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major holidays or Friday afternoon is not recommended. However, once scheduled,
sample observations on weekends and holidays should not be skipped over, since
important data points could be missed.
Step 8: Take sample and evaluate quality — Samples should be taken and
administratively and economically feasible, taking into account the heterogeneity of
the food. Maxcy and Wallen (1983) pointed out the problem of heterogeneity of
samples in shelf life prediction. Multiple subsamples (³ 3) should be done for nonhomogenous
samples. A single package is usually used as an experimental unit.
Replication of 3 or 4 units are desired for each measurement. For frozen foods, a
thawing process is often involved in the sampling procedure. Proper thawing or
microwave heating is critical to the product quality. All samples should be thawed or
microwaved in the same way to minimize any biases.
The intended analyses should be based on the specific mode of deterioration,
which was discussed earlier. Whatever the choice, the tests should be reasonable and

the vitamins listed, the analysis level cannot be below 80% of the label value if it is a
natural food with no added nutrients or cannot be below 100% (21 CFR 101.9(g)(1)(i))
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if the product has any added vitamin or nutrient whether or not it is the nutrient under
test. Thus one must base the label value on some predicted initial variability and
some predicted loss during distribution and storage. The FDA usually takes samples at
the supermarket level (where they can purchase them) for compliance testing, not fromStep 11: Implementation — One should get top management’s approval of the
test results so that they can be implemented. Management must believe and support
those test results. It is important for production, sales, distribution, purchasing and
quality control to work together to be sure that the production is properly handled from
the time of manufacture until this product is consumed.
19.4 Challenge study
19.4.1 Basis
Freezing reduces the microbial population of foods but considerable numbers usually
survive even prolonged frozen storage. A challenge study is often used in the
laboratory to study the factors and factor interactions as they affect the shelf life of the
product. Such simulated experiments enable the researcher to better control the study.
A challenge study is necessary for frozen foods for two reasons: (i) to predict microbial
growth and potential risk of the product upon temperature abuse in a distribution
chain; and (ii) to assess the relative stability and the relative risk of different formula,
different processes or different packaging materials, which is a must in new product
development. A challenge study may also be considered as a preliminary shelf life
determination in terms of microbiological safety. It is often used in the early stage of
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development since if microbial safety is a concern at this stage, then reformulating can
be done quickly.
19.4.2 Microbial abuse procedures
Step 1: Identify barriers — A composition/ingredient analysis should be done to
identify any barrier(s) against spoilage microbes and pathogens in case of
temperature abuse.as possible. Sometimes several inoculation levels are used.
should be packaged using the desired commercial packaging conditions, and
subjected to temperature abuse. Factorial design and response surface methodology
are often used in designing a challenge study. A typical temperature abuse condition
used by some food companies is provided in Table 19.5. It starts out with five sets of
test packages placed at -18 °C to begin the cycle. At the end of the first 24 hr, one set4 20 hr at -18 °C

5 20 hr at -18 °Cprocess. Appropriate detection and enumeration techniques should be used.
19.4.3 Applicability
The use of inoculated pack studies conducted by independent laboratories allows a
food processor to assess the relative risks that can occur under conditions of
temperature abuse of the food product in question. Taking frozen pizza as an
example, both the cheese and sausage, if naturally fermented, will have high total
counts of bacteria. Since the product is usually partially pre-baked and then frozen, the
numbers of vegetative microorganisms will decrease until thawing occurs.
Unfortunately, pathogens such as Staphylococcus aureus will not be totally
facilities because of the possible transfer of pathogens to food products. No sensory
on shelf life stability of the product being developed periodically since one can not
afford the relatively long shelf life period for a frozen food stored under normal freezing
conditions. In addition, temperature fluctuations may occur in distribution and retail
holding for frozen storage. Thus kinetic studies at several temperatures within that
range are necessary to predict its shelf life. Accelerated shelf life testing conducted at
elevated isothermal temperatures and/or with freeze/thaw cycles for frozen products
have been used extensively for several decades by industry and government
agencies (Labuza and Schmidl, 1985). The Arrhenius relation and the Q10 approach
are used to extrapolate the results to the expected lower storage temperature.

deterioration modes, such as moisture gain or loss and lipid oxidation (Labuza, 1984),
but rarely done for frozen foods.
19.5.2 Unique procedures

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