaluate the seriousness of the defects, and, if
necessary, identify, segregate, and hold the
affected product for appropriate follow-up
action. That may include, but is not limited to,
100% visual inspection of all affected containers
to remove the defective containers;
OR
Repack the affected product.
Corrective Action: Take one or more of the following

actions to regain control over the operation after a CL
deviation:
Adjust the cooking equipment to increase the
processing temperature;
OR
Adjust the post-cook process to minimize time
delays;
AND
Take one of the following actions to the product
OR
Recook the product;
OR
Segregate and hold the product for a safety
evaluation. If the product is found to be
unsafe, it should be destroyed, diverted to a
non-food use, or recooked to eliminate
potential pathogens of public health concern;
OR
limit is not applicable (e.g. divert to a canning
operation);
OR
Divert to a non-food use.


233
Continued

SYSTEM.

PROCEDURES.

significant hazard and critical control point in the
HACCP Plan Form (e.g. container sealing, water bath
container cooling and hot filling), list the records that
will be used to document the accomplishment of the
monitoring procedures discussed in Step #15. The
records should clearly demonstrate that the monitoring procedures have been followed, and should
contain the actual values and observations obtained
during monitoring.

significant hazard in the HACCP Plan Form (container sealing, water bath container cooling and hot
filling), establish verification procedures that will
address the hazard of introduction of pathogens
after pasteurization; and, 2) consistently being
followed.

recordkeeping system for the control option discussed in Step #12.

procedures for the control option discussed in Step
#12.

Verification: Obtain container seal guidelines from

Records: Record of visual examination of
containers;
AND
Record of detailed examination of containers.
container or sealing machine manufacturer;

AND
Review monitoring and corrective action records
within one week of preparation.

Records: Record of residual chlorine, or other
approved water treatment chemical, levels;

OR
Record of UV intensity testing;
AND
Record of flow rate testing.
For hot filling:

For hot filling:
Verification: Review monitoring and corrective action
records within one week of preparation.

HACCP Plan Form.
Records: Printout from digital time/temperature data
logger;
OR
Recorder thermometer chart.

234

235
Pathogen introduction
Water bath
container cooling
(5)
How
(4)
What
(6)
Who
(7)
Measurable residual
chlorine
Residual chlorine
in water bath
Rapid test
Every batch
Pasteurizer
operator
One can per

Seamer operator
Double seam
seaming head
teardown
examination,
every 4 hrs, at
startup, after
using micrometer
jams, adjustments,
at 3 points on
seam, 120oF
repairs, and
prolonged
apart.
shutdowns
Cover hook: .070"

minimum; body hook
.072-.088"; width:
.125" maximum;
thickness .052-.058";
tightness 80%.
Container
integrity
Visual seam
examination
No visible cutovers,
Container
seam sharpness, false
integrity
seams, deadheading,
droop, damage to the
countersink wall
indicating a broken chuck,
cable cuts, product
overlapping the flange,
product leakage, or other
obvious defects.
One can per

Seamer operator
seaming head
every 1/2 hr, at
startup, after
jams, adjustments,
repairs, and
prolonged
shutdowns
Frequency
Monitoring
(9)
Records
Add chlorine and

recheck for
residual
Same
Evaluate the
seriousness of
the defect, and
hold for further
evaluation if
necessary
Processing
record
Double seam
teardown record
Identify and
Visual seam
correct the source examination
of the defect, and
record
(8)
Corrective
Action(s)
Se
eT
ex
t f Exa
or mp
Fu le
ll R O
eco nly
mm
en
da
tio
ns
(3)
Critical Limits
for each Preventive
Measure
Pathogen introduction
(2)
Significant
Hazard(s)
Container sealing
(1)
Critical Control
Point (CCP)
Review
monitoring and
corrective action
records within
one week of
preparation
Same
Can seam guidelines from can

manufacturer
Review
monitoring and
corrective action
records within
one week of
preparation
(10)
Verification
This table is an example of a portion of a HACCP plan relating to the control of the introduction of pathogens after pasteurization
for a processor of pasteurized blue crab meat, packed in 301 X 408 size steel cans, using Control Strategy Example 1 - Control of
recontamination. It is provided for illustrative purposes only. Pathogen recontamination after pasteurization may be only one of several
significant hazards for this product. Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3) for other potential hazards (e.g. chemical contaminants,
pathogen growth and toxin formation during processing, pathogen survival through pasteurization, and metal fragments).
Control Strategy Example 1 - Control of recontamination
TABLE #18-1
Notes:

236
Chapter 19: Allergens, Food Intolerance Substances and

Prohibited Food & Color Additives (A Chemical Hazard)

HAZARD.
Certain food and color additives can cause an
allergic-type reaction (food intolerance) in consumers. Examples of such food and color additives that
are used on fish and fishery products include:
sulfiting agents and FD&C Yellow #5. Sulfiting
agents are mostly used during on-board handling of
shrimp and lobster to prevent the formation of
black spot. They are sometimes used by cooked
octopus processors as an antioxidant, to retain the
red color of the octopus skin. FD&C Yellow #5 is
used during in-plant processing. These food and
color additives are permitted for use in foods, with
certain restrictions, but their presence must be
declared on the label. This label declaration is
particularly important to sensitive individuals.
Certain other food and color additives are prohibited
from use in food because of a determination by FDA
that they present a potential risk to the public health.
Examples of such food and color additives include:
safrole and FD&C Red #4.
Additionally, a number of foods contain allergenic
proteins that can pose a health risk to certain sensitive individuals. Appendix 6 contains a list of such
foods that account for most of all food allergies.
While the controls in this chapter are not directly
applicable to the hazard of allergenic proteins, if
these foods are part of or are directly added to your
fishery product, you may use the principles contained in this chapter to ensure that the product is
properly labeled. However, these controls are not
designed to prevent the unintentional introduction of
allergenic proteins from such foods into your fishery
product because of cross-contact (e.g. use of common equipment, improper production scheduling, or
improper use of rework material). Unintentional
introduction of allergenic proteins must be controlled

through a rigorous sanitation regime, either as part of
a prerequisite program or as part of HACCP itself.
The Seafood HACCP Regulation requires such a
regime.
POTENTIAL HAZARD IS SIGNIFICANT
At each processing step, determine whether allergens/
additives is a significant hazard. The criteria are:
1. Is it reasonably likely that a food or color additive
that can cause an allergic-type reaction (e.g. sulfiting
agents or FD&C yellow #5) or a prohibited substance
(e.g. safrole and FD&C Red #4) will be introduced at a
level that can cause an allergic-type reaction at this
processing step (e.g. does it come in with the raw
material or will the process introduce it)?
For example, under ordinary circumstances, it would

be reasonably likely to expect that food or color
additives that can cause an allergic-type reaction
could enter the process under the following circumstances:
Sulfiting agents may be used on shrimp and lobster
between capture and delivery to the processor.
However, in some regions even with these products
(e.g. some aquacultured shrimp) this practice may
not be reasonably likely.
Sulfiting agents may also be used in the processing
of cooked octopus.
Sulfiting agents added directly to a finished food
must be declared on a products labeling regardless
of the concentration of the sulfiting agent. When not
directly added to the finished food, sulfiting agents
must be declared on a products labeling when the
level is at or above 10 ppm.
Chapter 19: Allergens/Additives

237
Continued
FD&C Yellow #5 may be used in the processing of

formulated fishery products or in the production of
smoked fish.

processing step(s).
2. Can the hazard be eliminated or reduced to an

acceptable level here? (Note: If you are not certain of

recorded a No.
the answer to this question at this time, you may

Step #12)
Allergens/additives should also be considered a
significant hazard at a processing step if a preventive
measure is or can be used to prevent or eliminate the
hazard or is adequate to reduce the likelihood of
occurrence of the hazard to an acceptable level, if it
is reasonably likely to occur. Preventive measures
for allergic-type reactions that can result from the
presence of certain food and color additives (e.g.
sulfiting agents and FD&C yellow #5) could include:

Intended use
Declaring the presence of food and color additives

that can cause an allergic-type reaction on finished
product labeling;
Testing incoming shrimp or lobster for residues of
sulfiting agents at or above 10 ppm;
Receiving a suppliers certification of the lack of
sulfiting agent use on incoming lots of shrimp or
lobster (with appropriate verification see Step
#18);
Reviewing the labeling (or accompanying
documents, in the case of unlabeled product) on
shipments of shrimp or lobster received from
another processor for the presence of a sulfiting
agent declaration
A preventive measure for the presence of prohibited
food and color additives could include:
Testing incoming lots of fish for the presence of
prohibited food and color additives which there is
reason to believe may be present.
Receiving a suppliers certification that prohibited
food and color additives were not used on the incoming lot of fish (with appropriate verification see
Step #18).

which you developed in Step #4. However, in the
case of allergens/additives, it is not likely that the
significance of the hazard will be affected by the
intended use of the product.
For each processing step where allergens/additives
determination.
allergens/additives:
1. In the case of shrimp or lobster for which you have
identified sulfiting agents as a significant hazard, will
the finished product label declare the presence of
sulfiting agents?

238
a. If it will, you may identify the finished product
labeling step as the CCP. Alternately, you may

identify the receipt of product labels as the CCP
(where you can check labels for the presence of a
sulfiting agent declaration). The raw material
receiving step would then not require control and
would not need to be identified as a CCP for the
hazard of improper use of allergens/additives.
In this case enter Yes in Column 6 of the
Hazard Analysis Worksheet for the finished
product labeling step or receipt of product labels
step, and enter No for the raw material
receiving step. In addition, for the raw material
receiving step enter in Column 5 that the hazard
is controlled by the finished product labeling step
or the receipt of product labels step. (Note: if
you have not previously identified allergens/
additives as a significant hazard at the finished
step in Column 3 of the Hazard Analysis
Worksheet, you should change the entry in
Column 3 to Yes.) This control approach will
be referred to as Control Strategy Example 1
in Steps #14 through 18.
Example:
A frozen shrimp processor that labels all
finished product with a sulfiting agent
declaration could set the critical control point
for sulfiting agents (allergens/additives) at
the finished product labeling step. The processor
would not need to have a critical control point
for this hazard at the shrimp receiving step.
b. If the finished product labeling will not declare
the presence of sulfiting agents, you may identify

the raw material receiving step as the CCP.
Hazard Analysis Worksheet for the raw material
receiving step. This control approach will be
referred to as Control Strategy Example 2 in
Steps #14 through 18.
Example:
A frozen shrimp processor that receives shrimp
directly from the harvest vessel and does not
label finished product with a sulfiting agent
declaration could set the critical control point
for sulfiting agents (allegens/additives) at the
raw material receiving step and test incoming
lots of shrimp for the presence of sulfiting agents.
The processor would not need to have a critical
control point for this hazard at finished product
labeling.
Example:
from another processor and does not label
finished product with a sulfiting agent declaration
could set the critical control point for sulfiting
agents (allegens/additives) at the raw material
receiving step and reject incoming lots that are
identified as having been treated with a sulfiting
agent (e.g. identified on the labeling or, in the
case of unlabeled product, on documents
accompanying the shipment). The processor
for this hazard at finished product labeling.
c. If the finished product labeling will only declare
the presence of sulfiting agents when it is present

in the raw material, you may identify the finished
product labeling step or the receipt of product
labels step (where you can check labels for the
presence of a sulfiting agent declaration) as the
CCP. Testing or certification at the raw material
receiving step will be necessary to ensure control
at the CCP. However, the raw material receiving
step would not need to be identified as a CCP for
the hazard of allergens/additives.
Hazard Analysis Worksheet for the finished
labels step, and enter No for the raw material
receiving step. In addition, for the raw material
receiving step enter in Column 5 that the hazard
is controlled by the finished product labeling step
or the receipt of product labels step. (Note: if
you have not previously identified allergens/
additives as a significant hazard at the finished

239
Continued

step in Column 3 of the Hazard Analysis
Worksheet, you should change the entry in
Column 3 to Yes.) This control approach will
be referred to as Control Strategy Example 3 in
Example:
directly from the harvest vessel and labels
finished product with a sulfiting agent declaration
only if testing at receipt identifies a residue of a
sulfiting agent could set the critical control point
for sulfiting agents (allergens/additives) at the
finished product labeling step or the receipt of
product labels step. The processor would not
need to have a critical control point for this
hazard at the raw material receiving step.
Example:
from another processor and labels finished
product with a sulfiting agent declaration only if
the incoming lot was identified as having been
treated with a sulfiting agent (e.g. identified on
the labeling or, in the case of unlabeled product,
on documents accompanying the shipment),
could set the critical control point for sulfiting
agents (allergens/additives) at the finished
labels step. The processor would not need to
have a critical control point for this hazard at the
raw material receiving step.
2. In the case of cooked octopus for which you have
identified sulfiting agents as a significant hazard, and
in the case of products for which you have identified
FD&C Yellow #5 as a significant hazard because you
use one of these food and color additives in the product
formulation, you should identify the finished product
labeling step or receipt of product labels step (where
you can check labels for the presence of a sulfiting
agent or FD&C Yellow #5 declaration, as appropriate)
as the CCP. The processing step at which you add a
sulfiting agent or FD&C Yellow #5 would then not
require control and would not need to be identified as
a CCP for the hazard of allergens/additives.
In this case enter Yes in Column 6 of the Hazard

Analysis Worksheet for the finished product labeling
step or receipt of product labels step, and enter No
for the treatment step. In addition, for the treatment
step enter in Column 5 that the hazard is controlled
by the finished product labeling step or receipt of
product labels step. (Note: if you have not previously
identified allergens/additives as a significant
hazard at the finished product labeling step or receipt
of product labels step in Column 3 of the Hazard
Analysis Worksheet, you should change the entry in
Column 3 to Yes.) This control approach will also
be referred to as Control Strategy Example 1 in
Example:
A smoked sablefish processor that treats the fish
with FD&C Yellow #5 before smoking could set
the critical control point for FD&C Yellow #5
(allergens/additives) at the finished product
labeling step or receipt of product labels step.
The processor would not need to have a critical
control point for this hazard at the treatment
step.
Example:
A cooked octopus processor that treats the fish
with a sulfiting agent could set the critical
control point for sulfiting agents (allergens/
additives) at the finished product labeling step or
receipt of product labels step. The processor
for this hazard at the treatment step.
3. In the case of products for which you have identified
prohibited food and color additives (e.g. safrole and
FD&C Red #4) as a significant hazard in incoming raw
materials you should identify the raw material receiving
step as the CCP.

Analysis Worksheet for the raw material receiving
Control Strategy Example 2 in Steps #14 through 18.

240

HACCP Plan Form
Plan Form identify the maximum or minimum value
OR
The labeling or shipping documents for incoming
lots of shrimp or lobster received from another
processor must not contain a sulfiting agent
declaration;
OR
Incoming lots of raw materials must not contain
a detectable level of prohibited food and color
additives;
OR
Incoming lots of raw materials must be
accompanied by a suppliers lot-by-lot certificate
that prohibited food and color additives were not
used.
CONTROL STRATEGY EXAMPLE 3 LABELING CONTROLS WITH RAW MATERIAL
SCREENING
Critical Limit: Finished product labels for product
processed from raw materials that contain a

detectable level of sulfite must contain a
sulfiting agent declaration.
Plan Form.
PROCEDURES.
Plan Form, describe monitoring procedures that will
LABELING CONTROLS
Critical Limit: All finished product labels must
contain a sulfiting agent or FD&C Yellow #5

declaration, as appropriate.

CONTROL STRATEGY EXAMPLE 2 RAW MATERIAL SCREENING

Critical Limit: Incoming lots of shrimp or lobster
must not contain a detectable level of sulfite;

OR
Incoming lots of shrimp or lobster must be
accompanied by a suppliers lot-by-lot certificate
that sulfiting agents were not used;


241
Continued


SCREENING
What:Finished product labels for presence of
sulfiting agent declaration;

AND
One of the following:
Representative sample of each lot for sulfiting
agent residual analysis;
OR
Suppliers lot-by-lot certificate that no sulfiting
agent was used on the lot (with appropriate
verification see Step #18);
OR
Labeling or accompanying documents for each
lot received from another processor, for the
presence of a sulfiting agent declaration.
CONTROL STRATEGY EXAMPLE 1 LABELING CONTROLS

What: Finished product labels for presence of
sulfiting agent or FD&C Yellow #5 declaration,

as appropriate.

How: Visual examination.
CONTROL STRATEGY EXAMPLE 2 What:Representative sample of each lot at receipt
for sulfiting agent residual analysis, or prohibited

food and color additive residual analysis, as
appropriate;
OR
Suppliers lot-by-lot certificate that no sulfiting
agent, or prohibited food and color additive,
as appropriate, was used on the lot (with
appropriate verification see Step #18);
OR
Labeling or accompanying documents for each
lot received from another processor, for the
presence of a sulfiting agent declaration.
RAW MATERIAL SCREENING

How: Screening test for sulfiting agents or prohibited
food and color additives, as appropriate;

OR
Visual examination of certificates;
OR
Visual examination of the labeling or
accompanying documents, for lots received from
another processor.

242

SCREENING
How: Visual examination of labels;
AND
Screening test for sulfiting agents;
OR
Visual examination of certificates;
OR
Visual examination of the labeling or
accompanying documents, for lots received from
another processor.
At least one label from every case of labels or

one label from each pallet of pre-labeled
packaging material received at the firm.
OR
Once per day for on-site computer generated
labels.
AND
Each lot of incoming shrimp or lobster.
Who: Monitoring may be performed by the labeling

(Frequency)?
equipment operator, the receiving employee, a

control staff, or any other person who has an
understanding of the proper content of the label.
Frequency: At least one label from every case of
labels or one label from each pallet of pre-labeled

packaging material delivered to the packaging
area;
OR
At least one label from every case of labels or
one label from each pallet of pre-labeled
packaging material received at the firm.
OR
Once per day for on-site computer generated
labels.

Who: Monitoring may be performed by the receiving
employee, a production supervisor, a member of

that has an understanding of the proper screening
procedure. Assignment of responsibility for
testing procedures should be based, in part, on
the degree of difficulty of the analysis.
SCREENING
Who: Monitoring may be performed by the labeling
Frequency: Each incoming lot.

SCREENING
Frequency: At least one label from every case of
labels or one label from each pallet of pre-labeled

packaging material delivered to the packaging
area;
OR
equipment operator, the receiving employee, a

control staff, or any other person that has an
understanding of proper content of the label or
the screening procedure, as appropriate.
Assignment of responsibility for testing
procedures should be based, in part, on the
degree of difficulty of the analysis.

243
Continued

ACTION PROCEDURES.
Plan Form, describe the procedures that you will use
when your monitoring indicates that the CL has not
been met.
Corrective Action: Segregate and relabel any
improperly labeled product;

AND
Segregate and return or destroy any label stock
or pre-labeled packaging stock that does not
contain the proper declaration.
Corrective Action: Reject any incoming lot in
which sulfiting agent or prohibited food and

color additive, as appropriate, is detected or
declared or which is not accompanied by a
suppliers certificate.

SCREENING
Corrective Action: Segregate and relabel any
improperly labeled product;

AND
Segregate and return or destroy any label stock
or pre-labeled packaging stock that does not
contain the proper declaration.
SYSTEM.
Plan Form, list the records that will be used to
document the accomplishment of the monitoring
procedures discussed in Step #15. The records
should clearly demonstrate that the monitoring
procedures have been followed, and should contain
the actual values and observations obtained during
monitoring.
Following is guidance on establishing a recordkeeping system for the control strategy examples
Records: Record of labeling checks.

Records: Test results for sulfiting agent or prohib-
ited food and color additives, as appropriate;

OR
Suppliers lot-by-lot certificates;
OR
Record of raw material labeling or
accompanying document checks.

244
LABELING CONTROLS WITH RAW MATERIAL

SCREENING
Records: Record of labeling checks;
AND
Sulfiting agent test results;
OR
Suppliers lot-by-lot certificates;
OR
Record of raw material labeling or
accompanying document checks.
PROCEDURES.
Plan Form, establish verification procedures that will
address the hazard of improper use of food and color
additives; and, 2) consistently being followed.

and, where applicable, verification records within

one week of preparation;
AND
When suppliers certificates are used for
monitoring, collect at least one representative
sample per quarter, randomly selected from
among your suppliers, and analyze for sulfiting
agents or prohibited food and color additives, as
appropriate. Additionally, collect at least one
representative sample for each new supplier, and
analyze for sulfiting agents or prohibited food
and color additives, as appropriate.
SCREENING
and, where applicable, verification records within

one week of preparation;
AND
When suppliers certificates are used for
monitoring, collect at least one representative
sample per quarter, randomly selected from
among your suppliers, and analyze for sulfiting
agents. Additionally, collect at least one
representative sample for each new supplier, and
analyze for sulfiting agents.
HACCP Plan Form.

245

246
Labeling receipt
(1)
Critical Control
Point (CCP)
Sulfiting agents
(2)
Significant
Hazard(s)
Visual
How
What
Finished product
labels for
presence of
sulfiting agent
declaration
(5)
(4)
(6)
One label from

each case of
labels at receipt
Frequency
Monitoring
Receiving
employee
Who
(7)
(9)
Records
Segregate and
Label receiving
return any labels
record
that do not contain
the sulfiting agent
declaration
(8)
Corrective
Action(s)
Se
eT
ex
t f Exa
or mp
Fu le
ll R O
eco nly
mm
en
da
tio
ns
All finished product

labels must contain
sulfiting agent
declaration
(3)
Critical Limits
for each Preventive
Measure
Review
monitoring and
correction action
records within
one week of
preparation
(10)
Verification
This table is an example of a portion of a HACCP plan relating to the control of sulfiting agents for a processor of wild-caught
shrimp, using Control Strategy Example 1 Labeling controls. It is provided for illustrative purposes only.
Allergens/additives may be only one of several significant hazards for this product.
Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3) for other potential hazards (e.g. chemical contaminants, and metal fragments).
Control Strategy Example 1 - Labeling controls
TABLE #19-1

247
Shrimp receiving
(1)
Critical Control
Point (CCP)
Sulfiting agents
(2)
Significant
Hazard(s)
Visual
How
What
Suppliers lot-bylot certificate that
no sulfiting agents
were used on
the lot
(5)
(4)
(6)
Every lot of
incoming shrimp
Frequency
Monitoring
Receiving
employee
Who
(7)
Reject any
incoming lot of
shrimp that is not
accompanied by
a suppliers
certificate
(8)
Corrective
Action(s)
Se
eT
ex
t f Exa
or mp
Fu le
ll R O
eco nly
mm
en
da
tio
ns
Incoming lots of shrimp

must be accompanied by
a suppliers certificate
that sulfiting agents were
not used on the lot
(3)
Critical Limits
for each Preventive
Measure
Copies of
suppliers
guarantees
(9)
Records
Review
monitoring,
correction
action and
verification
records within
one week of
preparation
Test one lot per

quarter for
sulfiting agent
residue, and test
one lot from
each new
supplier of
shrimp for
sulfiting agent
residue
(10)
Verification
frozen shrimp, using Control Strategy Example 2 Raw material screening. It is provided for illustrative purposes only.
Allergens/additives may be only one of several significant hazards for this product.
Control Strategy Example 2 - Raw material screening
TABLE #19-2

248
Finished product
labeling
(1)
Critical Control
Point (CCP)
Sulfiting agents
(2)
Significant
Hazard(s)
Visual
How
What
Finished
product labels
for presence of
sulfiting agent
declaration
(5)
(4)
(6)
Packaging
machine
operator
Quality control
employee
Three shrimp
from each lot of
raw material
shrimp
Who
(7)
One label from

each case of
labels delivered
to packaging
Frequency
Monitoring
Segregate and
relabel any
improperly
labeled product
(8)
Corrective
Action(s)
Three shrimp
collected
randomly from
each lot of raw
material shrimp
for sulfiting
agent residual
analysis
malachite green
test
Segregate and
return any label
stock that does
not contain the
proper
declaration
Se
eT
ex
t f Exa
or mp
Fu le
ll R O
eco nly
mm
en
da
tio
ns
Finished product labels

for product processed
from sulfite-containing
raw material shrimp must
contain a sulfiting agent
declaration
(3)
Critical Limits
for each Preventive
Measure
Label check
record
(9)
Records
Review
monitoring and
corrective action
records within
one week of
preparation
(10)
Verification
frozen shrimp, using Control Strategy Example 3 Labeling controls with raw material screening. It is provided for illustrative
purposes only. Allergens/additives may be only one of several significant hazards for this product.
Control Strategy Example 3 - Labeling controls with raw material screening
TABLE #19-3
Chapter 20: Metal Inclusion (A Physical Hazard)

HAZARD.
Metal fragments can cause injury to the consumer.
Metal-to-metal contact, especially in mechanical
cutting or blending operations, other equipment with
metal parts that can break loose, such as moving wire
mesh belts, injection needles, screens, portion control
equipment, metal ties and can openers are likely
sources of metal that may enter food during processing.
FDAs Health Hazard Evaluation Board has supported regulatory action against product with metal
fragments of 0.3 (7 mm) to 1.0 (25mm) in length.
See FDA Compliance Policy Guide #555.425.
At each processing step, determine whether metal
inclusion is a significant hazard. The criteria are:
1. Is it reasonably likely that metal fragments will be
introduced at this processing step (e.g. does it come in
with the raw material or will the process introduce it)?
For example, under ordinary circumstances, it would

be reasonably likely to expect that metal fragments
could enter the process from the following sources as
a result of worn, damaged or broken equipment parts:
Mechanical crabmeat pickers;
Wire-mesh belts used to convey product in a batter/
breading operation;
Teeth from saw blades used to cut portions or
steaks;
Wire from mechanical mixer blades;
Blades from mechanical chopping or blending
equipment;
Rings, washers, nuts, or bolts from sauce cooling,
liquid dispensing, and portioning equipment;
Blades from automatic filleting equipment;

Injection needles;
Metal ties used on raw material, in-process, or
finished product containers or equipment.
Under ordinary circumstances it would not be
reasonably likely to expect that metal fragments
could enter the food from the following sources:
Manual cutting, shucking, gutting, or boning
knives;
Metal processing tables or storage tanks;
Wire mesh baskets or utensils.
2. Can metal fragments, which were introduced at an
earlier step, be eliminated or reduced to an acceptable
level at this processing step? (Note: If you are not
certain of the answer to this question at this time, you

may answer No. However, you may need to
change this answer when you assign critical control
points in Step #12.)
Metal inclusion should also be considered a
preventive measure is or can be used to prevent or
eliminate the inclusion of metal fragments, that have
been introduced to the product at a previous step, or
is adequate to reduce the likelihood of occurrence of
the hazard to an acceptable level. Preventive measures for metal inclusion can include:
Periodically checking cutting or blending equipment
or wire-mesh belts for damage or missing parts;
Passing the product through metal detection or
separation equipment.
Visually inspecting equipment for damage or missing
parts may only be feasible with relatively simple
equipment, such as band saws, small orbital blenders,
and wire-mesh belts. Other, more complex, equipment may contain to many parts, some of which may
not be readily visible, to make such visual inspection
reliable in a reasonable time period.
Chapter 20: Metal

249
Continued

processing step(s).
recorded a No.
Intended use
which you developed in Step #4. In most cases you
should assume that the product will be consumed in a
way that would not eliminate any metal fragments
that may be introduced during the process. In this
case, you would need to identify the hazard as
significant if the above criteria are met.
However, in some cases, if you have assurance that
the product will be run through a metal detector, for
detection of metal fragments, or through screens or a
magnet, for separation of metal fragments, by a
subsequent processor you may not need to identify
metal fragment inclusion as a significant hazard.
Example:
A primary processor produces frozen fish blocks by
mechanically heading, eviscerating, and filleting fish
in-the-round. The primary processor sells exclusively
to breaded fish stick processors and has been given
assurance by these processors that the finished,
breaded product will be subjected to a metal detector.
The primary processor would not need to identify
metal inclusion as a significant hazard.
In this case, you should enter No in Column 3 of

the Hazard Analysis Worksheet for each of the
processing steps. In addition, for each No entry
briefly explain in column 4 that the hazard is controlled by a subsequent processor. In this case, you
need not complete Steps #12 through 18 for this
hazard.
For each processing step where metal inclusion is
determination.
metal inclusion:
Will the product be run through a metal detector, or
through a screen, magnet, flotation tank, or other
equipment for separation of metal fragments, on or
after the last step where metal inclusion is identified
as a significant hazard?
1. If it will be, you may identify final metal detection or
separation as the CCP. Processing steps prior to metal
detection will then not require control and will not need
to be identified as CCPs for the hazard of metal
fragments.

Analysis Worksheet for the metal detection or
separation step, and enter No for the other processing steps where metal inclusion was identified as a
significant hazard. In addition, for each No entry,
note in Column 5 that the hazard is controlled by the
final metal detection or separation step. (Note: if you
have not previously identified metal inclusion as a
significant hazard at the metal detection or separation
Chapter 20: Metal

250
Example:
A breaded fish processor could set the critical control
point for metal inclusion at the packaged product
metal detection step, and would not need to have
critical control points for this hazard at each of the
steps at which there was a reasonably likelihood that
metal fragments could be introduced.
You should recognize that by setting the critical
control point at or near the end of the process, rather
than at the point of potential metal fragment entry
into the process, you are likely to have more labor
and materials invested in the product before the
problem is detected or prevented.
2. If the product will not be run through such a device,
you should have procedures to periodically check the
processing equipment for damage or lost parts at each
processing step where metal inclusion is identified as
a significant hazard. In this case you should identify
those processing steps as CCPs. It would not ordinarily
be necessary to identify these steps as CCPs in addition
to identifying a final metal detection or separation step
as a CCP.
Visually inspecting equipment for damage or missing

parts may only be feasible with relatively simple
equipment, such as band saws, small orbital blenders,
and wire-mesh belts. Other, more complex, equipment may contain to many parts, some of which may
not be readily visible, to make such visual inspection
reliable in a reasonable time period.
In this case, You should enter Yes in column 6 of
the Hazard Analysis Worksheet for each of those
processing steps. This control approach will be
referred to as Control Strategy Example 2 in Steps
#14 through 18.
Example:
A processor that cuts tuna steaks from whole fish has
identified the band saw cutting step as the only step
that is reasonably likely to introduce metal fragments
to the process. The processor does not have a final
metal detection or separation step. The processor
checks the condition of the band saw blade every four
hours to ensure that it has not been damaged. The
processor identifies the band saw cutting step as the
CCP for this hazard.

HACCP Plan Form
CONTROL STRATEGY EXAMPLE 1 METAL DETECTION OR SEPARATION
Critical Limit: No metal fragments in finished
product. (Note: FDAs Health Hazard Evaluation

Board has supported regulatory action against
product with metal fragments of 0.3" [7 mm] to
1.0" [25mm] in length. See also FDA Compliance
Policy Guide #555.425.)
Chapter 20: Metal

251
Continued
CONTROL STRATEGY EXAMPLE 2 EQUIPMENT CHECKS
CONTROL STRATEGY EXAMPLE 1 Critical Limit: No broken or missing metal parts
EQUIPMENT CHECKS
from equipment at the CCPs for metal inclusion

What: The presence of metal fragments in product

Plan Form.
passing the CCP.


PROCEDURES.
METAL INCLUSION PREVENTION PROCEDURES

What: The presence of broken or missing metal parts

from equipment at the CCPs.



METAL DETECTION OR SEPARATION
How: Use a metal detection device;
OR
Use a magnet for separating metal fragments
from a product stream, where feasible (e.g. dry
ingredients);
OR
Use screens for separating metal fragments from
a product stream, where feasible (e.g. dry or
liquid ingredients).
How: Visually check the equipment for broken or
missing parts.
Examples:
Check saws for missing teeth;
Check that all parts are secure on blending
equipment;
Check for missing links in metal belts.
Chapter 20: Metal

252

(Frequency)?
METAL DETECTION OR SEPARATION

Frequency: Subject all product to the control.
Check that device is operating or is in place at

start of each production day.
EQUIPMENT CHECKS

member of the quality control staff, a member of
the maintenance or engineering staff, or any other
person who has a thorough understanding of the
proper condition of the equipment.
EQUIPMENT CHECKS
Frequency: Check before starting operations
each day;
AND
Check every four hours during operation;
AND
Check at the end of operations each day;
AND
Check whenever there is an equipment
malfunction that could increase the likelihood
that metal could be introduced into the food.
Who: Monitoring is performed by the equipment
itself. A check should be made at least once per

day to ensure that the device is operating or is in
place. This may be performed by the equipment
the quality control staff, a member of the
maintenance or engineering staff, or any other
person who has an understanding of the operation
of the equipment.

ACTION PROCEDURES.
the problem that caused the CL deviation. Remember
that deviations from operating limits do not need to
result in formal corrective actions.
Corrective Action: Take the following corrective
action to regain control over the operation after a

CL deviation:
Attempt to locate and correct the source of the
fragments found in product by the metal
detector or separated from the product stream
by the magnets, screens, or other devices;
Chapter 20: Metal

253
Continued
AND
Make adjustments to the materials, equipment,
introduction of metal fragments;
AND
Take the following action to product involved in
a CL deviation:
Destroy;
OR
Divert to non-food use;
OR
Rework to eliminate metal fragments;
OR
Hold and evaluate any product in which the metal
detector has detected metal fragments;
AND
when product is processed without a properly
functioning metal detector or separation device:
OR
Hold all product produced since controls were
last confirmed as functioning properly until it
can be run through a metal detector;
OR
last confirmed as functioning properly until an
inspection of the processing equipment that
could contribute metal fragments can be
completed to determine whether there are any
broken or missing parts;
OR
Divert all product produced since controls were
last confirmed as functioning properly to a use
in which it will be run through a metal detector
(e.g. divert fish fillets to a breading operation
that is equipped with a metal detector);
OR
Divert all product produced since controls
were last confirmed as functioning properly
to a non-food use;
AND
Repair or replace the metal detector or
separation device

Corrective Action: Take one of the following
corrective actions to regain control over the

Stop production;
AND
If necessary, adjust or modify the equipment to
reduce the risk of recurrence;
AND
Take one of the following actions to product
involved in a CL deviation:
Destroy all product produced since the previous
satisfactory equipment check;
OR
Run all product produced since the previous
satisfactory equipment check through a metal
detector;
OR
Divert all product produced since the previous
satisfactory equipment check to a use in which
it will be run through a metal detector (e.g.
divert fish fillets to a breading operation that is
equipped with a metal detector);
OR
satisfactory equipment check to a non-food use.
Chapter 20: Metal

254

SYSTEM.

PROCEDURES.


address the hazard of metal inclusion; and, 2) consistently being followed.

recordkeeping system for the control strategy examples discussed in Step #12.

Verification: Test the effectiveness of the metal
Records: Record documenting that the metal
in
detection or separation device is operating or is

place, as appropriate.

Records: Record of equipment inspections.
detection device, or check the condition of the

magnet, screen, or other metal separation device
at least once per day, before start of operations;
AND
preparation.


Enter the verification procedures in column 10 of the
HACCP Plan Form.
Chapter 20: Metal

255
Chapter 20: Metal

256
Metal detection
(1)
Critical Control
Point (CCP)
Metal inclusion
(2)
Significant
Hazard(s)
(6)
Every finished
product package,
with operation
check before
start-up
Frequency
Monitoring
Metal detector
How
What
Presence of
detectable metal
fragments in
finished product
(5)
(4)
Production
employee
Who
(7)
Destroy any
product rejected
by metal
detector
(8)
Corrective
Action(s)
If product is
processed
without metal
detection hold
for metal
detection
Identify source
of metal found
in product and
fix damaged
equipment
Se
eT
ex
t f Exa
or mp
Fu le
ll R O
eco nly
mm
en
da
tio
ns
No detectable metal
fragments in finished
product
(3)
Critical Limits
for each Preventive
Measure
Metal detector
operation log
(9)
Records
Review
monitoring,
corrective
action and
verification
records within
one week of
preparation
Test metal
detector with
three test units
before
production each
day, and
recalibrate if
needed
(10)
Verification
This table is an example of a portion of a HACCP plan relating to the control of metal fragment inclusion for a processor of
frozen fish sticks, using Control Strategy Example 1 - Metal detection or separation. It is provided for illustrative purposes only.
Metal inclusion may be only one of several significant hazards for this product. Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3)
for other potential hazards (e.g. chemical contaminants and Staphylococcus aureus toxin formation in the hydrated batter mix).
Control Strategy Example 1 - Metal detection or separation
TABLE #20-1
Chapter 20: Metal

257
Band saw
(1)
Critical Control
Point (CCP)
Metal inclusion
(2)
Significant
Hazard(s)
Visual
How
What
Check saw blade
for damage
(5)
(4)
(6)
Before start-up,
every four hours
during operation,
at end of day, and
after equipment
jam
Frequency
Monitoring
Saw operator
Who
(7)
Adjust
equipment
Stop production
(8)
Corrective
Action(s)
Hold product
until it can be
run through
metal detector
and destroy
rejects
Isolate product
since last visual
check
Se
eT
ex
t f Exa
or mp
Fu le
ll R O
eco nly
mm
en
da
tio
ns
No damage to saw blade
(3)
Critical Limits
for each Preventive
Measure
Equipment
maintenance log
(9)
Records
Review
monitoring and
corrective action
records within
one week of
preparation
(10)
Verification
This table is an example of a portion of a HACCP plan relating to the control of metal fragment inclusion
for a processor of frozen tuna steaks, using Control Strategy Example 2 - Metal inclusion prevention procedures.
It is provided for illustrative purposes only. Metal inclusion may be only one of several significant hazards for this product.
Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3) for other potential hazards (e.g. histamine and parasites).
Control Strategy Example 2 - Equipment Checks
TABLE #20-2
Notes:
Chapter 20: Metal

258
Chapter 21: Glass Inclusion (A Physical Hazard)

DRAFT
This chapter is provided as draft guidance at this

time. FDA requests that interested parties with
information on the hazard of glass inclusion and its
control provide comments on the content of the
chapter.
Under ordinary circumstances, it would be reasonably likely to expect that glass fragments could enter
the process during processing of any product that is
packed in a glass container. Likely areas of concern
for glass container breakage are:

HAZARD.
Glass fragments can cause injury to the consumer.
FDAs Health Hazard Evaluation Board has supported regulatory action against products with glass
fragments of 0.3 (7 mm) to 1.0 (25 mm) in length.
See FDA Compliance Policy Guide #555.425.
Glass inclusion can occur whenever processing
involves the use of glass containers. Normal handling
and packaging methods, especially mechanized
methods, can result in breakage. Most products
packed in glass containers are intended as a ready-toeat commodity.
The purpose of this chapter is to address only the
hazard of glass fragments that results from the use of
glass containers. Glass fragments originating from
other sources must be addressed where applicable in
a prerequisite sanitation program. The Seafood
HACCP Regulation requires such a program.
At each processing step, determine whether glass
inclusion is a significant hazard. The criteria are:
1. Is it reasonably likely that glass fragments from glass
containers will be introduced at this processing step
(e.g. does it come in with the raw material or will the
process introduce it)?
Receiving;
Storage, when cases are moved mechanically;
Mechanized Cleaning;
Conveyor Lines;
Mechanized Filling;
Hot-filling;
Mechanized Capping;
Pasteurizing.
2. Can glass fragments from glass containers, which

were introduced at an earlier step, be eliminated or
reduced to an acceptable level at this processing step?
(Note: If you are not certain of the answer to this

question at this time, you may answer No. However, you may need to change this answer when you
assign critical control points in Step 12.)
Glass inclusion should also be considered a
preventive measure is or can be used to prevent or
eliminate the inclusion of glass fragments from glass
containers, that have been introduced at a previous
step, or is adequate to reduce the likelihood of
occurrence of the hazard to an acceptable level.
Preventive measures for glass inclusion can
include:
Visual examination of empty glass containers;
Cleaning (water or compressed air) and inverting
empty glass containers;
Periodically monitoring processing lines for
evidence of glass breakage;
Proper adjustment of capping equipment
(not a complete control);
Visual examination of glass containers containing
transparent liquid fishery products;
Passing the product through x-ray equipment or
other defect rejection system.
Continued
Chapter 21: Glass

259

processing step(s).
the Hazard Analysis Worksheet. If neither criterion is
met you should answer No. You should record the
reason for your Yes or No answer in Column 4.
You need not complete Steps 12 through 18 for this
hazard for those processing steps where you have
recorded a No.
Intended use
which you developed in Step 4. In most cases you
should assume that the product will be consumed in a
way that would not eliminate any glass fragments
that may be introduced during the process. In this
case, you would need to identify the hazard as
significant if the above criteria are met.
For each processing step where glass inclusion is
to control the hazard. Figure A-2 (Appendix 3) is a
determination.
glass inclusion:
Will the containers be run through x-ray equipment

or other defect rejection system, undergo visual
inspection for detection of glass fragments, or be
cleaned (water or compressed air) and inverted on or
after the last step where glass inclusion is identified
as a significant hazard?
1. If it will be, you may identify final glass detection or
separation as the CCP. Processing steps prior to glass
detection or separation will then not require control
and will not need to be identified as CCPs for the
hazard of glass inclusion.

Analysis Worksheet for the glass detection or separation step, and enter No for the other processing
steps where glass inclusion was identified as a
significant hazard. In addition, for each No entry,
note in Column 5 that the hazard is controlled by the
glass detection or separation step. (Note: if you have
not previously identified glass inclusion as a
significant hazard at the glass detection or separation
Strategy Example 1 in Steps 14 through 18.
Example:
A pickled herring processor that mechanically packs
the product into glass jars could set the critical
control point for glass inclusion at the packaged
product x-ray examination step, and would not need
to have critical control points for this hazard at each
of the steps at which there was a reasonable likelihood that glass fragments could be introduced.
Example:
A processor that manually packs caviar into glass
jars has identified the glass container receiving and
storage steps as the only steps that are reasonably
likely to introduce glass fragments into the process.
The processor does not have finished product x-ray
equipment. The processor manually inspects each
container during the filling process. The processor
identifies the container inspection step as the CCP
for this hazard.
Chapter 21: Glass

260
Example:
Another processor that manually packs caviar into
glass jars has identified the glass container receiving
and storage steps as the only steps that are reasonably likely to introduce glass fragments into the
process. The processor does not have finished
product x-ray equipment. Just before filling, the
empty glass jars are inverted and cleaned, using
filtered, compressed air. The processor identifies the
container cleaning and inverting step as the CCP for
this hazard.
product that has moved through that area since the

last inspection is placed on hold to be run through
off-line x-ray equipment. The processor identifies
receiving, storage, mechanical conveying, mechanical filling, and mechanical capping as the CCPs for
this hazard.
You should recognize that by setting the critical

control point at or near the end of the process, rather
than at the point of potential glass fragment entry
into the process, you are likely to have more labor
and materials invested in the product before the
problem is detected or prevented.
Proceed to Step 13 (Chapter 2) or to Step 10 of the

2. If the containers will not be run through detection

equipment, visually inspected, or cleaned and inverted
on or after the last step where glass inclusion is
identified as a significant hazard, you should have
procedures to periodically check the processing areas
and equipment for glass breakage at each processing
step where glass inclusion is identified as a significant
hazard. In this case you should identify those processing steps as CCPs. It would not ordinarily be necessary
to identify these steps as CCPs in addition to identifying
a final glass detection or separation step as a CCP.

In this case, you should enter Yes in column 6 of

the Hazard Analysis Worksheet for each of those
processing steps. This control approach will be
referred to as Control Strategy Example 2
in Steps 14 through 18.
Example:
A processor bottles clam juice and has identified
receiving, storage, mechanical conveying, mechanical filling, and mechanical capping, as processing
steps reasonably likely to introduce glass fragments
into the process. The processor does not have on-line
x-ray equipment. The processor visually inspects all
processing areas for broken glass at start-up and
once every four hours. If broken glass is observed,
the line is stopped, the glass is removed and the

HACCP Plan Form

operating limit that is more restrictive than the CL. In
this way you can adjust the process when the operating limit is triggered, but before a triggering of the
CL would require you to take corrective action. You
should set operating limits based on your experience
with the variability of your operation and with the
closeness of typical operating values to the CL.
control strategy examples discussed in Step 12.
Chapter 21: Glass

261
Continued
CONTROL STRATEGY EXAMPLE 1 GLASS DETECTION OR SEPARATION

Critical Limit: No glass fragments in finished product.
(Note: FDAs Health Hazard Evaluation Board

has supported regulatory action against products
with glass fragments of 0.3 [7 mm] to 1.0
[25 mm] in length. See also FDA Compliance
Policy Guide #555.425.)

procedures for the control strategy examples discussed in Step 12. Note that the monitoring frequencies that are provided are intended to be considered
as minimum recommendations, and may not be

EQUIPMENT CHECKS
GLASS DETECTION OR SEPARATION
Critical Limit: No broken glass at the CCPs for
What: The presence of glass fragments in glass
glass inclusion.
containers passing the CCP.

Plan Form.

PROCEDURES.
What: The presence of broken glass on or near

EQUIPMENT CHECKS
equipment at the CCPs.

typically close to the CL. Additionally, the greater the
time span between measurements the more product
you are putting at risk should a measurement show
that a CL has been violated.

How: Use of x-ray equipment or other defect rejection
system;
OR
Visual examination of empty glass containers;
OR
Visual examination of glass containers
containing transparent liquid fishery products;
OR
Cleaning (water or compressed air) and inverting
of empty glass containers.
Chapter 21: Glass

262
CONTROL STRATEGY EXAMPLE 1 How: Visually check the glass handling areas for
broken glass.
Who: For x-ray detection, other defect rejection systems,
Examples:
Check pallets and cases of empty jars for damage,
broken jars, and glass fragments;
Check mechanical glass cleaning equipment and
surrounding floors for broken glass;
Check floors around conveyors for broken glass;
Check filling and capping equipment and
surrounding floors for broken glass;
Check hot-filling and pasteurizing equipment and
surrounding floors for broken glass.

(Frequency)?
glass separation equipment and visual examination,

monitoring is performed by the equipment itself
or by properly trained and qualified inspection
personnel. A check should be made at least once
per day to ensure that the device is operating or
that the appropriate personnel are on hand. This
check may be performed by the equipment
the quality control staff, a member of the
maintenance or engineering staff, or any other
person who has an understanding of the operation
of the equipment or the staffing needs.

Frequency: Continuous. Each container is subjected
to detection or separation. For x-ray equipment,

other defect rejection systems and glass separation
equipment, check that the device is operating at
least at the start of each production day. For
visual inspection, check that appropriate
personnel are assigned to the processing step at
the start of each production day.
Frequency: Check before starting operations each day;
AND
Check at least every four hours during operation;
AND
Check at the end of operations each day;
AND
Check whenever there is an equipment or other
malfunction that could increase the likelihood
that glass containers could be damaged.

member of the quality control staff, a member of
the maintenance or engineering staff, production
personnel, or any other person who has a
thorough understanding of the proper condition
of
the equipment and surrounding area. In
assigning
responsibility for
this monitoring function you
should consider the complexity of the equipment
and the level of understanding necessary to
evaluate its condition.
ACTION PROCEDURES.
Chapter 21: Glass

263
Continued

the problem that caused the CL deviation. Remember
that deviations from operating limits do not need to
result in formal corrective actions.
discussed in Step 12.
OR
Divert all product produced since controls
were last confirmed as functioning properly to
a non-food use;
AND
Repair or replace the glass detection or
separation equipment.
Corrective Action: Take one of the following
Corrective Action: Take the following corrective
actions to regain control over the operation after

a CL deviation:
Stop operations and attempt to locate and
correct the source of the glass fragments;
AND
Make adjustments to the materials, equipment,
introduction of glass fragments;
AND
Take one of the following corrective actions to
product in which glass fragments were
detected:
OR
Rework the product to eliminate the glass
fragments;
OR
Divert the product to non-food use;
OR
Hold and evaluate the product;
AND
Take one of the following corrective actions
when product is processed without properly
functioning glass detection or separation equipment
or without proper visual inspection:
Destroy all product produced since controls
were last confirmed as functioning properly;
OR
last confirmed as functioning properly until it
can be examined by x-ray equipment or other
defect rejection system, or visual inspection,
where appropriate;
corrective actions to regain control over the

Stop production;
AND
If necessary, adjust or modify the materials,
equipment and/or processes to reduce the risk
of recurrence;
AND
Remove all broken glass from the equipment
and surrounding area;
AND
Destroy all product produced since the
previous satisfactory equipment check;
OR
Hold all product produced since the previous
satisfactory equipment check until it can be
examined by x-ray equipment or other defect
rejection system, or visual inspection if
appropriate;
OR
satisfactory equipment check to a non-food use.
Chapter 21: Glass

264

SYSTEM.

PROCEDURES.

discussed in Step 15. The records should clearly

address the hazard of glass inclusion; and, 2) consistently being followed.

recordkeeping system for the control strategy examples discussed in Step 12.

procedures for the control strategy examples discussed in Step 12.
Verification: Test the effectiveness of the x-ray
Records: Records documenting that the glass detection
or separation device is operating, or that glass

inspection personnel are assigned to the
processing step, as appropriate.
equipment, other defect reject system or glass

separation equipment at least once per day,
before start of operations;
AND
verification records within one week of preparation.
Records: Records of equipment and processing area

Verification: Review monitoring and corrective action
inspection results.
records within one week of preparation.

Enter the verification procedures in column 10 of the

HACCP Plan Form.
Chapter 21: Glass

265
Chapter 21: Glass

266
(2)
Significant
Hazard(s)
X-ray equipment Glass inclusion
(1)
Critical Control
Point (CCP)
X-ray device
How
What
Presence of
detectable glass
fragments in
finished products
(5)
(4)
(6)
Every finished
product package,
with operation
check before
startup
Frequency
Monitoring
Production
employee
Who
(7)
Destroy any
product rejected
by x-ray
equipment
(8)
Corrective
Action(s)
If product is
processed
without x-ray
equipment, hold
for detection by
off-line x-ray
equipment
AND
Stop operations
and identify
source of glass
found in product
and fix damaged
equipment
AND
Se
eT
ex
t f Exa
or mp
Fu le
ll R O
eco nly
mm
en
da
tio
ns
No detectable glass
fragments in finished
product
(3)
Critical Limits
for each Preventive
Measure
X-ray operation
log
(9)
Records
Review
monitoring,
corrective
action and
verification
records within
one week of
preparation.
Test x- ray
device before
production each
day, and
recalibrate if
needed
(10)
Verification
This table is an example of a portion of a HACCP plan relating to the control of glass inclusion for a processor of pickled herring
in glass jars, using Control Strategy Example 1 - Glass Detection or Separation. It is provided for illustrative purposes only.
Glass inclusion may be only one of several significant hazards for this product. Refer to Tables 3-1, 3-2, 3-3 (Chapter 3)
for other potential hazards (e.g., parasites, histamine, chemical contaminants, unapproved food & color additives,
metal fragments, Clostridium botulinum toxin formation, and pathogen growth as a result of temperature abuse).
Control Strategy Example 1 - Glass Detection or Separation
TABLE #21-1
Chapter 21: Glass

267
Mechanical
filling and
capping
Receiving
(1)
Critical Control
Point (CCP)
Visual
Broken glass on
& around filler/
capper station
Visual
(6)
Each pallet of
jars
Frequency
Monitoring
Receiving
personnel
Who
(7)
Before start-up,
every 4 hours
during operation,
after breaks, and
after equipment
jams.
Capper operator
(9)
Records
Stop production
AND
Adjust capping
equipment
AND
Isolate and hold
product since
last satisfactory
check until it
can be run
through off-line
x-ray and
destroy rejects
AND
Remove broken
glass from area.
Equipment
maintenance log
Reject pallets
Receiving report
with more than 3
damaged cases or
with broken jars.
Isolate pallets
with 1 to 3
damaged cases
and open and
inspect all cases.
Reject cases that
contain broken
glass.
(8)
Corrective
Action(s)
Se
eT
ex
t f Exa
or mp
Fu le
ll R O
eco nly
mm
en
da
tio
ns
No broken glass at the
filler/capper station
How
What
Presence of
broken glass or
physical damage
to cases
(5)
(4)
No broken glass on
pallets of empty jars
(3)
Critical Limits
for each Preventive
Measure
Note: Storage and conveying of empty jars are not identified as CCPs because cases of empty jars are handled manually, without forklifts or mechanized conveyors
Glass Inclusion
Glass inclusion
(2)
Significant
Hazard(s)
Review
monitoring and
corrective action
records within
one week of
preparation
Review
monitoring and
corrective action
records within
one week of
preparation.
(10)
Verification
This table is an example of a portion of a HACCP plan relating to the control of glass inclusion for a processor of clam juice in
glass jars, using Control Strategy Example 2 Equipment checks. It is provided for illustrative purposes only. Glass inclusion may
be only one of several significant hazards for this product. Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3) for other potential hazards
(e.g., pathogens from the harvest area, chemical contaminants, natural toxins, unapproved food & color additives, and metal fragments)
Control Strategy Example 2 - Equipment Checks
TABLE #21-2
Notes:
Chapter 21: Glass

268
18
Codex Alimentarius Commission:

protecting food today and in the future
A.W. Randell, K. Miyagishima and J. Maskeliunas
Alan Randell is Senior Officer and Jeronimas Maskeliunas is Food Standards Officer, Joint FAO/WHO Food Standards Programme.
Kazuaki Miyagishima is Associate Professor, Department of Public Health, Faculty of Medicine, Kyoto University.
rade in food can be of great benefit to countries. Food

import increases the choice of products, allowing
improvements in the nutritional and health status of the
population. Food export stimulates the development of local
industry and helps to upgrade food production facilities,
standards and practices, which can lead to improvements in
the standard of living. Under these conditions, trade makes a
positive contribution to food security.
It is assumed that substantial economic losses result from
unsafe food entering the international market, although they
have not been systematically quantified worldwide. Such
losses involve the costs of food spoilage and damage from
contamination; the direct and indirect costs of illnesses
caused by unsafe food, including health care treatment and
losses in productivity resulting from morbidity, disability
and mortality; and the costs to the industry entailed in recall
of products, court actions and recovery of product
credibility.
Despite substantial progress in basic and applied science
relating to food safety, contaminated food (including water)
remains a major public health problem. Foodborne diseases
are very common in every country. They constitute one of the
most important types of health problem. Furthermore, they
are an important cause of reduced economic productivity
(WHO, 1984, 1995). In the United States alone, it has been
reported that as many as 9 000 deaths and 6.5 million to
33 million illnesses occurring each year are food related
(Foegeding et al., 1994). For only seven specific pathogens,
costs for lost productivity have been estimated to range
between US$6 000 million and $9 000 million. The cost of
salmonellosis alone in the United States was estimated to be
about US$1 000 million in 1987 (Roberts, 1988).
The observation of hygienic practices in food processing,
transport and storage has gained more importance as the
distance between producer and consumer has increased and
consumers have become more dependent on processed and
semi-prepared foods. A worldwide initiative on food safety
is therefore becoming indispensable. While the public
commonly shows concern about the safety of additives in
food, the scientific evidence indicates that unhygienic
practices represent more significant risks to human health

(WHO, 1992).
THE CODEX ALIMENTARIUS INITIATIVE
Food laws and regulations existed in some form in most

ancient cultures, as in modern societies, to address
consumers concerns. Historically speaking, regulations
dealing with food production, manufacture and trade were
chiefly related to the criterion of honesty in commerce.
During the first half of the twentieth century it was
scientifically validated that some substances in food can
damage consumers health. Contaminated or adulterated
food moving into the international market can impair health
in remote countries.
Consumer safety became a subject of international concern
in the late 1950s and early 1960s. FAO and the World Health
Organization (WHO) were requested to address this
emerging issue in food trade. The Codex Alimentarius
Commission (CAC) was established in 1962 as an executive
organ of the Joint FAO/WHO Food Standards Programme,
with the chief objective of protecting the health of consumers
and ensuring fair practices in food trade. CAC is the only
international forum that is able to bring together scientists,
technical experts, government regulators and international
consumer and industry organizations.
With over 200 Codex standards, more than 2 500
maximum limits for pesticide residues, 41 codes of practice
and 25 guideline levels for contaminants adopted to date,
CAC has proved to be one of the most successful
programmes of the specialized agencies of the United
Nations, contributing to international harmonization in the
important area of food quality and safety (Randell, 1995).
The final Codex texts are used by governments as part of
their national food safety requirements. They are also used
by commercial partners in specifying the grade and quality
of consignments moving in international trade.
During its more than 30 years of existence, CAC has never
been indifferent to the changing demands of consumers and
the needs of those who use international standards. After
adoption, Codex standards and other texts have been
FNA/ANA 21, 1998
19
revisited when the necessity has arisen; in fact, many of them

have been revised to take account of new scientific evidence
or current food manufacturing techniques. CAC has adapted
to emerging global challenges so that the international
standards elaborated by the commission will remain
pertinent and will always meet their purpose in the
international trade of foods.
NEW DEMANDS FOR CODEX
Recent changes in the international environment arising from

the conclusion of the Uruguay Round of multilateral trade
negotiations have nearly redefined the role of Codex
standards. These changes include the creation of the World
Trade Organization (WTO) and the Agreement on the
Application of Sanitary and Phytosanitary Measures (SPS
Agreement) which all members of WTO are expected to
observe. Under the SPS Agreement, which entered into force
in January 1995, Codex standards, guidelines and
recommendations have been granted the status of a reference
point for international harmonization. They also serve as the
basic texts to guide the resolution of trade disputes.
In 1991 the FAO/WHO Conference on Food Standards,
Chemicals in Food and Food Trade adopted a number of
recommendations which set new directions for CAC (FAO/
WHO/GATT, 1991). These have helped prepare the
commission for its new role. Among the recommendations
were:
the use of a horizontal approach regarding food
additives and possibly other areas;
the strengthening of the work of general subject
committees;
assurance of a sound scientific basis for standards;
the use of explicit risk assessment methods by
committees;
review of Codex elaboration and acceptance procedures;
the establishment of a Codex committee to deal with
import and export control problems.
Among the actions taken by CAC following these
recommendations was the establishment of the Codex
Committee on Food Import and Export Inspection and
Certification Systems.
CODEX COMMITTEE ON FOOD HYGIENE
The principal work of developing standards is undertaken by

the CACs subsidiary bodies. The Codex Committee on Food
Hygiene is one of the most long-standing and active of the
general subject committees. The recent work of the committee
provides a good example of how CAC keeps its food
standards and other texts relevant to current needs through
the establishment of appropriate working principles. Hosted
FNA/ANA 21, 1998
by the Government of the United States, the Codex

Committee on Food Hygiene had convened 30 sessions by
1997.
Food hygiene means all conditions and measures necessary
to ensure the safety and suitability of food at all stages of
the food chain. The main task of the Codex Committee on
Food Hygiene is to draft provisions on food hygiene that are
relevant to all foods as well as provisions that are applied to
specific food items or food groups. The basic texts on food
hygiene developed by the committee are meant for use in
preventing the spread of foodborne pathogens and diseases.
Considering both the health and economic consequences of
unsafe food, governments should give greater attention to the
prevention and control of food contamination at the national
level.
A look at the more than 30-year history of the Codex
Committee on Food Hygiene indicates that countries are
paying increased attention to its work. Participation in its
sessions has increased (see Figure). The thirtieth session, held
in October 1997, saw a record attendance of 266 delegates
representing 56 countries and 14 international scientific,
technical, industry and consumer organizations.
Recent work of the committee
The Recommended International Code of Practice General

Principles of Food Hygiene is one of the most widely used
Codex texts. It has been revised three times since its first
adoption. The 1997 revised version (FAO/WHO, 1997a) has
a new format and provisions based on the concept of risk
assessment. The revised text sets out the objectives to be met
throughout the food chain, from primary production to the
final consumer, in order to ensure safety and suitability of
food by applying a risk-based approach.
One of the methods referred to in the text is the Hazard
Analysis and Critical Control Point (HACCP) system.
Guidelines for the application of HACCP (FAO/WHO,
1997a) were initially adopted by CAC in 1993. The widest
possible use of the basic text in all areas of food
manufacturing implies the furthering of a horizontal
approach and is expected to facilitate the efficient use of
resources in key food safety and food control activities.
Another notable output of the Codex Committee on Food
Hygiene is the Principles for the Establishment and
Application of Microbiological Criteria for Foods (CAC/GL
21 1997), adopted by the twenty-second session of the
Codex Alimentarius Commission (FAO/WHO, 1997a). While
adherence to good hygienic practices in conjunction with the
use of the HACCP system is considered to be the best
preventive system to ensure food safety, microbiological
criteria may be used to examine foods of uncertain origin or
20
Number participating
60
50
Member countries
Developing countries
International non-governmental organizations
40
30
20
10
0
1964
1966
1969
1971
1973
1975
1977
1979
1982
1984
1986
1989
1993
1995
1997
Participation in sessions of the Codex Committee on Food Hygiene
when other means of verifying the efficiency of the HACCP

system or good hygienic practices are not available. They can
also be useful for determining whether processes are
consistent with the General Principles of Food Hygiene. To
avoid the possibility of microbiological criteria being applied
in an arbitrary and non-scientific manner, this new text fully
incorporates the idea of risk assessment and describes the
principles to be applied in establishing microbiological
criteria.
Ongoing work
Now that the text of the revised General Principles of Food

Hygiene has been adopted by CAC, the Codex Committee on
Food Hygiene will begin the work of revising the existing
commodity-specific codes of practice to reflect the new
philosophy in these texts: a preventive and risk-based
approach.
In parallel, the HACCP system is being promoted in many
areas. The Codex Committee on Food Hygiene, in
cooperation with other Codex committees such as the Codex
Committee on Food Inspection and Certification Systems, is
also looking into the modality whereby countries should
promote the use of HACCP or related systems nationally.
The future work should take account of:
the limited resources available in small businesses and
the opportunity of recommending alternative approaches
to the HACCP system;
the status of the HACCP system as a possible
component of more comprehensive quality control
systems operated by companies.
Both issues are closely related to how government agencies

should apply regulatory requirements to ensure compliance
with food hygiene standards.
Another field of food hygiene of increasing importance
regards fresh produce such as fruits and vegetables. As
consumers interest in foods perceived as healthy grows, so
does the need to ensure the safety of fresh produce, which is
often consumed raw or with minimal cooking.
The Codex Committee on Food Hygiene is also continuing
its work on the general methodology of risk assessment for
microbiological hazards. It has started elaborating the
Principles and Guidelines for the Conduct of Microbiological
Risk Assessment, which would provide guidance to CAC
itself as well as to governments conducting microbiological
risk assessment on their own. The principles are significant in
that they attempt to identify the basic concepts of risk
analysis, such as transparency, and to describe components
and steps of microbiological risk assessment (FAO/WHO,
1997b).
As shown above, the Codex Committee on Food Hygiene
will incorporate further risk-based principles in the Codex
texts addressing microbiological hazards for foods by
building on the available scientific knowledge and data. This
process will be pursued in close liaison with other bodies of
CAC. To consolidate the scientific basis for its
recommendations, the Codex Committee on Food Hygiene
has requested that FAO and WHO consider the
establishment of an expert group to conduct risk
assessments on microbiological hazards. This
recommendation has been endorsed by CAC. If approved by
FNA/ANA 21, 1998
21
FAO and WHO, such a body will play a crucial part in the
future work of the Codex Committee on Food Hygiene. With
the increasing input from scientific risk assessment , the
committee is expected to offer further contributions to
achieving CACs objectives of protecting human health and
facilitating food trade.
REFERENCES
FAO/World Health Organization (WHO). 1997a. Codex

Alimentarius, Suppl. to Vol. 1B, General requirements
(food hygiene). Rome. 2nd ed.
FAO/WHO. 1997b. Report of the 30th session of the Codex
Committee on Food Hygiene, Appendix IV. ALINORM
99/13. Rome.
FAO/WHO/General Agreement on Tariffs and Trade (GATT).
1991. FAO/WHO Conference on Food Standards,
Chemicals in Food and Food Trade, Vol. 1, Report. Rome,
18-27 March 1991. Rome.
FNA/ANA 21, 1998
Foegeding, P.M., Roberts, T., Bennet, J., Bryan, F.L., Cliver,

D.O., Doyle, M.P., Eden, R.F., Flowers, R.S., Forman,
C.T. & Lorber, B. 1994. Foodborne pathogens: risk and
consequences. Council for Agricultural Science and
Technology Task Force Report No. 122. Ames, Iowa,
USA, Council for Agricultural Science and Technology.
Randell, A. 1995. Codex Alimentarius: How it all began. Food
Nutr. Agric., 13/14: 35-40.
Roberts, T. 1988. Salmonellosis control, estimated economic
costs. Poultry Sci., 67(6): 936-943.
WHO. 1984. The role of food safety in health and development.
Report of a Joint FAO/WHO Expert Committee on Food
Safety. WHO Technical Report Series No. 705. Geneva,
Switzerland.
WHO. 1992. Our planet, our health. Report of the WHO
Commission on Health and Environment. Geneva,
Switzerland.
WHO. 1995. Food technologies and public health: food safety
issues. Geneva, Switzerland.
22
Summary/Rsum/Resumen
Codex
Alimentarius
Commission
protecting food
today and in the
future
Despite scientific progress, contaminated food (including water) remains a major public health problem
and foodborne diseases are common in every country. When unsafe food enters the international market,
there are substantial losses from food spoilage and damage; illnesses; and court actions, recall of
products and recovery of product credibility. Hygienic practices in food handling, processing, transport
and storage have gained importance as consumers depend more on processed and semi-prepared foods.
A worldwide initiative on food safety is becoming indispensable.
The Codex Alimentarius Commission, established in 1962, aims to protect the health of consumers and
ensure fair practices in the food trade. This international forum brings together scientists, technical
experts, government regulators and international consumer and industry organizations. It contributes to
international harmonization in the area of food quality and safety. Codex texts are used by governments
as part of their national food safety requirements and by commercial partners in specifying the grade and
quality of consignments. The creation of the World Trade Organization and the Agreement on the
Application of Sanitary and Phytosanitary Measures which arose from the Uruguay Round of multilateral
trade negotiations have nearly redefined the role of Codex standards. Codex standards, guidelines and
recommendations have become a reference point for international harmonization and serve as the basic
texts to guide the resolution of trade disputes.
The work of the Codex Committee on Food Hygiene illustrates how the Codex Alimentarius
Commission keeps its food standards and other texts relevant to current needs through the establishment
of appropriate working principles. This committee drafts provisions on food hygiene which are relevant to
all foods. It is working on risk assessment methodologies for microbiological hazards. The committee has
started elaborating principles and guidelines for the conduct of microbiological risk assessment. The
Codex Alimentarius Commission publishes texts on food hygiene to assist in preventing the spread of
foodborne pathogens and diseases.
Commission du
Codex
Alimentarius
protger les
aliments
aujourdhui et
demain
Malgr les progrs scientifiques, la contamination des aliments (y compris de leau) demeure un
important problme de sant publique et les maladies transmises par les aliments sont courantes dans
tous les pays. Lentre daliments malsains sur le march international est lourde de consquences:
aliments qui se gtent ou sont endommags; maladies; poursuites judiciaires suivies du retrait des
produits et ncessit de restaurer la crdibilit du produit. Les usages en matire dhygine lors du
traitement, de la transformation, du transport et de lentreposage des aliments ont pris de limportance
car les consommateurs dpendent davantage de produits alimentaires imports ou prconditionns. Une
initiative mondiale sur linnocuit des aliments est dsormais indispensable.
La Commission du Codex Alimentarius, tablie en 1962, vise protger la sant des consommateurs et
assurer des pratiques commerciales quitables dans le domaine alimentaire. Cette instance internationale
rassemble des scientifiques, des experts techniques, des responsables gouvernementaux de la
rglementation et des organisations internationales de consommateurs et dindustriels. Elle contribue
une harmonisation internationale des normes de qualit et de scurit des aliments. Les gouvernements se
rfrent aux textes du Codex pour tablir certaines de leurs dispositions nationales en matire de scurit
des aliments, de mme que les partenaires commerciaux pour spcifier la catgorie et la qualit de leurs
expditions. La cration de lOrganisation mondiale du commerce et lAccord sur lapplication des
mesures sanitaires et phytosanitaires issu des ngociations commerciales multilatrales du Cycle
dUruguay ont dj redfini le rle des normes Codex. Les normes, les directives et les recommandations
du Codex sont devenues un point de rfrence pour lharmonisation internationale et servent de guide
pour la rsolution des diffrends commerciaux.
Le travail du Comit du Codex sur lhygine alimentaire montre comment, grce ltablissement de
principes de travail appropris, les normes alimentaires et les autres textes de la Commission du Codex
Alimentarius restent adapts aux besoins actuels. Ce Comit prpare des dispositions concernant
lhygine alimentaire pour tous les types de produits. Actuellement, ses travaux portent sur les
mthodologies dvaluation des risques microbiologiques. Le Comit a commenc laborer des principes
FNA/ANA 21, 1998
23
Summary/Rsum/Resumen
et des directives rgissant la conduite de lvaluation des risques microbiologiques. La Commission du
Codex Alimentarius publie des textes sur lhygine alimentaire afin daider prvenir la propagation
dagents pathognes et de maladies transmises par les aliments.
Comisin del
Codex
Alimentarius:
La proteccin
de los alimentos
hoy y en el
futuro
FNA/ANA 21, 1998
A pesar de los progresos cientficos, la contaminacin de los alimentos (incluida el agua) sigue siendo un
importante problema de salud pblica y las enfermedades de origen alimentario son frecuentes en todos
los pases. Cuando un alimento insalubre llega al mercado internacional, se producen cuantiosos daos y
prdidas como consecuencia del deterioro de los alimentos, enfermedades, acciones judiciales, retirada de
productos y merma de la credibilidad de stos. Las prcticas de higiene en la elaboracin, el transporte y
el almacenamiento de alimentos han adquirido importancia al hacer un mayor uso los consumidores de
alimentos importados y precocinados. Se est haciendo indispensable una iniciativa a nivel mundial en
relacin con la inocuidad de los alimentos.
La Comisin del Codex Alimentarius, creada en 1962, tiene como finalidad proteger la salud de los
consumidores y asegurar prcticas leales en el comercio de alimentos. Este foro internacional rene a
cientficos, expertos tcnicos, funcionarios gubernamentales encargados de la reglamentacin y
organizaciones internacionales de consumidores y de la industria y contribuye a la armonizacin
internacional en el mbito de la calidad e inocuidad de los alimentos. Los textos del Codex son utilizados
por los gobiernos, que los incorporan a sus requisitos nacionales en materia de inocuidad de los
alimentos, y por los interlocutores comerciales para especificar la categora y la calidad de los envos. La
Ronda Uruguay de Negociaciones Comerciales Multilaterales y el Acuerdo de la Organizacin Mundial
del Comercio sobre la Aplicacin de Medidas Sanitarias y Fitosanitarias han realzado la funcin de las
normas del Codex. Las normas, directrices y recomendaciones del Codex han pasado a ser un punto de
referencia para la armonizacin internacional y son los textos fundamentales por los que se rige la
solucin de las diferencias comerciales.
El Comit del Codex sobre Higiene de los Alimentos es un ejemplo de cmo la Comisin del Codex
Alimentarius adapta sus normas alimentarias y otros textos a las necesidades existentes mediante el
establecimiento de principios adecuados. Este Comit prepara proyectos de disposiciones en materia de
higiene que son aplicables a todos los alimentos. En la actualidad est elaborando mtodos de evaluacin
de riesgos para determinar los peligros microbiolgicos y ha iniciado la preparacin de principios y
directrices para llevar a cabo evaluaciones de riesgos microbiolgicos. La Comisin del Codex
Alimentarius publica textos sobre higiene de los alimentos con la finalidad de ayudar a prevenir la
propagacin de patgenos y enfermedades transmitidos por los alimentos.

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Chap 1 - Introduction to Course and HACCP

Chapter 1: Introduction to Course and HACCP

This seafood HACCP course is divided into three distinct segments:

Chap 1 - Introduction to Course and HACCP

HACCP is a common sense technique used to control food-safety hazards.

HACCP is merely an acronym that stands for Hazard Analysis and

Chap 1 - Introduction to Course and HACCP

HACCP is a preventive system of hazard control rather than a reactive

The Pillsbury Co. pioneered the application of the HACCP concept to

The only way to ensure safety, Pillsbury concluded, would be to develop

Chap 1 - Introduction to Course and HACCP

In an assessment of the effectiveness of food regulation in the United

This recommendation led to the formation of the National Advisory

Seven principles of HACCP:

In 1992, NACMCF adopted the following seven HACCP principles.

Instructors and students

These principles will be explained in more detail in the following

Chap 1 - Introduction to Course and HACCP

HACCP has been endorsed worldwide by organizations such as

HACCP is a preventive system for ensuring food safety, but it is not a

The HACCP concept is used by regulators during inspections of food

Chap 1 - Introduction to Course and HACCP

With HACCP, the emphasis is to understand the process system. This

Chap 1 - Introduction to Course and HACCP

Chap 1 - Introduction to Course and HACCP

Continuous Monitoring: Uninterrupted collection and recording of

data such as temperature on a strip chart.

Control: (a) (verb) To manage the conditions of an operation to maintain

compliance with established criteria.

Measure: Any action or activity that can be used to prevent,

Control Point: Any point, step or procedure at which biological,

physical or chemical factors can be controlled.

Corrective Action: Procedures followed when a deviation occurs.

Control Point (CCP): A step at which control can be applied and is

essential to prevent or eliminate a food-safety hazard or reduce it to

Decision Tree: A sequence of questions asked to determine

whether a control point is a CCP.

Critical Limit: A maximum and/or minimum value to which a biological,

chemical or physical parameter must be controlled at a CCP to

Deviation: Failure to meet a critical limit.

HACCP: A systematic approach to the identification, evaluation and

control of food-safety hazards.

Plan: The written document that is based upon principles of

System: The result of the implementation of the HACCP plan.

implementing and maintaining the HACCP system.

Hazard: A biological, chemical or physical agent that is reasonably

likely to cause illness or injury in the absence of its control.

Chap 1 - Introduction to Course and HACCP

Monitor: To conduct a planned sequence of observations or

measurements to assess whether a CCP is under control and to

Operating Limits: Criteria that are more stringent than critical

limits and that are used by an operator to reduce the risk of

Prerequisite Programs: Procedures, including Good Manufacturing

Practices (GMPs), that address operational conditions providing the

Severity: The seriousness of a hazard (if not properly controlled).

Validation: The element of verification focused on collecting and

evaluating scientific and technical information to determine if the

Those activities that determine the validity of the HACCP

* National Advisory Committee on Microbiological Criteria for Foods,

1997. Hazard Analysis and Critical Control Point Principles and

Chap 1 - Introduction to Course and HACCP

Critical control point

Food and Drug Administration

GMP: Good Manufacturing Practice