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This guidance represents the Food and Drug Administrations (FDAs) 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.
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Goal of pasteurization
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EXAMPLES OF PROPERLY
PASTEURIZED PRODUCTS
PRODUCT
MINIMUM CUMULATIVE
TOTAL LETHALITY
Z VALUE
Fish and
fishery
products
generally
(e.g., surimi
based
products,
soups, or
sauces)
Blue
crabmeat
16F (9C)
Dungeness
crabmeat
15.5F (8.6C)
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Intended use
Because cooked or pasteurized products are
ready to eat, it is unlikely that the intended use
will affect the significance of the hazard.
Example:
A crabmeat processor cooks, picks,
packs, and pasteurizes the crabmeat.
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OR
CONTROL STRATEGY
MAY APPLY TO
PRIMARY
PROCESSOR
MAY APPLY TO
SECONDARY
PROCESSOR
OR
The EPIPT.
PASTEURIZATION
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OR
Visual observation;
AND
OR
Each batch.
AND
For cooking or pasteurization time, use:
Each batch;
AND
AND
OR
AND
OR
AND
AND
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AND
OR
For the EPIPT:
OR
Extend the length of the cooking or
pasteurization cycle to compensate for a
temperature drop, using a process developed
by a process authority;
OR
Process at a higher temperature to
compensate for a low initial temperature,
using a process developed by a process
authority;
AND
OR
AND
OR
OR
Cooking log that indicates visual observation
of boiling, where cooking is performed at
the boiling point;
AND
OR
AND
Records that are appropriate for the
other critical factors (e.g., a cooking or
pasteurization log that indicates the initial
temperature);
OR
Destroy the product;
OR
OR
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OR
For pasteurization, process validation study
(process establishment):
The adequacy of the pasteurization process
should be established by a scientific study. It
should be designed to ensure an appropriate
reduction in the number of target bacterial
pathogens. Selecting the target organism
is critical. In most cases, it will be the
spores of C. botulinum type E and non
proteolytic types B and F. In some cases
(e.g., products that are distributed frozen
or contain other barriers to prevent growth
and toxin formation by C. botulinum type
E and non-proteolytic types B and F), the
process will target another pathogen, such
as L. monocytogenes. Generally, a 6D process
is suitable, regardless of the target pathogen.
However, lower degrees of destruction may
be acceptable if supported by a scientific
study of the normal levels in the food. Tables
A-3 and A-4 provide 6D process times for
a range of internal product temperatures,
with L. monocytogenes and C. botulinum
type B (the most heat-resistant form of
non-proteolytic C. botulinum) as the target
pathogens. The values provided in Table A-4
may not be sufficient for the destruction of C.
botulinum type E and non-proteolytic types
B and F in products containing dungeness
crabmeat because of the potential protective
effect of naturally occurring substances, such
as lysozyme.
AND
Before a temperature-indicating device (e.g.,
a thermometer) or 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:
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OR
AND
Calibrate other instruments as necessary to
ensure their accuracy;
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.
AND
Once in service, check the temperatureindicating device or temperature-recording
device daily before the beginning of
operations. Less frequent accuracy checks
may be appropriate if they are recommended
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, where applicable, has
sufficient ink and paper;
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
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Shrimp size
Maximum
shrimp size: 40
count/pound
Scale
Temperature
of steam in
the cooker
Minimum cook
temperature:
210F
Note: To
achieve a 6D
reduction of L.
monocytogenes
(6)
Grader operator
Cooker
operator
Continuous,
with visual
check of
recorded data
once per day
Hourly and
after every
raw material
lot change
or grader
adjustment
Cooker
operator
WHO
(7)
FREQUENCY
MONITORING
Belt speed
measurement
with stopwatch
HOW
(5)
Length of the
cook cycle
WHAT
(4)
Minimum
cook time: 2.5
minutes
CRITICAL LIMITS
FOR EACH
PREVENTIVE
MEASURE*
(3)
*Note: The critical limits in this example are for illustrative purposes only and are not related to any recommended process.
Pathogenic
bacteria
survival
SIGNIFICANT
HAZARD(S)
CRITICAL
CONTROL
POINT
Cooking
(2)
(1)
Example Only
See Text for Full Recommendations
Extend process
or elevate
temperature
to compensate
for deviation
from critical
limit, based
on alternate
processes
provided by
the process
authority
CORRECTIVE
ACTION(S)
(8)
Grading
record
Data logger
printout
Cooking
record
RECORDS
(9)
Review
monitoring,
corrective action and
verification, records within
1 week of
preparation
Check the
data logger for
accuracy and
damage and to ensure that
it is operational
before putting
into operation; check it
daily, at the beginning of
operations; and calibrate it
once per year
VERIFICATION
(10)
Pathogenic bacteria survival through cooking and pasteurization may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3)
for other potential hazards (e.g., environmental chemical contaminants and pesticides, pathogenic bacteria growth and toxin formation during processing, food and color
additives, and metal fragments).
This table is an example of a portion of a HACCP plan using Control Strategy Example - Cooking and Pasteurization (Cooking Model). This example illustrates how a
processor of wild-caught cooked shrimp can control cooking using a continuous steam cooker. It is provided for illustrative purposes only.
TABLE 16-1
328
Initial
temperature
Time up to
189F and
time cycle
ends
Temperature
of water bath
Minimum
length of
pasteurization
cycle:
120 minutes
Minimum
water bath
temperature:
189F
WHAT
(4)
Minimum
initial
product
temperature:
37F
CRITICAL LIMITS
FOR EACH
PREVENTIVE
MEASURE*
(3)
Temperaturerecording
device
Temperaturerecording
device
Dial
thermometer
(6)
Continuously,
with visual
check at end
of batch
Each batch
Coldest
can entering
each batch
FREQUENCY
MONITORING
HOW
(5)
Recorder
thermometer,
with visual
check by
pasteurizer
operator
Pasteurizer
operator
Pasteurizer
operator
WHO
(7)
*Note: The critical limits in this example are for illustrative purposes only and are not related to any recommended process.
Pathogenic
bacteria
survival
SIGNIFICANT
HAZARD(S)
CRITICAL
CONTROL
POINT
Batch
pasteurization
(2)
(1)
Example Only
See Text for Full Recommendations
Segregate
and hold for
evaluation
Extend the
process or
elevate the
temperature
to compensate
for
deviation
from the
critical
limit
CORRECTIVE
ACTION(S)
(8)
Recorder
thermometer
chart
Pasteurization
log
Pasteurization
log
RECORDS
(9)
Review
monitoring,
verification, and
corrective action records
within 1 week of
preparation
Check the
temperaturerecording device and
dial thermometer for
accuracy and damage
and to ensure that they
are operational before
putting into operation;
check it daily, at the
beginning of operations;
and calibrate it once per
year
Process
establishment
VERIFICATION
(10)
Pathogenic bacteria survival through cooking and pasteurization may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for
other potential hazards (e.g., environmental chemical contaminants and pesticides, pathogenic bacteria growth and toxin formation during processing, recontamination after
pasteurization, and metal fragments).
This table is an example of a portion of a HACCP plan using Control Strategy Example - Cooking and Pasteurization (Pasteurization Model). This example illustrates how
a processor of pasteurized, refrigerated blue crabmeat can control pasteurization. It is provided for illustrative purposes only.
TABLE 16-2
BIBLIOGRAPHY.
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