Heat Process Validation

Though consumers may not know the term “heat processed seafood” they know what it means --
cooked, ready to eat right out of the package - and they expect it to be safe. Heat process validation
tests the effectiveness of a firm’s heat process to ensure the safety of their seafood products. There are
several kinds of heat processes including blanching, cooking, pasteurization, retorting, even hot holding
and all of these processes can destroy or control microbial growth. In this video, we’ll focus on the
pasteurization, cooking and smoking processes.

Heat process validation is complex, so it may be best to hire a professional who’s familiar with the
product and process to be validated. If that’s not an option, there are some basic steps that processors
should know and do, and we will discuss these steps in this video.

A successful heat process validation consists of four steps; determining the target pathogen; pathogen
reduction; verifying pathogen reduction; and identifying the controls and critical limits to include in the
HACCP plan to ensure a consistently safe product. We’ll go through each of these and show how they
interrelate to provide an effective heat process validation.

Let’s look at the first step, determining the target pathogen.

A target pathogen in any heat process is the most heat resistant pathogen of public health significance
that is reasonably likely to occur in the product. The goal of the heat process is to eliminate the target
pathogen or reduce it to a low enough level that it’s unable to cause illness under normal storage and
handling. The pathogen may occur naturally in the raw seafood or may be introduced during processing
and handling of the product. The most common target pathogens associated with ready to eat seafood
are Clostridium botulinum and Listeria monocytogenes, but these aren’t necessarily the only target
pathogens. FDA’s Fish and Fishery Products Hazards and Controls Guidance, or the Hazards Guide, has
tables in the appendices for several common target pathogens associated with seafood products.

To identify the target pathogen, you need a complete description of the finished product, including final
packaging, storage and distribution. If the process changes the pH, the water activity, the water phase
salt or any combination of these in the final product, then these changes may provide additional barriers
that will affect the target pathogen chosen. Table A-1 in Appendix 4 of the Hazards Guide lists these
possible barriers and we will discuss them more later.

The product’s packaging and distribution also have a significant impact the target pathogen chosen. The
2 basic types of packaging used for ready to eat foods are oxygen permeable packaging and reduced
oxygen packaging. Nearly all packaging has some degree of oxygen transmission, but packaging that
provides an oxygen transmission rate of 10,000 cubic centimeters per meter squared per 24 hours at 75
degrees Fahrenheit or 24 degrees Celsius can be regarded as oxygen permeable. Any packaging with a
transmission rate less than this is considered reduced oxygen packaging.

Reduced oxygen packaging includes vacuum packaging, modified atmosphere packaging, and controlled
atmosphere packaging. It’s important to note that a reduced oxygen environment can form within
oxygen permeable packaging under certain circumstances, such as within deep containers, in products
packaged in oil, or products that are compacted in the container preventing the flow of oxygen
throughout the entire container.

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Product distribution and storage will usually fall into one of three categories, refrigerated storage,
frozen storage or shelf-stable.

As we mentioned previously, the two most common target pathogens for cooked, ready to eat products
are Clostridium botulinum and Listeria monocytogenes.

C. bot. strains fall into two categories – non-proteolytic and proteolytic, both of which form protective
spores that allow the pathogen to survive extremes like cooking. C. bot. is an anaerobe – meaning it
grows best and produces toxin in the absence of oxygen.

Listeria doesn’t produce spores, so it’s more susceptible to destruction by cooking; however, Listeria is a
facultative anaerobe – meaning that it’s able to grow with or without oxygen.

These pathogens grow under different conditions created by the products’ final packaging. That’s why
without other barriers, the type of packaging helps dictate the pathogen the heat process should target.

Non-proteolytic C. bot. is typically the target pathogen for products in reduced oxygen packaging stored
under refrigeration because it’s the most heat stable pathogen of public health concern likely to be
present, grow and produce toxin under refrigerated conditions. In contrast, proteolytic C. bot. is unable
to grow and produce toxin at most refrigerated temperatures, so the heat process targeting proteolytic
C. bot. doesn’t need to be lethal so long as the product is stored at proper refrigeration temperatures.

Listeria is usually the target pathogen chosen for refrigerated products in oxygen permeable packaging.
While Listeria can grow in reduced oxygen packaging, it’s only chosen as a target pathogen here when
other barriers are present that prevent growth and toxin production by C. bot., like salt or low pH.
Otherwise, any heat process that targets C. bot. is also sufficient to control Listeria.

Let’s apply this general information to some specific examples to illustrate how you would select the
target pathogen.

Our first example is refrigerated, pasteurized crabmeat, which is cooked, picked, packaged then
pasteurized. For seafood, pasteurization is a heat process applied to the product after it’s in the final
container. For example, the crabmeat is packaged in hermetically sealed containers closed under
vacuum, creating a reduced oxygen environment, then pasteurized and stored at refrigeration
temperatures. Both C. bot. and Listeria can be present and grow in crabmeat, so the product itself will
determine the appropriate target pathogen for pasteurization. Since we haven’t processed the
crabmeat in any manner that would lower the pH, reduce the water activity, or alter the water phase
salt, there are no alternate barriers to prevent the growth of C. bot.. As we pointed out earlier, C. bot. is
inactivated at higher temperatures than Listeria, so our pasteurization process to control C. bot. will also
control Listeria, but not vice-versa. We identify C. bot. as our target pathogen, but there are different
forms of C. bot.. Both proteolytic and non-proteolytic types are likely to be present in the crabmeat.
Because temperatures below 50 degrees Fahrenheit will control the growth of proteolytic types, the
heat process does not target them here. Non-proteolytic types, though, are not controlled through
refrigeration and must be subjected to a heat process. That means the target pathogen in the heat
processing of pasteurized crabmeat is non-proteolytic Clostridium botulinum.

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Our next example is whole, cooked Dungeness crabs that are boiled and then placed on ice. Cooking is a
heat treatment, usually performed before placing the product in the finished product container, and is
applied to fishery products that are distributed either refrigerated or frozen.

Like the pasteurized crabmeat scenario, both C. bot. and Listeria are likely to be present in the raw
crabmeat, but here the packaging is oxygen permeable so we target Listeria rather than C. bot.. It’s
important to note that strict sanitation measures are needed to prevent Listeria from recontaminating
the product after the cook.

Our final example is refrigerated, hot smoked salmon that’s vacuum packaged. Hot smoking is a process
that uses a combination of smoke and heat for drying along with the addition of salt and sometimes
nitrites to control pathogen growth. The vacuum package creates a reduced oxygen environment
where C. bot. and Listeria, which are both likely to be present, are able to grow. The finished product is
stored under refrigeration, which controls proteolytic types of C. bot.. That leaves us with non-
proteolytic types of C. bot. and Listeria as potential target pathogens.

Unlike our prior examples, how the hot smoked salmon is prepared dictates the target pathogen. For
this example, we use a salt brine soak prior to the actual smoking process. A combination of salt,
smoke, and drying brings the salmon’s water phase salt to 3.5% or greater, as recommended in the
Hazards Guide. These barriers along with the heat applied during smoking will control the non-
proteolytic types of C. bot. and will eliminate the Listeria. Again, strict sanitation measures are needed
to prevent Listeria from recontaminating the product after the cook.

The second step in developing a successful heat process is determining the process time and
temperature to achieve pathogen reduction.

The heat process should typically be designed to achieve a reduction of six orders of magnitude – called
a 6D reduction. The D-value is the time needed to kill 90% of the target organism at a specific
temperature. A 90% reduction means reducing 1 million organisms to one-hundred thousand, which is a
1- log reduction in numbers. A 6D reduction, which is 6 times the D value, is suitable in most cases, and
means that you’re achieving a six logarithmic reduction in the target pathogen. A 6-log reduction
would provide a 99.9999 percent reduction in the number of the target pathogen in the product.

Tables A-3 and A-4 in Appendix 4 of the Hazards Guide provide 6D process time and temperature
combinations for Listeria and non-proteolytic C. bot. that have been determined to be effective in most
cases. However, processors are still responsible to verify their effectiveness. An alternative cook can be
used if a heat resistance study is conducted to determine the D value needed for the specific product or
if the scientific literature supports using a different D value. We’ll discuss this further a little later.

The normal, active growing state for microorganisms is the vegetative state. Under stressful conditions,
some microorganisms form spores. A spore is a thick-walled dormant cell that’s highly resistant to
extreme conditions. Generally, spores are more heat tolerant than vegetative cells, and several
different pathogens are able to form spores to protect them until suitable growing conditions return.
The pathogenic bacteria capable of forming spores, like C. bot., are the greatest concern because the
spores may be capable of surviving processes such as pasteurization and cooking. In addition, different
spores have different levels of heat resistance, so some pathogen spores are more difficult to kill than
others.

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There’s a vast difference in the heat tolerance of vegetative cells, too. For example, Listeria and Vibrio
vulnificus are both vegetative cells, but Listeria is quite heat tolerant and more difficult to kill compared
to Vibrio. Neither of these compare to the heat tolerance of proteolytic C. bot. or Bacillus cereus in their
spore form, whose spores will survive most heat processes other than retorting.

Some of a food’s characteristics make it easier or harder to destroy the pathogens in it. Sugars and oils
in food tend to shield pathogens from the effects of heat, while pathogens are killed more easily in
foods with an acidic pH or with high moisture contents.

While there’s scientific data available for many pathogens, when developing new or unusual products,
processors need to collect their own data to establish a heat process for the target pathogen in their
particular product. Product-specific heat resistance data that’s developed may be used to determine the
appropriate time and temperature necessary to achieve a 6D process for control of Listeria or C. bot. in
the product, in lieu of using one of the more conservative time-temperature processes recommended in
the Hazards Guide.

Just because a processor has successfully used a process for years without any associated consumer
illness doesn’t mean that the process is safe. Processors are responsible for validating that their heat
process consistently renders a safe product for consumers.

This leads us to the third step -- verifying that the process delivers enough heat to reach an acceptable
level of pathogen reduction.

The effectiveness of the heat process is dependent on 3 factors -- first, how heat is distributed to the
product within the heating vessel; second, the rate that heat penetrates into the product; and finally,
how the target pathogen responds to the heat. These three factors are interdependent when it comes
to achieving an acceptable level of pathogen reduction. Earlier in this video, we talked about the
interaction between the target pathogen and the food, so now we’ll look at the role of heat in the
process.

Let’s begin with the first factor -- how heat is distributed to the product within the heating vessel.
This is accomplished through a temperature distribution study. This study evaluates how evenly heat is
distributed throughout the heating equipment.

Temperature distribution is influenced by the type of heat processing system, the heating medium such
as hot water or steam, the design of the equipment, the amount and distribution of the product to be
heated, and the position of the product containers within the heating equipment. For example, is there
a cold spot in a certain location?. A temperature distribution study will help ensure that every unit of
product in the heating equipment is exposed to the heating media at the desired temperature.
Temperature measuring devices placed throughout the heating equipment will identify any
inconsistencies in the temperature distribution within the heating equipment.

The second factor -- verifying an acceptable level of pathogen reduction, is the rate that heat penetrates
into the product.

After establishing the time and temperature combination needed to achieve a 6D reduction, the next
step is to determine how long it takes the coldest point in the food to reach the target temperature.
This is determined by performing a heat penetration study.

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Many factors affect heat penetration, including the size and initial temperature of the raw food, the
type of heating medium, and the proportion of liquid to solid. The 6D time and temperature
combination is applied to the food’s cold spot under the worst possible conditions that could occur
during regular processing.

Heat penetration into the food can be measured using thermocouples or other measuring devices
placed within the product prior to starting the heat process. These devices measure how long it takes
for product in the cold spot of the heating vessel to reach the appropriate temperature.

Let’s review some of the basics of “heating”. There are two principal ways that heat is transferred
within a container of food. The first is conduction, where the heat transfer is slow, moving from one
particle of food to the next. This is how heat transfers when crabmeat is pasteurized in a can or a surimi
analog is pasteurized in a reduced oxygen package. With conduction, the slowest part of the food to
heat is typically the center because it’s the furthest away from the heat source. Place the thermocouple
here for the heat penetration study.

A faster method of heat transfer is convection. Here, as the food heats, it rises, usually along the sides
of the container. At the same time, the cooler food at the center falls, creating a current that moves
heat throughout the cooking vessel. Convection only occurs if the food can move within the cooking
vessel. Examples include liquids like soup, or mixtures of solids and liquids like boiling crabs. In this
case, the slowest heating point is usually along the container’s vertical centerline where the currents
diverge, about a third of the way up from the bottom. This is where the thermocouple is placed in the
heat penetration study.

For products that heat by a combination of convection/conduction, such as formulated soups or

Pathogens in the food’s cold spot will be inactivated more slowly than those at the surface because the
heat takes longer to reach them, so cumulatively they are subjected to less total heat. This is why, as we
have already pointed out, the final cooking time should be long enough to inactivate or destroy any
pathogens in the food’s cold spot.

Pasteurization, cooking, and smoking are achieved with specific types of processing equipment. While
there are standard temperatures that must be reached during processing, each individual piece of
equipment will have its own rate of heating as well as possible temperature variations within the
heating unit. These variations in processing equipment also lead to cold spots. If you find cold spots
during the temperature distribution study, the equipment should be redesigned to achieve uniform
temperature distribution, or, if that can’t be achieved, operated in a manner that compensates for the
lowest temperature in those cold spots. The processing equipment should be designed so that every
unit of the product is subjected to the minimum time and temperature to eliminate the target
pathogen.

The third factor in verifying an acceptable level of pathogen reduction evaluates how the target
pathogen responds to heat. The combination of heat penetration and temperature distribution should
allow your heat process to achieve the 6D reduction.

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In order to verify that an acceptable level of pathogen reduction has been reached, use the parameters
established during the heat resistance, heat penetration and temperature distribution studies in actual
trial runs. Using the cold spot, measure the temperature in the product continuously as its processed –
verifying that the desired time and temperature for pathogen reduction has been reached. In short, a
successful process will apply the correct amount of heat, use the appropriate heating method, and
result in a 6D reduction of the target pathogen in the particular product. A heat process should be
tailored for each individual product taking all the characteristics of the food, the packaging, the
processing equipment, and the pathogen into consideration.

Let’s go back to our examples and pull all this information together.

We’ll begin with refrigerated pasteurized crabmeat. In the first step, we established that non-
proteolytic C. bot. is the appropriate target pathogen for the heat step. In our second step we said that
pathogen inactivation is called a 6D process, which means that the process should provide a 6 log
reduction of the pathogen load in the product. Processors can either have a study conducted for them
or use the time and temperature combinations listed in Appendix 4 in the Hazards Guide, which may be
adequate for most seafood products. For our examples, we use Table A-4 of the Hazards Guide for non-
proteolytic Clostridium botulinum type B to determine the starting time and temperature combination
needed to achieve a 6D process. It's important to remember that the table rates are based on the cold
spot in the product reaching the stated temperature and remaining at that temperature for the
designated period of time.

The heat penetration and temperature distribution studies can be conducted simultaneously. In order
to do this, we use thermocouples placed throughout the product within multiple cans of crabmeat. We
then place these cans in various locations throughout the pasteurizer. We also place additional
thermocouples throughout the pasteurizer itself, but not inside the cans of product. Then, we run a
pasteurization cycle at the time and temperature we established to reach a 6D process. We repeat this
process multiple times and record all the data collected and evaluate it for consistency. The information
we gain from these experiments includes how heat is distributed throughout the pasteurizer, how the
heat penetrates into the canned product, where the cold spot in the canned product is, and whether the
time and temperature combination we established is actually applied to that cold spot. Now remember,
it’s imperative that all the crabmeat within the can receives enough heat for enough time to destroy the
pathogens.

For our boiled crabs and other cooked products, the heat validation process is similar. There will be
variations based on the actual process used, but the general questions to answer are largely the same.

Now, let’s validate the heat process for refrigerated, reduced oxygen packaged, hot smoked salmon.
We’ve already established that our target pathogen is non-proteolytic C. bot.. Evaluating the
effectiveness of our heat process is somewhat more involved than in the first two examples for
pasteurized and cooked crab. Here, we must validate the effectiveness of the barriers to control C. bot.
such as measuring the water phase salt level in the product to confirm that the brine step is effective.

The heat treatment for properly salted, hot smoked salmon is an internal temperature of 145 degrees
Fahrenheit for 30 minutes. The brine concentration must be high enough so that the salmon reaches a
water activity of 0.97 or below by the end of the hot smoking and drying process. We conduct our heat
penetration and temperature distribution studies simultaneously as we did for our pasteurized canned
crabmeat example, though we also have the option of conducting them separately.

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When conducting the heat penetration and temperature distribution studies, we must consider the
thickness of the raw salmon, accounting for the thickest possible fish we may process. Again, we use
thermocouples placed in the thickest pieces of salmon and place these pieces throughout the smoker.
We also place thermocouples throughout the smoker itself to measure how evenly the temperature is
distributed in the smoker. We complete multiple smoking cycles in this manner, collect and record the
data obtained, and evaluate the data for consistency. Finally, we test the product to determine the
water phase salt level and or water activity.

Now we come to the fourth step in validating the heat process - making sure that the appropriate
controls are in place for the target pathogen and the critical limits necessary to ensure a consistently
safe product are incorporated into the HACCP plan. The data collected during the heat penetration and
temperature distribution studies along with the heat resistance of the target pathogen will provide the
basis for the time and temperature critical limits.

It’s best to set the critical limits using the worst possible conditions that may occur during processing.

Using these worst case scenarios will better ensure that the critical limits reflect not only the minimum
times and temperatures necessary to heat the product adequately under normal conditions, but also
under conditions that are not ideal. One way to do this is to base the critical limit determination on
starting temperatures for raw materials that are cooler than the norm. For example, whole cooked
crabs might start out at a temperature of 50 degrees Fahrenheit before cooking. So, the studies for the
thermal process could use raw crabs that are at 35 degrees instead of 50 degrees. Product that begins
at a colder temperature will take longer to heat. Basing critical limits on this worst case scenario builds
in additional cook time and provides further assurance that the product is heated long enough to
control pathogen growth, even when the initial product temperatures are lower than would normally be
expected.

Another worst-case scenario is the use of raw product that is larger than what you would normally
expect to process. For example, let’s look again at hot smoked salmon. A smoked salmon processor
could determine its critical limits by smoking thicker pieces than are processed under normal conditions.
Thicker pieces require more time to reach the necessary internal temperature, which will build in extra
cooking time to account for variation in product thickness during the normal course of processing.

Time and temperature may not be the only critical-limits. For example, with hot smoked salmon, the
time and temperature during the smoke step is combined with the brine strength and brine time in
order to achieve the required 3.5% water phase salt that controls the non-proteolytic C. bot.. So, in this
example, brine critical limits must be set to work in combination with the time and temperature critical
limits established for the heat process.

Remember that the critical limits are based on the factors defined during the heat distribution study and
vary based on the processing equipment. For example, if the product is processed in a continuous
cooker, then belt speed would be a critical limit.

Once the critical limits are established, then a monitoring system that assures the critical limits are met
should be established.

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A heat process with time and temperature critical limits may require continuous monitoring to ensure
that the time and temperatures critical limits are always met. And, with monitoring comes record
keeping. Records permanently document that the critical limits were met for each batch or lot,
providing valuable information about the product safety.

The Seafood HACCP regulation requires processors to provide monitoring records to FDA during their
inspections. They’re one of the tools that FDA uses to ensure that processors are implementing the
HACCP plan.

The Hazards Guide can be used as a resource to help validate a heat process. It can provide answers to
questions regarding target pathogens and guidance that would likely help create a HACCP plan
acceptable to FDA.

We can’t stress enough the importance of maintaining records of any validation procedures and studies
conducted. These records and resulting data should include the methods used to establish the D value –
if different than those in the Hazards Guide’s, the data from the heat resistance, heat penetration and
temperature distribution studies, as well as verification that the final process actually provides the right
amount of heat to each piece of seafood in the cooking vessel.

Consumers depend on processors to provide them with safe fish and fishery products, so you must have
thorough and effective heat processing procedures in place addressing all the issues we’ve discussed.
As we stated in the beginning of this video, because of the difficulty involved in heat process validation,
FDA recommends that processors consider seeking professional assistance to perform this important
task. While the initial costs may seem high, knowing that the product has been processed properly and
is safe for the consumer will be worth the cost by providing peace of mind and minimizing foodborne
illness associated with these products.