CHAPTER 21
The HACCP System and
Food Safety
Among the desirable qualities that should be
associated with foods is freedom from infectious
organisms. Although it may not be possible to
achieve a zero tolerance for all such organisms
under good manufacturing practices (GMP), the
production of foods with the lowest possible
numbers is the desirable goal. With fewer pro-
cessors producing more products that lead to
foods being held longer and shipped farther be-
fore they reach consumers, new approaches are
needed to ensure safe products. Classic ap-
proaches to microbiological quality control have
relied heavily on microbiological determinations
of both raw materials and end products, but the
time required for results is too long for many
products. The development and use of certain
rapid methods have been of value, but these alone
have not obviated the need for newer approaches
to ensuring safe foods. The hazard analysis criti-
cal control point (HACCP) system is presented
in this chapter as the method of choice for ensur-
ing the safety of foods from farm to table. When
deemed necessary, microbiological criteria may
be established for some ingredients and foods,
and these in connection with sampling plans are
presented as components of the HACCP system.
HAZARD ANALYSIS CRITICAL
CONTROL POINT SYSTEM
The concept and early history of the HACCP
system are presented in the previous edition of
this text. The presentation that follows is not in-
tended to be used alone to establish an HACCP
program in either a food production plant or food
service establishment. For these purposes, a more
detailed HACCP reference should be con-
sulted.5'8111516'27 Also, additional references may
be consulted for meat and poultry plants and they
include references 1, 20, and 29; and for
seafoods, references 9 and 17. More general in-
formation and background can be found in ref-
erences 6, 21, 25, and 26.
The objective of this section is to provide a
general overview of what HACCP is, and ex-
amples of how one might go about setting up an
HACCP system.
HACCP is a system that should lead to the
production of microbiologically safe foods by
analyzing for the hazards of raw materials—those
that may appear throughout processing and those
that may occur from consumer abuse. It is a pro-
active, systematic approach to controlling
foodborne hazards. Although some classic ap-
proaches to food safety rely heavily on end prod-
uct testing, the HACCP system places emphasis
on the quality of all ingredients and all process
steps on the premise that safe products will re-
sult if these are properly controlled. The system
is thus designed to control organisms at the point
of production and preparation. The five leading
factors that contributed to foodborne illness in
the United States for the years 1961-1982 are
noted in Table 21-1, and it may be noted that
events associated with the handling and prepa-
Table 21-1 Leading Factors Contributing to Outbreaks of Foodborne Illness in the United States
Factors
Improper cooling
Lapse of 12 or more hours between preparation/eating
Contaminated by handlers
Raw ingredient added without subsequent heating/cooking
Inadequate cooking/canning/heating
/Vote:/V =1,918.
Source: From Bryan. 23
ration of foods were significant.3 Mishandling
of foods in food service establishments in Canada
in 1984 was involved in about 39% of foodborne
incidents.28 Proper implementation of HACCP
in food service establishments and the home will
lead to a decrease in foodborne illness.
A subcommittee of the U.S. National Research
Council, National Academy of Sciences, made
the following recommendation in 198518: Be-
cause the application of the HACCP system pro-
vides for the most specific and critical approach
to the control of microbiological hazards pre-
sented by foods, use of this system should be
required of industry. Accordingly, this subcom-
mittee believes that government agencies respon-
sible for control of microbiological hazards in
foods should promulgate appropriate regulations
that would require industry to utilize the HACCP
system in their food protection programs. Be-
fore an HACCP program is developed, there are
some prerequisite programs that should be in
place.
Prerequisite Programs
Prerequisite programs include a wide range
of activities and events that may have an impact
on an HACCP system for a specific food prod-
uct even though they are not parts of the HACCP
system per se. Some examples of prerequisite
programs are noted in reference 16, and they are
explained in more detail in reference 24.
1961-1982
44%
23
18
16
16
Briefly stated, prerequisite programs include
concerns and aspects of the entire food environ-
ment before the HACCP system is initiated. They
include the suitability of facilities, control of
suppliers, safety and maintenance of production
equipment, cleaning and sanitation of equipment
and facilities, personal hygiene of employees,
control of chemicals, pest control, and the like.
These prerequisites include good manufacturing
practices,14 and they should be brought up to ac-
ceptable standards before the HACCP system is
initiated.
Definitions
The following terms and concepts are valu-
able in the development and execution of an
HACCP system and are taken from International
Commission on Microbiological Specifications
for Foods (ICMSF)10 and/or National Advisory
Committee on the Microbiological Criteria for
Foods (NACMCF)16:
Control point: Any point in a specific food
system where loss of control does not lead
to an unacceptable health risk
Critical control point (CCP): Any point or
procedure in a food system where control
can be exercised and a hazard can be mini-
mized or prevented
 Critical limit: One or more prescribed toler-
ances that must be met to ensure that a CCP
effectively controls a microbiological
health hazard
CCP decision tree: A sequence of questions
to assist in determining whether a control
point is a CCP
Corrective action: Procedures followed when
a deviation occurs
Deviation: Failure to meet a required critical
limit for a CCP
HACCPplan: The written document that delin-
eates the formal procedures to be followed
in accordance with these general principles
Hazard: Any biological, chemical, or physi-
cal property that may cause an unaccept-
able consumer health risk (unacceptable
contamination, toxin levels, growth, and/
or survival of undesirable organisms)
Monitoring: A planned sequence of observa-
tions or measurements of critical limits de-
signed to produce an accurate record and
intended to ensure that the critical limit
maintains product safety
Risk category: One of six categories priori-
tizing risk based on food hazards
Validation: That element of verification focused
on collecting and evaluating scientific and
technical information to determine whether
the HACCP plan, when properly imple-
mented, will effectively control the hazards
Verification: Methods, procedures, and tests
used to determine whether the HACCP sys-
tem is in compliance with the HACCP plan
HACCP Principles
Although interpreted variously, the ICMSF
and NACMCF view HACCP as a natural and
systematic approach to food safety and as con-
sisting of the following seven principles:
1. Assess the hazards and risks associated
with the growing, harvesting, raw materi-
als, ingredients, processing, manufactur-
ing, distribution, marketing, preparation,
and consumption of the food in question.
2. Determine the CCP(s) required to control
the identified hazards.
3. Establish the critical limits that must be met
at each identified CCP.
4. Establish procedures to monitor the
CCP(s).
5. Establish corrective actions to be taken
when there is a deviation identified by
monitoring a given CCP.
6 Establish procedures for verification that
the HACCP system is working correctly.
7. Establish effective recordkeeping systems
that document the HACCP plan.
Each of these principles is discussed in more
detail below.
Principle 1: Assess Hazards and Risks
Hazards and risks may be assessed for indi-
vidual food ingredients from the flow diagram
or by ranking the finished food product by as-
signing to it a hazard rating from A through F. A
plus sign (+) is assigned when a hazard exists.
Six hazard categories have been defined, repre-
senting an expansion of the three proposed by
the National Research Council (NRC)19 for sal-
monellae control. However, this system of rank-
ing and hazard category assignment is not popu-
lar in the late 1990s and it may be ignored (see
reference 16 for alternative). It is presented here
for historical purposes:
A. This is a special class of foods that consist
of nonsterile products designated and in-
tended for consumption by individuals at
risk, including infants, the aged, inf irmed,
and immunoincompetents.
B. The product contains "sensitive" ingredi-
ents relative to microbiological hazards
(e.g., milk, fresh meats).
C. There is no controlled processing step
(such as heat pasteurization) that effec-
tively destroys harmful microorganisms.
D. The product is subject to recontamination
after processing but before packaging (e.g.,
pasteurized in bulk and then packaged
separately).
 E. Substantial potential for abusive handling
exists in distribution and/or by consumers
that could render the product harmful when
consumed (e.g., products to be refrigerated
are held above refrigerator temperatures).
F. There is no terminal heat process after
packaging or when cooked in the home.
Next, the formulated product should be as-
signed to one of six hazard categories, expanded
from four suggested by the NRC18:
VI. A special category that applies to
nonsterile products designated and in-
tended for individuals in hazard cat-
egory A
V Food products subject to all five gen-
eral hazard characteristics (B, C, D, E,
and F)
IV Food products subject to any four gen-
eral hazard characteristics
III. Products subject to any three of the gen-
eral hazard characteristics
II. Products subject to any two general haz-
ard characteristics
I. Products subject to any one of the gen-
eral hazard characteristics
0. Products subject to no hazards
Principle 2: Determine CCP(s)
The ICMSF11 recognized two types of CCPs:
CCPl, to ensure control of a hazard, and CCP2,
to minimize a hazard. Typical of CCPs are the
following:
• Heat process steps where time-temperature
relations must be maintained to destroy
given pathogens
• Freezing and time to freezing before patho-
gens can multiply
• The maintenance of pH of a food product
at a level that prevents growth of pathogens
• Employee hygiene
A decision tree such as the one in Figure 21-1 is
often used to identify CCPs.
Principle 3: Establish Critical Limits
A critical limit is one or more prescribed tol-
erances that must be met to ensure that a CCP
effectively controls a microbiological hazard.
This could mean keeping refrigeration tempera-
tures within a certain specific and narrow range
or making sure that a certain minimum destruc-
tive temperature is achieved and maintained long
enough to effect pathogen destruction. Examples
of the latter include adherence to the tempera-
tures noted in Table 21-2 for the control of the
respective organisms.
Principle 4: Establish Procedures To
Monitor CCPs
The monitoring of a CCP involves the sched-
uled testing or observation of a CCP and its lim-
its; monitoring results must be documented. If,
for example, the temperature for a certain pro-
cess step should not exceed 40 0 C, a chart re-
corder may be installed. Microbial analyses are
not used to monitor since too much time is re-
quired to obtain results. Physical and chemical
parameters such as time, pH, temperature, and
water activity (^) can be quickly determined and
results obtained immediately.
Principle 5: Establish Corrective Actions
Establish corrective actions to be taken when
deviations occur in CCP monitoring. The actions
taken must eliminate the hazard that was created
by deviation from the plan. If a product is in-
volved that may be unsafe as a result of the de-
viation, it must be removed. Although the ac-
tions taken may vary widely, in general they must
be shown to bring the CCP under control.
Principle 6: Establish Procedures for
Verification
Establish procedures for verification that the
HACCP system is working correctly. Verifica-
tion consists of methods, procedures, and tests
used to determine that the system is in compli-
 Q1. Is there a hazard associated with this
raw material?

yes no

Q2. Are you or the customer going to Proceed*

process this hazard out of the product?

yes no

Q3. Is there a cross-contamination risk Sensitive raw material

to the facility or to other products High level of control required
which will not be controlled? CCP"

yes no

Proceed*

Sensitive raw material

High level of control required
CCP"

* Proceed to your next raw material

*# Following the hazard analysis, you are likely to find that this raw material must be
managed as a CCP

Figure 21-1 Raw material control decision tree. Source: From Mortimore and Wallace.15 Copyright © 1994 by
Chapman & Hall.

ance with the plan. Verification confirms that all
hazards were identified in the HACCP plan when
it was developed, and verification measures may
include compliance with a set of established
microbiological criteria when established. Veri-
fication activities include the establishment of
verification inspection schedules, including re-
view of the HACCP plan, CCP records, devia-
tions, random sample collection and analysis, and
written records of verification inspections. Veri-
fication inspection reports should include the
designation of persons responsible for adminis-
tering and updating the HACCP plan, direct
monitoring of CCP data while in operation, cer-
tification that monitoring equipment is properly
calibrated, and deviation procedures employed.
Principle 7: Establish Effective
Recordkeeping Systems
Establish effective recordkeeping systems to
document the HACCP plan. The HACCP plan
must be on file at the food establishment and
must be made available to official inspectors
upon request. Forms for recording and docu-
menting the system may be developed, or stan-
dard forms may be used with necessary modifi-
cations. Typically, these may be forms that are
completed on a regular basis and filed away. The
forms should provide documentation for all in-
gredients, processing steps, packaging, storage,
and distribution.
Table 21-2 USDA Cooking and Cooling Parameters for Perishable Uncured Meat and Poultry
Products
Cooking parameters
USDA/FSIS has established minimal internal temperatures required for cooking perishable un-
cured meat and poultry products. These temperature requirements are referenced in Title 9 of the
CFRs (CFR 301-390) or in policies disseminated through the FSIS Policy Book or Notices.
Cooking requirements*
Cooked beef and roast beef 130-145°F
(9 CFR 318.17) (54.4-62.7°C)
(121 min at 1300F to instantaneous at 145°F)
Baked meatloaf 1600F
(9 CFR 317.8) (71.10C)
Baked pork cut 1700F
(9 CFR 317.8) (76.7°C)
Pork (to destroy trichinae) 120°-144°F
(9 CFR 318.10) (48.9°-62.2°C)
(21 h at 1200F to instantaneous at 144°F)
Cooked poultry rolls and other 1600F
uncured poultry products (71.10C)
(9 CFR 381.150)
Cooked duck, salted 155°F
(FSIS Policy Book) (68.3°C)
Jellied chicken loaf 1600F
(FSIS Policy Book) (71.10C)
Partially cooked, comminuted >1510F for 1 min
products >148°F for 2 min
(FSIS Notice 92-85) >146°F for 3 min
>145°Ffor4 min
>144°Ffor5 min
Cooling parameters
Similarly, parameters for cooling and storing refrigerated products, including temperatures and times,
are reflected in agency regulations (9 CFR) and policies.
Cooling requirements
Guidelines for refrigerated storage temperature 400F
and internal temperature control point (4.4°C)
Recommended refrigerated storage temperature 35°F
for periods exceeding 1 week (FSIS Directive 7110.3) (1.70C)
Cooling procedures require that the product's internal temperature not remain between 1300F
(54.4°C) and 800F (26.7°C) for more than 1.5 h or between 800F (26.7°C) and 40°F (4.4°C) for
more than 5 h (FSIS Directive 7110.3).
Cooling procedures for products consisting of intact muscle (e.g., roast beef) require that chilling
be initiated within 90 min of the cooking cycle. Product shall be chilled from 1200F (48°C) to
55°F (12.7°C) in not more than 6 h. Chilling shall continue and the product shall not be packed
for shipment until it has reached 400F (4.4°C).
Roast beef for export to the United Kingdom must be chilled to 68°F (200C) or less within 5 h after
leaving the cooker and to 46°F (7°C) or less within the following 3 h.
*Some temperature requirements are based on appearance and labeling characteristics rather than safety.

Note: USDA = United States Department of Agriculture; CFR = Code of Federal Regulations; FSIS = Food Safety and Inspec-
tion Service.
Flow Diagrams 1. Receiving (Beef)

The development of an HACCP plan for a food 2. Grinding

establishment begins with the construction of a
flow diagram for the entire process. The diagram
should begin with the acquisition of raw materi- 3. Mixing

als and include all steps through packaging and

subsequent distribution. A flow diagram for the 4. Forming
production of frozen, cooked beef patties is il-
lustrated in Figure 21-2. To begin the HACCP
5. Cooking
process, the three questions in Figure 21-1
should be raised. When this is done, the answer
to all three is yes, as outlined below: 6. Freezing

Ql. Is there a hazard? Raw ground beef 7. Boxing

patties are known to be vehicles for
Escherichia coli 0157:H7, Toxo-
plasma gondii, and salmonellae.
Q2. Will the hazard be processed out?
This will be achieved in step 5
(cooking).
Q3. Is there a risk of cross-contamination?
This can occur in steps 7, 8, and 10.
Application of HACCP Principles
This section deals with an application of the
seven HACCP principles to the manufacture of
frozen, cooked beef patties as outlined in Fig-
ure 21-2, and the steps referred to are those on
the flow diagram.
8. Distributing
9. Reheating
10. Serving
Figure 21-2 Example of a flow diagram for the pro-
duction of frozen, cooked beef patties. Source: Re-
printed with permission from The International Com-
mittee on Microbiological Specifications for Foods
of the International Union of Microbiological Soci-
eties (ICMSF), Journal of Food Protection, Vol. 61,
p. 1255, © 1998. Copyright held by the International
Association of Milk, Food and Environmental Sani-
tarians, Inc.

Principle 1—Hazards and Risks

Raw meat is a sensitive ingredient and the
cooked product is subject to recontamination
after processing and during distribution.
Principle 2—CCPs
An important concern about step 1 is the over-
all condition of the beef carcasses or cuts. The
comments below are based on the assumption
that the beef has been produced and handled
under GMR Step 5 is the indisputable CCPl,
since it can eliminate the hazards. CCP2s may
be assigned to steps 6 and 8, and possibly to step 7.
Principle 3—Critical Limits
Temperature is the critical parameter from
steps 1 to 9, and it consists of proper refrigera-
tion temperature in steps 1-4; proper cooking
temperature in step 5; freezing in steps 6-8; and
heating in step 9.The overall objective is to keep
the fresh beef at or below 400F at all times, cook
patties to 1600F, freeze to -20 0 F, and store at the
same temperature.
Principle 4—Monitoring HACCP
Use chart recorders for steps 2-4, use ther-
mometers for steps 5 and 6, and temperature re-
corders for step 8.
Principle 5—Corrective Actions
These refer to deviations from critical limits
identified during monitoring of CCPs. Specific
corrective actions to be taken should be clearly
spelled out. For example, if the target tempera-
ture in step 5 is not reached, will the batch be
discarded, reprocessed, or assigned to another
use?
Principle 6—Verification
Overall, this is an assessment of how effec-
tive the HACCP system is performing. Typically,
some microbial analyses are in order, for ex-
ample, were all relevant pathogens destroyed in
step 5? Have the products in retail stores been
contaminated after being cooked?
Principle 7—Recordkeeping
This should be done by product lot number in
such way that records are available to verify the
events in steps 2-A. Where room temperatures
are involved, chart recorder tracings should be kept.
A flow diagram for the production of roast
beef is presented in Figure 21-3. Cooking is the
most important CCP for this product (CCPl),
followed by chilling and prevention of recontami-
nation after cooking. The cooking temperature
should reach 145°F or otherwise be sufficient to
effect a 4-log cycle reduction of Listeria
monocytogenes. This will not destroy Clostridium
perfringens spores, and their germination and
growth must be controlled by proper chilling and
storage. Cooking and cooling parameters
for perishable uncured meats are presented in
Table 21-2.
Some Limitations of HACCP
Although it is the best system yet devised for
controlling microbial hazards in foods from the
Raw material
CCP2
selecting
Seasoning
Bagging
Cooking CCPI
Chilling CCP2
Rebagging CCP2
Storing and
distributing
CCP2
O indicates a site of minor contamination
• indicates a site of major contamination
CCPI effective CCP. CCP2 not absolute
Figure 21-3 Flow diagram for production of roast
beef. Source: From ICMSF,ll copyright © 1988 by Black-
well Scientific Publications. Used with permission.
farm to the table, the uniform application of
HACCP in the food manufacturing and service
industries will not be without some debate.
Among the lingering questions and concerns
raised by Tompkin29 are the following:
• HACCP requires the education of nonpro-
fessional food handlers, especially in the
food service industry and in homes; whether
this will be achieved remains to be seen. The
failure of these individuals to get a proper
understanding of HACCP could lead to its
failure.
• To be effective, this concept must be ac-
cepted not only by food processors but also
by food inspectors and the public. Its inef-
fective application at any level can be detri-
mental to its overall success for a product.
• It is anticipated that experts will differ as to
whether a given step is a CCP and how best
to monitor such steps. This has the poten-
 tial of eroding the confidence of others in
HACCP.
• The adoption of HACCP by industry has the
potential of giving false assurance to con-
sumers that a product is safe, and, therefore,
there is no need to exercise the usual pre-
cautions between the purchase and con-
sumption of a product. Consumers need to
be informed that most outbreaks of
foodborne illness are caused by errors in
food handling in homes and food service
establishments and that no matter what steps
a processor takes, HACCP principles must
be observed after foods are purchased for
consumption.
MICROBIOLOGICAL CRITERIA
The concept that microbial limits be assigned
to at least some foods to designate their safety
or overall quality was suggested as early as 1903
by Marxer, who suggested an aerobic plate count
(APC) limit of 106 for hamburger meat. Simi-
larly, APC and indicator organism limits were
suggested for many other products through the
1920s and 1930s, with pasteurized milk being
notable among those for which limits were widely
accepted. The early history of microbiological
limits for foods has been reviewed.7 In an effort
to eliminate confusion and to agree upon an in-
ternational language, the Codex Alimentarius
Commission4 has established definitions. The
ICMSF has endorsed the Codex definitions with
some modifications. The Codex definitions are
summarized below, with ICMSF modifications
noted.
Definitions
Microbiological criteria fall into two main
categories: mandatory and advisory. A manda-
tory criterion is a microbiological standard that
normally should contain limits only for patho-
gens of public health significance, but limits for
nonpathogens may be set. The ICMSF10 regards
a standard as being part of a law or regulation
that is enforceable by the regulatory agency hav-
ing jurisdiction. An advisory criterion is either a
microbiological end product specification in-
tended to increase assurance that hygienic sig-
nificance has been met (it may include spoilage
organisms) or a microbiological guideline that
is applied in a food establishment at a point dur-
ing or after processing to monitor hygiene (it,
too, may include nonpathogens). Before recom-
mending a criterion, the ICMSF10 believes that
each product must be in international trade, must
have associated with it good epidemiological
evidence that it has been implicated in foodborne
disease, and have associated with it good evi-
dence that a criterion will reduce the potential
hazard(s) in Principle 2.
The Codex definition of a microbiological
criterion consists of five components:
1. a statement of the organisms of concern
and/or their toxins
2. the analytical methods for their detection
and quantitation
3. a sampling plan, including when and where
samples are to be taken
4. microbiological limits considered appro-
priate to the food
5. the number of sample units that should
conform to these limits
These five components are embodied in a sam-
pling plan.
Sampling Plans
A sampling plan is a statement of the criteria
of acceptance applied to a lot based on appro-
priate examinations of a required number of
sample units by specified methods. It consists
of a sampling procedure and decision criteria and
may be a two-class or a three-class plan.
A two-class plan consists of the following
specifications: n, c, m; a three-class plan requires
n, c, m, and M, where
n = the number of sample units (packages,
beef patties, and so forth) from a lot that
 must be examined to satisfy a given
sampling plan.
c = the maximum acceptable number, or the
maximum allowable number of sample
units that may exceed the microbiologi-
cal criterion m. When this number is
exceeded, the lot is rejected.
m = the maximum number or level of rel-
evant bacteria per gram; values above
this level are either marginally accept-
able or unacceptable. It is used to sepa-
rate acceptable from unacceptable foods
in a two-class plan, or, in a three-class
plan, to separate good quality from
marginally acceptable quality foods.
The level of the organism in question
that is acceptable and attainable in the
food product is m. In the presence/ab-
sence situations for two-class plans, it
is common to assign m = 0. For three-
class plans, m is usually some nonzero
value.
M = a quantity that is used to separate mar-
ginally acceptable quality from unac-
ceptable quality foods. It is used only
in three-class plans. Values at or above
M in any sample are unacceptable rela-
tive to health hazard, sanitary indicators,
or spoilage potential.
A two-class plan is the simpler of the two and in
its simplest form may be used to accept or reject
a larger batch (lot) of food in a presence/absence
decision by a plan such as n = 5, c — 0, where
n = 5 means that five individual units of the lot
will be examined microbiologically for, say, the
presence of salmonellae, and c = 0 means that
all five units must be free of the organisms by
the method of examination in order for the lot to
be acceptable. If any unit is positive for salmo-
nellae, the entire lot is rejected. If it is desired
that two of the five samples may contain
coliforms, in a presence/absence test, for ex-
ample, the sampling plan would be n = 5, c = 2.
By this plan, if three or more of the five-unit
samples contained coliforms, the entire lot would
be rejected. Whereas presence/absence situations
generally obtain for salmonellae, an allowable
upper limit for indicator organisms such as
coliforms is more often the case. If it is desired
to allow up to 100 coliforms/g in two of the five
units, the sampling plan would be n = 5, c — 2,
m = 102. After the five units have been examined
for coliforms, the lot is acceptable if no more
than two of the five contain as many as 102
coliforms/g but is rejected if three or more of
the five contain 102 coliforms/g. This particular
sampling plan may be made more stringent by
increasing n (e.g., n = 10, c = 2, m = 102) or by
reducing c (e.g., n = 5, c = 1, m = 102) On the
other hand, it can be made more lenient for a
given size n by increasing c.
Whereas a two-class plan may be used to des-
ignate acceptable/unacceptable foods, a three-
class plan is required to designate acceptable/
marginally acceptable/unacceptable foods. To
illustrate a typical three-class plan, assume that
for a given food product, the standard plate count
(SPC) shall not exceed 106/g (M) or be higher
than 105/g from three or more of five units ex-
amined. The specifications are thus n = 5, c = 2,
m = 105, M= 106. If any of the five units exceeds
106/g, the entire lot is rejected (unacceptable). If
not more than c sample units give results above
m, the lot is acceptable. Unlike two-class plans,
the three-class plan distinguishes values between
m and M (marginally acceptable).
With either two- or three-class attributes plans,
the numbers n and c may be employed to find the
probability of acceptance (P3) of lots of foods by
reference to appropriate tables.10 The decision to
employ a two-class or three-class plan may be de-
termined by whether presence/absence tests are
desirable, in which case a two-class plan is re-
quired, or whether count or concentration tests are
desired, in which case a three-class plan is preferred.
The latter offers the advantages of being less af-
fected by nonrandom variations between sample
units and of being able to measure the frequency
of values in the m to M range. The ICMSF report
and recommendations10 should be consulted for
further details on the background, uses, and inter-
pretations of sampling plans. Further informa-
tion may also be obtained from Kilsby.12
Microbiological Criteria and Food Safety
The application of criteria to products in the
absence of an HACCP program is much less
likely to be successful than when the two are
combined. Thus, microbiological criteria are best
applied as part of a comprehensive program.
When criteria are not applied as components of
a systematic approach to food safety or quality,
the results are known to be less than satisfac-
tory, as found by Miskimin et al.13 and Solberg
et al.23 These investigators studied over 1,000
foods consisting of 853 ready-to-eat and 180 raw
products.They applied arbitrary criteria for APC,
coliforms, and E. coli and tested the efficacy of
the criteria to assess safety of the foods with re-
spect to Staphylococcus aureus, C. perfringens,
and salmonellae. An APC criterion of less than
106/g for raw foods resulted in 47% of the
samples being accepted even though one or more
of the three pathogens were present, whereas 5%
were rejected from which pathogens were not
isolated, for a total of 52% wrong decisions. An
APC of less than 1 OVg for ready-to-eat foods
resulted in only 5% being accepted that contained
pathogens, whereas 10% that did not yield patho-
gens were rejected. In a somewhat similar man-
ner, a coliform criterion of less than 102/g re-
sulted in a total of 34% wrong decisions for raw
and 15% for ready-to-eat foods. The lowest per-
centage of wrong decisions for ready-to-eat
foods (13%) occurred with E. coli criterion of
less than 3/g, whereas 30% of the decisions were
wrong when the same criterion was applied to
raw foods. Although the three pathogens were
found in both types of foods, no foodborne out-
breaks were reported over the 4-year period of
the study, during which time more than 16 mil-
lion meals were consumed.22
These findings represent some initial data
from the Rutgers Foodservice Program. After a
17-year experience with modifications in surveil-
lance tests, food audits, laundry evaluations, and
more than 30 million meals served, this HACCP-
type system has been very effective.22 The mi-
crobial guidelines employed by this program for
raw and ready-to-eat foods are presented in
Table 21-3. Of over 1,600 food samples exam-
ined over the period 1983-1989, only 1.24% con-
tained pathogens, with protein salads most often
contaminated (4.3%). Among the foods that
failed microbial surveillance were raw vegetables
(they had excessive coliform numbers).22 The
Rutgers Foodservice HACCP-based system is an
example of how microbial criteria can be inte-
grated to provide for safe foods; in the 17-year
program, no foodborne illness occurred.22
Microbiological Criteria for Various
Products
Prior to the development of the HACCP and
sampling plan concepts, microbiological crite-
ria (generally referred to as standards at the time)
were applied to a variety of products.
Presented below are foods and food ingredi-
ents that are covered under microbiological stan-
dards of various organizations along with fed-
eral, state, and city standards in effect (after
W.C. Frazier, Food Microbiology, 1968, courtesy
of McGraw-Hill Publishing Company).
1. Standards for Starch and Sugar (National
Canners Association)
A. Total thermophilic spore count: Of the
five samples from a lot of sugar or
starch none shall contain more than 150
spores per 10 g, and the average for all
samples shall not exceed 125 spores per
10g.
B. Flat-sour spores: Of the five samples,
none shall contain more than 75 spores/
1Og, and the average for all samples
shall not exceed 50 spores per 10 g.
C. Thermophilic anaerobe spores: Not
more than three (60%) of the five
samples shall contain these spores, and
in any one sample, not more than four
(65%) of the six tubes shall be positive.
D. Sulfide spoilage spores: Not more than
two (40%) of the five samples shall
contain these spores, and in any one
sample, there shall be no more than five
colonies per 1Og (equivalent to two
colonies in the six tubes).
Table 21-3 ICMSF Sampling Plans and Recommended Microbiological Limits

Class
Products Tests Case Plan n C /77 M Comments

Precooked breaded fish APC 2 3 5 2 5 x 105 107

E. coli 5 3 5 2 11 500
S. aureus 8 3 5 1 103 104 Products likely to be
mishandled
Raw chicken (fresh or frozen), during APC 1 3 5 3 5 x 105 107 In-plant processing
processing
Frozen vegetables and fruit, pH 4.5 E. coli 5 3 5 2 102 103 /77 value is an estimate
Comminuted raw meat (frozen) and APC 1 3 5 3 106 107 In-plant control
chilled carcass meat
Cereals Molds 5 3 5 2 102-104 105 /77 values are estimates
Frozen entrees containing rice or corn S. aureus 8 3 5 1 103 104 m value is estimated
flour as a main ingredient
Noncarbonated natural mineral and Coliforms 5 2 5 0 0 Not for use in infant formula
bottled noncarbonated waters or use by highly
susceptibles
Roast beef Salmonella 12 2 20 0 0
Frozen raw crustaceans S. aureus 7 3 5 2 103 104
V. parahaemolyticus 8 3 5 1 102 103
Salmonella* 10 2 5 0 0
APCt 2 3 5 2 5x105 107
E. coin 5 3 5 2 11 500
S. aureusf 8 2 5 0 103

Note: Except where noted for in-plant use, they are intended primarily for foods in international trade and are cited here primarily to illustrate the assignment of products to case
and limits on a variety of organisms. The ICMSF reference10 should be consulted for methods of analysis and more details in general.

*Normal plans and limits.

Additional tests where appropriate.
2. Standard for "Bottlers" Granulated Sugar,
Effective July 1, 1953 (American Bottlers
of Carbonated Beverages)
A. Mesophilic bacteria: Not more than
200 per 1Og.
B. Yeasts: Not more than 10 per 1Og.
C. Molds: Not more than 10 per 1Og.
3. Standard for "Bottlers" Liquid Sugar, Ef-
fective in 1959 (American Bottlers of Car-
bonated Beverages). All figures based on
dry-sugar equivalent (D.S.E.)
A. Mesophilic bacteria (a) Last 20
samples average 100 organisms or less
per 10 g of D.S.E.; (b) 95% of last 20
counts show 200 or less per 1Og; (c) 1
of 20 samples may run over 200; other
counts as in (a) or (b).
B. Yeasts: (a) Last 20 samples average 10
organisms or less per 10 g of D.S.E.; (b)
95% of last 20 counts show 18 or less
per 10 g; (c) 1 of 20 samples may run
over 18; other counts as in (a) and (b).
C. Molds: Standards like those for yeasts.
4. Standards for Dairy Products
A. From 1965 recommendations of the
U.S. Public Health Service.
a. Grade A raw milk for pasteuriza-
tion: Not to exceed 100,000 bacte-
ria per milliliter prior to commin-
gling with other producer milk; and
not exceeding 300,000 per millili-
ter as commingled milk prior to pas-
teurization.
b. Grade A pasteurized milk and milk
products (except cultured prod-
ucts): Not over 20,000 bacteria per
milliliter, and not over 10 coliforms
per milliliter.
c. Grade A pasteurized cultured prod-
ucts: Not over 10 coliforms per
milliliter.
Note: Enforcement procedures for
(a), (b), and (c) require a three-out-
of-five compliance by samples.
Whenever two of four successive
samples do not meet the standard, a
fifth sample is tested; and if this ex-
ceeds any standard, the permit from
the health authority may be sus-
pended. It may be reinstated after
compliance by four successive
samples has been demonstrated.
B. Certified milk (American Association
of Medical Milk Commissions, Inc.)
a. Certified milk (raw): Bacterial plate
count not exceeding 10,000 colo-
nies per milliliter; coliform colony
count not exceeding 10 per millili-
ter.
b. Certified milk (pasteurized): Bac-
terial plate count not exceeding
10,000 colonies per milliliter before
pasteurization and 500 per millili-
ter in route samples. Milk not ex-
ceeding 10 coliforms per milliliter
before pasteurization and 1
coliform per milliliter in route
samples.
C. Milk for manufacturing and process-
ing (USDA, 1955)
a. Class 1: Direct microscopic clump
count (DMC) not over 200,000 per
milliliter.
b. Class 2: DMC not over 3 million
per milliliter.
c. Milk for Grade A dry milk prod-
ucts: must comply with require-
ments for Grade A raw milk for pas-
teurization (see above).
D. Dry milk
a. Grade A dry milk products: at no
time a standard plate count over
30,000 per gram, or coliform count
over 90 per gram (U.S. Public
Health Service).
b. Standards of Agricultural Market-
ing Service (USDA):
(1)Instant nonfat: U.S. Extra
Grade, a standard plate count
not over 35,000 per gram, and
coliform count not over 90 per
gram.
(2) Nonfat (roller or spray): U.S.
Extra Grade, a standard plate
 count not over 50,000 per gram;
U.S. Standard Grade, not over
100,000 per gram
(3) Nonfat (roller or spray): Direct
microscopic clump count not
over 200 million per gram; and
must meet the requirements of
U.S. Standard Guide. U.S. Ex-
tra Grade, such as used for
school lunches, has an upper
limit of 75 million per gram,
c. Dried milk (International Dairy
Federation proposed microbiologi-
cal specifications, 1982).
Mesophilic count: n = 5, c = 2,
m = 5x 1 0 \ M = 2 x 105
Coliforms: n = 5, c= I, m = 10,
M = 100
Salmonella: n = 15, c = 09 m = 0
E. Frozen desserts
States and cities that have bacterial
standards usually specify a maximal
count of 50,000 to 100,000 per millili-
ter or gram. The U.S. Public Health Or-
dinance and Code sets the limit at
50,000 and recommends bacteriologi-
cal standards for cream and milk used
as ingredients. Few localities have
coliform standards.
5. Standard for Tomato Juice and Tomato
Products—Mold-count Tolerances (Food
and Drug Administration)
The percentage of positive fields tolerated
is 2% for tomato juice and 40% for other
comminuted tomato products, such as cat-
sup, puree, paste, and so forth. A micro-
scopic field is considered positive when
an aggregate length of not more than three
mold filaments present exceeds one-sixth
of the diameter of the field (Howard mold
count method). This method also has been
applied to raw and frozen fruits of various
kinds, especially berries.
Other Criteria/Guidelines
1. Sampling plans and microbiological lim-
its for nine products as recommended by
ICMSF10 are presented in Table 21-3 (for
an explanation of plan stringency or case,
see Table 2 1 ^ ) . The examples presented
were selected to reflect different plan strin-
gencies (for two- and three-class plans) and
limits for a variety of organisms.
2. Suggested guidelines for further processed
deboned poultry products studied in
Canada. See Table 21-5.
3. Canadian criteria for cottage cheese and
ice cream18:
Coliforms: n = 5, c = 1, m = 10, M = 103
(for cottage cheese and ice cream)
Aerobic plate count: n = 5, c = 2, m = 105,
M=IO 6 (for ice cream only)
4. Recommended criteria for cooked ready-
to-eat shrimp17:
S. aureus: n = 5,c = 2, m = 50, M = 500
Coliforms: n = 5,c = 2,m = 102, M= 103
5. Recommended criteria for cooked ready-
to-eat crabmeat 17 :
S. aureus: n = 5, c = 2, m = 102, M= 103
Coliforms: n = 5,c = 2,m = 500,M- 5,000
Both products in criteria 4 and 5 should be free
of salmonellae and L. monocytogenes. The
coliform criteria are recommended for process
integrity.
Table 21-4 Plan Stringency in Relation to Degree of Health Hazard and Conditions of Use

Conditions in Which Food Is Expected To Be Handled

and Consumed after Sampling

Reduce Degree Cause No Change May Increase

Type of Hazard of Hazard in Hazard Hazard

No direct health hazard

Utility (e.g., general contamination, Case 1 Case 2 Case 3
reduced shelf life, and spoilage)
Health hazard
Low, indirect (indicator) Case 4 Case 5 Case 6
Moderate, direct, limited spread Case 7 Case 8 Case 9
Moderate, direct, potentially extensive Case 10 Case 11 Case 12
spread
Severe, direct Case 13 Case 14 Case 15

Source: ICMSF,10 copyright © 1986 by University of Toronto Press, used with permission.

Table 21-5 Suggested Guidelines for Further Processed Deboned Poultry Products

Tests/Conditions n c m M
4
APC (heat before serving) 5 3 10 105
APC (cook before serving) 5 3 106 107
APC (bring to boil before serving) 5 3 105 106
S.aureus 5 1 102 104

E.coli 5 2 10 102

Note: No salmonellae, yersinae, or campylobacters allowed.

Source: From Warburton et al.30

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