cess parameters described in the literature apply to your specific product.
Document your findings in the food
safety plan. If risks do exist, construct
a strategy for mitigation and management. An example can be found in
Table 2. Develop procedures and training for personnel.
The following are example strategies for managing the potential risk of
pathogenic microorganism growth and
subsequent toxin production. Strategies
may vary with the type of matrix, sanitary design of the equipment, manufacturing practices, sanitation frequency,
or other factors. Work with an expert
microbiologist to formulate an effective
control strategy tailored to your manufacturing facility. Examples include:
1. Control of residence time
Establish allowable maximum resi-
dence time based on the highest occur-
ring temperature in the matrix. If the
temperature of the material at its warm-
est area in the system can be maintained
at 50 °F or lower, then residence time
will most likely depend on other factors
such as quality. Do not allow the high-
moisture matrix to remain at a tempera-
ture longer than results from modeling
or a challenge study dictate. Remove
material from production before that
occurs. If the process for the matrix is
continuous, then the maximum length
of time between full sanitation cycles
will be determined by the results of
modeling or the challenge study unless
interdictive cleaning is implemented.
2. Sanitation and interdictive cleaning
Interdictive cleaning is a step that
may be taken between full sanitation
cycles. It refers to simple scraping to
remove product from the specific locations identified as hang-up points
in the initial risk assessment. A food
manufacturer needs to tailor sanitation
practices to the holding time allowed
for high-moisture WIP based on the
warmest temperature of the material.
So that growth cannot reach the food
safety limit for toxin production (e.g.,
of slurry in
the tank or
> 96 °F
Rinse-down (or other
measures) of the
hang-up points must
be performed within:
< 2 hours
Table 1. Maximum Allowable Residence
Time for Slurry Based on Temperature
Note: The above example is provided for
illustration purposes only. These temperatures and times may vary based on the intrinsic and extrinsic properties of the evaluated matrix and manufacturing conditions.
Manufacturing facilities must perform a
Hazard Analysis specific to their matrix and
identify appropriate preventive controls.
Slurry Temperature Control
Growth of B. cereus to levels where enterotoxin may be produced. (Water activity of slurry is > 0.95 and pH is 6.0.)
Parameters for control:
During normal manufacturing, slurry temperature is maintained below 65 °F and a maximum time of less than 17 hours
between interdictive cleanings is allowed. When downtime occurs, temperatures are monitored every 30 minutes and compared with Table 1 to determine allowable hold time until such time that slurry must be destroyed and interdictive cleaning
What: Holding tank temperatures
How: Programmable logic controller probes
Who: SPC system
Corrective actions in the event of monitoring failure: All product produced back to the start of the deviation shall be restricted and placed on HOLD for a food safety evaluation OR product is destroyed OR product is diverted to nonfood use.
Appropriate Sanitation Standard Operating Procedures shall be implemented.
Record keeping: Printouts, charts, or readings from continuous temperature-recording devices AND record of visual checks
of recorded data are maintained per the company policy.
Verification: Temperatures are collected from temperature-reading/recording devices and compared/calibrated daily to a
National Institute of Standards-certified thermometer using accepted procedures. All records are reviewed within 1 week to
ensure completeness and to ensure that any critical-limit deviations were appropriately addressed.
Validation/reference: Based on Pathogen Modeling Program modeling.
Table 2. Slurry Management Strategy for the Control of B. cereus
Note: The above example is provided for illustration purposes only. Manufacturing facilities must perform a Hazard Analysis specific to their
matrix and identify appropriate preventive controls. Qualified individuals assigned to preventive controls monitoring, corrective actions, verification, and record-keeping activities must receive appropriate training for the tasks.