We all rely heavily
on food producers and handlers to ensure that
the products we eat are safe. The Food and Drug
Administration’s seafood Hazard Analysis Critical
Control Point regulation, or HACCP, is a powerful
tool to help fish and fishery processors prevent
unsafe food from reaching consumers. One of the specific safety
issues a seafood processor must address through
HACCP is the threat of scombrotoxin poisoning
caused by the improper handling of certain
types of fish. In this video, we’ll
provide an overview of scombrotoxin poisoning and
FDA’s recommendations to primary processors when
receiving fish from harvesters. Fishermen are exempt
from the seafood HACCP regulation. However, FDA requires
primary processors, who generally are the first
to receive fish from the harvest vessels, take
steps to ensure the fish they receive are
safe for consumption. When fishermen or primary
processors fail to take appropriate precautions,
consumers of these fish could become ill. This means that the fish
are to be harvested and handled in a way to
prevent scombrotoxin from forming. Scombrotoxin is an
accumulation of compounds, including histamine,
in the fish. Throughout this video we
will refer to scombrotoxin in a general sense when
discussing the formation and controls of these
toxic compounds. However, because histamine
is a primary component of scombrotoxin and is easily
measured in the fish, we will refer to histamine
specifically when we are talking about testing
for scombrotoxin. Scombrotoxin occurs in
certain species of finfish if bacterial growth isn’t
controlled by adequately chilling the fish
after they die. When time and temperature
exposures are not controlled, consumers of
the fish can get sick with scombrotoxin poisoning,
which is sometimes called histamine poisoning. It can form with or
without other spoilage indicators, so even fish
that appear and smell fresh and safe may contain
these toxic compounds and can make consumers sick. Susceptible fish include
tuna, mahi-mahi, marlin, bluefish, mackerel,
sardines, anchovies, and many others. A full list of susceptible
fish can be found in FDA’s Fish and Fishery Products
Hazards and Controls Guidance located
on FDA’s web site. The bacteria occur
naturally in the gut, gills, and exterior
surfaces of the fish. Live fish have natural
defenses preventing a bacterial invasion. But once the fish dies,
bacteria can grow, multiply, and produce
enzymes, which cause scombrotoxin to form. The best way to prevent
this microbial activity is to chill the fish soon
after death and keep the fish chilled. Abusive time-temperature
exposures can occur while the fish is dead on a
line or in a net before landing; while on the boat
deck; or while stored in the boat’s hold. It can also form when
improperly handled at processing plants, in
transit, at retail, or even in the hands
of the consumers. Therefore, the harvesting
and handling practices onboard the harvest
vessels may well be the most critical of all
the steps the fish will receive before
reaching the consumer. And, once scombrotoxin
has formed, it cannot be removed or destroyed. Here you see a list of
symptoms associated with Scombrotoxin. Symptoms may last from
12 hours to a few days. However, the rapid and
intense onset of the symptoms, which usually
occur within a few minutes to a few hours of
consuming the bad fish, can cause the victim
serious concern and distress. Some victims seek
professional medical attention and some
are hospitalized. FDA recommends two general
strategies for preventing scombrotoxin formation
at the receiving critical control point. In the harvest vessel
records strategy, the processor typically
obtains records from the fishermen that document
the harvesting, handling, and storage of the catch
to show that the fish were chilled rapidly and held
chilled throughout the fishing trip. In the histamine testing
strategy, the processor collects meaningful
samples from the vessel lots received and conducts
analytical testing to ensure histamine
levels are low. In both strategies, the
processor measures the internal temperatures of
the representative fish and conducts sensory
examinations of the fish collected from the lots to
ensure that there are no signs of time and
temperature abuse detected in the fish. Working cooperatively with
the fishermen, processors using the harvest vessel
records strategy should develop recordkeeping
forms to be used by the fishermen to capture
pertinent chilling and handling activities on the
boats that ensure their critical limits for
chilling the fish are met. The details of this
strategy are covered in another video titled
Primary Processor Scombrotoxin Controls –
Harvest Vessel Records. In this video, we’ll be
focusing on monitoring internal temperatures
and sensory examinations. We’ll also discuss
histamine testing considerations important
in both control strategies and we’ll touch on some
corrective action and verification procedures
associated with the receipt of
scombrotoxin-forming fish by the primary processor. Whether using the harvest
vessel record strategy or the histamine testing
strategy, processors should measure the
internal temperatures of the fish as they’re
off-loaded from the vessels. These measurements won’t
guarantee that the fish were chilled onboard
within the proper timeframes or that they
remained properly chilled throughout the
fishing trip. However, elevated fish
temperatures taken at off-loading serve as a
signal to the processor that the harvester’s
practices and controls may be inadequate and the
potential for conditions favorable to scombrotoxin
formation may have been permitted by the
boat operators. FDA recommends the
following critical limits for the internal
temperatures of fish when off-loading a supplier’s
vessel: If it’s been 24 hours or more since the
fish being measured died, the internal temperatures
should be 40 degrees Fahrenheit or less. For fish that have been
dead for 15 to 24 hours, internal temperatures
should be 50 degrees or less. Fish that have been dead
for 12 to 15 hours should have internal temperatures
of 60 degrees or less. For fish that have been
dead for less than 12 hours, the temperatures
should indicate that appropriate efforts were
made to chill the fish onboard. In this situation,
the processor could effectively use cooling
profiles established for the types of fish received
under typical ambient temperatures of harvest to
determine if the fish were properly chilled within
the short timeframes till delivery. The processor may use
other time and temperature limits that are
scientifically established for the particular
fishery if the criteria recommended by FDA aren’t
applicable to its fishery. These recommendations
won’t fit every situation. For example, fishermen
who deliver fish that have been dead 14 hours
and have an internal temperature of 60 degrees
would technically meet FDA’s recommendation. But, suppose the air and
seawater temperatures for the fishing trip
were 62 degrees? Then, depending on the
harvest method or the size of the fish, the 60 degree
internal temperature could indicate that the
fisherman didn’t make much of an effort to chill the
fish or to keep the fish chilled for the 14
hours after death. In that case, the
processor should take corrective action
on the lot. FDA’s recommendations are
based on the cooling of fairly large fish. Because smaller fish chill
more rapidly, it may be appropriate to establish
limits with lower temperatures or shorter
timeframes in order to better ensure that the
small fish were handled and stored
properly onboard. When handling very large
fish that chill more slowly at the core, a
processor might establish temperature limits that
are more pertinent to the fishery, such as
temperatures at a designated depth within
the fish muscle in addition to the deep
backbone or core temperatures of the fish. This processor should also
validate the adequacy of these newly
established limits. FDA recommends monitoring
the internal temperature of a representative number
of the largest fish in every vessel lot
at off-loading. Processors should
concentrate on any fish showing signs of
mishandling, such as inadequate icing. A minimum of 12 fish
randomly selected and representative of the lot
is advised; but larger sample sizes may be
applicable to ensure adequate representation
of larger lots or where increased temperature
variability is expected or found in the lot. Portions of fish no longer
surrounded by ice or other coolant, as well as
smaller fish with inadequate coolant, may
warm more rapidly than the core of larger fish or
portions of the same fish that are properly iced. So, checking the core
temperature of only the larger fish may not
provide sufficient information. When a vessel lot arrives
with depleted coolant, a processor should measure
the temperature of some of the smaller fish in the
lot, in addition to muscle nearer the surface of any
exposed fish portions. Obtaining meaningful
temperature measurements of extremely small fish
can be a little trickier. Although small fish chill
quickly when surrounded by ice or coolant, coolant
doesn’t easily penetrate clusters of small fish
that may form in the hold. Ensuring that every fish
is, in fact, adequately surrounded with coolant
may be challenging for the fishermen. In these circumstances,
processors may find it necessary to measure the
temperature of far more than the recommended
minimum 12 fish for a better representation of
the overall condition of the fish in the lot. FDA’s recommendations for
internal temperatures of fish at receipt are based
on the time of death of the fish. So, processors using the
histamine testing control strategy may still need
some record of time of death from the fishermen
in order to make sure the temperatures at receipt
meet the appropriate critical limit. On the other hand, you may
not need the time of death when using the histamine
testing control strategy if you can safely assume
that all the fish in the vessel lot have been dead
for 24 hours or more. In this case, only
the 40 degree internal temperature limit
would apply. Most harvest vessels
deliver fish that have been dead for different
lengths of time. Recently caught fish
may have higher internal temperatures than those
that were caught earlier in the trip and had longer
exposures to coolant. The processor can’t rely
on the temperatures of only the last-caught or
first-caught fish when assessing the
condition of a lot. The fish measured should
be randomly selected to represent the entire
vessel lot and the processor may need time
of death records from the fishermen to make an
appropriate assessment of those fish. Internal temperatures are
an indication of onboard handling practices, so
off-loading fish shouldn’t be delayed simply so the
fish can further cool to meet the temperature
critical limits. That would make the
monitoring useless. Nor should a processor
delay off-loading the fish after temperature
measurements have been made. If a delay is unavoidable,
for example when a glut of vessel deliveries prevents
immediate off-loading, either the processor or
the vessel operator should ensure the fish being held
up on the boats are stored in sufficient coolant
during the entire period until offloading
can commence. Documentation of the
holding conditions may be warranted. Let’s review some issues
primary processors may have with collecting
samples for histamine testing or sensory
examinations. Proper sample collection
will help the processor to make good decisions
about the lot. Meaningful sampling
begins with the proper designation of lots. Many primary processors
consider all of the fish on a vessel delivered at a
particular time to be one lot. Processors receiving very
large freezer vessel loads often break up the vessel
lot into smaller, more manageable, sublots. These may or may not
be appropriate sampling approaches. With any sampling
approach, the designation of “lots” should be done
in a way to minimize the variability of time and
temperature exposure history in the particular
group of fish to be sampled. This better ensures that
the few samples taken will provide a reliable
indication of the presence of scombrotoxin
in the lot. Sometimes lots are
expected to have a great deal of variability in the
kind of exposures that the fish were subjected to. For example, longline
vessels land everything from live fish to fish
that have been dead at sea for many hours. Subdividing the lot into
smaller portions wouldn’t typically reduce the
inherent variability caused by the
harvest method. When faced with this kind
of scenario, processors should consider larger
sample sizes than the minimums recommended to
ensure that any problems in the lot are more
likely to be detected. When very large lots are
subdivided into smaller, more manageable sublots as
a means of expanding the sampling and
representation of the harvest vessel delivery,
the processor should recognize that the purpose
of the sampling and testing is still intended
to provide an indication of the care and handling
practices implemented by the vessel operators. The sampling sizes are
typically still far too small to conclude that
when one sublot has deviated from the critical
limit the other sublots will be safe. Instead, a critical limit
deviation in any sublot should trigger an alarm
for the processor that there may be undesirable
handling practices by the vessel operators and the
entire vessel delivery, all sublots, should be
suspect and subject to corrective action. FDA generally recommends
separately sampling and testing each species of
scombrotoxin-forming fish received in a vessel lot. This is a good practice
where vessel lots containing sizeable
quantities of different species and allows
the processor to give consideration to the
different morphology and composition of the species
that could affect their cooling rates. Lots delivered from
collection vessels or transporters usually
contain fish from more than one harvest vessel. These lots should be
delivered with each harvest vessel’s load
clearly identified and remain intact for separate
sampling by the processor. If commingled loads are
delivered in a manner that prevents testing fish
from each harvest vessel separately, a practice
that’s strongly discouraged, then a much
more extensive sampling plan should be implemented
to deal with the increased variability in the
commingled lot. Also, when these
collection vessels or transporters off-load
fresh fish from harvest vessels for subsequent
delivery to the processors, it’s desirable
for the operators of the collection vessel or
transporter to measure and record internal
temperatures of each harvest vessel lot, much
as a primary processor would do, to provide
appropriate documentation to the land-based
processor upon delivery. Processors should not
pass on responsibility for sampling and testing of
off-loaded fish to other processors unless lots are
kept intact, are clearly identified, and there’s a
written arrangement with the subsequent processor
on file describing specific sampling
and testing terms. These arrangements should
be limited to histamine testing or sensory
examinations, never temperature measurements
of unfrozen fish. Delaying temperature
measurements until after transport and receipt by
the next processor defeats the purpose of those
measurements as an indication of
vessel practices. Temperature measurements
intended to help the processor assess the
safety of the fish as they’re off-loaded are
only meaningful if they’re performed at the time fish
are off-loaded from the vessel. Now let’s look at the
sensory examination and histamine testing
control elements. Along with internal
temperature measurements at receiving, FDA
recommends that primary processors of
scombrotoxin-forming fish conduct sensory
examinations for both the harvest vessel record
control strategy and the histamine testing
control strategy. FDA recommends a receiving
critical limit that alerts the processor when a lot
consists of two and a half percent or more of
decomposed fish. This can be determined by
sensory examinations of a representative sample
by properly trained examiners. Examinations should
include at least 118 fish from any given lot and
if more than 2 of the 118 fish are decomposed,
take corrective actions. Examine additional fish
when increased variability in potential time and
temperature exposures is expected in the lot or
for large volume lots. Processors are reminded
that this critical limit recommendation of two
and a half percent decomposition for the
HACCP control is intended only to warn the processor
that the fish have been exposed to some levels
of time and temperature abuse. The recommendation does
not mean that the lots containing some decomposed
fish are acceptable for commerce as long as the
total is less than two and a half percent. Processors are obligated
under the law to prevent product from entering
commerce if it consists in whole or in part of any
decomposed substance. Further, for HACCP
applications, the processor shouldn’t reject
individual fish only after they’ve reached advanced
stages of decomposition. Instead, the decomposition
criteria should be indicative of time and
temperature abuse, as in the loss of fresh quality
attributes and entering the earliest
reject stages. These can be determined
by properly trained and qualified
sensory analysts. After all, none of the
fish coming off of the vessel should already
exhibit decomposition if harvested and
handled properly. In the histamine testing
control strategy, the receiving critical control
point should include testing of a
representative number of fish, a minimum of 18
fish, from each lot received to ensure that
all the fish contain less than 50 parts per
million histamine. Testing additional fish
is recommended when high variability in histamine
content is expected or observed in the lot or
for large volume lots. Processors should
recognize that fish with histamine in excess of
50 parts per million are adulterated. If the fish will be
subjected to further processing steps with
significant exposures to temperatures above 40
degrees Fahrenheit, additional histamine
may form during the processing. In this case, the
processor should consider a receiving critical limit
below 50 parts per million to avoid adulterating the
food during the subsequent processes. It’s important for
processors to recognize that histamine will not
form in fish without gross time and
temperature abuse. Experts find that freshly
harvested fish typically contain less than 2 parts
per million histamine. And vigilant harvesters
and processors applying effective Good
Manufacturing Practices and HACCP controls can
produce fishery products containing histamine
levels well below 15 parts per million. Consequently, FDA
is reassessing the appropriate levels of
histamine expected in samples of fish. Processors are encouraged
to do research on their own fishery to establish
applicable acceptance criteria to ensure high
quality and safe fish from their suppliers. In addition to the general
sampling issues previously discussed, a very
important part of the histamine testing strategy
is the location on each fish where the histamine
sample is collected. When fresh fish are time
and temperature abused on the harvest vessels in
a manner that allows for histamine formation, the
lower anterior loin of the affected fish provides
a good likelihood of detecting the
elevated histamine. Therefore, sampling
procedures should target the lower anterior
loins during receiving. FDA recommends collecting
a minimum of 250 grams of muscle from one of the
lower anterior loins of each fish to be tested. Because it’s not unusual
for histamine to form more on one side of a fish than
another, processors that choose to obtain the
sample from equal portions of both anterior loins of
each fish should consider halving the appropriate
critical limit histamine level trigger to account
for the potential dilution factor. However, rather than
sampling muscle from both sides of the same fish,
in most instances, FDA recommends sampling from
only one side of each fish selected for testing. By alternating sides
for each test fish, bias toward one side or
another will be minimized. If the morphology of the
fish makes it difficult to get 250 grams from the
lower anterior loin of one side of the fish, the
processor may include some of the upper anterior loin
portion but never in lieu of the lower
anterior portion. When both the upper
and lower anterior loin portions of the test fish
still don’t provide 250 grams, the processor may
include the middle section of the lower loin as well. If the fish are smaller
yet, such that all three portions don’t provide
250 grams, the processor should collect multiple
fish for each sample unit and collect the three
portions from one side of each fish until the target
250 grams is obtained. When the fish are so
small such that the entire edible portion from both
sides of the fish yields less than 250 grams, the
processor can collect multiple fish for each
test unit and utilize the entire edible portions
from each fish until 250 grams of edible
portion are obtained. The sample portions should
be individually ground and the amount to be tested,
called the test aliquot, should be taken from each
of the ground samples. Some processors may choose
to reduce the testing costs by combining
fish samples into fewer composite samples. Here’s an example. Collect 250 grams from
each of the 18 fish and grind each sample
separately. Then, divide the 18
samples into 6 groups consisting of
3 samples each. Take a minimum of 100
grams from each of the 3 ground portions per group,
combine them, and re-grind them together to make
one composite sample. Repeat this for each
of the six groups. A test aliquot is taken
from each of the six composite samples. When compositing, the
processor should reduce the critical limit level
according to the number of fish represented in each
composite sample so that elevated histamine levels
in any one fish sample won’t be masked or diluted
by the other portions in the composite. So, in our example, if 18
individual fish samples are composited into 6
composites of 3 fish each, the critical limit for
each composite sample would be a maximum of
16.7 parts per million histamine rather than a
maximum of 50 parts per million because we would
divide 50 parts per million by 3 for the
number of fish in the composite. Processors should use a
validated test method for histamine determination. The test method should
be specified in the HACCP plan and any changes made
in the method should be re-validated. The validation should
ensure reliable results under the specific
testing conditions at the processing plant for the
specific species received. There are several
commercial test kits for histamine available. If a test kit is used,
it’s up to the processor to ensure that the kit
gives reliable results under the processor’s
specific conditions. It’s not enough to simply
buy a kit based on the kit manufacturer’s promotions
without validating the results. If compositing subsamples
for analysis, then the kit’s ability to perform
reliably at the lower detection limits should
also be verified. Be aware, test kit
sampling instructions may not be designed for HACCP
control applications. FDA’s recommended sample
of a minimum of 250 grams from the lower anterior
loin of an appropriate number of fish should be
collected regardless of the kit’s instructions. If compositing samples,
follow the procedures previously described to
prepare the samples for analysis with the kit. Once the samples are
ground and prepared, follow the kit
instructions for the size of the test aliquot
and further analysis. Now let’s look at some
issues related to the best time to conduct
the monitoring. The receiving controls
recommended so far are intended to be applied
at the time fish are off-loaded from the
vessels to allow processors to make a
decision about the safety and acceptability of the
fish from the harvest vessel. However, sometimes a
processor may receive fish at a wharf while its
actual processing facility is at another location. Monitoring for some
receiving critical limits should be done immediately
at the wharf while monitoring for others can
wait until the fish are delivered to the
processing facility. Sensory exams and
histamine testing can be delayed until the fish
are transported to the processing facility
because decomposition and histamine levels won’t
improve with time. However, for this delayed
testing to have meaning, the fish should be
transported with each vessel delivery intact,
separate, and clearly identified. This allows the processor
to make reliable vessel-by-vessel delivery
acceptance decisions just as it would at the wharf. In contrast, you should
not delay temperature measurements of the fish
coming off the boats. Remember that temperature
measurements of fish at receiving are an
indication of control practices onboard the
vessel and are only meaningful at the
time of off-loading. Temperature measurements
taken after the fish are off-loaded, re-iced, and
transported, no longer reflect the temperature
control practices onboard the vessel. Reviews of harvest vessel
records are also best done at the wharf. Inadequate records or
indications in the records that the catch wasn’t
chilled, handled, or stored properly may be
reason to reject the catch before off-loading. In addition to the
primary processor controls discussed so far, transit
controls associated with secondary processors may
also be necessary whenever a processing facility is
somewhere other than the wharf. The transit controls
ensure that the fish are delivered from the wharf
to the processing facility in a safe manner. We discuss these transit
controls in another video for Secondary Processor
Receiving and Storage Controls. In these cases, processors
would have two receiving critical control points –
receipt from fishermen at the wharf and receipt at
the processing facility after transport
from the wharf. Further processing won’t
mitigate scombrotoxin formed in the fish during
harvest, onboard handling, or prior to receipt at
the processing facility. Therefore, if the
processor plans to further process the fish, such
as by salting, drying, pickling, smoking,
canning, or fermentation, it’s still responsible for
controlling scombrotoxin in the raw fish it
receives from the harvest vessels, just as it would
if it were marketing the fish as fresh. Even in the case of
natural fermentations, researchers have shown
that elevated histamine in the final product can
be prevented by proper chilling and handling of
the fish on the harvest vessels and proper initial
preparation steps of the fish for fermentation. Also, histamine is water
soluble and can form and remain in the muscle
of the fish despite substantial processing. So, even when the
finished product no longer resembles the fish from
which it came, such as fish protein concentrate,
processors should have the same primary processor
scombrotoxin control concerns as processors of
other fishery products. Processors of fish
oil products, in which histamine is not soluble,
may not require controls for the scombrotoxin
hazard for those products. The critical limits and
monitoring procedures we’ve discussed so far
aren’t all that processors should do to control
scombrotoxin formation. The HACCP plan should also
outline corrective actions to take if the critical
limits are not met and verification procedures
to ensure the established controls are effective. Appropriate corrective
actions may well be the most crucial element
of any HACCP program. No matter how well the
critical limits and monitoring procedures of
a HACCP plan are designed and followed, the
processor’s decisions and actions following a
critical limit deviation will greatly determine if
the food distributed is safe. After all, consumers
are most vulnerable when product is produced
outside the measured controls. If the processor
determines that the fish received were exposed to
conditions potentially favorable to scombrotoxin
formation, it’s required to take corrective action. The processor has two
options; either reject the lot or, if elevated
histamine wasn’t already detected during the
histamine monitoring, to conduct expanded sampling
and histamine testing to ensure no portions of
the lot contain elevated histamine and the fish
are still safe for consumption. Re-icing fish doesn’t
eliminate scombrotoxin that may have already
formed during time and temperature abuse. Once formed, scombrotoxin
will remain even if the fish are frozen. So, it’s not an
appropriate corrective action to simply
re-ice or freeze the time-temperature
abused fish. Histamine can’t be
reliably detected by sensory examinations or
temperature monitoring alone. So, culling out decomposed
fish or fish with elevated temperatures from an
affected lot doesn’t provide an adequate
scombrotoxin control; elevated histamine might
still be in the remaining fish. If the decomposition
or temperature critical limits are exceeded,
processors should reject the entire lot or conduct
extensive histamine testing before accepting
any portion of the lot. When histamine testing is
conducted as a corrective action in a lot that
failed the internal temperature or the sensory
criteria, FDA recommends testing a minimum of 60
fish in the lot including all fish that have
elevated temperatures or are decomposed. Additionally, if high
histamine is not found in the fish tested following
a deviation in the sensory exam critical limit,
processors should perform a 100 percent inspection
of the lot to cull and reject all decomposed fish
before further processing or distributing
the lot of fish. FDA’s current guidance
no longer includes subdividing and retesting
of lots as a viable corrective action for fish
that have tested positive for elevated histamine. This subdividing approach
didn’t provide adequate protection for consumers. Addressing the cause of a
critical limit deviation is an important part of
taking corrective action. FDA recommends that
processors discontinue the use of a supplier until
evidence shows that the supplier’s harvesting
and onboard practices and controls have
been improved. A proactive processor
won’t just rely on testing and monitoring of
a supplier’s future deliveries to determine
if improvements were made. Primary processors should
seek improvements by working with the fishermen
to identify any of the fishermen’s practices
that may be deficient and appropriate actions to
correct the deficient practices. Processors can document
observations of their supplier’s modifications
as part of the evidence that improvements
have been made. The processor should then
consider increased levels of histamine testing
from several subsequent deliveries of fish from
the same supplier and revert back to its
original receiving controls only after the
supplier has documented improvements in harvesting
and onboard practices and has delivered several
consecutive problem-free vessel lots. Further, when a critical
limit is not met, and a processor applies FDA’s
recommendation to “reject the lot,” appropriate
means of rejection at the time of receiving can
include refusal to accept the lot from the supplier,
destruction of the lot, or diversion of the lot
to a non-food use. The HACCP plan must also
include verification procedures to ensure a
processor’s controls are adequate and that its
plan is effectively implemented. This includes the
verification procedures common to most seafood
HACCP plans, such as reviewing records
and calibrating temperature-monitoring
devices. But there are a couple
of verification elements specifically related
to handling of scombrotoxin-forming
fish worth emphasizing. FDA recommends that new
sensory examiners receive training to ensure
reliable identification of decomposition in fish. All sensory examiners
should also receive periodic refresher
training. As a verification
procedure for primary processors using the
harvest vessel record control strategy, FDA
recommends conducting histamine testing of a
representative sample at least quarterly. This sample can come from
raw material, in-process product, or
finished product. However, because the
testing is intended to serve as a measure of
the adequacy of the processor’s receiving
controls, the lower anterior loins of raw
material accepted may serve as the best
verification sample for this application. Fish further along in
the processing line may introduce unwanted
variability due to the commingling of fish from
various vessels and, depending on the type of
processes performed, could make identification of the
lower anterior loins more difficult or could result
in portions other than the lower anterior loins
having higher histamine levels. To obtain the most useful
information about the effectiveness of
the control program, verification samples
should be collected from lots containing marginally
acceptable fish or from suppliers with
questionable or lax vessel records. Concentrating on these
types of lots provides processors greater
confidence in the effectiveness of their
HACCP controls than testing pristine lots from
vessels known to handle the fish properly or
simple random selection of lots. When doing periodic
histamine testing for verification, processors
should test a minimum of 18 fish from the selected
lot; more if the histamine content is expected
to vary considerably. Processors should also
increase the amount or frequency of verification
testing if they receive fish from many different
vessels or any time they have concerns about the
condition of fish received or the validity of the
harvest vessel records received. FDA emphasizes the
critical role that harvesters and primary
processors play in protecting consumers from
scombrotoxin poisoning. Without vigilance by the
harvesters and the primary processors, controls
applied later in the distribution chain
may be futile. Providing safe products
to the consumers requires emphasis on proper
preventative controls from the moment the fish are
caught so that fish are brought to the market free
of time-temperature abuse or elevated concentrations
of scombrotoxin.

Primary Processor Scombrotoxin Controls – Overview and Testing at Receiving
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