FOOD ENGINEERING APPLIED TO ACCOMMODATE FOOD

REGULATIONS, QUALITY AND TESTING

Stanley E. Charm ScD. Charm Sciences, Inc
Lawrence, MA USA. Email: drcharm@charm.com Internet: www.charm.com
SUMMARY

PREVENTING MYCOTOXINS IN GRAIN

The new approach to controlling food production and

manufacturing is through prevention of problems rather than
solving after occurring. Testing finished product is not always
an effective option for control. This becomes obvious from
statistical considerations. Examples of employing prevention
are examined with respect to mycotoxin in grain, microbial
contamination of extended shelf life and UHT products,
allergen cross contact, and E.coli in bagged fresh cut produce.
Calculation of product shelf-life using Arrhenius equation
format is performed.
Problem prevention in several cases is associated with validated
sanitation. There is the consideration of economics of
prevention vs. economics of cure.
The Six Sigma concept is noted for producing near-perfect
products and is an idea for food engineering study.

Molds infect agricultural products in the field when moisture

and temperature conditions are sufficiently high. The type of
toxin is dependent on type of mold, product and conditions.
Mold also occurs in storage silos where mold infected grain
may infect other grain or may generate when storage conditions
are favorable.

INTRODUCTION
There is increasing interest in preventing the causes of
problems in contrast to solving problems after they occur.
There is no question about the wisdom of an ounce of
prevention is worth a pound of cure. However, the ounce of
prevention may be costly. The engineering challenge is to make
prevention practical.
There have been a number of food poisoning outbreaks from
time to time, some of which change industry practice, so that a
particular problem wont reoccur, for example, botulinum
poisoning that occurred in 1922 due to under heat processing
canned olives. This resulted in determining how to calculate
proper heating and cooling of canned food to prevent such an
event and introduced the 12D process.

Control of mold infection in the field is attempted with

chemicals and in storage, by controlling temperature and
moisture, e.g. Figure 1 & Figure 2 (Morantes, 2006). The final
control for mycotoxin is in testing product at storage silos.
Testing is awkward. When a grain truck is to be unloaded, a
representative sample is collected, ground up, extracted in
methanol-water, and extract testing that can take up to 20
minutes. If the test is positive, the truck is rejected. It is
estimated that mycotoxin contamination costs 1 billion dollars
per year. In addition to grain and feed, other products affected
include milk, meat, spices, wine, and nuts.
If mold infection of farm products can be eliminated before
storage in a silo and if moisture and temperature can be
controlled in storage, mycotoxin generation could be reduced.
One way this might be done is through irradiation using
electron beam, as grain is being transferred from trucks to
storage silos. Relative low levels of irradiation would be
needed. However, preliminary results indicate that grain can be
damaged by irradiation. This is a challenge.
Controlling storage humidity so that grain is less than 13%
moisture and temperature is about 20C, should limit the
generation of mycotoxin, (Figure 2). Irradiation and
temperature-humidity control in storage are costly. It is not
clear that the remedies suggested can be engineered to be
financially acceptable. The example offers a guide to thinking.

Today, the idea of prevention finds its way into food

manufacturing with US FDA good manufacturing practices or
CGMP. These are federal regulations enforced by US FDA that
apply to all human food regulated by FDA. CGMPs are
preventative control programs that work with other preventive
control programs such as HACCP, which are specific for a
particular process. The FDA has begun the process of
upgrading the CGMP (Zink and Seltzer, 2006).
Certain problems associated with food processing are selected
for analysis with respect to how problems might be prevented
(although the cost of prevention might make the prevention
impossible). These problems are now controlled by testing
which is not always effective. The problems include: 1)
Mycotoxin in grain, 2) Microbial contamination in UHT fruit
juice, 3) Allergen cross contamination from common
equipment, 4) E. coli H0157 contamination on fresh cut
spinach.
Problem prevention is exemplified in the Six Sigma concept.
This provides the methodology for problem prevention by
discovering and eliminating sources of variation inherent in a
system. The Six Sigma denotes a production where a defect is
six standard deviations from an acceptable average in a normal
distribution. This is a failure rate of 3.4 per million. The Six
Sigma concept is under consideration in food industries to
reduce failure rates.

Figure 1. Temperature range for mold growth.

(G. Mortantes, 2006)

Moisture Content of the Grain(%)

Temp. (C)
20
25
30
35

13.0

14.0

15.0

100
59
35
21

41
24
15
9

20
12
7
4

Figure 2. Days of safe storage by temperature and moisture

convert. (G. Mortantes, 2006)

WHEN THE PERCEPTION OF CONTROL BY TESTING

IS MISLEADING AND PREVENTION IS NEEDED
It is common practice in manufacturing extended shelf-life or
UHT products to store samples of finished product for several
days at appropriate incubation temperature to accelerate
spoilage and determine if there are defects before the lot is
released from a warehouse for commerce.
In some cases a system using the increase in ATP (adenosine
triphosphate) over 48 hrs incubation at temperature for
microbial growth identifies defects. The increase in ATP
indicates growth of microorganisms.
A UHT juice plant using ATP for control tested 100 incubated
samples from each lot of 50,000 packages. Although no defects
were detected, there were complaints from customers. The plant
wanted to have a failure rate of 0.01% or 1 in 10,000. From the
statistical Table 1, it can be seen that testing could produce zero
defect, while up to 3% of the lot is defective or 1500 defects.
The only way to achieve the 0.01% defect rate is to prevent the
defects by examining where and why they occur and revising
the manufacturing and maintenance. In this case, engineering a
plant sanitation program with a validated procedure would be a
good start for prevention.

A plant processing nuts determined that when the ATP level in

rinse water tested below a certain level, (950,000 RLU), rinse
water was negative by a specific allergen test. Comparing 100
samples this way, only one ATP test failed with respect to the
allergen test. Testing with ATP permitted immediate recleaning
if it exceeded 950,000 RLU. The specific allergen test was used
to check only when cleaning was satisfactory by ATP. This
saved both time and money. It points out that with proper
sanitation and test by ATP, allergen cross contact can be
prevented (Salter, 2006)
CALCULATION OF SHELF LIFE
Shelf life designation is a critical attribute associated with a
product that prevents misuse. It must be determined for each
manufactured lot, usually by stressing the product under storage
conditions that accelerate spoilage and predict shelf life under
less severe conditions.
The Arrhenius equation format is used to predict shelf life at
any given storage temperature.
The format of the Arrhenius equation is:
1)

k = Ae-H/T

where

k= rate constant (hr)

A= kinetic constant (hr)
H= kinetic constant (K)
T= absolute temperature (K)

Assume degradation is first order:

ln(N/N0)= k

where:

N/N0 = fraction of product that is acceptable after

time,
= storage time (hr)

To use equation (2) it is necessary to define a characteristic of

the product that limits shelf life and be able to numerically
measure it. For example, it may be flavor, (measured by taste
panel), pH, color, etc. It is essential to have a numerical
definition of degradation as well as numerical definition of
amount that still leaves an acceptable product.

* Extrapolated
Table 1. Number of samples tested and maximum defects
detected (%). Samples are selected randomly from lot.
(TETRAPAK, 2004)
CROSS CONTACT FROM ALLERGENIC
RESIDUE ON PROCESSING EQUIPMENT

2)

FOOD

Allergenic food residue contamination is a major regulatory

concern. The FDA CGMPS consider cross contact prevention
and validated cleaning procedures for food contact equipment
areas that must be addressed (Zink and Seltzer, 2006). When
various products are processed in the same equipment where
contact leaves a residue, it is possible to have cross
contamination unless the equipment is adequately cleaned. For
example, a candy manufacturer may make products with and
without peanut. With one in 200 people allergic to peanut, it
would be important to have a cleaning procedure to avoid
peanut contamination. This can be done by correlating a
sensitive ATP test for equipment sanitation with the sensitivity
of a specific peanut allergen test. The ATP test must be able to
detect 0.02 femtomoles ATP to be comparable with specific
allergen tests. The specific allergen test takes 15 minutes, while
ATP test takes 30 seconds (Salter et al, 2005). The engineering
challenge is to design and validate an acceptable cleaning
procedure and water system. Final rinse water is tested along
with swabbing equipment surfaces. The following example
demonstrates this.

Consider the shelf life calculation for an ATP Hygiene test

swab that has a defined limit of acceptability with a numerical
result. Degradation is measured by the decrease in response to a
given concentration of ATP. The control result, N0, is obtained
by testing samples stored at 4C at zero time. One hundred test
samples are stored at each of 5 higher temperatures, 64C,
52C, 45C, 37C, and 30C. At each temperature at various
times, groups of 10 samples are tested and results are averaged.
An example of raw data at 64C is in Table 2. The ln average
result, ln(N/N0), is plotted against time in Figure 3a for the
various storage temperatures. The ln slope associated with each
temperature is plotted against 1/T in Figure 3b. From this H
and A in equation (1) are calculated.
In this case H is 16363k and A is 1.678 x 1019. The
average fraction that is acceptable for degradation for shelf life
is N/N0 = 0.8
Using equations (1) and (2), the shelf life at 25C is

16363
19

ln( 0.8) = 1.678 10 e

25+ 273

= 9346 hr or 13 months at 25C

It should be recognized that 0.8 is acceptable and not failure.
Failure at the end of shelf life should not encompass a
significant amount of the lot. The average Failure Point

(N/N0 = 0.4) in this case is separated from the acceptable limit

by at least 6 standard deviations (SD) i.e. about one per hundred
failure rate at the end of shelf life, see Fig 4.
For variable storage, the temperature as a function of time,
Tf(), is substituted for T and equations (1) and (2) become
equation (3)

1 1
T K
0.002950

0.003150

0.003350

0.003550

0.00
-2.00

0
H

N
ln
N

3)

= A

Tf ( )

-4.00

-6.00

-8.00
-10.00
-12.00
-14.00
1
25 (C) Calculatedln(-slope) = 16363
T
Linear Regression H = 16363K

+ 44267

Figure 3b. Calculation of kinetic constants A and H.

number
of units

Failure Pt. End of Shelf Life

Start of Shelf Life
and Limit of
Acceptability

3 SD
0 N/N0

0.4

3 SD
0.8

Fail

1.0

Acceptable
N/N0

Table 2. Example of raw data at various time intervals at 64C.

Figure 4. Comparison of unit distribution in a lot at the end of
shelf life with the failure distribution. Shaded area shows
failures. At the end of shelf life there should be no significant
failures.

Hours
0

500

1000

1500

2000

2500

0.20

SIX SIGMA CONCEPTS FOR PREVENTING

PROBLEMS IN MANUFACTURE, E.G. E.COLI H0157 IN
FRESH CUT BAGGED SPINACH

0.00

ln (N/N o )

-0.20

-0.40
-0.60

-0.80

-1.00

y=-0.00095x
R2 =0.95396
y=-0.00181x
2
R =0.99513
y=-0.01362x
2
R =0.99715

y=-0.00026x
2
R =0.95609

y=-0.00005x
R2 =0.18956

64
52
45
37
30
#N/A

-1.20

Figure 3a. Acceptable Fraction plotted for various temperatures

and time.

Six Sigma is a concept for producing near perfect products. It

requires significant commitment to put in place. Digital
measurement at every step is needed, along with
documentation. It includes comprehensive maintenance and
equipment replacement to prevent equipment failure. It also
extends to suppliers. Six Sigma company employees like to do
business with Six Sigma suppliers. This is somewhat idealistic
but it points a way to improving manufacturing.
It is estimated that many food companies operate between 2 and
3 Sigma. An advance to 4 Sigma would be a significant
improvement. It is interesting to note the State of Wisconsin is
awarding grants to have cheese companies employees trained in
the initial steps of Six Sigma (Cheese Market News, 2006).
These include: define, measure, analyze, improve, and control.
An example of Six Sigma thinking may be applied to
preventing contamination in fresh cut and bagged spinach.
Recently, this product was responsible for 3 deaths and about
200 poisonings in the U.S., from E.coli H0157. It was caused
by growing produce close to dairy and beef cattle. It is
associated with soil, irrigation water and fertilizer. Washing
spinach reduces E.coli about 2 log cycles. Some contamination

is systemic and cannot be washed out. The problem is thought

to occur when the bagged contaminated spinach is exposed to
higher temperatures that encourage E.coli toxin development.
In order to prevent this event from ever occurring, it is
necessary to:
1.
2.
3.
4.
5.

Decontaminate irrigation water

Decontaminate fertilizer
Clean wash water
Have temperature control
Clean harvesting systems

1.

Decontaminated irrigation water could be obtained by

pasteurizing the raw water possibly by solar heating and
storing in a tank. Also chemical treatment might work.
Decontaminating fertilizer could be done by heating
chemically or by solar means.
Clean wash water can be obtained by reclaiming or
replacing.
Temperature control can be checked with temperature tags
and proper control equipment.
Harvesting equipment can be cleaned and tested with
validated methods.

2.
3.
4.
5.

Every step mentioned must be measured or tested and

documented. Finally alarms must be in place to alert when
accepted limits are exceeded.
The testing of bagged spinach as a check against
contaminations is difficult because of test time required and as
mentioned in the case of the juice example, the number of
samples needed would make this an impractical control, since
such a low level of failure is tolerable. For example, if there are
1 million bags/day shipped, there should be no failure due to
toxic contamination, i.e. defect must be less than one in a
million. Noting Table 1, the number of samples tested to check
this failure rate, would be greater than 100,000 bags. If one
hundred bags were tested and none came up positive, the failure
rate could be up to 3%, obviously a disaster. Thus, negatives in
testing this way cannot be a measure of safety.
It has been suggested that fresh cut bagged produce should be
irradiated to destroy pathogens. A recent study by the USDA
Research Service notes Most fresh cut fruits and vegetables
can tolerate a radiation of 1.0 kGy, a dose that can reduce E.coli
5 log cycles. Mexico, India, and Thailand are starting to
irradiate most of the food they export to the U.S. (Wall Street
Journal, 2006).
This may be useful to treat the problem, but it does not remove
the cause. However, since systemic contamination, e.g. from
contaminated soil, has not been accommodated, this is certainly
worth considering.
Thoroughly washing with chemical treated water is used. But
washing by itself wont take care of the problem because
E.Coli sometimes gets inside the cells of produce, (Chemical
Engineering News, 2007).

CONCLUSIONS:
It is suggested that problems in food production should be dealt
with through prevention rather than just treatment. Examining a
number of contamination problems, it appears that sanitation
and cleaning are frequently part of prevention. As food
engineers, more engineering attention should be focused on
how to accomplish this. The Six Sigma approach is just now
emerging in food manufacturing and should be part of a good
food engineering curriculum. There are a number of industries
where this approach is used successfully, e.g. pharma industry.

REFERENCES:
Cheese Marketing News, 2006.
Wisconsin Awards Grants to Each Dairy Plant Workers CostEffective Manufacturing Skills, September 1, P15.
Chemical Engineering News, 2007.
Food Irradiation, recent E.Coli outbreaks heighten interest in
the technology. By Bette Hiceman Chen, January 15, p.41-43.
Morantes G. 2006.
Mold and Mycotoxin: Managing Risk in the Global Feed
Supply Chain. April 25, www.wattnet.com
Salter R.S, Hefle S, Jackson L, Swanson K. 2005.
Use of a Sensitive ATP Method to Quickly Verify Wet
Cleaning Effectiveness at Removing Food Soils and Allergens
from Food Contact Surfaces. Poster IAFP, Baltimore, see
www.charmsciences.com, Allergiene.
Salter R, Holmes S. 2006
Practical Use of Sensitive ATP Test (Allergiene) to Verify
Equipment Cleaning As Part of Allergen Cross-Contact
Avoidance Programs, Abstract 033-09, IFT, Orlando, Florida.
TETRAPAK Company, 2004.
Personal communication. Also Sampling Plan Analyzer 2.0
software www.variation.com
Wall Street Journal, December 18, 2006 Editorial, E.Coli
Enablers.
Zink D. and Seltzer H. 2006.
FDA Regulatory Report, Opportunities for Food CGMP
Modernization.
Food Safety Magazine, August/September P35-62.
Submitted in February 2007 for CIBIA VI, November 2007.