Fish And Fishery Products Hazards Controls Guidance 252400 UCM252400

User Manual: 252400

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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.

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

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).

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 low-

temperature 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.

Freezing may inactivate some of the enzyme-

forming 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 histamine-

forming 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.

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

species that generate heat, resulting in internal

temperatures that may exceed environmental

temperatures and increasing the likelihood

of conditions favorable to growth of enzyme-

forming 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.

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.

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

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CHAPTER 7: Scombrotoxin (Histamine) Formation

116

TABLE 7-1

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

SCOMBROTOXIN FORMATION1

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

THE TIME OF…

THE WATER

TEMPERATURE (°F) IS…

AND THE AIR TEMPERATURE (°F) IS… DEATH OF THE FISH OR EARLIEST ESTIMATED

TIME OF DEATH IS…

ONBOARD LANDING IS…

FOR UNEVISCERATED FISH:

> 65 > 83 6 --

> 83 Any 6 --

> 65, but ≤ 83 ≤ 83 9 --

≤ 652 > 83 -- 6

≤ 652 ≤ 83 -- 9

FOR FISH EVISCERATED ONBOARD BEFORE CHILLING:

> 65 Any 12 --

≤ 652 Any -- 12

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.

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.

• The size of the ﬁsh;

• The chilling method:

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.

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 time required to lower the internal

temperature of ﬁsh after capture will be

dependent upon a number of factors, including:

• 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;

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.

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.

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 enzyme-

forming 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:

• 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

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CHAPTER 7: Scombrotoxin (Histamine) Formation

119

TABLE 7-2

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

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

WHEN THE AMBIENT TEMPERATURE (°F) OF EXPOSURE IS… THEN, THE MAXIMUM HOURS OF EXPOSURE TIME FOR…

Fresh ﬁsh (not heat processed

or previously frozen) is …

Previously frozen ﬁsh, or heat processed ﬁsh (that has been

exposed to possible recontamination), is…

> 70 AT ANY TIME ≤ 4 ≤ 12

≤ 70 DURING ENTIRE EXPOSURE ≤ 8 ≤ 24

• Detection

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.

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

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.

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.

CHAPTER 7: Scombrotoxin (Histamine) Formation

120

DETERMINE WHETHER THE POTENTIAL

HAZARD IS SIGNIFICANT.

The following guidance will assist you in

determining whether scombrotoxin (histamine)

formation is a signiﬁcant hazard at a 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)?

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.

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.

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

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.

2. Is it reasonably likely that unsafe levels of

histamine will form at this processing step?

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.

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.

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:

• 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;

• Testing incoming ﬁsh for

histamine levels;

• Ensuring that incoming ﬁsh

were handled properly during

refrigerated transportation from the

previous processor, including:

Controlling refrigeration temperatures

during transit;

Performing proper icing during

transit;

• 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;

• 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.

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.

IDENTIFY CRITICAL CONTROL POINTS.

The following guidance will assist you in

determining whether a processing step is a

critical control point (CCP) for scombrotoxin

(histamine) formation:

1. If scombrotoxin (histamine) formation is a

signiﬁcant hazard at the receiving step, you

should identify receiving as a CCP for this

hazard.

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:

• Examining harvest vessel records

to ensure that incoming ﬁsh

were properly handled onboard

the harvest vessel, including:

Rapidly chilling the ﬁsh

immediately after death;

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.

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.

This control approach is a control strategy

referred to in this chapter as “Control

Strategy Example 1 - Harvest Vessel

Control.”

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 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.

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),

you should identify the following

preventive measures for control of this

hazard:

• 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.

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.

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:

• 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.

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.

a. The preventive measures for this type of

control are:

• Controlling refrigeration

temperatures in your plant or,

• 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.

This control approach is a control strategy

referred to in this chapter as “Control

Strategy Example 5 - Storage Control.”

• Likely CCPs

Following is further guidance on processing

steps that are likely to be identiﬁed as CCPs

for this hazard:

• Receiving;

• Processing, such as:

Thawing;

° Brining and salting;

° 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.

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.

• Unlikely CCPs

Time and temperature controls will usually

not be needed at processing steps that meet

the following conditions:

• Continuous, mechanical processing

steps that are brief, such as:

Mechanical ﬁlleting;

• Processing steps that are brief and

unlikely to contribute signiﬁcantly

to the cumulative time and

temperature exposure, such as:

Date code stamping;

° Case packing;

• Processing steps where the product

is held in a frozen state, such as:

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));

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:

CONTROL STRATEGY

MAY APPLY TO

PRIMARY

PROCESSOR

MAY APPLY TO

SECONDARY

PROCESSOR

Harvest vessel control 

Histamine testing 

Transit control  

Processing control  

Storage Control  

• 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.

Set Critical Limits.

The critical limits for this control strategy should

include three components:

• Harvest vessel records;

• Sensory examination;

• Internal temperature measurements.

Harvest vessel records:

• All scombrotoxin-forming ﬁsh lots received

are accompanied by harvest vessel records

that show:

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;

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;

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;

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;

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

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.

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.

AND

For ﬁsh held refrigerated (not frozen)

onboard the vessel:

• The ﬁsh were stored at or below

40°F (4.4°C) after cooling;

• 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;

AND

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;

• For ﬁsh held iced or refrigerated (not frozen)

onboard the vessel from 15 to less than 24

hours after death:

The internal temperature should be 50°F

(10°C) or below;

• For ﬁsh held iced or refrigerated (not frozen)

onboard the vessel from 12 to less than 15

hours after death:

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:

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;

• For ﬁsh held iced or refrigerated (not frozen)

onboard the vessel:

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.

Establish Monitoring Procedures.

» What Will Be Monitored?

Harvest vessel records containing the following

information:

• Method of capture*;

AND

Where applicable to the critical limit, the •

CHAPTER 7: Scombrotoxin (Histamine) Formation

126

date and time of landing the ﬁsh onboard

the harvest vessel;

AND

• 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);

AND

• Where applicable to the critical limit, the

air and water temperatures at the time of

landing the ﬁsh onboard the harvest vessel*;

AND

• Where applicable to the critical limit, the

water temperature at the depth where dead

ﬁsh may remain until harvest;

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;

AND

• 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);

AND

• For ﬁsh held iced or refrigerated (not frozen)

onboard the vessel:

The storage temperature, as evidenced by:

• The temperature of refrigerated

seawater or brine in which

the ﬁsh are stored;

• The presence of ice that completely

and continuously surrounds the ﬁsh.

(*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

Sensory examination:

• Amount of decomposition in the lot;

AND

Internal temperature measurement:

• For 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, concentrating on

any ﬁsh that show signs of having been

mishandled (e.g., inadequately iced);

AND

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

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:

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;

AND

• For ﬁsh held iced or refrigerated (not frozen)

onboard the vessel:

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

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

Visually determine the date and time of

off-loading.

» 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:

• 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

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;

Reject the lot;

AND

• When the sensory examination critical limit

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 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), and reject the

lot if any ﬁsh is found with histamine

greater than or equal to 50 ppm;

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;

Reject the lot.

AND

Take the following corrective action to regain control

over the operation after a critical limit deviation:

• Discontinue use of the supplier until

evidence is obtained that the identiﬁed

harvesting and onboard practices and

controls have been improved.

Establish a Recordkeeping System.

• Harvest vessel records containing the

information described above;

AND

• Receiving records showing the date and time

of off-loading;

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.

• Collect a representative sample of the raw

material, in-process product, or ﬁnished

product, and analyze it for histamine at least

quarterly;

AND

• 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

• 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

• 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:

Immersing the sensor in an ice slurry

(32°F (0°C)), if the device will be used at

or near refrigeration temperature;

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 temperature-

indicating 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

TABLE 7-3

CONTROL STRATEGY EXAMPLE 1 - HARVEST VESSEL CONTROL

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.

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).

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

CRITICAL

CONTROL

POINT

SIGNIFICANT

HAZARD(S)

CRITICAL

LIMITS

FOR EACH

PREVENTIVE

MEASURE

MONITORING

CORRECTIVE

ACTION(S) RECORDS VERIFICATION

WHAT HOW FREQUENCY WHO

Receiving

fresh

mahi-

mahi on

ice from

harvest

vessels

Scombrotoxin

formation

All lots received are accompanied

by harvest vessel records that show

(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;

(2) The ﬁsh were stored

completely and continuously

surrounded by ice after capture

Harvest vessel

records

Review of

controls

documented

in the records

Every

lot

received

Receiving

supervisor

Reject

the lot

Discontinue

use of the

supplier

until

evidence

is obtained

that

harvesting

and

onboard

practices

and

controls

have been

improved

Harvester

vessel

records

Perform histamine analysis on

1 incoming lot every 3 months

(18 ﬁsh per sample)

Review monitoring, corrective

action, and veriﬁcation records

within 1 week of preparation

Less than 2.5% decomposition

(persistent and readily perceptible)

in the incoming lot

Amount

decomposition

in the incoming

lot

Sensory

examination

(118 ﬁsh per

lot; or all ﬁsh

in the lot if

less than 118

ﬁsh)

Every

lot

received

Quality

control

staff

Receiving

record

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

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

Internal

temperature

of the ﬁsh at

time of

off-loading

from vessel;

Date and time

of off-loading

Digital

thermometer

(1 ﬁsh/1,000

pounds;

minimum of

12 ﬁsh per

lot)

Every

lot

received

Receiving

supervisor

Receiving

record

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

Review monitoring, corrective

action, and veriﬁcation records

within 1 week of preparation

• 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.

Set Critical Limits.

The critical limits for this control strategy should

include three components:

• Histamine testing;

• Sensory examination;

• Internal temperature measurements.

Histamine testing:

• Analysis of a representative sample of

scombrotoxin-forming ﬁsh shows less than

50 ppm histamine in all ﬁsh in the sample;

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;

AND

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;

• For ﬁsh held iced or refrigerated (not frozen)

onboard the vessel from 15 to less than 24

hours after death:

The internal temperature should be 50°F

(10°C) or below;

• For ﬁsh held iced or refrigerated (not frozen)

onboard the vessel from 12 to less than 15

hours after death:

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:

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;

• For ﬁsh held iced or refrigerated (not frozen)

onboard the vessel:

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.

Establish Monitoring Procedures.

» What Will Be Monitored?

Histamine testing:

• Histamine content in the scombrotoxin-

forming ﬁsh ﬂesh;

AND

CHAPTER 7: Scombrotoxin (Histamine) Formation

132

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.

» How Will Monitoring Be Done?

• For histamine analysis:

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

• 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. 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

• For ﬁsh held iced or refrigerated (not frozen)

onboard the vessel:

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

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

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:

Any person who is qualiﬁed by

experience or training to perform the

work;

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:

• 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;

• Reject the lot;

AND

• When the sensory examination critical limit

has not been met:

If histamine did not exceed 50 ppm in

the initial testing:

• 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;

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:

• Discontinue use of the supplier until evidence

is obtained that the identiﬁed harvesting and

onboard practices have been improved.

Establish a Recordkeeping System.

• 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);

AND

• 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

• 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:

Immersing the sensor in an ice slurry

(32°F (0°C)), if the device will be used at

or near refrigeration temperature;

Comparing the temperature reading on

the device with the reading on a known

accurate reference device (e.g., a NIST-

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;

Following the manufacturer’s instructions;

AND

• Once in service, check the temperature-

indicating 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

• 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

TABLE 7-4

CONTROL STRATEGY EXAMPLE 2 - HISTAMINE TESTING

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.

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).

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

CRITICAL

CONTROL

POINT

SIGNIFICANT

HAZARD(S)

CRITICAL

LIMITS

FOR EACH

PREVENTIVE

MEASURE

MONITORING

CORRECTIVE ACTION(S) RECORDS VERIFICATION

WHAT HOW FREQUENCY WHO

Receiving

frozen

tuna from

harvest

vessels

Scombrotoxin

formation

Less than

50 ppm

histamine in

all ﬁsh in the

sample

Fish ﬂ esh for

histamine

content

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)

Every lot

received

Quality

assurance

staff

Reject the lot;

Discontinue use of the supplier

until evidence is obtained

that harvesting and onboard

practices have been improved

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

Reports of

histamine

analysis

Do a quarterly

comparison of histamine

test results with AOAC

method

Review

monitoring,

corrective action, and

veriﬁcation records

within 1 week of

preparation

Less than 3

decomposed

ﬁsh

(persistent

and readily

perceptible)

in a 118-ﬁsh

sample

Amount of

decomposition

in the

incoming lot

Sensory

examination (118

ﬁsh per lot, or all

ﬁsh if lot is less

than 118 ﬁsh)

Every lot

received

Quality

assurance

staff

Conduct sensory evaluation of

all ﬁsh in the lot, removing and

destroying all decomposed ﬁsh

Discontinue use of the supplier

until evidence is obtained

that harvesting and onboard

practices have been improved

Sensory

examination

record

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

• CONTROL STRATEGY EXAMPLE 3 - TRANSIT

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.

• 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;

• 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;

AND

The internal temperature of the ﬁsh at the

time of delivery is 40°F (4.4°C) or below;

• For ﬁsh delivered under chemical cooling

media such as gel packs:

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;

AND

The internal temperature of the ﬁsh at the

time of delivery is 40°F (4.4°C) or below;

• For ﬁsh delivered refrigerated (not frozen)

with a transit time (including all time outside

a controlled temperature environment) of 4

hours or less (optional control strategy):

Time of transit does not exceed 4 hours;

AND

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.

Establish Monitoring Procedures.

» What Will Be Monitored?

• For scombrotoxin-forming ﬁsh delivered

refrigerated (not frozen):

The internal temperature of the ﬁsh

throughout transportation;

The ambient temperature within the truck

or other carrier throughout transportation;

• For scombrotoxin-forming ﬁsh delivered under

ice:

The adequacy of ice surrounding the

product at the time of delivery;

• For scombrotoxin-forming ﬁsh delivered under

ice on an open-bed truck:

The adequacy of ice surrounding the

product at the time of delivery;

AND

The internal temperature of the ﬁsh at

time of delivery;

• For scombrotoxin-forming ﬁsh held under

chemical cooling media such as gel packs:

The quantity and frozen status of cooling

media at the time of delivery;

AND

The internal temperature of the ﬁsh at the

time of delivery;

CHAPTER 7: Scombrotoxin (Histamine) Formation

137

• 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 under ice:

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;

• 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:

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;

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 refrigerated (not frozen)

with a transit time of 4 hours or less:

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

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:

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:

Any person who has an understanding of

the nature of the controls.

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.

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;

• Reject the lot.

AND

Take the following corrective action to regain control

over the operation after a critical limit deviation:

• Discontinue use of the supplier or carrier

until evidence is obtained that the identiﬁed

transportation-handling practices have been

improved.

Establish a Recordkeeping System.

• Receiving records showing:

For continuous temperature monitoring:

• Printouts, charts, or readings from

temperature-recording devices (e.g.,

temperature recorder);

For ice checks:

• The number of containers examined

and the sufﬁciency of ice for each;

AND

• The number of containers in the lot;

For chemical cooling media checks:

• The number of containers

examined and the frozen status

of the cooling media for each;

AND

• The number of containers in the lot;

AND

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

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.

• 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:

Immersing the sensor in an ice slurry

(32°F (0°C)), if the device will be used at

or near refrigeration temperature;

Comparing the temperature reading on

the device with the reading on a known

accurate reference device (e.g., a NIST-

traceable 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;

Following the manufacturer’s instructions;

AND

• Once in service, check the temperature-

indicating 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

• 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

the device with the reading on a known

accurate reference device (e.g., a NIST-

traceable 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;

AND

• 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.

CHAPTER 7: Scombrotoxin (Histamine) Formation

140

CHAPTER 7: Scombrotoxin (Histamine) Formation

141

TABLE 7-5

CONTROL STRATEGY EXAMPLE 3 - TRANSIT CONTROL

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.

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).

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

CRITICAL

CONTROL

POINT

SIGNIFICANT

HAZARD(S)

CRITICAL

LIMITS

FOR EACH

PREVENTIVE

MEASURE

MONITORING

CORRECTIVE ACTION(S) RECORDS VERIFICATION

WHAT HOW FREQUENCY WHO

Receiving Scombrotoxin

formation

Adequate

quantity of

frozen gel

packs to

maintain the

product at

40°F or less

throughout

transit; and

Quantity

and frozen

condition of

gel packs

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)

Every lot

received

Receiving

clerk

Reject the lot

Discontinue use of the

supplier or carrier until

evidence is obtained that

transportation-handling

practices have been

improved

Receiving

record

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

Review

monitoring,

corrective action,

and veriﬁcation

records within 1

week of preparation

Internal

temperatures

of all ﬁsh at

delivery are

40°F or below

Internal core

temperature

and a

near-surface

temperature

of each ﬁsh

Digital thermometer

for internal

temperature of

one ﬁsh in 25% of

shipping containers

but not fewer than

12 containers (or

all containers if lot

has less than 12

containers)

Every lot

received

Receiving

clerk

Reject the lot

Discontinue use of the

supplier or carrier until

evidence is obtained that

transportation-handling

practices have been

improved

Receiving

record

• 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 4 hours, cumulatively, if any

portion of that time is at temperatures

above 70°F (21.1°C);

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: 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 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);

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.

» 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 ambient temperatures during the

exposure periods.

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.

» 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));

AND

• Measure ambient air temperature, using:

A continuous temperature-recording

device (e.g., a recording thermometer)

located in the processing area;

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:

At least every 2 hours;

AND

• For temperature measurements:

For a continuous temperature-recording

device:

• 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;

For a temperature-indicating device:

• At least every 2 hours.

» Who Will Do the Monitoring?

• For a continuous temperature-recording device:

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;

• For other checks:

Any person who has an understanding of

the nature of the controls.

Establish Corrective Action Procedures.

Take the following corrective action to a product

involved in a critical limit deviation:

• 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;

• Destroy the product;

• 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;

• 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.

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:

Immersing the sensor in an ice slurry

(32°F (0°C)), if the device will be used at

or near refrigeration temperature;

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;

Doing a combination of the above if

the device will be used at or near room

temperature;

Comparing the temperature reading on

the device with the reading on a known

accurate reference device (e.g., a NIST-

traceable 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;

AND

• Once in service, check the temperature-

indicating device or temperature-recording

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 has sufﬁcient ink and paper,

where applicable;

AND

• 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

• 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

144

CHAPTER 7: Scombrotoxin (Histamine) Formation

145

TABLE 7-6

CONTROL STRATEGY EXAMPLE 4 - PROCESSING CONTROL

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.

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).

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

CRITICAL

CONTROL

POINT

SIGNIFICANT

HAZARD(S)

CRITICAL

LIMITS

FOR EACH

PREVENTIVE

MEASURE

MONITORING

CORRECTIVE

ACTION(S) RECORDS VERIFICATION

WHAT HOW FREQUENCY WHO

Processing

(butchering,

cleaning,

packaging,

labeling, and

boxing)

Scombrotoxin

formation

The product

is not out of

refrigeration

for more

than 4 hours

cumulatively

Time of product

exposure to

unrefrigerated

conditions

during

processing

operations

Visual tracking

of time for a

marked batch

of product to

move from raw

material cold

storage to ﬁnal

product cold

storage

Every batch of

ﬁsh

removed from

raw material

cold storage for

processing

Quality control

supervisor

Ice and hold

the

affected batch

in raw material

cooler

Perform

histamine

analysis on a

minimum of

60 ﬁsh in the

affected batch

Destroy the

entire batch

if any ﬁsh

exceeds

50 ppm

histamine

Modify the

process, if

necessary, to

reduce delays

Processing

record

Review

monitoring,

corrective

action, and

veriﬁcation

records within

1 week of

preparation

• CONTROL STRATEGY EXAMPLE 5 - STORAGE

CONTROL

Establish Monitoring Procedures.

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.

• For refrigerated (not frozen) storage or

processing of raw material, in-process

product, or ﬁnished product:

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;

• For raw material, in-process product, or

ﬁnished product stored under ice:

The product is completely and

continuously surrounded by ice

throughout the storage time.

» What Will Be Monitored?

• For refrigerated storage of scombrotoxin

forming ﬁsh:

The temperature of the cooler;

• For storage under ice of scombrotoxin-

forming ﬁsh:

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);

• 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;

• For storage under ice:

Monitoring with sufﬁcient frequency to

ensure control.

» Who Will Do the Monitoring?

• For continuous temperature-recording devices:

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

• For other checks:

Any person who has an understanding of

the nature of the controls.

Establish Corrective Action Procedures.

Take the following corrective action to a product

involved in a critical limit deviation:

• 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;

• Destroy the product;

• 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:

• Prevent further deviation:

Add ice to the product;

Move some or all of the product in the

malfunctioning cooler to another cooler;

AND

• Address the root cause:

Make repairs or adjustments to the

malfunctioning cooler;

Make adjustments to the ice application

operations.

Establish a Recordkeeping System.

• For refrigerated storage:

Printouts, charts, or readings from

continuous temperature-recording

devices;

AND

Record of visual checks of recorded data;

• For storage under ice:

The number of containers examined and

the sufﬁciency of ice for each;

AND

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:

Immersing the sensor in an ice slurry

(32°F (0°C)), if the device will be used at

or near refrigeration temperature;

Comparing the temperature reading on

the device with the reading on a known

accurate reference device (e.g., a NIST-

traceable 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;

AND

• Once in service, check the temperature-

recording 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

TABLE 7-7

CONTROL STRATEGY EXAMPLE 5 - STORAGE CONTROL

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.

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).

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

CRITICAL

CONTROL

POINT

SIGNIFICANT

HAZARD(S)

CRITICAL

LIMITS

FOR EACH

PREVENTIVE

MEASURE

MONITORING

CORRECTIVE

ACTION(S) RECORDS VERIFICATION

WHAT HOW FREQUENCY WHO

Raw material

and ﬁnished

product cold

storage (shared

cooler)

Scombrotoxin

formation

Maximum

cooler

temperature of

40°F

Cooler

temperature

Time and

temperature

data logger

Continuous,

with a visual

check of

recorded data

once per day

Production

supervisor

Ice and hold the

affected product

inside the cooler

Check

sufﬁciency of ice

on the product

two times per

day until cooler

is functioning

reliably

Perform

histamine analysis

on a minimum

of 60 ﬁsh

representative

of the affected

product

Destroy all

affected

product if any ﬁsh

exceeds 50 ppm

histamine

Adjust and repair

cooler as needed

Data

logger

printout

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

Review

monitoring,

corrective

action, and

veriﬁcation

records within

1 week of

preparation

BIBLIOGRAPHY.

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.

• 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.

• 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.

• 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

seafood science). Elsevier, New York, NY.

• 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 histamine-

forming bacteria isolated during the ripening

of salted anchovies (Engraulis encrasicholus).

J. Food Prot. 62(5):509-514.

• Inestia, C. 1973. Signiﬁcance and detection

of histamine in food, p. 327-347. In

Microbiological safety of food. Academic

Press, New York, NY.

• 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

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,

N Y.

• 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

Fish And Fishery Products Hazards Controls Guidance 252400 UCM252400

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