Fish And Fishery Products Hazards Controls Guidance 252400 UCM252400

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CHAPTER 7: Scombrotoxin (Histamine) Formation
This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create
or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative
approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss
an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the
appropriate FDA staff, call the telephone number listed on the title page of this guidance.

UNDERSTAND THE POTENTIAL HAZARD.
Scombrotoxin (histamine) formation as a result
of time and temperature abuse of certain species
of fish can cause consumer illness. The illness
is closely linked to the development of histamine
in these fish. In most cases, histamine levels in
illness-causing fish have been above 200 ppm,
often above 500 ppm. However, there is some
evidence that other chemicals (e.g., biogenic
amines such as putrescine and cadaverine) may
also play a role in the illness. The possible role of
these chemicals in consumer illness is the subject
of Chapter 8.
Seafood-related scombrotoxin poisoning is
primarily associated with the consumption of
tuna, mahi-mahi, marlin, and bluefish. Table 3-2
(Chapter 3) identifies other species that are also
capable of developing elevated levels of histamine
when temperature abuse occurs.

that the methods of control used to inhibit the
bacteria that result in histamine formation will
also inhibit the bacteria that produce other
biogenic amines.
Symptoms of scombrotoxin poisoning include
tingling or burning in or around the mouth or
throat; rash or hives on the upper body; drop in
blood pressure; headache; dizziness; itching of the
skin; nausea; vomiting; diarrhea; asthmatic-like
constriction of the air passage; heart palpitation;
and respiratory distress. Symptoms usually
occur within a few minutes to a few hours of
consumption and last from 12 hours to a few days.
•

Scombrotoxin (histamine) formation

Certain bacteria produce the enzyme histidine
decarboxylase during growth. This enzyme reacts
with histidine, a naturally occurring amino acid
that is present in larger quantities in some fish
than in others. The result is the formation of
scombrotoxin (histamine).

The illness caused by the consumption of fish
in which scombrotoxin has formed is most
appropriately referred to as “scombrotoxin
poisoning.” The illness has historically been
known by other names. Originally, the illness
was termed “scombroid poisoning” because of its
association with fish in the families Scombridae
and Scomberesocidae. However, other species
of fish are now known to cause the illness. The
terms “histamine poisoning” and “histamine fish
poisoning” have also been applied to the illness.
However, because biogenic amines other than
histamine have been associated with the illness,
these terms also present difficulties. Nonetheless,
this chapter refers to control measures to prevent
the formation of histamine. It is expected

Histamine-forming bacteria are capable of growing
and producing histamine over a wide temperature
range. Growth of histamine is more rapid, however,
at high-abuse temperatures (e.g., 70°F (21.1°C)
or higher) than at moderate-abuse temperatures
(e.g., 45°F (7.2°C)). Growth is particularly rapid
at temperatures near 90°F (32.2°C). Histamine is
more commonly the result of high temperature
spoilage than of long-term, relatively lowtemperature spoilage, which is commonly associated
with organoleptically detectable decomposition.
Nonetheless, there are a number of opportunities
for histamine to form under more moderate-abuse
temperature conditions.

CHAPTER 7: Scombrotoxin (Histamine) Formation

113

Once the enzyme histidine decarboxylase is
present in the fish, it can continue to produce
histamine in the fish even if the bacteria are not
active. The enzyme can be active at or near
refrigeration temperatures. The enzyme remains
stable while in the frozen state and may be
reactivated very rapidly after thawing.

species that generate heat, resulting in internal
temperatures that may exceed environmental
temperatures and increasing the likelihood
of conditions favorable to growth of enzymeforming bacteria.
The potential for histamine formation is increased
when the scombrotoxin-forming fish muscle is in
direct contact with the enzyme-forming bacteria.
This direct contact occurs when the fish are
processed (e.g., butchering or filleting) and can
be particularly problematic when the surface-to
volume ratio of the exposed fish muscle is large,
such as minced tuna for salads. Even when such
products are prepared from canned or pouch
retorted fish, recontamination can occur during
salad preparation, especially with the addition of
raw ingredients. The mixing in of the bacteria
throughout the product and the high surface-to
volume ratio can result in substantial histamine
formation if time and temperature abuse occurs.

Freezing may inactivate some of the enzymeforming bacteria. Both the enzyme and
the bacteria can be inactivated by cooking.
However, once histamine is produced, it cannot
be eliminated by heat (including retorting) or
freezing. After cooking, recontamination of
the fish with the enzyme-producing bacteria
is necessary for additional histamine to form.
For these reasons, histamine development is
more likely in raw, unfrozen fish but should
not be discounted in other product forms of
scombrotoxin-forming fish species.
The kinds of bacteria that are associated with
histamine development are commonly present in
the saltwater environment. They naturally exist
on the gills, on external surfaces, and in the gut
of live, saltwater fish, with no harm to the fish.
Upon death, the defense mechanisms of the fish
no longer inhibit bacterial growth in the muscle
tissue, and histamine-forming bacteria may start
to grow, resulting in the production of histamine.
Evisceration and removal of the gills may reduce,
but not eliminate, the number of histamineforming bacteria. Packing of the visceral cavity
with ice may aid in chilling large fish in which
internal muscle temperatures are not easily
reduced. However, when done improperly, these
steps may accelerate the process of histamine
development in the edible portions of the fish by
spreading the bacteria from the visceral cavity to
the flesh of the fish.

At least some of the histamine-forming bacteria
are halotolerant (salt tolerant) or halophilic (salt
loving). Some are more capable of producing
histamine at elevated acidity (low pH). As a
result, histamine formation is possible during
processes such as brining, salting, smoking,
drying, fermenting, and pickling until the product
is fully shelf-stable. Refrigeration can be used
to inhibit histamine formation during these
processes.
A number of the histamine-forming bacteria are
facultative anaerobes that can grow in reduced
oxygen environments. As a result, reduced
oxygen packaging (e.g., vacuum packaging,
modified atmosphere packaging, and controlled
atmosphere packaging) should not be viewed as
inhibitory to histamine formation.
Histamine is water soluble (dissolves in water)
and would not be expected in significant
quantity in products such as fish oil that do not
have a water component. However, histamine
could be present in products such as fish protein
concentrate that are prepared from the muscle or
aqueous (water-based) components of fish tissue.

With some harvesting practices, such as
longlining and gillnetting, death may occur many
hours before the fish is removed from the water.
Under the worst conditions, histamine formation
can already be underway before the fish is
brought onboard the vessel. This condition
can be further aggravated with certain tuna

CHAPTER 7: Scombrotoxin (Histamine) Formation

114

•

Controlling scombrotoxin (histamine)
formation

Rapid chilling of scombrotoxin-forming fish
immediately after death is the most important
element in any strategy for preventing the
formation of scombrotoxin (histamine), especially
for fish that are exposed to warm waters or air,
and for tunas which generate heat in their tissues.
Some recommendations follow:
•

Fish exposed to air or water temperatures
above 83°F (28.3°C) should be placed in
ice, or in refrigerated seawater, ice slurry,
or brine of 40°F (4.4°C) or less, as soon as
possible after harvest, but not more than 6
hours from the time of death; or

•

Fish exposed to air and water temperatures
of 83°F (28.3°C) or less should be placed
in ice, or in refrigerated seawater, ice slurry,
or brine of 40°F (4.4°C) or less, as soon as
possible after harvest, but not more than 9
hours from the time of death; or

•

Fish that are gilled and gutted before chilling
should be placed in ice, or in refrigerated
seawater, ice slurry, or brine of 40°F (4.4°C)
or less, as soon as possible after harvest, but
not more than 12 hours from the time of
death; or

•

Fish that are harvested under conditions that
expose dead fish to harvest waters of 65°F
(18.3°C) or less for 24 hours or less should
be placed in ice, or in refrigerated seawater,
ice slurry, or brine of 40°F (4.4°C) or less, as
soon as possible after harvest, but not more
than the time limits listed above, with the
time period starting when the fish leave the
65°F (18.3°C) or less environment.

Note: If the actual time of death is not known, an estimated time
of the first fish death in the set may be used (e.g., the time the
deployment of a longline begins).

CHAPTER 7: Scombrotoxin (Histamine) Formation

115

CHAPTER 7: Scombrotoxin (Histamine) Formation

116

-
-

≤ 83
> 83
≤ 83

> 65, but ≤ 83

≤ 652

Any

1. This table is a summary of the preceding recommendations. For complete understanding of the recommendations, refer to the text above.
2. Provided exposure of the fish in the water at 65°F or less is ≤ 24 hours.

Any

> 65

FOR FISH EVISCERATED ONBOARD BEFORE CHILLING:

≤ 652

≤ 65

Any

> 83

> 65

DEATH OF THE FISH OR EARLIEST ESTIMATED
TIME OF DEATH IS…

FOR UNEVISCERATED FISH:

AND THE AIR TEMPERATURE (°F) IS…

ONBOARD LANDING IS…

THEN, THE MAXIMUM TIME IN HOURS TO GET THE FISH INTO CHILLING MEDIUM (≤ 40°F) FROM
THE TIME OF…

> 83

THE WATER
TEMPERATURE (°F) IS…

WHEN…

RECOMMENDED MAXIMUM TIME TO GET SCOMBROTOXIN-FORMING FISH INTO CHILLING MEDIUM ONBOARD HARVEST VESSELS TO PREVENT
SCOMBROTOXIN FORMATION1

TABLE 7-1

The controls listed above for onboard chilling
will prevent the rapid formation of the enzyme
histidine decarboxylase. Once this enzyme is
formed, control of the hazard is unlikely. It is
important to recognize that the parameters listed
above are intended to control scombrotoxin
formation; these criteria may not effectively control
the activity of other spoilage organisms, raising
the possibility that fish may become adulterated
because of decomposition (not a food safety
hazard covered by the Procedures for the Safe and
Sanitary Processing and Importing of Fish and
Fishery Products regulation, 21 CFR 123, called
the Seafood Hazard Analysis Critical Control Point
(HACCP) Regulation in this guidance document)
before scombrotoxin (histamine) is formed.

Although it may be possible for a harvest vessel
to completely avoid onboard chilling and still
deliver fish to the processor within the time and
temperature limitations recommended above
for chilling the fish, this practice is discouraged.
Failure to chill onboard may permit bacteria and
enzymes, including those that form scombrotoxin
(histamine), to increase unnecessarily.

The harvest method:
Delays in removing fish from the water
after capture, such as those captured by
a longline, may significantly limit the
amount of time left for chilling and may
allow some fish to heat up;

Large quantities of fish captured in a
single fishing set, such as those captured
on a purse seiner, may exceed a vessel’s
ability to rapidly chill the product;

•

The chilling method:

Ice alone takes longer to chill fish
than does an ice slurry or recirculated
refrigerated seawater or brine, a
consequence of reduced contact area
and heat transfer;

The quantity of ice or ice slurry and
the capacity of refrigerated seawater or
brine systems, as well as the physical
arrangement of the fish in the chilling
media, should be suitable for the
quantity of catch.

Extended frozen storage (e.g., 24 weeks) or
cooking minimizes the risk of additional
histamine development by inactivating the
enzyme-forming bacteria and, in the case
of cooking, the enzyme itself. As previously
mentioned, recontamination with enzymeforming bacteria and significant temperature
abuse is necessary for histamine formation
following cooking. Such recontamination may
not be likely if the fish is processed under a
conscientious sanitation program. However,
addition of raw ingredients, employee contact,
or poor sanitary conditions could reintroduce
contamination. Further guidance is provided
below:

The time required to lower the internal
temperature of fish after capture will be
dependent upon a number of factors, including:

The size of the fish;

Once chilled, the scombrotoxin-forming fish
should be maintained as close as possible to the
freezing point (or held frozen) until it is consumed.
Exposure to temperatures above 40°F (4.4°C)
should be minimized. The amount of post-harvest
time at elevated temperatures (after proper chilling
onboard the harvest vessel) to which a fish can
be exposed (e.g., during processing, storage, and
distribution) without adverse effects is dependent
primarily upon whether the fish was previously
frozen (e.g., onboard the harvest vessel) or heat
processed sufficiently to destroy scombrotoxin
forming bacteria.

Further chilling toward the freezing point is also
desirable to safeguard against the less common,
longer term, lower temperature development of
histamine. Additionally, the shelf life and quality
of the fish are significantly compromised when
product temperature is not rapidly dropped to
near freezing.

•

Scombrotoxin-forming fish that have not
been previously frozen or heat processed
sufficiently to destroy scombrotoxin
forming bacteria should not be exposed to

CHAPTER 7: Scombrotoxin (Histamine) Formation

117

temperatures above 40°F (4.4°C) for:

•

More than 4 hours, cumulatively, if any
portion of that time is at temperatures
above 70°F (21.1°C); or

More than 8 hours, cumulatively, as
long as no portion of that time is at
temperatures above 70°F (21.1°C).

Scombrotoxin-forming fish that have
been previously frozen, or heat processed
sufficiently to destroy scombrotoxin-forming
bacteria and are subsequently handled in
a manner in which there is an opportunity
for recontamination with scombrotoxin
forming bacteria (e.g., contact with fresh
fish, employees, or introduction of raw
ingredients), should not be exposed to
temperatures above 40°F (4.4°C) for:

More than 12 hours, cumulatively, if any
portion of that time is at temperatures
above 70°F (21.1°C); or

More than 24 hours, cumulatively, as
long as no portion of that time is at
temperatures above 70°F (21.1°C);

Scombrotoxin-forming fish that have been
heat processed sufficiently to destroy
scombrotoxin-forming bacteria and enzymes
and are not subsequently handled in a
manner in which there is an opportunity for
recontamination with scombrotoxin-forming
bacteria (e.g., no contact with fresh fish,
employees, or raw ingredients) are at low
risk for further scombrotoxin (histamine)
development.

CHAPTER 7: Scombrotoxin (Histamine) Formation

118

CHAPTER 7: Scombrotoxin (Histamine) Formation

119

≤8

≤ 70 DURING ENTIRE EXPOSURE

1. This table is a summary of the preceding recommendations. For complete understanding of the recommendations, refer to the text above.

≤4

≤ 24

≤ 12

Previously frozen fish, or heat processed fish (that has been
exposed to possible recontamination), is…

THEN, THE MAXIMUM HOURS OF EXPOSURE TIME FOR…

Fresh fish (not heat processed
or previously frozen) is …

> 70 AT ANY TIME

WHEN THE AMBIENT TEMPERATURE (°F) OF EXPOSURE IS…

RECOMMENDED MAXIMUM HOURS OF EXPOSURE OF SCOMBROTOXIN-FORMING FISH TO AMBIENT TEMPERATURES GREATER THAN
40°F TO PREVENT SCOMBROTOXIN FORMATION AFTER PROPER ONBOARD HARVEST VESSEL CHILLING, FOR DIFFERING TEMPERATURE
EXPOSURE AND PREVIOUS PROCESSING CONDITIONS1

TABLE 7-2

•

Detection

histamine testing is dependent upon the design
of the sampling plan. The amount of sampling
required to accommodate such variability of
distribution is necessarily quite large. The
method of collection of the fish sample is also
critical. In large scombrotoxin-forming fish, the
lower, anterior (forward) portion of the fish loin
(not the belly flap) is likely to provide the best
information about the histamine content of the
fish. The number of samples (i.e., scombrotoxin
forming fish) necessary to make a judgment
about a lot depends on the anticipated variability,
but should not be fewer than 18 samples per lot,
unless the lot contains less than 18 fish, in which
case a sample should be collected from each fish.

Sensory evaluation

Sensory evaluation is generally used to screen
fish for indicators of spoilage that develop when
the fish is exposed to time and temperature
abuse. Odor in particular is an effective means
of detecting fish that have been subjected to a
variety of abusive conditions. However, odors of
decomposition that are typical of relatively low
temperature spoilage may not be present if the
fish has undergone high temperature spoilage.
This condition makes sensory examination
alone an ineffective control for preventing
scombrotoxin (histamine) formation.
It is important to recognize that the Federal
Food, Drug, and Cosmetic Act (the FFD&C Act)
prohibits interstate commerce of adulterated
foods (21 U.S.C. 331). Under the FFD&C
Act, a food that is decomposed is considered
adulterated (21 U.S.C 342). Accordingly, a fish
or fishery product that is decomposed in whole
or in part is prohibited from entering interstate
commerce even if the type of decomposition
may not lead to scombrotoxin (histamine)
formation. You should distinguish between
recommendations in this chapter for sensory
screening, as a component of a HACCP control
strategy for scombrotoxin formation, and your
obligation to avoid otherwise violating the
FFD&C Act with regard to the distribution of
decomposed food.

Where samples are composited to reduce the
number of analyses needed on a lot, it should
be done in a manner that ensures meaningful
results. No more than three samples should be
composited, in order to minimize masking of
problematic fish. Furthermore, the analytical
method and instrument used should be capable
of reliably detecting histamine at the lower levels
that are necessary for composited samples (e.g.,
17 ppm histamine in a three-sample composite,
rather than 50 ppm in an uncomposited sample ).
Combining additional indicators of conditions
that can lead to histamine formation, such as
sensory examination and internal temperature
measurement, with histamine testing can provide
better assurance of product safety. Observation
for the presence of honeycombing (voids in
the fish flesh) in cooked tuna loins intended
for canning is a valuable means of screening
for fish that have been exposed to the kinds of
temperature abuse that can lead to histamine
development. Any scombrotoxin-forming fish
that demonstrate the trait should be destroyed or
diverted to a non-food use.

Chemical testing

Chemical testing is an effective means of
detecting the presence of histamine in fish flesh.
However, the variability in histamine levels
between fish and within an individual fish can be
large, even in fish from the same harvest vessel.
For this reason, a guidance level has been set of
50 ppm histamine in the edible portion of fish.
If 50 ppm is found in one section of a fish or lot,
there is the possibility that other sections may
exceed 500 ppm.
Because histamine is generally not uniformly
distributed in a fish or a lot, the validity of

CHAPTER 7: Scombrotoxin (Histamine) Formation

120

DETERMINE WHETHER THE POTENTIAL
HAZARD IS SIGNIFICANT.

a refrigerated (not frozen) raw or cooked
product from another processor (see Chapter
12). The in-transit controls for secondary
processors recommended in Chapter 12 are
similar to those recommended in this chapter.

The following guidance will assist you in
determining whether scombrotoxin (histamine)
formation is a significant hazard at a processing
step:

2. Is it reasonably likely that unsafe levels of
histamine will form at this processing step?

1. Is it reasonably likely that unsafe levels of
histamine will be introduced at this processing step
(do unsafe levels come in with the raw material)?

To answer this question, you should consider
the potential for time and temperature abuse
in the absence of controls. You may already
have controls in your process that minimize
the potential for time and temperature abuse
that could result in unsafe levels of histamine.
This guidance will help you determine
whether those or other controls should be
included in your HACCP plan.

Table 3-2 (Chapter 3) lists those species of
fish that are generally known to be capable
of producing elevated levels of histamine if
temperature abused. Such species of fish
have this capability because they contain
naturally high levels of histidine. They also
have this capability because they are marine
fish that are likely to harbor the kinds of
bacteria that produce histidine decarboxylase.
It is, therefore, reasonable to assume that
without proper onboard vessel controls, these
species of fish will contain unsafe levels of
histamine upon receipt by the primary (first)
processor.

Time and temperature abuse that occurs
at successive processing and storage steps
may be sufficient to result in unsafe levels
of histamine, even when abuse at one
step alone would not result in such levels.
For this reason, you should consider the
cumulative effect of time and temperature
abuse during the entire process. Information
is provided above to help you assess the
significance of time and temperature abuse
that may occur in your process.

However, 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, onboard controls may not be
necessary. For example, such conditions
might exist if the fish are harvested when air
and water temperatures do not exceed 40°F
(4.4°C), as evidenced by supporting data.

3. Can unsafe levels of histamine formation that are
reasonably likely to occur be eliminated or reduced
to an acceptable level at this processing step?

Scombrotoxin (histamine) formation should
also be considered a significant hazard at any
processing or storage step where a preventive
measure is or can be used to eliminate the
hazard if it is reasonably likely to occur.
Preventive measures for scombrotoxin
(histamine) formation can include:

It is also reasonable to assume that without
proper controls during refrigerated (not
frozen) transportation between processors,
scombrotoxin-forming species of fish will
contain unsafe levels of histamine upon
receipt by the secondary processor (including
warehouses). In addition, you may need
to exercise control to prevent pathogen
growth or toxin formation when receiving

•

Examining harvest vessel records
to ensure that incoming fish were
properly handled onboard the
harvest vessel, including:

Rapidly chilling the fish immediately
after death;

CHAPTER 7: Scombrotoxin (Histamine) Formation

121

Controlling onboard refrigeration
(other than frozen storage)
temperatures;

Performing proper onboard icing;

IDENTIFY CRITICAL CONTROL POINTS.

•

Testing incoming fish for
histamine levels;

The following guidance will assist you in
determining whether a processing step is a
critical control point (CCP) for scombrotoxin
(histamine) formation:

•

Ensuring that incoming fish
were handled properly during
refrigerated transportation from the
previous processor, including:

1. If scombrotoxin (histamine) formation is a
significant hazard at the receiving step, you
should identify receiving as a CCP for this
hazard.

Controlling refrigeration temperatures
during transit;

Performing proper icing during
transit;

a. If you are the primary processor of the

scombrotoxin-forming fish (i.e., if you
receive the fish directly from the harvest
vessel) and have a relationship with the
operator of the harvest vessel(s) from
which you purchase fish that enables
you to obtain documentation of onboard
practices, you should identify the
following preventive measures for control
of this hazard:

•

Checking incoming fish to ensure
that they are not at an elevated
temperature at time of receipt;

•

Checking incoming fish to ensure
that they are properly iced or
refrigerated at time of receipt;

•

Performing sensory examination on
incoming fish to ensure that they do
not show signs of decomposition;

•

Controlling refrigeration
temperatures in your plant;

Rapidly chilling the fish
immediately after death;

•

Performing proper icing in your plant;

•

Controlling the amount of time that the
product is exposed to temperatures
that would permit histamine
formation during processing.

Controlling onboard refrigeration
(other than frozen storage)
temperatures;

Performing proper onboard icing;

•

Checking incoming fish to ensure
that they are not at an elevated
temperature at time of receipt; and,

•

Performing sensory examination of
incoming fish to ensure that they do
not show signs of decomposition.

These preventive measures are ordinarily employed
at receiving, processing, and storage steps.
•

Intended use

Because of the heat stable nature of histamine,
the intended use of the product is not likely to
affect the significance of this hazard.

Examining harvest vessel records
to ensure that incoming fish
were properly handled onboard
the harvest vessel, including:

Example:
A mahi-mahi processor that regularly
purchases from the same harvest
vessels should require harvest vessel
records as a condition of purchase.

CHAPTER 7: Scombrotoxin (Histamine) Formation

122

The processor should also check
the internal temperatures of
incoming fish and perform sensory
examination of these fish. The
processor should then set a CCP for
histamine formation at receiving.

you should identify the following
preventive measures for control of this
hazard:

This control approach is a control strategy
referred to in this chapter as “Control
Strategy Example 1 - Harvest Vessel
Control.”

•

Ensuring that incoming fish were
properly refrigerated during
transportation from the previous
processor, by controlling refrigeration
temperatures during transit or,

•

Checking incoming fish to
ensure that they are properly
iced at time of receipt.

b. If you are the primary processor of the

scombrotoxin-forming fish (i.e., if you
receive the fish directly from the harvest
vessel) and do not have a relationship
with the operator of the harvest vessel(s)
that enables you to obtain documentation
of onboard practices, you should identify
the following preventive measures for
control of this hazard:
•

Testing incoming fish for
histamine levels;

•

Checking incoming fish to ensure
that they are not at an elevated
temperature at time of receipt and,

•

Performing sensory examination of
incoming fish to ensure that they do
not show signs of decomposition.

Example:
A tuna processor that receives fish
from another processor should require
evidence of temperature control
throughout transit as a condition of
receipt. The processor should then
set a CCP for histamine formation at
receiving.
This control approach is a control strategy
referred to in this chapter as “Control
Strategy Example 3 - Transit Control.”
This control strategy, in addition to
“Control Strategy Example 1 - Harvest
Vessel Control” or “Control Strategy
Example 2 - Histamine Testing,” may
also be applicable if you are a primary
processor and transport the fish by truck
from your harvest vessel unloading site to
your processing facility.

Example:
A canned tuna processor that
purchases from a variety of harvest
vessels should subject incoming fish
from each harvest vessel to histamine
testing, internal temperature checks,
and sensory examination. The
processor should then set a CCP for
histamine formation at receiving.

2. If scombrotoxin (histamine) formation is a
significant hazard at one or more processing
steps, you should identify the processing step(s)
as a CCP for this hazard.
a. The preventive measure for this type of

control is:

This control approach is a control strategy
referred to in this chapter as “Control
Strategy Example 2 - Histamine Testing.”
c.

•

If you are a secondary processor of the
scombrotoxin-forming fish (i.e., if you
receive the fish from another processor),

Controlling the amount of time
that the scombrotoxin-forming
product is exposed to temperatures
that would permit histamine
formation during processing.

CHAPTER 7: Scombrotoxin (Histamine) Formation

123

Example:
A mahi-mahi processor should
control histamine formation
by limiting exposure time and
temperature of the product during
processing. The processor should
then set CCPs for histamine
formation at the processing steps.

•

Receiving;

•

Processing, such as:

°
°
°
°
°
°
°
°
°
°
°

This control approach is a control strategy
referred to in this chapter as “Control
Strategy Example 4 - Processing Control.”
This control strategy is intended for
processing at ambient and air-conditioned
temperatures. “Control Strategy
Example 5 - Storage Control” may be
more appropriate for processing under
refrigerated conditions.
3. If scombrotoxin (histamine) formation is a
significant hazard at a storage step for raw
material, in-process product, or finished product,
you should identify the storage step(s) as a CCP
for this hazard.

control are:

•

Controlling refrigeration
temperatures in your plant or,

Smoking;
Heading and gutting;
Manual filleting and steaking;
Fermenting;
Pickling;
Drying;
Stuffing;
Mixing (e.g., salad preparation);
Portioning;

•

Packaging;

•

Final chilling after processing
and packaging;

•

Storing raw material, in-process product,
and finished product under refrigeration.

Unlikely CCPs

Time and temperature controls will usually
not be needed at processing steps that meet
the following conditions:

Performing proper icing
in your plant.

•

Example:
A mahi-mahi processor should control
histamine formation by icing the
product during raw material, in-process
product, and finished product storage.
The processor should then set CCPs for
histamine formation at the storage steps.

Continuous, mechanical processing
steps that are brief, such as:

°
•

•

Likely CCPs

Date code stamping;
Case packing;

Processing steps where the product
is held in a frozen state, such as:

°
°

Following is further guidance on processing
steps that are likely to be identified as CCPs
for this hazard:

Mechanical filleting;

Processing steps that are brief and
unlikely to contribute significantly
to the cumulative time and
temperature exposure, such as:

°
°

This control approach is a control strategy
referred to in this chapter as “Control
Strategy Example 5 - Storage Control.”
•

Brining and salting;

Note: Rather than identify each processing step as an individual
CCP when the controls are the same at those steps, it may be more
convenient to combine into one CCP those processing steps that
together contribute to a cumulative time and temperature exposure.

a. The preventive measures for this type of

•

Thawing;

Assembly of orders for distribution;
Frozen product storage;

CHAPTER 7: Scombrotoxin (Histamine) Formation

124

•

Retorting and post-retorting steps (if the
product is covered by the Thermally
Processed Low-Acid Foods Packaged
in Hermetically Sealed Containers
regulation, 21 CFR 113 (called the
Low-Acid Canned Foods Regulation
in this guidance document));

•

Sensory examination;

•

Internal temperature measurements.

Harvest vessel records:

•

All scombrotoxin-forming fish lots received
are accompanied by harvest vessel records
that show:

DEVELOP A CONTROL STRATEGY.
The following guidance provides examples of five
control strategies for scombrotoxin (histamine)
formation. It may be necessary to select more
than one control strategy in order to fully control
the hazard, depending upon the nature of your
operation. You may select a control strategy
that is different from those which are suggested,
provided it complies with the requirements of the
applicable food safety laws and regulations.

The following are examples of control strategies
included in this chapter:

•

MAY APPLY TO
PRIMARY
PROCESSOR

Harvest vessel control



Histamine testing



Transit control



Processing control



Storage Control



MAY APPLY TO
SECONDARY
PROCESSOR

Fish that were gilled and gutted
before chilling were placed in ice, or
in refrigerated seawater, ice slurry, or
brine of 40°F (4.4°C) or less, as soon
as possible after harvest, but not longer
than 12 hours from the time of death;
OR

CONTROL STRATEGY EXAMPLE 1 - HARVEST
VESSEL CONTROL

It may be necessary to select more than one
control strategy in order to fully control the
hazard, depending upon the nature of your
operation.

Fish that were harvested under
conditions that expose dead fish to
harvest waters of 65°F (18.3°C) or less
for 24 hours or less were placed in ice,
or in refrigerated seawater, ice slurry, or
brine of 40°F (4.4°C) or less, as soon
as possible after harvest, but not more
than the time limits listed above, with the
time period starting when the fish left the
65°F (18.3°) or less environment;
OR

Set Critical Limits.

The critical limits for this control strategy should
include three components:
•

Fish exposed to air and water temperatures
of 83°F (28.3°C) or less were placed in
ice, or in refrigerated seawater, ice slurry,
or brine of 40°F (4.4°C) or less, as soon as
possible after harvest, but not longer than 9
hours from the time of death;
OR

˚
CONTROL STRATEGY

Fish exposed to air or water temperatures
above 83°F (28.3°C) were placed in ice,
or in refrigerated seawater, ice slurry, or
brine of 40°F (4.4°C) or less, as soon
as possible after harvest, but not longer
than 6 hours from the time of death;

Harvest vessel records;

Other critical limits for onboard handling
(e.g., maximum refrigerated brine or
seawater temperature, maximum fish
size, maximum fish to brine/seawater/
ice ratio, maximum initial temperature of

CHAPTER 7: Scombrotoxin (Histamine) Formation

125

(10°C) or below;

the fish) necessary to achieve a cooling
rate that will prevent development of
an unsafe level of histamine in the
specific species, as established through a
scientific study.

OR
•

Note: If the actual time of death is not known, an estimated time
of the first fish death in the set may be used (e.g., the time the
deployment of a longline begins). Table 7-1 provides a summary of
the preceding recommended critical limits.

˚
•

For fish held refrigerated (not frozen)
onboard the vessel:
•

The fish were stored at or below
40°F (4.4°C) after cooling;

For fish held iced or refrigerated (not frozen)
onboard the vessel less than 12 hours after
death:

OR
•

The fish were stored completely
and continuously surrounded
by ice after cooling;

AND
Sensory examination:

•

Sensory examination of a representative
sample of scombrotoxin-forming fish shows
decomposition (persistent and readily
perceptible) in less than 2.5% of the fish in
the sample. For example, no more than 2
fish in a sample of 118 fish may show signs
of decomposition. Note that the FFD&C
Act prohibits interstate commerce of any
decomposed fish whether or not the HACCP
critical limit has been exceeded;

•

For fish held iced or refrigerated (not frozen)
onboard the vessel:

Internal temperature measurements:

Elapsed time from death and internal
temperatures at the time of off-loading
from the vessel by the processor should
be consistent with cooling curves that
will prevent development of an unsafe
level of histamine in the specific species,
as established through a scientific study.

For fish held iced or refrigerated (not frozen)
onboard the vessel 24 or more hours after
death:

Establish Monitoring Procedures.

The internal temperature should be 40°F
(4.4°C) or below;

For fish held iced or refrigerated (not frozen)
onboard the vessel from 15 to less than 24
hours after death:

What Will Be Monitored?

Harvest vessel records containing the following
information:

OR
•

The internal temperature should
be sufficiently below water and air
temperatures to indicate that appropriate
chilling methods were implemented
onboard the harvest vessel. Chilling
of the fish should begin on the harvest
vessel regardless of the time from death
until off-loading from the vessel by the
processor unless the environmental
conditions (e.g., air and water
temperatures) are below 40°F (4.4°C)
from the time of death until off-loading
from the vessel by the processor;

AND
•

The internal temperature should be 60°F
(15.6°C) or below;

AND

For fish held iced or refrigerated (not frozen)
onboard the vessel from 12 to less than 15
hours after death:

•

Method of capture*;
AND

•

The internal temperature should be 50°F

Where applicable to the critical limit, the

CHAPTER 7: Scombrotoxin (Histamine) Formation

126

•

date and time of landing the fish onboard
the harvest vessel;
Where applicable to the critical limit, the
estimated earliest date and time of death for
fish brought onboard in the fishing set (e.g.,
trawl, gillnet, longline, or purse seine);

(*These items may be documented by the primary (first) processor,
on the receiving records, rather than by the harvest vessel operator,
on the harvest vessel records, provided the primary processor has
direct knowledge about those aspects of the harvesting practices and
has made first-hand observations for each lot received. The vessel
operator should document other onboard handling information. The
primary processor should maintain all relevant information.)

AND

AND
•

•

Where applicable to the critical limit, the
air and water temperatures at the time of
landing the fish onboard the harvest vessel*;

Sensory examination:

•

Amount of decomposition in the lot;

AND

Where applicable to the critical limit, the
water temperature at the depth where dead
fish may remain until harvest;

Internal temperature measurement:

•

For fish held iced or refrigerated (not frozen)
onboard the vessel:

AND
•

Where applicable to the critical limit, the
method of cooling* and temperature of the
cooling medium;
AND

•

Where applicable to the critical limit, the
date and time cooling began and/or the date
and time when the last fish in a fishing set
(e.g., trawl, gillnet, longline, or purse seine)
was placed in the cooling medium;

Where applicable to the critical limit, those
factors of the cooling process that have been
established through a scientific study as critical
to achieving the cooling rate critical limits (e.g.,
refrigerated brine or seawater temperature, fish
size, fish to brine/seawater/ice ratio, maximum
initial temperature of the fish);
For fish held iced or refrigerated (not frozen)
onboard the vessel:

The storage temperature, as evidenced by:
•

Date and time of off-loading.
Example:
A primary processor receives
bluefish from several day-boats
that catch the fish when the air
and water temperatures are below
83°F (28.3°C). The day-boats take
on ice at the processor’s facility
immediately before setting out for the
day and return within 9 hours to the
processor’s facility with the iced catch.
The processor monitors and records
the date and time of departure of
the vessels after they take on ice; the
date and time of the return of the
vessels; the ambient water and air
temperatures of the fishing grounds;
and the adequacy of icing of the
catch at the time of off-loading. The
processor also conducts sensory
evaluations and checks the internal

AND
•

The internal temperature of a
representative number of the largest
fish in the lot at the time of off-loading
from the harvest vessel, concentrating on
any fish that show signs of having been
mishandled (e.g., inadequately iced);
AND

AND
•

The presence of ice that completely
and continuously surrounds the fish.

The temperature of refrigerated
seawater or brine in which
the fish are stored;
OR

CHAPTER 7: Scombrotoxin (Histamine) Formation

127

temperature of the catch upon arrival.
The harvest vessel operators perform
no monitoring or record keeping.

How Will Monitoring Be Done?

•

For harvest vessel records:

of the fish. Randomly select fish from
throughout the lot. Lots that show a high
level of temperature variability or lots
of very small fish may require a larger
sample size;
AND

Review controls documented in the
records;

AND
•

For sensory examination:

Examine at least 118 fish, collected
representatively throughout each lot (or the
entire lot, for lots smaller than 118 fish).
Additional fish should be examined if
variability in fish-to-fish histamine content
is expected to be high. Lots should
consist of only one species of fish; for
vessels delivering multiple species, testing
should generally be done separately on
each species. All fish within a lot should
have a similar history of harvest. If the
fish are received frozen, this monitoring
procedure may be performed by a
sensory examination on the warmed flesh
produced by drilling the frozen fish (drill
method). It may also be performed after
thawing, rather than at receipt;

How Often Will Monitoring Be Done (Frequency)?

•

Every lot of scombrotoxin-forming fish
received.

Who Will Do the Monitoring?

•

For sensory examination:
Any person who is qualified by
experience or training to perform the
examination;

AND
•

For other checks:

Any person who has an understanding of
the nature of the controls.

Establish Corrective Action Procedures.
Take the following corrective actions to a product
involved in a critical limit deviation:

•

For fish held iced or refrigerated (not frozen)
onboard the vessel:

AND
•

Visually determine the date and time of
off-loading.

Use a temperature-indicating device
(e.g., a thermometer) to measure the
internal temperature of a representative
number of the largest fish in each
lot, concentrating on any that show
signs of having been mishandled (e.g.,
inadequately iced). For example,
when receiving 10 tons or more of fish,
measure a minimum of one fish per ton,
and when receiving less than 10 tons of
fish, measure a minimum of one fish per
1,000 pounds. Measure a minimum of
12 fish, unless there are fewer than 12
fish in the lot, in which case measure all

In the absence of harvest vessel records or
when one of the harvester-related critical
limits has not been met, or when the internal
temperature critical limit at receiving has not
been met:

Chill and hold the affected lot (i.e.,
fish of common origin) until histamine
analysis is performed on a minimum
of 60 fish representatively collected
from throughout the lot, including any
fish measured to have temperatures
that exceeded the critical limit (or the
entire lot for lots smaller than 60 fish).
Reject the lot if any fish are found with
histamine greater than or equal to 50
ppm. The fish collected for analysis
may be composited for analysis if the
action point is reduced accordingly. For

CHAPTER 7: Scombrotoxin (Histamine) Formation

128

Establish a Recordkeeping System.

example, a sample of 60 fish may be
composited into 20 units of 3 fish each,
provided the action point is reduced
from 50 ppm to 17 ppm for each unit;

•

AND

•

Reject the lot;

AND
•

•
•

•

Collect a representative sample of the raw
material, in-process product, or finished
product, and analyze it for histamine at least
quarterly;
AND

•

If any fish in the lot are to proceed
into commerce for food use, perform
a sensory examination of all fish in the
lot to ensure that no decomposed fish
proceed;

Ensure that new sensory examiners receive
training to calibrate their ability to identify
decomposed fish and that all sensory
examiners receive periodic refresher training;
AND

•

Any individual fish found to be
decomposed (persistent and readily
perceptible) should be destroyed or
diverted to a non-food use;

Where histamine testing is part of a
corrective action plan, periodically verify
the findings (e.g., by comparing results with
those obtained using an Association of
Official Analytical Chemists (AOAC) method);
AND

•

Reject the lot.

AND
Take the following corrective action to regain control
over the operation after a critical limit deviation:

•

Internal temperatures of the fish.

Establish Verification Procedures.

For fish held iced or refrigerated (not frozen)
onboard the vessel:

AND

Results of sensory examination;
AND

Receiving records showing the date and time
of off-loading;
AND

When the sensory examination critical limit
has not been met:

Harvest vessel records containing the
information described above;

Before a temperature-indicating device (e.g.,
a thermometer) is put into service, check
the accuracy of the device to verify that the
factory calibration has not been affected.
This check can be accomplished by:

Discontinue use of the supplier until
evidence is obtained that the identified
harvesting and onboard practices and
controls have been improved.

Immersing the sensor in an ice slurry
(32°F (0°C)), if the device will be used at
or near refrigeration temperature;
OR

Comparing the temperature reading
on the device with the reading on a

CHAPTER 7: Scombrotoxin (Histamine) Formation

129

known accurate reference device (e.g.,
a thermometer traceable to the National
Institute of Standards and Technology
(NIST) standards) under conditions that
are similar to how it will be used (e.g.,
product internal temperature) within
the temperature range at which it will
be used;

•

Review monitoring, corrective action,
and verification records within 1 week of
preparation to ensure they are complete and
any critical limit deviations that occurred
were appropriately addressed.

Following the manufacturer’s instructions;

AND
•

Once in service, check the temperatureindicating device daily before the
beginning of operations. Less frequent
accuracy checks may be appropriate if
they are recommended by the instrument
manufacturer and the history of use of the
instrument in your facility has shown that
the instrument consistently remains accurate
for a longer period of time. In addition
to checking that the device is accurate by
one of the methods described above, this
process should include a visual examination
of the sensor and any attached wires for
damage or kinks. The device should be
checked to ensure that it is operational;
AND

•

Calibrate the temperature-indicating device
against a known accurate reference device
(e.g., a NIST-traceable thermometer) at
least once a year or more frequently if
recommended by the device manufacturer.
Optimal calibration frequency is dependent
upon the type, condition, past performance,
and conditions of use of the device.
Consistent temperature variations away from
the actual value (drift) found during checks
and/or calibration may show a need for more
frequent calibration or the need to replace
the device (perhaps with a more durable
device). Calibration should be performed at
a minimum of two temperatures that bracket
the temperature range at which it is used;
AND
CHAPTER 7: Scombrotoxin (Histamine) Formation

130

CHAPTER 7: Scombrotoxin (Histamine) Formation

131

Scombrotoxin
formation

SIGNIFICANT
HAZARD(S)

CRITICAL
CONTROL
POINT

Receiving
fresh
mahi
mahi on
ice from
harvest
vessels

(2)

(1)

Internal
temperature
of the fish at
time of
off-loading
from vessel;

Internal temperatures of all fish
are to meet the following criteria
based on the time since the death
of the fish:
>24 hours g ≤ 40°
15 to < 24 hours g ≤ 50°
12 to < 15 hoursg ≤ 60°
< 12 hours g below ambient
air and water temperatures
commensurate with size of fish and
time since death

Date and time
of off-loading

Amount
of
decomposition
in the incoming
lot

Harvest vessel
records

WHAT

(4)

Less than 2.5% decomposition
(persistent and readily perceptible)
in the incoming lot

(2) The fish were stored
completely and continuously
surrounded by ice after capture

(1) placement of fish on ice
within 9 hours of death if the
maximum exposure temperature
does not exceed 83°F or within 6
hours if the maximum exposure
temperature exceeds 83°F;

All lots received are accompanied
by harvest vessel records that show

CRITICAL
LIMITS
FOR EACH
PREVENTIVE
MEASURE

(3)

Digital
thermometer
(1 fish/1,000
pounds;
minimum of
12 fish per
lot)

Sensory
examination
(118 fish per
lot; or all fish
in the lot if
less than 118
fish)

Review of
controls
documented
in the records

HOW

(6)

Every
lot
received

FREQUENCY

MONITORING

(5)

Example Only
See Text for Full Recommendations

Receiving
supervisor

Quality
control
staff

Receiving
supervisor

WHO

(7)

Discontinue
use of the
supplier
until
evidence
is obtained
that
harvesting
and
onboard
practices
and
controls
have been
improved

Reject
the lot

CORRECTIVE
ACTION(S)

(8)

Receiving
record

Harvester
vessel
records

RECORDS

(9)

Review monitoring, corrective
action, and verification records
within 1 week of preparation

Review monitoring, corrective
action, and verification records
within 1 week of preparation
Check the digital thermometer
for accuracy and damage and
to ensure that it is operational
before putting it into operation;
perform these same checks
daily, at the beginning of
operations; and calibrate it once
per year

Provide sensory training
for new fish examiners and
annual training for all fish
examiners

Review monitoring, corrective
action, and verification records
within 1 week of preparation

Perform histamine analysis on
1 incoming lot every 3 months
(18 fish per sample)

VERIFICATION

(10)

Histamine formation may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., metal fragments).

This table is an example of a portion of a HACCP plan using “Control Strategy Example 1 - Harvest Vessel Control.” This example illustrates how a fresh mahi-mahi processor that
receives the fish on ice directly from harvest vessels that use a hook and line technique (fish brought onboard alive) can control scombrotoxin formation. It is provided for illustrative
purposes only. It may be necessary to select more than one control strategy in order to fully control the hazard, depending upon the nature of your operation.

CONTROL STRATEGY EXAMPLE 1 - HARVEST VESSEL CONTROL

TABLE 7-3

•

CONTROL STRATEGY EXAMPLE 2 - HISTAMINE
TESTING

It may be necessary to select more than one
control strategy in order to fully control the
hazard, depending upon the nature of your
operation.

OR
•

For fish held iced or refrigerated (not frozen)
onboard the vessel from 12 to less than 15
hours after death:

Set Critical Limits.

The critical limits for this control strategy should
include three components:

OR
•

•

Histamine testing;

•

Sensory examination;

•

Internal temperature measurements.
Analysis of a representative sample of
scombrotoxin-forming fish shows less than
50 ppm histamine in all fish in the sample;

AND
Sensory examination:

•

For fish held iced or refrigerated (not frozen)
onboard the vessel:

Internal temperature measurements:

For fish held iced or refrigerated (not frozen)
onboard the vessel 24 or more hours after
death:

The internal temperature should be 40°F
(4.4°C) or below;

Establish Monitoring Procedures.
»

OR
•

The internal temperature should
be sufficiently below water and air
temperatures to indicate that appropriate
chilling methods were implemented
onboard the harvest vessel. Chilling
of the fish should begin on the harvest
vessel regardless of the time from death
until off-loading from the vessel by the
processor, unless the environmental
conditions (e.g. air and water
temperatures) are below 40°F (4.4°C)
from the time of death until off-loading
from the vessel by the processor;

AND
•

The internal temperature should be 60°F
(15.6°C) or below;

For fish held iced or refrigerated (not frozen)
onboard the vessel less than 12 hours after
death:

Histamine testing:

•

The internal temperature should be 50°F
(10°C) or below;

What Will Be Monitored?

Histamine testing:

For fish held iced or refrigerated (not frozen)
onboard the vessel from 15 to less than 24
hours after death:

•

Histamine content in the scombrotoxin
forming fish flesh;

AND
CHAPTER 7: Scombrotoxin (Histamine) Formation

132

Sensory examination:

•

For sensory examination:

Amount of decomposition in the
scombrotoxin-forming fish lot;

AND
Internal temperature measurement:

•

For scombrotoxin-forming fish held iced or
refrigerated (not frozen) onboard the vessel:

The internal temperature of a
representative number of the largest
fish in the lot at the time of off-loading
from the harvest vessel by the processor,
concentrating on any fish that show
signs of having been mishandled (e.g.,
inadequately iced);
AND

Date and time of off-loading.

Examine at least 118 fish, collected
representatively throughout each lot
(or the entire lot, for lots smaller than
118 fish). Additional fish should be
examined if variability in fish-to-fish
histamine content is expected to be high.
Lots should consist of only one species
of fish; for vessels delivering multiple
species, testing should generally be
done separately on each species. If the
fish are received frozen, this monitoring
procedure may be performed by a
sensory examination on the warmed
flesh produced by drilling the frozen fish
(drill method). It may also be performed
after thawing, rather than at receipt;

AND

How Will Monitoring Be Done?

•

For histamine analysis:

For fish held iced or refrigerated (not frozen)
onboard the vessel:

•

Test a minimum of 18 fish, collected
representatively throughout each lot (or
the entire lot when there are fewer than
18 fish in the lot). Additional fish should
be examined if variability in fish-to-fish
histamine content is expected to be high.
Lots should consist of only one species
of fish; for vessels delivering multiple
species, testing should generally be done
separately on each species. Reject the
lot if any fish are found with histamine
greater than or equal to 50 ppm. The
fish collected for analysis may be
composited if the critical limit is reduced
accordingly. For example, a sample of
18 fish may be composited into 6 units
of 3 fish each, provided the critical limit
is reduced from 50 ppm to 17 ppm for
each unit;

AND

Visually determine the date and time of
off-loading.

CHAPTER 7: Scombrotoxin (Histamine) Formation

133

How Often Will Monitoring Be Done (Frequency)?

•

Every lot of scombrotoxin-forming fish received.

Who Will Do the Monitoring?

•

For sensory examination and histamine
testing:

OR
•
AND
•

When the sensory examination critical limit
has not been met:

Any person who is qualified by
experience or training to perform the
work;

If histamine did not exceed 50 ppm in
the initial testing:
•

AND
•

For other checks:

Any person who has an understanding of
the nature of the controls.

Establish Corrective Action Procedures.
Take the following corrective actions to a product
involved in a critical limit deviation:

•

When the histamine-level critical limit at the
receiving step has not been met, reject the lot;
AND

•

When the internal temperature critical limit
has not been met:

If histamine did not exceed 50 ppm in
the initial testing:
•

Reject the lot;

Chill and hold the affected lot
(i.e., fish of common origin) until
histamine analysis is performed on a
minimum of 60 fish representatively
collected from throughout the lot,
including any fish measured to
have temperatures that exceeded
the critical limit (or the entire lot
for lots smaller than 60 fish). Reject
the lot if any fish are found with
histamine greater than or equal
to 50 ppm. The fish collected for
analysis may be composited for
analysis if the action point is reduced
accordingly. For example, a sample
of 60 fish may be composited into
20 units of 3 fish each, provided
the action point is reduced from
50 ppm to 17 ppm for each unit;

Chill and hold the affected lot
(i.e., fish of common origin) until
histamine analysis is performed on a
minimum of 60 fish representatively
collected from throughout the lot,
including all fish in the lot that
show evidence of decomposition
(persistent and readily perceptible
odors) (or the entire lot for lots
smaller than 60 fish). Reject the
lot if any fish are found with
histamine greater than or equal
to 50 ppm. The fish collected for
analysis may be composited for
analysis if the action point is reduced
accordingly. For example, a sample
of 60 fish may be composited into
20 units of 3 fish each, provided
the action point is reduced from
50 ppm to 17 ppm for each unit;

AND

If any fish in the lot are to proceed
into commerce for food use, perform
a sensory examination of all fish in the
lot to ensure that no decomposed fish
proceed;
AND

Any individual fish found to be
decomposed (persistent and readily
perceptible) should be destroyed or
diverted to a non-food use;
OR

Reject the lot.

AND

CHAPTER 7: Scombrotoxin (Histamine) Formation

134

Take the following corrective action to regain control
over the operation after a critical limit deviation:

•

traceable thermometer) under conditions
that are similar to how it will be used (e.g.,
product internal temperature) within the
temperature range at which it will be used;

Discontinue use of the supplier until evidence
is obtained that the identified harvesting and
onboard practices have been improved.

Establish a Recordkeeping System.
•

AND

Receiving records showing:

•

Date and time of off-loading;

AND
•

Results of histamine analysis;
AND

•

Results of sensory examination;
AND

•

For fish held iced or refrigerated (not frozen)
onboard the vessel:

Internal temperatures of the fish.

Establish Verification Procedures.
•

Periodically verify histamine findings (e.g., by
comparing results with those obtained using
an AOAC method or by analyzing proficiency
samples);

•

Ensure that new sensory examiners receive
training to calibrate their ability to identify
decomposed fish and that all sensory
examiners receive periodic refresher training;
AND

•

Immersing the sensor in an ice slurry
(32°F (0°C)), if the device will be used at
or near refrigeration temperature;

•

Once in service, check the temperatureindicating device daily before the beginning
of operations. Less frequent accuracy checks
may be appropriate if they are recommended
by the instrument manufacturer and the history
of use of the instrument in your facility has
shown that the instrument consistently remains
accurate for a longer period of time. In
addition to checking that the device is accurate
by one of the methods described above, this
process should include a visual examination of
the sensor and any attached wires for damage
or kinks. The device should be checked to
ensure that it is operational;
AND

AND
•

Following the manufacturer’s instructions;

Comparing the temperature reading on
the device with the reading on a known
accurate reference device (e.g., a NIST-

Review monitoring, corrective action,
and verification records within 1 week of
preparation to ensure they are complete and
any critical limit deviations that occurred
were appropriately addressed.

CHAPTER 7: Scombrotoxin (Histamine) Formation

135

CHAPTER 7: Scombrotoxin (Histamine) Formation

136

Scombrotoxin
formation

SIGNIFICANT
HAZARD(S)

CRITICAL
CONTROL
POINT

Receiving
frozen
tuna from
harvest
vessels

(2)

(1)

Histamine testing
using the AOAC
977.13 method
on a minimum
of 18 fish per
lot (36 fish from
vessels with
high variability
of histamine
detected
between fish
or when 1 of
the first 18 fish
exceeds 30 ppm
histamine)
Sensory
examination (118
fish per lot, or all
fish if lot is less
than 118 fish)

Amount of
decomposition
in the
incoming lot

Less than 3
decomposed
fish
(persistent
and readily
perceptible)
in a 118-fish
sample

HOW

MONITORING

(5)

Fish flesh for
histamine
content

WHAT

(4)

Less than
50 ppm
histamine in
all fish in the
sample

CRITICAL
LIMITS
FOR EACH
PREVENTIVE
MEASURE

(3)

Quality
assurance
staff

Every lot
received

WHO

(7)

FREQUENCY

(6)

Reject the lot;

CORRECTIVE ACTION(S)

(8)

Discontinue use of the supplier
until evidence is obtained
that harvesting and onboard
practices have been improved

Conduct sensory evaluation of
all fish in the lot, removing and
destroying all decomposed fish

If the initial histamine sample
was <50 ppm, perform
histamine analysis on a
min, of 60 fish, collected
representatively from the lot
and reject the lot if any fish
contains ≥50 ppm histamine;
and if all fish <50 ppm

Discontinue use of the supplier
until evidence is obtained
that harvesting and onboard
practices have been improved

Example Only
See Text for Full Recommendations

Sensory
examination
record

Reports of
histamine
analysis

RECORDS

(9)

Review monitoring,
corrective action, and
verification records
within 1 week of
preparation

Provide sensory training
for new fish examiners
and annual training for
all fish examiners

Review
monitoring,
corrective action, and
verification records
within 1 week of
preparation

Do a quarterly
comparison of histamine
test results with AOAC
method

VERIFICATION

(10)

Histamine formation may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., Clostridium
botulinum growth and toxin formation).

This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Histamine Testing.” This example illustrates how a canned tuna processor that
receives frozen tuna directly from the harvest vessel can control scombrotoxin formation. It is provided for illustrative purposes only. It may be necessary to select more than
one control strategy in order to fully control the hazard, depending upon the nature of your operation.

CONTROL STRATEGY EXAMPLE 2 - HISTAMINE TESTING

TABLE 7-4

•

CONTROL STRATEGY EXAMPLE 3 - TRANSIT
CONTROL

a controlled temperature environment) of 4
hours or less (optional control strategy):

It may be necessary to select more than one
control strategy in order to fully control the hazard,
depending upon the nature of your operation.

AND

Set Critical Limits.
•

For fish delivered refrigerated (not frozen):

All lots received are accompanied by
transportation records that show that the
fish were held at or below an ambient
or internal temperature of 40°F (4.4°C)
throughout transit. Note that allowance
for routine refrigeration defrost cycles may
be necessary;

Establish Monitoring Procedures.
»

What Will Be Monitored?

•

For scombrotoxin-forming fish delivered
refrigerated (not frozen):

For fish delivered under ice:

Fish are completely surrounded by ice at
the time of delivery;

For fish delivered under ice on an open-bed
truck:

˚
•

Fish are stored completely surrounded by
ice;
The internal temperature of the fish at the
time of delivery is 40°F (4.4°C) or below;

•

For scombrotoxin-forming fish delivered under
ice on an open-bed truck:

There is an adequate quantity of
cooling media that remain frozen to
have maintained product at an internal
temperature of 40°F (4.4°C) or below
throughout transit;

The internal temperature of the fish at
time of delivery;

The internal temperature of the fish at the
time of delivery is 40°F (4.4°C) or below;

For scombrotoxin-forming fish held under
chemical cooling media such as gel packs:

OR
•

The adequacy of ice surrounding the
product at the time of delivery;
AND

•

AND

The adequacy of ice surrounding the
product at the time of delivery;

For fish delivered under chemical cooling
media such as gel packs:

For scombrotoxin-forming fish delivered under
ice:

OR
•

The ambient temperature within the truck
or other carrier throughout transportation;

AND

The internal temperature of the fish
throughout transportation;
OR

OR
•

Internal temperature of the fish at the
time of delivery does not exceed 40°F
(4.4°C).

Note: Processors receiving fish with transit times of 4 hours or less may
elect to use one of the controls described for longer transit times instead.

OR
•

Time of transit does not exceed 4 hours;

The quantity and frozen status of cooling
media at the time of delivery;
AND

For fish delivered refrigerated (not frozen)
with a transit time (including all time outside

The internal temperature of the fish at the
time of delivery;

CHAPTER 7: Scombrotoxin (Histamine) Formation

137

OR
•

For scombrotoxin-forming fish delivered
refrigerated (not frozen) with a transit time of
4 hours or less:

The date and time fish were removed
from a controlled temperature
environment before shipment and the
date and time delivered;

AND

The internal temperature of a representative
number of fish at the time of delivery.

How Will Monitoring Be Done?

•

For fish delivered refrigerated (not frozen):

•

Use a continuous temperature-recording
device (e.g., a recording thermometer)
for internal product temperature or
ambient air temperature monitoring
during transit;

For fish delivered refrigerated (not frozen)
with a transit time of 4 hours or less:

OR
•

Make visual observations of the adequacy
of ice in a representative number of
containers (e.g., cartons and totes) from
throughout the shipment, at delivery;

OR
•

For fish delivered under ice on an open-bed
truck:

Make visual observations of the
adequacy of ice surrounding the product
in a representative number of containers
(e.g., cartons and totes) from throughout
the shipment, at delivery;
AND

Use a temperature-indicating device (e.g.,
a thermometer) to determine internal
product temperatures in a representative
number of fish from throughout the
shipment, at delivery;

For fish delivered under chemical cooling
media such as gel packs:

Use a temperature-indicating device (e.g.,
a thermometer) to determine internal
product temperatures in a representative
number of fish randomly selected from
throughout the shipment, at delivery.
Measure a minimum of 12 fish, unless
there are fewer than 12 fish in a lot, in
which case measure all of the fish. Lots
that show a high level of temperature
variability or lots of very small fish may
require a larger sample size.

How Often Will Monitoring Be Done (Frequency)?

•

Every scombrotoxin-forming fish lot received.

Who Will Do the Monitoring?

•

For continuous temperature-recording
devices:

OR
•

Review carrier records to determine the
date and time fish were removed from
a controlled temperature environment
before shipment and the date and time
delivered;
AND

For fish delivered under ice:

Use a temperature-indicating device (e.g.,
a thermometer) to determine internal
product temperatures in a representative
number of fish from throughout the
shipment, at delivery;

Make visual observations of the
adequacy and frozen state of the cooling
media in a representative number of
containers (e.g., cartons and totes) from
throughout the shipment;

Monitoring is performed by the device itself.
The visual check of the data generated
by the device, to ensure that the critical
limits have consistently been met, may
be performed by any person who has an
understanding of the nature of the controls;

CHAPTER 7: Scombrotoxin (Histamine) Formation

138

•

For other checks:

The number of containers examined
and the sufficiency of ice for each;

AND

OR
•

Any person who has an understanding of
the nature of the controls.

•
OR

Establish Corrective Action Procedures.

Take the following corrective action to a product
involved in a critical limit deviation:

•

Chill and hold the affected lot until histamine
analysis is performed on a minimum of
60 fish representatively collected from
throughout the lot, including any with
temperatures that exceeded a critical limit
and any fish observed to have been exposed
to inadequate cooling media (or the entire lot
for lots smaller than 60 fish). Reject the lot if
any fish is found with histamine greater than
or equal to 50 ppm.

•

Results of internal product temperature
monitoring, where applicable, including:
•

The number of containers
examined and the internal
temperatures observed for each;
AND

•

The number of containers in the lot;

AND

Reject the lot.

Take the following corrective action to regain control
over the operation after a critical limit deviation:

Date and time fish were initially
removed from a controlled temperature
environment and the date and time fish
were delivered, when applicable.

Establish Verification Procedures.
•

Discontinue use of the supplier or carrier
until evidence is obtained that the identified
transportation-handling practices have been
improved.

Receiving records showing:

Immersing the sensor in an ice slurry
(32°F (0°C)), if the device will be used at
or near refrigeration temperature;

Establish a Recordkeeping System.

•

The number of containers in the lot;

AND

•

The number of containers
examined and the frozen status
of the cooling media for each;
AND

•

For chemical cooling media checks:
•

The fish collected for analysis may be
composited if the action point is reduced
accordingly. For example, a sample of 60 fish
may be composited into 20 units of 3 fish
each, provided the action point is reduced
from 50 ppm to 17 ppm for each unit;
•

The number of containers in the lot;

For continuous temperature monitoring:

Printouts, charts, or readings from
temperature-recording devices (e.g.,
temperature recorder);

For ice checks:

Comparing the temperature reading on
the device with the reading on a known
accurate reference device (e.g., a NISTtraceable thermometer) under conditions
that are similar to how it will be used

CHAPTER 7: Scombrotoxin (Histamine) Formation

139

(e.g., product internal temperature)
within the temperature range at which it
will be used;

the device with the reading on a known
accurate reference device (e.g., a NISTtraceable thermometer) under conditions that
are similar to how it will be used (e.g., air
temperature) within the temperature range at
which it will be used;

Following the manufacturer’s instructions;

AND
•

AND

Once in service, check the temperatureindicating device daily before the beginning
of operations. Less frequent accuracy checks
may be appropriate if they are recommended
by the instrument manufacturer and the
history of use of the instrument in your
facility has shown that the instrument
consistently remains accurate for a longer
period of time. In addition to checking that
the device is accurate by one of the methods
described above, this process should include
a visual examination of the sensor and any
attached wires for damage or kinks. The
device should be checked to ensure that it is
operational;

•

When visual checks of ice are used,
periodically measure internal temperatures
of fish to ensure that the ice are sufficient
to maintain product temperatures at 40°F
(4.4°C) or less;
AND

•

Review monitoring, corrective action,
and verification records within 1 week
of preparation are complete and any
critical limit deviations that occurred were
appropriately addressed.

AND
•

•

Check the accuracy of temperature-recording
devices that are used for monitoring transit
conditions upon receipt of each lot. The
accuracy of the device can be checked
by comparing the temperature reading on
CHAPTER 7: Scombrotoxin (Histamine) Formation

140

CHAPTER 7: Scombrotoxin (Histamine) Formation

141

Scombrotoxin
formation

SIGNIFICANT
HAZARD(S)

CRITICAL
CONTROL
POINT

Receiving

(2)

(1)

Internal core Digital thermometer
for internal
temperature
temperature of
and a
near-surface one fish in 25% of
temperature shipping containers
but not fewer than
of each fish
12 containers (or
all containers if lot
has less than 12
containers)

Internal
temperatures
of all fish at
delivery are
40°F or below

Visual observation
of a minimum of
25% of shipping
containers in the
lot but not fewer
than 12 containers
(or all containers if
lot has less than 12
containers)

HOW

(6)

Every lot
received

FREQUENCY

MONITORING

(5)

Quantity
and frozen
condition of
gel packs

WHAT

(4)

Adequate
quantity of
frozen gel
packs to
maintain the
product at
40°F or less
throughout
transit; and

CRITICAL
LIMITS
FOR EACH
PREVENTIVE
MEASURE

(3)

(7)

Receiving
clerk

WHO

Example Only
See Text for Full Recommendations

Discontinue use of the
supplier or carrier until
evidence is obtained that
transportation-handling
practices have been
improved

Reject the lot

Discontinue use of the
supplier or carrier until
evidence is obtained that
transportation-handling
practices have been
improved

Reject the lot

CORRECTIVE ACTION(S)

(8)

Receiving
record

RECORDS

(9)

Review
monitoring,
corrective action,
and verification
records within 1
week of preparation

Check the
thermometer for
accuracy and
damage, and to
ensure that it
is operational
before putting
into operation;
perform these
same checks daily
at the beginning
of operations, and
calibrate it once per
year

VERIFICATION

(10)

Histamine formation may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., metal fragments).

This table is an example of a portion of a HACCP plan using “Control Strategy Example 3 - Transit Control.” This example illustrates how a fresh mahi-mahi secondary processor that
receives the product by air under chemical coolant (gel packs) can control scombrotoxin formation. It is provided for illustrative purposes only. It may be necessary to select more than
one control strategy in order to fully control the hazard, depending upon the nature of your operation.

CONTROL STRATEGY EXAMPLE 3 - TRANSIT CONTROL

TABLE 7-5

•

CONTROL STRATEGY EXAMPLE 4 - PROCESSING
CONTROL

It may be necessary to select more than one
control strategy in order to fully control the
hazard, depending upon the nature of your
operation.

Set Critical Limits.
•

During processing (e.g., butchering,
cleaning, brining, salting, smoking, drying,
fermenting, pickling, mixing, fermenting,
stuffing, packing, labeling, and staging) of
scombrotoxin-forming fish that have not
been previously frozen or heat processed
sufficiently to destroy scombrotoxin-forming
bacteria:

The fish are not exposed to ambient
temperatures above 40°F (4.4°C) for
more than 24 hours, cumulatively, as
long as no portion of that time is at
temperatures above 70°F (21.1°C).

Note: Only one of the two limits above should be selected. They
should not be added for a total exposure of 36 hours.

Establish Monitoring Procedures.

The fish are not exposed to ambient
temperatures above 40°F (4.4°C) for
more than 4 hours, cumulatively, if any
portion of that time is at temperatures
above 70°F (21.1°C);

What Will Be Monitored?

•

The length of time the scombrotoxin-forming
fish are exposed to unrefrigerated conditions
(i.e., above 40°F (4.4°C));
AND

•

The fish are not exposed to ambient
temperatures above 40°F (4.4°C) for
more than 8 hours, cumulatively, as
long as no portion of that time is at
temperatures above 70°F (21.1°C).

Note: If the critical limit is based on an assumption that temperatures
may exceed 70°F (21.1°C), then only the length of exposure may
need to be monitored.

Note: Only one of the two limits above should be selected. They
should not be added for a total exposure of 12 hours.

During processing (e.g., thawing, butchering,
cleaning, brining, mixing, fermenting,
stuffing, packing, labeling, and staging)
of scombrotoxin-forming fish or fishery
products that have been (1) previously
frozen or (2) heat processed sufficiently to
destroy scombrotoxin-forming bacteria and
are processed in a manner where there is
an opportunity for recontamination with
scombrotoxin-forming bacteria (e.g., contact
with fresh fish, employees, or introduction
of raw ingredients), such as in a tuna salad
made from canned tuna with added raw
ingredients:

The ambient temperatures during the
exposure periods.

How Will Monitoring Be Done?

•

Make visual observations of the length of
time of product exposure to unrefrigerated
conditions (i.e., above 40°F (4.4°C));

OR
•

The fish are not exposed to ambient
temperatures above 40°F (4.4°C) for
more than 12 hours, cumulatively, if any
portion of that time is at temperatures
above 70°F (21.1°C);

AND
•

Measure ambient air temperature, using:

A continuous temperature-recording
device (e.g., a recording thermometer)
located in the processing area;
OR

A temperature-indicating device (e.g., a
thermometer) located in the processing
area.

Note: Where multiple processing locations are combined in a
cumulative exposure control strategy, temperature monitoring may be
needed in each of the processing locations.

CHAPTER 7: Scombrotoxin (Histamine) Formation

142

Example:
A fresh tuna processor using raw
material that was not previously
frozen has identified a series of
processing steps (i.e., from raw
material cooler to finished product
cooler) as CCPs for scombrotoxin
formation. The processor establishes
a critical limit of no more than 4
cumulative hours of exposure to
unrefrigerated temperatures in
excess of 40°F (4.4°C) during these
processing steps. The processor uses
a marked product to monitor the
progress of the product through the
processing steps. The time that the
marked product is removed from
refrigeration to the time the last of
the marked product is placed in the
finished product cooler is monitored
visually and recorded. It is not
necessary for the processor to measure
temperature because the critical limit
is based on an assumption that the
product temperature may exceed 70°F
(21.1°C).

How Often Will Monitoring Be Done (Frequency)?

•

For exposure time:

Who Will Do the Monitoring?

•

For a continuous temperature-recording device:

OR
•

Take the following corrective action to a product
involved in a critical limit deviation:

•

At least every 2 hours;

•
•

Divert the product to a non-food use.

AND
Take the following corrective actions to regain control
over the operation after a critical limit deviation:

•

Add ice to the product;
OR

For a temperature-indicating device:
•

Destroy the product;
OR

Continuous monitoring during
processing operations is
accomplished by the device itself,
with a visual check of the device
at least once per lot or batch, but
no less often than once per day;

Chill and hold the affected product until
histamine analysis is performed on a
minimum of 60 fish representatively collected
from throughout the affected lot. Destroy
the lot or divert it to a non-food use if any
fish is found with histamine greater than
or equal to 50 ppm. The fish collected for
analysis may be composited if the action
plan is reduced accordingly. For example,
a sample of 60 fish may be composited into
20 units of 3 fish each, provided the action
point is reduced from 50 ppm to 17 ppm for
each unit;
OR

For a continuous temperature-recording
device:
•

Any person who has an understanding of
the nature of the controls.

Establish Corrective Action Procedures.

For temperature measurements:

For other checks:

AND
•

Monitoring is performed by the device
itself. The visual check of the data
generated by the device, to ensure that
the critical limits have consistently been
met, may be performed by any person
who has an understanding of the nature
of the controls;

•

At least every 2 hours.

Return the affected product to the cooler;
AND

CHAPTER 7: Scombrotoxin (Histamine) Formation

143

•

Modify the process as needed to reduce the
time and temperature exposure.

by the instrument manufacturer and the
history of use of the instrument in your
facility has shown that the instrument
consistently remains accurate for a longer
period of time. In addition to checking that
the device is accurate by one of the methods
described above, this process should include
a visual examination of the sensor and any
attached wires for damage or kinks. The
device should be checked to ensure that it is
operational and has sufficient ink and paper,
where applicable;

Establish a Recordkeeping System.
•

Processing records showing the results
of time and temperature exposure
measurements.

Establish Verification Procedures.
•

Before a temperature-indicating device (e.g.,
a thermometer) or a temperature-recording
device (e.g., a recording thermometer) is
put into service, check the accuracy of the
device to verify that the factory calibration
has not been affected. This check can be
accomplished by:

AND
•

Doing a combination of the above if
the device will be used at or near room
temperature;

Calibrate the temperature-indicating device
or temperature-recording device against a
known accurate reference device (e.g., a
NIST-traceable thermometer) at least once a
year or more frequently if recommended by
the device manufacturer. Optimal calibration
frequency is dependent upon the type,
condition, past performance, and conditions
of use of the device. Consistent temperature
variations away from the actual value (drift)
found during checks and/or calibration may
show a need for more frequent calibration
or the need to replace the device (perhaps
with a more durable device). Calibration
should be performed at a minimum of two
temperatures that bracket the temperature
range at which it is used;

AND

Immersing the sensor in an ice slurry
(32°F (0°C)), if the device will be used at
or near refrigeration temperature;
OR

Immersing the sensor in boiling water
(212°F (100°C)) if the device will be used
at or near the boiling point. Note that
the temperature should be adjusted to
compensate for altitude, when necessary;
OR

•

Comparing the temperature reading on
the device with the reading on a known
accurate reference device (e.g., a NISTtraceable thermometer) under conditions
that are similar to how it will be used (e.g.,
air temperature) within the temperature
range at which it will be used;

Review monitoring, corrective action,
and verification records within 1 week of
preparation to ensure they are complete and
any critical limit deviations that occurred
were appropriately addressed.

AND
•

Once in service, check the temperatureindicating device or temperature-recording
device daily before the beginning of
operations. Less frequent accuracy checks
may be appropriate if they are recommended
CHAPTER 7: Scombrotoxin (Histamine) Formation

144

CHAPTER 7: Scombrotoxin (Histamine) Formation

145

Processing
(butchering,
cleaning,
packaging,
labeling, and
boxing)

CRITICAL
CONTROL
POINT

(1)

Scombrotoxin
formation

SIGNIFICANT
HAZARD(S)

(2)

The product
is not out of
refrigeration
for more
than 4 hours
cumulatively

CRITICAL
LIMITS
FOR EACH
PREVENTIVE
MEASURE

(3)

Time of product
exposure to
unrefrigerated
conditions
during
processing
operations

WHAT

(4)

Visual tracking
of time for a
marked batch
of product to
move from raw
material cold
storage to final
product cold
storage

(6)

Every batch of
fish
removed from
raw material
cold storage for
processing

FREQUENCY

MONITORING
HOW

(5)

Example Only
See Text for Full Recommendations

Quality control
supervisor

WHO

(7)

Modify the
process, if
necessary, to
reduce delays

Destroy the
entire batch
if any fish
exceeds
50 ppm
histamine

Perform
histamine
analysis on a
minimum of
60 fish in the
affected batch

Ice and hold
the
affected batch
in raw material
cooler

CORRECTIVE
ACTION(S)

(8)

VERIFICATION

Review
monitoring,
corrective
action, and
verification
records within
1 week of
preparation

Processing
record

(10)

RECORDS

(9)

Histamine formation may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., metal
fragments).

This table is an example of a portion of a HACCP plan using “Control Strategy Example 4 - Processing Control.” This example illustrates how a fresh bluefish processor
that butchers, cleans, packs, labels, and boxes the fish at ambient temperature can control scombrotoxin formation. It is provided for illustrative purposes only. It may be
necessary to select more than one control strategy in order to fully control the hazard, depending upon the nature of your operation.

CONTROL STRATEGY EXAMPLE 4 - PROCESSING CONTROL

TABLE 7-6

•

Establish Monitoring Procedures.

CONTROL STRATEGY EXAMPLE 5 - STORAGE
CONTROL

It may be necessary to select more than one
control strategy in order to fully control the
hazard, depending upon the nature of your
operation.

The temperature of the cooler;

For storage under ice of scombrotoxin
forming fish:

The product is held at a cooler
temperature of 40°F (4.4°C) or
below. Note that allowance for
routine refrigeration defrost cycles
may be necessary. On the other
hand, minor variations in cooler
temperature measurements can be
avoided by submerging the sensor
for the temperature-recording device
(e.g., temperature-recorder) in a liquid
that mimics the characteristics of the
product. Also note that critical limits
during refrigerated storage that specify
a cumulative time and temperature
of exposure to temperatures above
40°F (4.4°C) are not ordinarily suitable
because of the difficulty in tracking
the specific products and the specific
cumulative temperature exposures
that those products experience. The
cumulative exposure for each product
would then need to be determined prior
to shipping. If you chose this approach,
the critical limit for cumulative exposure
to temperatures above 40°F (4.4°C)
should include time during transit,
refrigerated storage, and refrigerated and
unrefrigerated processing;

The adequacy of ice surrounding the
product.

How Will Monitoring Be Done?

•

For refrigerated storage:

Measure cooler temperature using a
continuous temperature-recording device
(e.g., a recording thermometer);

OR
•

For storage under ice:

Make visual observations of the
adequacy of ice in a representative
number of containers (e.g., cartons and
totes) from throughout the cooler.

How Often Will Monitoring Be Done (Frequency)?

•

For continuous temperature-recording devices:

Continuous monitoring during storage is
accomplished by the device itself, with a
visual check of the recorded data at least
once per day;

OR
•

For storage under ice:

The product is completely and
continuously surrounded by ice
throughout the storage time.

Monitoring with sufficient frequency to
ensure control.

Who Will Do the Monitoring?

•

For continuous temperature-recording devices:

For raw material, in-process product, or
finished product stored under ice:

For refrigerated storage of scombrotoxin
forming fish:

•

OR
•

•

For refrigerated (not frozen) storage or
processing of raw material, in-process
product, or finished product:

What Will Be Monitored?

Set Critical Limits.
•

Monitoring is performed by the device
itself. The visual check of the data
generated by the device, to ensure that
the critical limits have consistently been
met, may be performed by any person
who has an understanding of the nature
of the controls;

CHAPTER 7: Scombrotoxin (Histamine) Formation

146

OR
•

For other checks:

Any person who has an understanding of
the nature of the controls.

Establish a Recordkeeping System.

Establish Corrective Action Procedures.

•

Chill and hold the product until it can
be evaluated based on its total time and
temperature exposure, including exposures
during prior processing operations.

•

˚
•

Chill and hold the affected product until
histamine analysis is performed on a
minimum of 60 fish collected from throughout
each affected lot. Destroy the lot or divert
it to a non-food use if any fish is found
with histamine greater than or equal to 50
ppm. The fish collected for analysis may
be composited if the action point is reduced
accordingly. For example, a sample of 60 fish
may be composited into 20 units of 3 fish
each, provided the action point is reduced
from 50 ppm to 17 ppm for each unit;

For storage under ice:

˚
˚

The approximate number of containers
in the cooler.

Establish Verification Procedures.
•

Before a temperature-recording device (e.g.,
a recording thermometer) is put into service,
check the accuracy of the device to verify that
the factory calibration has not been affected.
This check can be accomplished by:

Destroy the product;

Divert the product to a non-food use.

Prevent further deviation:

Add ice to the product;
OR

Move some or all of the product in the
malfunctioning cooler to another cooler;

AND
•

AND
Address the root cause:

Immersing the sensor in an ice slurry
(32°F (0°C)), if the device will be used at
or near refrigeration temperature;
OR

Take the following corrective actions to regain control
over the operation after a critical limit deviation:

•

The number of containers examined and
the sufficiency of ice for each;
AND

AND

•

Record of visual checks of recorded data;

OR
•

Printouts, charts, or readings from
continuous temperature-recording
devices;
AND

OR
•

For refrigerated storage:

Take the following corrective action to a product
involved in a critical limit deviation:

•

Make adjustments to the ice application
operations.

Make repairs or adjustments to the
malfunctioning cooler;

Once in service, check the temperaturerecording device daily before the beginning
of operations. Less frequent accuracy checks
may be appropriate if they are recommended
by the instrument manufacturer and the

CHAPTER 7: Scombrotoxin (Histamine) Formation

147

history of use of the instrument in your
facility has shown that the instrument
consistently remains accurate for a longer
period of time. In addition to checking that
the device is accurate by one of the methods
described above, this process should include
a visual examination of the sensor and any
attached wires for damage or kinks. The
device should be checked to ensure that it
is operational and, where applicable, has
sufficient ink and paper;
AND
•

Calibrate the temperature-recording device
against a known accurate reference device
(e.g., a NIST-traceable thermometer) at
least once a year or more frequently if
recommended by the device manufacturer.

•

Optimal calibration frequency is dependent
upon the type, condition, past performance,
and conditions of use of the device.
Consistent temperature variations away from
the actual value (drift) found during checks
and/or calibration may show a need for more
frequent calibration or the need to replace
the device (perhaps with a more durable
device). Calibration should be performed at
a minimum of two temperatures that bracket
the temperature range at which it is used;
AND

•

When visual checks of ice are used,
periodically measure internal temperatures
of fish to ensure that the ice is sufficient
to maintain product temperatures at 40°F
(4.4°C) or less;
AND

•

Review monitoring, corrective action,
and verification records within 1 week of
preparation to ensure they are complete and
any critical limit deviations that occurred
were appropriately addressed.

CHAPTER 7: Scombrotoxin (Histamine) Formation

148

CHAPTER 7: Scombrotoxin (Histamine) Formation

149

Scombrotoxin
formation

SIGNIFICANT
HAZARD(S)

CRITICAL
CONTROL
POINT

Raw material
and finished
product cold
storage (shared
cooler)

(2)

(1)

(3)

Maximum
cooler
temperature of
40°F

CRITICAL
LIMITS
FOR EACH
PREVENTIVE
MEASURE

Cooler
temperature

WHAT

(4)

Time and
temperature
data logger

(6)

Continuous,
with a visual
check of
recorded data
once per day

FREQUENCY

MONITORING
HOW

(5)

Example Only
See Text for Full Recommendations

Production
supervisor

WHO

(7)

Adjust and repair
cooler as needed

Destroy all
affected
product if any fish
exceeds 50 ppm
histamine

Perform
histamine analysis
on a minimum
of 60 fish
representative
of the affected
product

Check
sufficiency of ice
on the product
two times per
day until cooler
is functioning
reliably

Ice and hold the
affected product
inside the cooler

CORRECTIVE
ACTION(S)

(8)

Check the
data logger for
accuracy and
damage and to
ensure that it
is operational
before putting
into operation;
perform these
checks daily, at
the beginning
of operations;
and calibrate it
once per year

Data
logger
printout

Review
monitoring,
corrective
action, and
verification
records within
1 week of
preparation

VERIFICATION

(10)

RECORDS

(9)

Histamine formation may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., metal
fragments).

This table is an example of a portion of a HACCP plan using “Control Strategy Example 5 - Storage Control.” This example illustrates how a fresh fish processor can
control scombrotoxin formation. It is provided for illustrative purposes only. It may be necessary to select more than one control strategy in order to fully control the hazard,
depending upon the nature of your operation.

CONTROL STRATEGY EXAMPLE 5 - STORAGE CONTROL

TABLE 7-7

BIBLIOGRAPHY.

seafood science). Elsevier, New York, NY.

We have placed the following references on
display in the Division of Dockets Management,
Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. You may
see them at that location between 9 a.m. and 4
p.m., Monday through Friday. As of March 29,
2011, FDA had verified the Web site address for
the references it makes available as hyperlinks
from the Internet copy of this guidance, but FDA
is not responsible for any subsequent changes
to Non-FDA Web site references after March 29,
2011.
•

Arnold, S., and D. Brown. 1978. Histamine
toxicity from fish products. Adv. Food Res.
24:113-154.

•

Fletcher, G. C., G. Summers, and P. W. C.
van Veghel. 1998. Levels of histamine and
histamine-producing bacteria in smoked fish
from New Zealand markets. J. Food Prot.
61(8):1064-1070.

•

Frank, H. A., and D. H. Yoshinaga. 1984.
Histamine formation in tuna, p. 443-451. In
E. Ragelis (ed.), Seafood toxins. American
Chemical Society, Washington, DC.

•

Frank, H. A., D. H. Yoshinaga, and W.
Nip. 1981. Histamine formation and
honeycombing during decomposition of
skipjack tuna. Katsuwonus pelamis, at
elevated temperatures. Mar. Fisheries Rev.
43(10):9-14.

•

Hernández-Herrero, M. M., A. X. Roig-Sagués,
J. J. Rodríguez-Jerez, and M. T. Mora-Ventura.
1999. Halotolerant and halophilic histamineforming bacteria isolated during the ripening
of salted anchovies (Engraulis encrasicholus).
J. Food Prot. 62(5):509-514.

•

Baranowski, J. D., H. A. Frank, P. A. Brust,
M. Chongsiriwatana, and R. J. Premaratne.
1990. Decomposition and histamine content
in mahimahi (Coryphaena hippurus). J. Food
Prot. 53(3):217−222.

•

Behling, A. R., and S. L. Taylor. 1982.
Bacterial histamine production as a function
of temperature and time of incubation. J.
Food Sci. 47:1311-1317.

•

Inestia, C. 1973. Significance and detection
of histamine in food, p. 327-347. In
Microbiological safety of food. Academic
Press, New York, NY.

•

Bjeldanes, L. F., D. E. Schultz, and M. M.
Morris. 1978. On the aetiology of scombroid
poisoning: cadaverine potentiation of
histamine toxicity in the guinea pig. Food
Cosmet. Toxicol. 16:157-159.

•

Lehane, L., and J. Olley. 2000. Review:
histamine fish poisoning revisited. Int. J.
Food Microbiol. 58:1-37.

•

Predy, G., L. Honish, W. Hohn, and S. Jones.
2003. Was it something she ate? Case report
and discussion of scombroid poisoning. Can.
Med. Assoc. J. 168(5):587-588.

•

Silva, C. C. G., J. B. Da Ponte, and M. L. N.
Enes Dapkevicius. 1998. Storage temperature
effect on histamine formation in big eye tuna
and skipjack. J. Food Sci. 63(4):644-647.

•

Staruszkiewicz, W. F. April 2007. Report
on the 2005 Hawaii Bigeye Tuna Research
Project. Effects of onboard fish handling on
the formation of histamine.

•

Staruszkiewicz, W. F., J. D. Barnett, P. L.
Rogers, R. A. Benner, Jr., L. L. Wong, and
J. Cook. 2004. Effects of on-board and

•

Brillantes, S., S. Paknol, and A. Totakien.
2002. Histamine formation in fish sauce
production. J. Food Sci. 67:2090-2094.

•

Concon, J. (ed.), 1988. Food toxicology, p.
511-605. Marcel Dekker, Inc., New York, NY.

•

Eitenmiller, R., and S. DeSouza. 1984.
Enzymatic mechanisms for amine formation
in fish, p. 431-442. In E. Ragelis (ed.),
Seafood toxins. American Chemical Society,
Washington, DC.

•

Farn, G., and C. Sims. 1987. Chemical indices
of decomposition in tuna, p. 175-184. In D.
Kramer and J. Liston (ed.), Seafood quality
determination (Book 15 of Developments in

CHAPTER 7: Scombrotoxin (Histamine) Formation

150

dockside handling on the formation of
biogenic amines in mahimahi (Coryphaena
hippurus), skipjack tuna (Katsuwonus
pelamis), and yellowfin tuna (Thunnus
albacares). J. Food Prot. 67(1):134-141.
•

Stratton, J., and S. Taylor. 1991. Scombroid
poisoning, p. 331-351. In D. Ward and C.
Hackney (ed.), Microbiology of marine food
products. Van Nostrand Reinhold, New York,
NY.

•

Taylor, S. 1985. Histamine poisoning
associated with fish, cheese, and other foods,
p. 1-47. World Health Organization, VPH/
FOS/85.1. Geneva, Switzerland.

•

Taylor, S. 1988. Marine toxins of microbial
origin. Food Technol. 42:94-98.

•

Taylor, S., and S. Summer. 1987. Detection
of histamine, cadaverine, and putrescine,
p. 235-246. In D. Kramer and J. Liston (ed.),
Seafood quality determination (Book 15 of
Developments in seafood science). Elsevier,
New York, NY.

•

Taylor, S. L., J. Y. Hui, and D. E. Lyons.
1984. Toxicology of scombroid poisoning, p.
417-430. In E. Ragelis (ed.), Seafood toxins.
American Chemical Society, Washington, DC.

•

van Spreckens, K. 1987. Histamine
production by psychrophilic flora, p.
309-318. In D. Kramer and J. Liston (ed.),
Seafood quality determination (Book 15 of
Developments in seafood science). Elsevier,
New York, NY.

•

Yongsawatdigul, J., Y. J. Choi, and S.
Udomporn. 2004. Biogenic amines
formation in fish sauce prepared from
fresh and temperature-abused Indian
anchovy (Stolephourus indicus). J. Food Sci.
69(4):312-319.

CHAPTER 7: Scombrotoxin (Histamine) Formation

151

NOTES:

CHAPTER 7: Scombrotoxin (Histamine) Formation

152

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