Chapter 6: Refrigerated Fish and Fishery Products
Updated 9/21/00
Contents
Potential Food Safety Hazard
Pathogen growth and toxin formation as a result of time/temperature abuse
of fish and fishery products can cause consumer illness. This hazard is
limited to bacterial pathogens since viral pathogens (viruses) are not
able to grow in food. Temperature abuse occurs when product is allowed
to remain at temperatures favorable to pathogen growth for sufficient time
to result in unsafe levels of pathogens or their toxins in the product.
Chapters 10-21 provide guidance about the conditions under which certain
pathogens are able to grow. The pathogens listed are those of greatest
concern in fish and fishery products (FDA, 1998b).
1. Raw fish and fishery products to be cooked before consumption
Pathogens can enter the process on raw materials. They can also be
introduced into foods during processing from the air, unclean hands, insanitary
utensils and equipment, unsafe water, sewage, and through cross-contamination
(FDA, 1998b).
2. Raw fish that is intended to be eaten raw
Pathogens can enter the process on raw materials. They can also be
introduced into foods during processing from the air, unclean hands, insanitary
utensils and equipment, unsafe water, sewage, and through cross-contamination
(FDA, 1998b).
3. Raw molluscan shellfish that may be eaten raw
Pathogens found in waters from which molluscan shellfish are harvested
can cause disease in consumers. Molluscan shellfish include 1) oysters;
2) clams; 3) mussels; and, 4) scallops, except where the final product
is the shucked adductor muscle only. The pathogens of concern include both
bacteria and viruses.
Pathogens from the harvest area are of particular concern in molluscan
shellfish because: 1) environments in which molluscan shellfish grow are
commonly subject to contamination from sewage, which may contain pathogens,
and to naturally occurring bacteria, which may also be pathogens; 2) molluscan
shellfish filter and concentrate pathogens that may be present in surrounding
waters; and, 3) molluscan shellfish are often consumed whole, either raw
or partially cooked (FDA, 1998i).
4. Fish and fishery products sensitive to scombrotoxin (histamine) formation
Scombrotoxin formation as a result of time/ temperature abuse of certain
species of fish can cause consumer illness. The illness is most 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.
Scombroid poisonings have primarily been associated with the consumption
of tuna, mahi mahi, and bluefish. However, FDA's Hazards and Controls Guide,
Chapter 3, Table 3-1 (FDA, 1998n) lists a number of species that are also
capable of developing elevated levels of histamine when temperature abused.
Certain bacteria produce the enzyme histidine decarboxylase during growth.
This enzyme reacts with free histidine, a naturally occurring chemical
that is present in larger quantities in some fish than in others. The result
is the formation of histamine.
Histamine-forming bacteria are capable of growing and producing histamine
over a wide temperature range. Growth is more rapid, however, at high-abuse
temperatures (e.g., 21.1ºC (70°F) than at moderate-abuse temperatures
(e.g., 7.2ºC [45°F]). Growth is particularly rapid at temperatures
near 32.2ºC (90°F). Histamine is more commonly the result of high
temperature spoilage than of long term, relatively low temperature spoilage.
Nonetheless, there are a number of opportunities for histamine to form
under more moderate conditions.
Once the enzyme histidine decarboxylase has been formed, 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
is likely to be more stable than the bacteria in the frozen state and may
be reactivated very rapidly after thawing. Recent studies suggest that
if histamine production is advanced (i.e., high levels of histidine decarboxylase),
histamine formation can continue even in frozen storage.
Freezing for an extended period of time (e.g., 24 weeks) may inactivate
the enzyme-forming bacteria. Cooking can inactivate both the enzyme and
the bacteria. However, once the toxin is formed, it cannot be eliminated
by heat (including retorting) or freezing. After cooking, recontamination
of the fish with the enzyme-forming bacteria is necessary for additional
histamine to form. For these reasons, histamine development is more likely
in raw, unfrozen fish.
The kinds of bacteria that are associated with histamine development
are commonly present in the salt-water environment. They naturally exist
on the gills and in the gut of live fish, with no harm to the fish. Upon
death, the defense mechanisms of the fish no longer inhibit bacterial growth,
and histamine-forming bacteria start to grow and produce histamine. With
some harvesting practices, such as longlining, death can occur before the
fish is removed from the water. Under the worst conditions histamine formation
can already be underway before the fish is landed on the vessel. This condition
can be aggravated when the fish is allowed to struggle on the line for
a period of time, a situation that in certain tuna species may cause its
internal temperature to increase to a more favorable growth range for the
enzyme-forming bacteria.
The potential for histamine formation is increased when the flesh of
the fish is directly exposed to the enzyme-forming bacteria. This occurs
when the fish are processed (e.g., butchering or filleting) (FDA, 1998h).
5. Acidified (pickled), fermented, salted, and smoked fish and fishery
products
Pathogens can enter the process on raw materials. They can also be
introduced into foods during processing from the air, unclean hands, insanitary
utensils and equipment, unsafe water, sewage, and through cross-contamination
(FDA, 1998b). Pathogen growth can occur if the % salt, water activity,
water-phase salt, pH, and/or level of preservatives are not adequate.
6. Cooked fish and fishery products
Pathogens can enter the process on raw materials. They can also be
introduced into foods during processing from the air, unclean hands, insanitary
utensils and equipment, unsafe water, sewage, and through cross-contamination
from raw to cooked products (FDA, 1998b).
Proper cooking kills most pathogens, but cross-contamination, vacuum
packaging and time/temperature abuse can result in pathogen growth and,
possibly, toxin production.
Contents
Control Measures
1. Raw fish and fishery products to be cooked before consumption
For many products (e.g., raw fish fillets) there is no cooking, pasteurizing,
or retorting step performed by the processor. For most of these products,
the consumer or end user cooks the product before consumption (FDA, 1998i).
Normal cooking procedures (e.g., heating all parts of the food to 63ºC
(145ºF) or above for 15 s (FDA, 1997a)), will kill most pathogens.
2. Raw fish that is intended to be eaten raw
For fish and fishery products intended to be eaten raw, there is no
cooking, pasteurizing, or retorting step performed by the processor or
the consumer. HACCP controls are necessary to prevent time-temperature
abuse that could result in pathogen growth during receiving, processing,
and storage.
3. Raw molluscan shellfish that may be eaten raw
To minimize the risk of molluscan shellfish containing pathogens of
sewage origin, State and foreign government agencies, called Shellfish
Control Authorities, classify waters in which molluscan shellfish are found,
based, in part, on an assessment of water quality. As a result of these
classifications, molluscan shellfish harvesting is allowed from some waters,
not from others, and only at certain times or under certain conditions
from others. Shellfish Control Authorities then exercise control over the
molluscan shellfish harvesters to ensure that harvesting takes place only
when and where it has been permitted.
Significant elements of Shellfish Control Authorities' efforts to control
the harvesting of molluscan shellfish include: 1) a requirement that containers
of in-shell molluscan shellfish (shellstock) bear a tag that identifies
the type and quantity of shellfish, harvester, harvest location, and date
of harvest; 2) a requirement that molluscan shellfish harvesters be licensed;
3) a requirement that processors that shuck molluscan shellfish or ship,
reship, or repack the product be certified; and, 4) a requirement that
containers of shucked molluscan shellfish bear a label with the processor's
name, address, and certification number.
These controls serve to minimize the risk of molluscan shellfish containing
pathogens of sewage origin, but do not fully eliminate the risk. As a result,
consumption of raw molluscan shellfish may not be safe for individuals
with certain health conditions, such as liver disease, chronic alcohol
abuse, diabetes, and stomach, blood, and immune disorders. For this reason
Shellfish Control Authorities require that shellstock bear a tag that instructs
retailers to inform their customers that cooking reduces the risk of food-borne
illness, and that individuals with these health conditions are at higher
risk of illness if they consume the product raw.
Processors can also eliminate the hazard of "pathogens from the harvest
area" by properly cooking or retorting the product. Guidance on cooking
controls is provided in Chapter 3. Mandatory retorting controls are described
in the low-acid canned foods regulation (21 CFR 113). It should be noted
that neither cooking nor retorting will eliminate the hazards of "natural
toxins" or "chemical contamination" that may be associated with molluscan
shellfish that are harvested from closed waters (see Chapters 23 and 26).
Additionally, the laws and regulations of states that participate in the
National Shellfish Sanitation Program currently require that all molluscan
shellfish be harvested from waters approved for harvesting by the Shellfish
Control Authority, regardless of how it will be processed.
Pathogens, such as V. parahaemolyticus, V. cholerae, and
L.
monocytogenes that may be present in low numbers at the time that molluscan
shellfish are harvested, may increase to more hazardous levels if they
are exposed to time/temperature abuse. To minimize the risk of pathogen
growth, Shellfish Control Authorities place limits on the time between
harvest and refrigeration. The length of time is dependent upon either
the month of the year or the average monthly maximum air temperature (AMMAT)
at the time of harvest, which is determined by the Shellfish Control Authority.
Additionally, to minimize the risk of illness from the consumption of
molluscan shellfish containing V. vulnificus, Shellfish Control
Authorities place certain controls on the harvest of molluscan shellfish
harvested from waters which have been associated with V. vulnificus
infection.
V. vulnificus is a naturally occurring bacterial pathogen that is
frequently associated with the consumption of raw oysters harvested from
the Gulf of Mexico during the warm weather months. The controls for V.
vulnificus discussed in this chapter only apply to such molluscan shellfish
if they are intended for raw consumption. For example, they would not be
applied to oyster shellstock from the Gulf of Mexico if tags on the containers
of shellstock indicate that they must be shucked and cooked before consumption.
In most cases, control for V. vulnificus involves limits on the
time from harvest to refrigeration. The length of time is dependent upon
the average monthly maximum water temperature (AMMWT) at the time of harvest,
which is determined by the Shellfish Control Authority. This is an interim
control measure, which is contained in the National Shellfish Sanitation
Program Manual of Operations. FDA and the Interstate Shellfish Sanitation
Conference (ISSC) plan to re-evaluate the effectiveness of this control
measure.
As with pathogens of sewage origin, the above controls for naturally
occurring pathogens, such as V. vulnificus and V. parahaemolyticus,
minimize the risk of molluscan shellfish containing these pathogens, but
do not fully eliminate the risk. For this same reason, Shellfish Control
Authorities require that shellstock bear a tag containing a warning relative
to raw consumption (described above).
Cooking, pasteurizing, and retorting can also eliminate V. vulnificus.
Guidance for these control mechanisms can be found in Chapters 3 (cooking)
and 5 (pasteurization) and the low-acid canned foods regulation (21 CFR
113) (FDA, 1998i).
4. Fish and fishery products sensitive to scombrotoxin (histamine) formation
Rapid chilling of fish immediately after death is the most important
element in any strategy for preventing the formation of scombrotoxin. For
fish other than tuna above 20 lbs., if the fish have not been exposed to
water temperatures above 28.3ºC (83°F), the fish should be placed
in refrigerated seawater or brine at 10ºC (50°F) or less within
9 h of death, or placed in ice within 12 h of death. For tuna above
20 lbs., or if the fish have been exposed to water temperatures above 28.3ºC
(83°F), the internal temperature of the fish should be brought to 10ºC
(50°F) or less within 6 h of death. This will prevent the rapid
formation of the enzyme histidine decarboxylase. Once this enzyme is formed
control of the hazard is unlikely.
Further chilling towards the freezing point is also desirable to safeguard
against longer-term, low-temperature development of histamine. Additionally,
the shelf life of the fish is significantly compromised when product temperature
is not rapidly dropped to near freezing.
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 a long line may significantly limit the amount
of time left for chilling and may allow the fish to heat up as it struggles;
-
The quantity of fish landed in a purse seine may exceed a vessel's ability
to rapidly chill the product;
-
The size of the fish; and
-
The chilling method;
-
Ice alone takes longer to chill than does an ice slurry or recirculated
refrigerated sea water or brine, a consequence of reduced contact area;
-
The quantity of ice or ice slurry and the capacity of refrigerated sea
water or brine systems must be suitable for the quantity of catch.
Once chilled, the fish should be maintained as close as possible to
the freezing point (or held frozen) until it is consumed. Exposure to ambient
temperature should be minimized. The allowable exposure time is dependent
primarily upon the speed with which the fish were chilled on-board the
harvest vessel and whether the fish has been previously frozen (e.g., on-board
the harvest vessel).
Unfrozen scombrotoxin-forming fish has a safe shelf life, which is dependent
upon the storage temperature. Table 6-1 shows an approximate safe shelf
life for fish stored at various temperatures. The safe shelf-life periods
in the table include the time aboard the harvest vessel.
Any time above 4.4ºC (40°F) significantly reduces the expected
safe shelf life. For this reason, fish should not be exposed to temperatures
above 4.4ºC (40°F) for more than 4 h, cumulatively, after
chilling on board the harvest vessel. The safety of this limit is dependent
upon proper handling at sea.
Fish that have been handled particularly well on-board the harvest vessel
may be able to safely withstand somewhat more exposure to elevated temperatures
during post-harvest handling.
Table 6-1. Approximate safe shelf life for scombrotoxin-forming species
at various storage temperatures (FDA, 1998h).
Product
Temperature
|
Safe Shelf-life (d) with Rapid Cooling
|
Safe Shelf-life (d) with Delayed Cooling
|
ºC
|
ºF
|
-17.8 |
0 |
No limit
|
No limit
|
0 |
32 |
14 |
8 |
3.3 |
38 |
10 |
7 |
4.4 |
40 |
7 |
5 |
10 |
50 |
3 |
0 |
21.1 |
70 |
0 |
0 |
32.2 |
90 |
0 |
0 |
Fish that have undergone extended frozen storage (e.g., 24 weeks)
can safely withstand considerably more exposure to elevated temperatures
during post-harvest handling. Such fish should not be exposed to temperatures
above 4.4ºC (40°F) for more than 12 h, cumulatively, after
chilling on board the harvest vessel. An uninterrupted period of exposure
should not exceed 6 h. Intermittent refrigeration breaks the cycle
of rapid bacterial growth and slows the formation of histamine. The safety
of these limits is again dependent upon proper handling at sea.
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 under these conditions.
Such recontamination may not be likely if the fish is processed under a
conscientious sanitation program (FDA, 1998h).
5. Acidified (pickled), fermented, salted, and smoked fish and fishery
products
Hazards from C. botulinum can be controlled by inhibiting growth
of the bacteria or by destroying it in seafood. Proper thermal processes
for canned seafood destroy the bacteria. Heavy salting or drying to reduce
the water activity below 0.93 and fermentation or acidification to below
pH 4.7 are effective means of preventing C. botulinum growth. Maintaining
proper storage temperatures alone is not considered an adequate control
measure for C. botulinum Type E because of its ability to grow at
low temperatures and because of the severity of the illness. Nonetheless,
in many products, it is an important second barrier to growth (Ward et
al., 1997).
6. Cooked fish and fishery products
Generally, after cooking, fishery products are referred to as cooked,
ready-to-eat. Examples of cooked, ready-to-eat products are: crabmeat,
lobster meat, crayfish meat, cooked shrimp, surimi-based analog products,
seafood salads, and hot-smoked fish.
Controlling pathogen survival through the cook step is accomplished
by:
-
Scientifically establishing a cooking process that will eliminate pathogens
or reduce their numbers to acceptable levels; and
-
Designing and operating the cooking equipment so that every unit of product
receives at least the established minimum process (FDA, 1998d).
A thorough hazard analysis is important when evaluating a thermal
process. In some cases, a cooking or heating step will not present a potential
health hazard even if it is sublethal to pathogens. Examples include a
blanching step to inactivate enzymes and a par-fry operation to set the
breading on products to be fully cooked by the consumer (Rippen, 1998).
Contents
FDA Guidelines
1. Raw fish and fishery products to be cooked before consumption
FDA is not aware of any HACCP controls that may exist internationally
for the control of pathogens in fish and fishery products that are intended
to be fully cooked by the consumer or end user before consumption, other
than a rigorous sanitation regime as part of either a prerequisite program
or as part of HACCP itself. The Seafood HACCP Regulation requires such
a regime. The proper application of sanitation controls is essential because
of the likelihood that any pathogens that may be present in seafood products
are introduced through poor handling practices (e.g., by the aquacultural
producer, the fisherman, or the processor) (FDA, 1998i).
Processing battered fish and fishery products:
Hydrated batter mix temperatures should not exceed 10ºC (50°F)
for more than 12 h, cumulatively; and
Hydrated batter mix temperatures should not exceed 21.1ºC (70°F)
for more than 3 h, cumulatively (FDA, 1998c).
2. Raw fish that is intended to be eaten raw
Receiving:
-
For refrigerated (not frozen) fish: all lots received are accompanied by
transportation records that show that the fish was maintained at or below
4.4ºC (40°F) throughout transit; or
-
For fish held under ice or chemical cooling media: there is an adequate
quantity of ice or other cooling media at the time of delivery (e.g., adequate
ice to completely surround the product); and
-
For refrigerated (not frozen) fish and fish held under ice or chemical
cooling media: internal temperature of fish at time of receipt not to exceed
4.4ºC (40°F) (FDA, 1998h).
Processing:
-
If the product is held at internal temperatures that may exceed 21.1ºC
(70°F) during processing, exposure time should ordinarily be limited
to 2 h (3 h if S. aureus is the only pathogen of concern);
-
If the product is held at internal temperatures that may exceed 10ºC
(50°F), but do not exceed 21.1ºC (70°F), exposure time should
ordinarily be limited to 6 h (12 h if S. aureus is the only
pathogen of concern) (FDA, 1998b).
Storage:
-
A maximum cooler temperature of 4.4ºC (40ºF); or
-
Sufficient ice to cover the containers at all times (FDA, 1998b).
3. Raw molluscan shellfish that may be eaten raw
Shellstock temperature control:
The NSSP approves the following options for shellfish temperature
control before delivery (ISSC, 1997):
Table 6-2. Option 1 for receiving live shellfish (Mandatory for confirmed
V.
vulnificus problem) (ISSC, 1997).
Water Temperature |
Time to
Refrigeration
|
November through March
|
Options 2 or 3
|
18.3-23.3ºC (65-74ºF)
|
14 h
|
23.9-28.9ºC (75-84ºF)
|
12 h
|
>28.9ºC (84ºF)
|
10 h
|
Table 6-3. Option 2 for receiving live shellfish (ISSC, 1997).
Months
|
Time to
Refrigeration
|
April through November |
20 h
|
December through March |
36 h
|
Table 6-4. Option 3 for receiving live shellfish (ISSC, 1997).
Average monthly
Maximum air
Temperature
|
Maximum h from harvest to
temperature control
|
>27ºC (81ºF)
|
20
|
19-27ºC (66-80ºF)
|
24
|
11-18ºC (51-65ºF)
|
36
|
<10ºC (50ºF)
|
48
|
Shellstock transportation:
Shellstock shall be transported in adequately
refrigerated trucks when the shellstock have been previously refrigerated
or when ambient air temperature and time of travel are such that unacceptable
bacterial growth or deterioration may occur.
Prechilling trucks or other vehicles shall
be required when ambient air temperatures are such that unacceptable bacterial
growth or deterioration may occur.
When mechanical refrigeration units are used,
the units shall be:
-
Equipped with automatic controls; and
-
Capable of maintaining the ambient air temperature
in the storage area at temperatures of 45ºF (7.2ºC) or less (ISSC,
1997).
Shellstock shipping time of 4 h or less:
When the shipping time is four h or less,
the dealer shall ship all shellfish:
-
Well iced; or
-
Using other acceptable means of refrigeration.
When mechanical refrigeration units are
used, the units shall be equipped with automatic controls and shall be
capable of maintaining the ambient air in the storage area at temperatures
of 45ºF (7.2ºC) or less.
The dealer shall not be required to provide
thermal recorders during shipment.
Lack of ice or other acceptable types of
refrigeration shall be considered an unsatisfactory shipping condition.
Shellstock shipping time of greater than 4 h:
When the shipping time is greater than four
h, the dealer shall ship all shellfish in:
-
Mechanically refrigerated conveyances which
are equipped with automatic controls and capable of maintaining the ambient
air in the storage area at temperatures of 45ºF (7.2ºC) or less;
or
-
Containers with an internal ambient air temperature
maintained at or below temperatures of 45ºF (7.2ºC) or less.
Unless the dealer has an approved HACCP
plan with an alternate means of monitoring time-temperature, the initial
dealer shall assure that a suitable time-temperature recording device accompanies
each shipment of shellfish.
The initial dealer shall note the date and
time on the temperature indicating device, if appropriate.
Each receiving dealer shall write the date
and time on the temperature indicating device, if appropriate, when the
shipment is received and the doors of the conveyance or the containers
are opened.
The final receiving dealer shall keep the
time-temperature recording chart or other record of time and temperature
in his files and shall make it available to the Authority upon request.
An inoperative temperature indicating device
shall be considered as no recording device (ISSC, 1997).
Receiving:
Shellfish shipments shall be considered acceptable
when:
-
Shipments are properly identified with tags
and shipping documents;
-
Shellstock is alive and cooled to an internal
shellstock body temperature of 50ºF (10ºC) or less;
-
Shucked shellfish is cooled to a temperature
of 45ºF (7.2ºC) or less; and
-
The time-temperature indicating device shows
that the ambient air temperature has exceeded 45ºF (7.2ºC) but
the shellstock internal body temperature is 50ºF (l0ºC) or less;
and
-
All other ISSC conditions of shipment are met
(ISSC, 1997).
Processing:
-
If the product is held at internal temperatures that may exceed 21.1ºC
(70°F) during processing, exposure time should ordinarily be limited
to 2 h (3 h if S. aureus is the only pathogen of concern);
-
If the product is held at internal temperatures that may exceed 10ºC
(50°F), but do not exceed 21.1ºC (70°F), exposure time should
ordinarily be limited to 6 h (12 h if S. aureus is the only
pathogen of concern) (FDA, 1998b).
Storage of shellstock:
A maximum internal body temperature of 50ºF
(10ºC) (ISSC, 1997).
Storage of shucked shellfish:
-
A maximum cooler temperature of 4.4ºC (40ºF); or
-
Sufficient ice to cover the containers at all times (FDA, 1998b).
4. Fish and fishery products sensitive to scombrotoxin (histamine) formation
Receiving by primary (first) processor:
Option 1
Harvest vessel records that accompany all lots received show:
-
For fish other than tuna above 20 pounds (9.1 kg), if the fish have not
been exposed to water temperatures above 28.3ºC (83°F), the fish
should be placed in seawater or brine at 10ºC (50°F) or less within
9 h of death, or placed in ice within 12 h of death; or
-
For tuna above 20 pounds (9.1 kg), or if the fish have been exposed to
water temperatures above 28.3ºC (83°F), the internal temperature
of the fish should be brought to 10ºC (50°F) or less within 6
h of death; and
-
For unfrozen fish: the fish were maintained at or below 4.4ºC (40°F)
thereafter; and
-
Sensory examination of a sample of the fish shows no more than 2.5% decomposition
(persistent and readily perceptible) in the sample. For example, no more
than 3 fish in a sample of 118 fish may show signs of decomposition; and
-
For unfrozen fish: there is an adequate quantity of ice, refrigerated seawater,
refrigerated brine, or other cooling media at the time of delivery (e.g.,
adequate ice to completely surround the product); and
-
For unfrozen fish: if the fish are delivered 12 or more h after death,
the internal temperature should be at or below 10ºC (50°F). However,
if the fish are delivered 24 or more h after death, the internal temperature
should be 4.4ºC (40°F) or below (FDA, 1998h).
Option 2
-
Analysis of a sample of fish shows less than 50 ppm histamine in all fish
in the sample; and
-
Sensory examination of a sample of fish shows no more than 2.5% decomposition
(persistent and readily perceptible) in the sample. For example, no more
than 3 fish in a sample of 118 fish may show signs of decomposition; and
-
For unfrozen fish: there is an adequate quantity of ice, refrigerated seawater,
refrigerated brine, or other cooling media at the time of delivery (e.g.,
adequate ice to completely surround the product); and
-
For unfrozen fish: if the fish are delivered 12 or more h after death,
the internal temperature should be at or below 10ºC (50°F). However,
if the fish are delivered 24 or more h after death, the internal temperature
should be 4.4ºC (40°F) or below (FDA, 1998h).
Receiving by (secondary processor including warehouse):
-
For refrigerated (not frozen) fish: all lots received are accompanied by
transportation records that show that the fish was maintained at or below
4.4ºC (40°F) throughout transit; or
-
For fish held under ice or chemical cooling media: there is an adequate
quantity of ice or other cooling media at the time of delivery (e.g., adequate
ice to completely surround the product); and
-
For refrigerated (not frozen) fish and fish held under ice or chemical
cooling media: internal temperature of fish at time of receipt not to exceed
4.4ºC (40°F) (FDA, 1998h).
Processing:
-
For fish that have not been previously frozen and for all fish (i.e., frozen
or unfrozen) that were subjected to a corrective action as a result of
a receiving critical limit deviation: The fish are exposed to temperatures
above 4.4ºC (40°F) for no more than 4 h, cumulatively, before
cooking (e.g., canned tuna "precook") or final freezing; or
-
For fish that have been previously frozen for 24 weeks or longer: The fish
are exposed to temperatures above 4.4ºC (40°F) for no more than
12 h, cumulatively, before cooking (e.g., canned tuna "precook") or
final freezing. An uninterrupted period of exposure should not exceed 6
h (FDA, 1998h).
Storage:
-
A maximum cooler temperature of 4.4ºC (40ºF); or
-
Sufficient ice to cover the containers at all times (FDA, 1998b).
5. Acidified (pickled), fermented, salted, and smoked fish and fishery
products
Note: Fish and fishery products with a pH of 4.6 or below,
a water phase salt level of at least 10%, or a water activity of 0.85 or
below do not require refrigeration (FDA, 1998a).
Receiving for storage or further processing:
The product must not be exposed during transportation to temperatures above
10ºC (50°F), which may be assured by:
A maximum refrigerated container temperature of 10ºC (50°F) throughout
transit; or
The presence of sufficient cooling media (e.g., adequate ice to completely
surround the product) upon receipt (FDA, 1998a).
Processing:
"Pickled," smoked, smoke-flavored, or salted fish and fishery products
must not be exposed to temperatures above 10ºC (50°F) for more
than 12 h nor to temperatures above 21.1ºC (70°F) for more
than 4 h, excluding time above 60ºC (140°F) (FDA, 1998a).
Storage:
The product must not be exposed to temperatures above 10ºC (50ºF),
which may be assured by:
A maximum cooler temperature of 10ºC (50°F); and/or
The presence of sufficient cooling media (e.g., adequate ice to completely
surround the product) (FDA, 1998b).
6. Cooked fish and fishery products
Receiving:
-
For refrigerated (not frozen) fish: all lots received are accompanied by
transportation records that show that the fish was maintained at or below
4.4ºC (40°F) throughout transit; or
-
For fish held under ice or chemical cooling media: there is an adequate
quantity of ice or other cooling media at the time of delivery (e.g., adequate
ice to completely surround the product); and
-
For refrigerated (not frozen) fish and fish held under ice or chemical
cooling media: internal temperature of fish at time of receipt not to exceed
4.4ºC (40°F) (FDA, 1998h).
Processing:
-
If the product is held at internal temperatures that may exceed 21.1ºC
(70°F) during processing, exposure time should ordinarily be limited
to 2 h (3 h if S. aureus is the only pathogen of concern);
-
If the product is held at internal temperatures that may exceed 10ºC
(50°F), but do not exceed 21.1ºC (70°F), exposure time should
ordinarily be limited to 6 h (12 h if S. aureus is the only
pathogen of concern) (FDA, 1998b).
Cooling cooked fish and fishery products:
-
Cooked products should generally be cooled from 60ºC (140°F) to
21.1ºC (70°F) or below within 2 h and to 4.4ºC (40°F)
or below within another 4 h (FDA, 1998d).
Storage:
-
A maximum cooler temperature of 4.4ºC (40ºF); or
-
Sufficient ice to cover the containers at all times (FDA, 1998b).
Contents
Critical Aspects of Processes
Critical aspects of processes may include:
1. Raw fish and fishery products to be cooked before consumption
-
Standard sanitation operation procedures.
2. Raw fish that is intended to be eaten raw
Receiving:
-
The internal temperature of the fishery product throughout transportation;
-
The temperature of the truck or other carrier throughout transportation;
-
The quantity of ice or chemical cooling media at time of delivery (FDA,
1998b).
Processing:
-
The length of time of exposure of the product to unrefrigerated conditions,
and either the internal temperature of the product or the ambient temperature;
-
The length of time of exposure of the product to unrefrigerated conditions
(where the critical limit assumes a temperature greater than 21.1ºC
(70°F) or where a study demonstrates that under ordinary conditions
product does not exceed 21.1ºC (70°F) when exposed for the length
of time specified by the critical limits and that time/temperature combination
is adequate to control the growth of the pathogens of concern);
-
The internal temperature of the product (where temperatures are held below
a temperature at which growth is minimized (e.g., 10ºC [50°F])
for Salmonella spp.) or held above 60ºC (140°F) during
processing);
-
The ambient air temperature (where ambient air temperature is low enough
to control microbial growth (e.g., 10ºC [50°F]) for Salmonella
spp.) (FDA, 1998b).
Storage:
-
The temperature of the storage cooler; or
-
The quantity of ice or chemical cooling media (FDA, 1998b).
3. Raw molluscan shellfish that may be eaten raw
Receiving:
-
Time harvesting began;
-
Time shellstock was placed under refrigeration.
Processing and Packaging:
-
The length of time of exposure of the product to unrefrigerated conditions,
and either the internal temperature of the product or the ambient temperature;
or
-
The length of time of exposure of the product to unrefrigerated conditions
(where the critical limit assumes a temperature greater than 21.1ºC
(70°F) or where a study demonstrates that under ordinary conditions
product does not exceed 21.1ºC (70°F) when exposed for the length
of time specified by the critical limits and that time/temperature combination
is adequate to control the growth of the pathogens of concern); or
-
The internal temperature of the product (where temperatures are held below
a temperature at which growth is minimized (e.g., 10ºC [50°F])
for Salmonella spp.) or held above 60ºC (140°F) during
processing); or
-
The ambient air temperature (where ambient air temperature is low enough
to control microbial growth (e.g., 10ºC [50°F]) for Salmonella
spp.) (FDA, 1998b).
Storage:
-
The temperature of the cooler; or
-
The quantity of ice or chemical cooling media (FDA, 1998b).
4. Fish and fishery products sensitive to scombrotoxin (histamine) formation
Receiving by primary (first) processor (option 1):
Harvest vessel records for the following information:
-
Method of capture; and
-
Time of landing; and
-
Estimated earliest time of death for fish landed at the same time (if other
than time of landing); and
-
Where applicable to the critical limit, method of cooling; and
-
Where applicable to the critical limit, time cooling began; and
-
Where applicable to the critical limit, cooling rate, as evidenced by:
-
Temperature after h of cooling (or time when 10ºC [50°F] is
reached) for a representative number of fish; or
-
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); and
-
The air and water temperature if the cooling rate CL is base on a maximum
exposure temperature of 28.3ºC (83ºF); and
-
For unfrozen fish: the storage temperature, as evidenced by:
-
The temperature of refrigerated seawater or brine; or
-
The presence of an adequate quantity of ice to surround the fish; and
-
Decomposition in the lot; and
-
For unfrozen fish: the adequacy of ice, refrigerated seawater, refrigerated
brine, or other cooling media at the time of delivery; and
-
For unfrozen fish: the internal temperature of a representative number
of fish at delivery.
Receiving by primary (first) processor (option 2):
-
Histamine content of fish flesh; and
-
Decomposition in the lot; and
-
For unfrozen fish: the adequacy of ice, refrigerated seawater, refrigerated
brine, or other cooling media at the time of delivery; and
-
For unfrozen fish: the internal temperature of a representative number
of fish at time of delivery.
Receiving by secondary processor (including warehouse):
-
For refrigerated (not frozen) fish: the internal temperature of the fish
throughout transportation; or
-
For refrigerated (not frozen) fish: the temperature of the truck or other
carrier throughout transportation; or
-
For fish held under ice or chemical cooling media: the adequacy of ice
or chemical cooling media at time of delivery; and
-
For refrigerated (not frozen) fish and fish held under ice or chemical
cooling media: the internal temperature of the fish at time of delivery.
Processing:
-
For raw material, in-process, or finished product refrigerated storage:
the temperature of the cooler; or
-
For raw material, in-process, or finished product storage under ice or
chemical cooling media: the quantity of ice or chemical cooling media;
and
-
For processing and packaging: the length of time of exposure of the fish
to unrefrigerated conditions; and
-
For fish frozen for 24 weeks or longer: the length of frozen storage.
Storage:
-
The temperature of the cooler; or
-
The quantity of ice or chemical cooling media (FDA, 1998b).
5. Acidified (pickled), fermented, salted, and smoked fish and fishery
products
Processing and Packaging:
-
The length of time of exposure of the product to unrefrigerated conditions,
and either the internal temperature of the product or the ambient temperature;
or
-
The length of time of exposure of the product to unrefrigerated conditions
(where the critical limit assumes a temperature greater than 21.1ºC
(70°F) or where a study demonstrates that under ordinary conditions
product does not exceed 21.1ºC (70°F) when exposed for the length
of time specified by the critical limits and that time/temperature combination
is adequate to control the growth of the pathogens of concern); or
-
The internal temperature of the product (where temperatures are held below
a temperature at which growth is minimized (e.g., 10ºC [50°F])
for Salmonella spp.) or held above 60ºC (140°F) during
processing); or
-
The ambient air temperature (where ambient air temperature is low enough
to control microbial growth (e.g., 10ºC [50°F]) for Salmonella
spp.) (FDA, 1998b).
Storage:
-
The temperature of the cooler; or
-
The quantity of ice or chemical cooling media (FDA, 1998b).
6. Cooked fish and fishery products
Receiving of products to be stored, or processed without further cooking:
-
The internal temperature of the fishery product throughout transportation;
or
-
The temperature of the truck or other carrier throughout transportation;
or
-
The quantity of ice or chemical cooling media at time of delivery (FDA,
1998b).
Cooling after Cooking:
-
The internal temperature of the product, and the length of time between
the end of the cook (or the time that the product internal temperature
fell below 60ºC [140°F]) and the time that measurement was made;
or
-
The critical aspects of the process that affect the rate of cooling, as
established by a cooling rate study (e.g., product internal temperature
at the start of cooling, cooler temperature, quantity of ice, volume or
size of product being cooled) (FDA, 1998b).
Processing and Packaging:
-
The length of time of exposure of the product to unrefrigerated conditions,
and either the internal temperature of the product or the ambient temperature;
or
-
The length of time of exposure of the product to unrefrigerated conditions
(where the critical limit assumes a temperature greater than 21.1ºC
(70°F) or where a study demonstrates that under ordinary conditions
product does not exceed 21.1ºC (70°F) when exposed for the length
of time specified by the critical limits and that time/temperature combination
is adequate to control the growth of the pathogens of concern); or
-
The internal temperature of the product (where temperatures are held below
a temperature at which growth is minimized (e.g., 10ºC [50°F])
for Salmonella spp.) or held above 60ºC (140°F) during
processing); or
-
The ambient air temperature (where ambient air temperature is low enough
to control microbial growth (e.g., 10ºC [50°F]) for Salmonella
spp.) (FDA, 1998b).
Storage:
-
The temperature of the cooler; or
-
The quantity of ice or chemical cooling media (FDA, 1998b).
Contents
Labeling Guidelines
Group A foods
Group A foods are potentially hazardous foods, which, if subjected to temperature
abuse, will support the growth of infectious or toxigenic microorganisms
that may be present. Outgrowth of these microorganisms would render the
food unsafe. Foods that must be refrigerated for food safety possess the
following characteristics: (1) Product pH > 4.6; (2) water activity aw
> 0.85; (3) do not receive a thermal process or other treatment in the
final package that is adequate to destroy food-borne pathogens that can
grow under conditions of temperature abuse during storage and distribution;
and (4) have no barriers (e.g., preservatives such as benzoates, salt,
acidification), built into the product formulation that prevent the growth
of food-borne pathogens that can grow under conditions of temperature abuse
during storage and distribution.
The appropriate label statement for Group A foods is:
IMPORTANT
Must Be Kept Refrigerated To Maintain Safety
Group B foods
Group B includes those foods that are shelf-stable as a result of processing,
but once opened, the unused portion is potentially hazardous unless refrigerated.
These foods possess the following characteristics: (1) Product pH > 4.6;
(2) water activity aw > 0.85; (3) receive a thermal process
or other treatment that is adequate to destroy or inactivate food-borne
pathogens in the unopened package, but after opening, surviving or contaminating
microorganisms can grow and render the product unsafe; and (4) have no
barriers (for example, preservatives such as benzoates, salt, acidification)
built into the product formulation to prevent the growth of food-borne
pathogens after opening and subsequent storage under temperature abuse
conditions.
The appropriate label statement for Group B foods is:
IMPORTANT
Must Be Refrigerated After Opening
To Maintain Safety
Group C foods
Group C are those foods that do not pose a safety hazard even after opening
if temperature abused, but that may experience a more rapid deterioration
in quality over time if not refrigerated. The manufacturer determines whether
to include on the label a statement that refrigeration is needed to maintain
the quality characteristics of the product to maximize acceptance by the
consumer. These foods do not pose a safety problem. Foods in this group
possess one or more of the following characteristics to ensure that the
food does not present a hazard if temperature abused: (1) Product pH £
4.6 to inhibit the outgrowth and toxin production of C. botulinum; or (2)
water activity aw £ 0.85; or
(3) have barriers built into the formulation (for example, preservative
systems such as benzoates, salt, acidification) to prevent the growth of
food-borne pathogens if the product is temperature abused.
The suggested optional label statement for Group C foods is:
Refrigerate for Quality
or some other statement that explains to the consumer that the storage
conditions are recommended to protect the quality of the product. To avoid
confusion between refrigeration for safety purposes and refrigeration for
quality reasons, Group A and Group B statements should not be used on Group
C foods (FDA, 1997d).
Contents
Temperature Measurement
Contents
Thermometers
Liquid-in-glass thermometer
The liquid-in-glass is made of a glass tube with a bulb on one end. On
the tube are Fahrenheit or Celsius measurement marks. The glass bulb is
filled with either mercury or spirits (alcohol, kerosene, xylene and pentane,
etc.). When the temperature around it changes, the liquid in the bulb and
tube either expands or contracts. If it is hotter, it will expand. This
causes the liquid to rise in the tube. If it is cooler, it will contract.
This causes the liquid to fall back down the glass tube. On both the Fahrenheit
and Celsius scales, hotter is higher and cooler is lower (Anonymous, 1999).
Some liquid-in glass thermometers are NIST certified thermometers or
thermometers calibrated to NIST-traceable standards.
Electrical resistance thermometer
This thermometer does not actually measure temperature, but resistance
in a platinum or nickel wire, whose resistance changes as temperature changes.
An electrical meter measures the changes in resistance which is related
to temperature using a technique called calibration. In order to use calibration,
you must determine in advance exactly how the resistance of various metals
vary with changes in temperature (Ruscher and Lusher, 1999).
Thermistor thermometer
Thermistors are electrical resistance thermometers which use ceramic materials
whose resistance increases as temperature increases (Ruscher and Lusher,
1999).
Thermocouple thermometer
The thermocouple works on the principle that a metal will react to temperature
changes by affecting the amount of electrical current which flows through
it. If two different metals are connected, then their response to temperature
changes will be different. By measuring the change in an electrical current
which passes across these two metals, the actual temperature can be determined
using calibration (Ruscher and Lusher, 1999).
Radiometer thermometer
This type of thermometer actually measures the amount of emitted radiation
(usually infrared) and the wavelength of maximum emission of a particular
substance. With calibration techniques, the amount of radiation and the
wavelength of maximum emission are directly related to the temperature
of that substance (Ruscher and Lusher, 1999).
Bimetallic thermometer
This type of thermometer consists of two different metals (usually iron
and brass) which are welded together to form a single strip. As the temperature
changes, one metal will expand more than the other, causing the strip to
bend. This bending is amplified by a series of levers which is attached
to a pointer on a scale. Your household thermostat is an example of a bimetallic
thermometer. A thermograph is another type of bimetallic thermometer. The
metal strip is connected to a pen which traces the temperature on a piece
of paper attached to a drum which rotates with time. Bimetallic thermometers
are not nearly as accurate as the thermometers discussed above (Ruscher
and Lusher, 1999).
Contents
Temperature recorders
Graphic recorders
Graphic recorders use electric temperature measurement systems and record
the time and temperature data on strip charts or circular charts. These
charts are a permanent record of times and temperatures. Graphic recorders
are available as stationary equipment or as portable, battery powered devices.
Data loggers
Data loggers use electric temperature measurement systems and periodically
report the information to a computer and memory "chip" inside the logger.
The data logger can be permanently connected to a computer, or connected
at the end of the recording episode. Time and temperature data are displayed
graphically or as a list of readings on the computer monitor. The data
can be copied onto the computer’s hard or floppy disk for a permanent record.
Data loggers are available as stationary equipment or as portable, battery
powered devices. Data loggers can record data from one or a group of temperature
measuring devices simultaneously.
Data logger systems are available with computer-generated call up services,
either via e-mail, FAX, computer-generated voice messages or digital pager
messages. When the data input shows a discrepancy from a normal or expected
condition, the computer generates the telephone-based message to key personnel.
The message type (FAX, voice, e-mail or pager) and destination telephone
number are pre-determined by the user depending upon the location and type
of discrepancy (Cox, 1999).
Contents
Suppliers of temperature measuring/recording equipment:
Cole-Parmer Instrument Company
625 East Bunker Court
Vernon Hills, IL 60061-1844
Phone: 888-409-3663
Fax: 847-247-2929
Web: http://www.coleparmer.com/catalog/default.asp
Cox Technologies
69 McAdenville Road
Belmont, NC 28012
Phone: 704-825-8146
Fax: 704-825-5128
Web: http://www.cx-en.com/cox.htm
Fisher Scientific
Pittsburgh, PA
Phone: 800-766-7000
Fax: 800-926-1166
Web: http://www.fishersci.com
The Foxboro Company
Phone: 888-369-2676
Web: http://www.foxboro.com/index1.htm
Hantover
700 Karnes Blvd.
Kansas City, MO 64108
Phone: 800-821-2227
Fax: 816-931-3272
Web: http://www.hantover.com/home.html
Taylor Precision Products, L.P.
2311 West 22nd Street
Oak Brook, IL 60523
Phone: 630-954-1250
Fax: 630-954-1275
Web: http://www.taylor-enviro.com/
Weber Scientific
2732 Kuser Road
Hamilton, NJ 08691
Phone:800-328-8378
Fax: 609-584-8388
Web: http://www.weberscientific.com
Contents
Thermometer calibration
See Chapter 2.
Contents
Temperature Measurement Monitoring Tags
Table 6-4. Temperature measurement monitoring tags
Test Kit
|
Analytical Technique
|
Supplier
|
3M MonitorMarkTM
Threshold Indicators
[Used to determine maximum temperature exposure for frozen
and refrigerated products] |
Blue-dyed chemicals with specific
melting points |
3M Microbiology Products
3M Center, Building 275-5W-05
St. Paul, MN 55144-1000
Phone: 800/228-3957
E-mail: microbiology@mmm.com |
ColdSNAP+ dual-temperature recorder |
Bimetallic sensing element that
snaps at pre-determined temperatures |
Telatemp Corp.
Fullerton, CA
Phone: 800-321-5160
Web: http://www.telatemp.com |
VITSAB® TTI
[Temperature monitoring carton and pallet tag.] |
Enzymatic color indictors to show
the amount of temperature exposure of a stored or shipped temperature-sensitive
commodity. |
Cox Technologies, Inc.
Attn: James Cox
69 McArdenville Rd.
Belmont, NC 28012
Phone: 704/825-8146
Web: www.cx-en.com/default.htm |
Contents
References
Anonymous. "Thermometers" EarthLab Digital Library, Ross Computational Resources, http://earthlab.meteor.wisc.edu/~grb/leveltxt/advanced/wxinst/thermom.htm (26 May 1999).
Cox. 1999. "What is RealTimeAlert™?" Cox Technologies, Belmont, NC. http://cx-en.com/RealTimeAlert.htm (27 May, 1999).
FDA. 1997. Guidance on labeling of foods that need refrigeration by consumers. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Seafood, Washington, DC. Federal Register: February 24, 1997. 62(36):8248-8252.
FDA. 1998a. Clostridium botulinum toxin formation. Ch. 13. In Fish and Fishery Products Hazards and Controls Guide, 2nd ed., p. 151-174. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Seafood, Washington, DC.
FDA. 1998b. Pathogen growth & toxin formation (other than Clostridium botulinum) as a result of time/temperature abuse. Ch. 12. In Fish and Fishery Products Hazards and Controls Guide, 2nd ed., p. 133-150. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Seafood, Washington, DC.
FDA. 1998c. Staphylococcus aureus toxin formation in hydrated batter mixes. Ch. 15. In Fish and Fishery Products Hazards and Controls Guide, 2nd ed., p. 183-188. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Seafood, Washington, DC.
FDA. 1998d. Pathogen survival through cooking. Ch. 16. In Fish and Fishery Products Hazards and Controls Guide, 2nd ed., p. 189-196. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Seafood, Washington, DC.
FDA. 1998e. Scombrotoxin (histamine) formation. Ch. 7. In Fish and Fishery Products Hazards and Controls Guide, 2nd ed., p. 73-90. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Seafood, Washington, DC.
FDA. 1998f. Pathogens from the harvest area. Ch. 4. In Fish and Fishery Products Hazards and Controls Guide, 2nd ed., p. 47-58. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Seafood, Washington, DC.
FDA. 1998g. Potential species-related and process-related hazards. Ch. 3. In Fish and Fishery Products Hazards and Controls Guide, 2nd ed., p. 11-46. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Seafood, Washington, DC.
ISSC. 1997. Guide for the control of molluscan shellfish, 1997 Revision. Interstate Shellfish Sanitation Conference, U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Washington, DC.
Rippen, T.E. 1998. Personal communication. University of Maryland, Princess Anne, MD.
Ruscher, P. and Lusher, R. 1999. "Thermometers" http://www.met.fsu.edu/explores/thermometera.html (26 May 1999).
Ward, D., Bernard, D., Collette, R., Kraemer, D., Hart, K., Price, R., and Otwell, S. (Eds.) 1997. Hazards found in seafoods, Appendix III. In HACCP: Hazard Analysis and Critical Control Point Training Curriculum, 2nd ed. p. 173-188. UNC-SG-96-02. North Carolina Sea Grant, Raleigh, NC.