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Executive
Summary
In September 1980 four federal agencies) requested that the National
Research Council convene a panel of experts to formulate general prin-
ciples for the application of microbiological criteria to food and food
ingredients and to provide recommendations for a unified, coordinated
appproach to the subject by policy-setting agencies. This report has been
prepared by the Food and Nutrition Board Subcommittee on Microbio-
logical Criteria in response to that request. The summary presented here
follows the structure of the report:
I. Introduction (Chapter 1)
II. Basic Considerations
A. Definitions, Purposes, and Needs for Microbiological Cri-
teria (Chapter 2)
B. Selection of Foods for Criteria Related to Safety (Chapter 3)
C. Selection of Pathogens as Components of Microbiological
Criteria (Chapter 4)
D. Selection of Indicator Organisms and Agents as Components
of Microbiological Criteria (Chapter 5)
E. Consideration of Sampling Associated with a Criterion
(Chapter 6)
F. Consideration of Decision (Action) to be taken when a Cri-
terion (Limit) is Exceeded (Chapter 7)
The National Marine Fisheries Service (NMFS), the U.S. Department of Agriculture (USDA),
the Food and Drug Administration (FDA), and the U.S. Army Natick Research and Development
Center.
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2 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA
G. Current Status of Microbiological Criteria and Legislative
Bases (Chapter 8)
III. Application of Microbiological Criteria to Foods and Food In-
gredients (Chapter 9)
IV. Expansion of the HACCP System in Food Protection Programs
(Chapter 10)
V. Plans of Action for Implementation of the HACCP System and
of Microbiological Criteria for Foods and Food Ingredients
(Chapter 11)
Summary responses to 13 specific contract items related to certain
aspects of microbiological criteria are given in Appendix A.
INTRODUCTION
Microorganisms are always associated with harvested plants and slaugh-
tered animals, the raw materials of the food industry. Except for foods
that are heat processed to the degree that they are sterilized, microorgan-
isms are usually associated with food products. Some of these microor-
ganisms may cause spoilage, others may cause foodborne disease, and
still others may bring -about desirable changes as a result of growth in
foods with which they are associated.
There are two broad categories of foods, i.e., those that are shelf-stable
and those that are perishable. The factors responsible for the stability of
shelf-stable products must be properly controlled. With perishable foods,
processing and storage conditions must be controlled to achieve maximum
shelf-life consistent with product safety. Approaches to assurance of con-
trol have varied. Among these have been (1) education and training,
(2) inspection of facilities and operations, and (3) microbiological testing.
The limitations of each are discussed in this report.
The subcommittee concluded that the Hazard Analysis Critical Control
Point system (HACCP), first presented at the 1971 National Conference
on Food Protection, provides a more specific and critical approach to the
control of microbiological hazards in foods than that provided by tradi-
tional inspection and quality control approaches (see Chapters 1 and 10~.
The system consists of (1) identification and assessment of hazards as-
sociated with growing, harvesting, processing, marketing, preparation,
and use of a given raw material or food product; (2) determination of
critical control points to control any identifiable hazard; and (3) establishment
of systems to monitor critical control points. Properly applied, the HACCP
system separates the essential from the superfluous aspects of microbio-
logical control by focusing attention on those points that directly affect
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EXECUTIVE SUMMARY
-
safety and quality and by monitoring to determine whether or not these
points are under control.
Monitoring may involve the application of microbiological testing, but
more often physical and chemical tests as well as visual observations are
used (see Chapter 101.
The HACCP system has been successfully applied to microbiological
control of low-acid canned foods, in which case it is mandated by federal
law. It is likewise employed by some food processors in the control of
products other than low-acid canned foods. But the use of the HACCP
system by the food industry is far from universal, despite its merits.
The HACCP system offers the food processor a rational approach to
microbiological control. Of equal importance, the application of the HACCP
system can lead to more effective and economical utilization of regulatory
personnel as the inspector can focus attention on review of monitoring
results. If these indicate satisfactory control over critical control points,
the inspector has a high degree of assurance that the control of micro-
biological hazards has been effective and can expend his efforts elsewhere.
Chapter 10 presents the details of the HACCP system and the problems
that must be solved if this system is to be embraced by the food industry
and regulatory authorities.
BASIC CONSIDERATIONS
Standards, guidelines, and specifications are the terms used to identify
the microbiological criteria that are discussed in this report (Chapter 21.
A standard is part of a law or ordinance and is a mandatory criterion. A
guideline is a criterion used to assess microbiological conditions during
the processing, distribution, and marketing of foods. Guidelines are man-
datory in that they signal when there are microbiological problems that
require attention. A specification is used in purchase agreements between
buyers and vendors of a food or ingredient. They may be mandatory or
advisory.
The components of a microbiological criterion are described and some
of the potential contributions of criteria to food safety and quality are
discussed (Chapter 21. The report emphasizes that microbiological criteria
should be established and implemented only when there is a need and
when the criterion can be shown to be effective and practical. It was
concluded that microbiological quality standards such as those recently
proposed for seafoods by FDA should be reviewed and evaluated according
to the plan proposed in Chapter 11.
There are a number of factors that will determine the foods for which
criteria related to safety might be applied (Chapter 31. Of special impor
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4 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA
lance is epidemiological evidence that the food in question is a significant
vehicle of disease. Also important are various hazard considerations which
include (1) susceptibility of the food to contamination by pathogens, (2) the
opportunity for the survival of pathogens, (3) the likelihood of microbial
growth during manufacture, storage, distribution, and preparation for serv-
ing, (4) whether or not the food is to be cooked prior to serving, and
(5) the susceptibility of Probable consumers to infectious agents or toxins.
Microorganisms suitable as components of microbiological criteria
(standards, guidelines, specifications) have been placed in two catego-
r~es-pathogens and indicator organisms. Pathogens (Chapter 4) suitable
for this purpose are those likely to be found in a food or ingredient that
thereby becomes a potential vehicle for transmission of the organism or
its toxin to consumers. Indicator organisms (Chapter 5) are those whose
presence in a food indicates (1) that a pathogen or its toxin of concern
may be present, (2) that faulty practices occurred that may adversely affect
safety or shelf-life of the product, or (3) that the food or ingredient is
unsuited for an intended use.
Although the list of foodborne diseases and the microbial agents that
cause them is long, only about 20 are known to be transmitted by foods
with a consequence and/or frequency serious enough to cause concern.
The discussion of each of these organisms2 includes its relative importance,
the status of the methodist available for its detection and/or enumeration,
and conclusions on the suitability of each to be a component of a micro-
biological criterion; with respect to the latter, specific recommendations
have been made.
Indicator organisms and agents were evaluated relative to their use for
the assessment of (1) numbers of microorganisms and/or microbial activ-
ity,3 (2) potential human or fecal contamination or potential presence of
~- ~ ~ ~ ~
2For emphasis the pathogens have been grouped in three categories according to the severity
of the hazard they present:
Severe hazards: Clostridium botulinum, Shigella, Vibrio cholerae, Salmonella typhi, Sal-
monella paratyphi A, Salmonella paratyphi B. Salmonella paratyphi C, Salmonella sendai, Sal-
monella cholerae-suis, Brucella abortus, Brucella melitensis, Brucella suds, Mycobacterium
bovis, hepatitis A virus, fish and shellfish toxins, and certain mycotoxins.
Moderate hazards, potentially extensive spread: Salmonella (species other than those given
above), pathogenic Escherichia colt, and Streptococcus pyogenes.
Moderate hazards, limited spread: Staphylococcus aureus, Clostridium perfringens, Bacillus
cereus, Vibrio parahaemolyticus, Coxiella burnetii, Yersinia enterocolitica, Campylobacterfetus
subsp. jejuni, Trichinella spiralis, and histamine.
3Aerobic plate count, thermoduric, psychrotrophic, thermophilic, proteolytic and lipolytic
counts, the direct microscopic count, Howard mold count, rot fragment count, "machinery
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EXECUTIVE SUMMARY
s
pathogens,4 and (3) post-heat processing contamination.5 Each of these
organisms, in addition to agents, 3 6 was discussed relative to its impor-
tance, its status and limitation of method of detection or enumeration, and
its suitability as a part of a microbiological criterion.
It is recognized that the sampling plan and decision criteria are essential
components of a microbiological criterion (Chapter 6~. They should be
based on sound statistical concepts. The International Commission on
Microbiological Specifications for Foods (ICMSF) concept of relating the
stringency of the sampling plan to the degree of hazard of the food was
endorsed by the subcommittee as an effective means in the selection
process. Whenever applicable, attributes sampling plans such as the-ICMSF
2- and 3-class plans are recommended for microbiological criteria of foods
and food ingredients in the United States.
The action taken when the limit of a criterion is exceeded relates to the
purpose for which the criterion was established (Chapter 71. Actions that
may be taken under the following circumstances are discussed: (1) evidence
of existence of a direct health hazard, (2) evidence that a direct health
hazard could develop, (3) indications that a product was not produced
under conditions assuring safety, (4) indications that a raw material may
adversely affect shelf-life, and (5) evidence that a critical control point is
not under control.
Microbiological criteria are applied at the international, federal, and
state or local levels (Chapter 81. The programs of the Joint FAD/WHO
Codex Alimentarius Commission, the European Economic Community
(EEC) and the ICMSF are described. The Canadian food standards also
are discussed.
The role and activities of the Food and Drug Administration (FDA),
the U.S. Department of Agriculture (USDA), the U.S. Army Natick Re-
search and Development Center of the Department of Defense, and the
National Marine Fisheries Service (NMFS) of the Department of Com-
merce relative to microbiological criteria for foods are outlined.
mold," yeast and mold count, heat-resistant molds, and thermophilic spore count. Examination
for metabolic products such as by organoleptic examination, dye or indicator reduction time,
pH, trimethylamine, total volatile nitrogen, indole, ethanol, diacetyl, histamine, endotoxins
(Limulus amoebocyte lysate test), extract release volume, and adenosine triphosphate.
4Staphylococci, Escherichia colt, fecal coliforms, enterococci, and Pseudomonas aeruginosa.
sColiform bacteria and Enterobacteriaceae.
6Thermonuclease and the use of U.V. light are discussed in a section on metabolic products
of pathogens that indicate a potential health hazard. Included also is the application of the
phosphatase test for milk and milk products.
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6 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA
APPLICATION OF MICROBIOLOGICAL
CRITERIA TO FOODS AND FOOD INGREDIENTS
Detailed information on the application of microbiological criteria to
22 groups of foods and food ingredients is given in Chapter 9.
Dairy Products
Microbiological criteria play an important role as part of overall quality
assurance programs applied by both industry and regulatory authorities.
Microbiological safety of dairy products can be assured only through
(1) pasteurization or more severe heat treatments, (2) prevention of post-
heat treatment contamination and, for certain products, (3) end-product
testing for appropriate pathogens or toxins. Microbiological criteria for
most dairy products are included as an integral part of documents that
present in detail the FDA and USDA dairy products control programs.
The subcommittee concluded that, with few exceptions, there appears to
be no need for imposing more severe or additional criteria.
The Salmonella testing of dried milk as provided for in the USDA
Salmonella Surveillance Program is a case in point. This Program has
been reviewed in this report, and deilclencles primarily in sampling plans
(which directly affect the severity of criteria imposed) have been pointed
out. Recommendations for correction of these deficiencies as well as
strengthening of the program have been made.
Cheese is the other product for which greater attention to finished-
product testing for a pathogen or its toxin is indicated. Of primary concern
is S. aureus, especially its enterotoxins. The hazard is limited primarily
to hard varieties, e.g., Cheddar and similar types and Swiss or Emmen-
thaler. This hazard has been discussed and suggestions have been made
for more rigorous application of microbiological criteria in programs to
control this hazard.
The continuous problem of the hazard of consuming raw milk and fresh
cheese made from raw milk have been given particular attention. Outbreaks
of milkborne disease caused by drinking raw milk purchased legally con-
tinue to occur in the United States with regularity. Brucellosis due to
consumption of fresh cheese made from raw milk and enterocolitis caused
by certain pathogenic strains of E. cold are of recent occurrence. A strong
position has been taken pointing out that health professionals have a
responsibility to encourage efforts to see that the public and policymakers
are kept adequately informed so that public policy on raw milk and dairy
products made from raw milk is compatible with scientific knowledge and
protection of the public's health.
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EXECUTIVE SUMMARY
7
Raw Meats and Poultry
The causes and contributing factors of foodborne illness from meats
and poultry have been thoroughly examined. The subcommittee could not
establish a need for microbiological standards for pathogens in raw meat
and poultry. Efforts to reduce foodborne illness caused by cooked meat
and poultry should be directed to improved education, e.g., recognition
of the potential presence of pathogens in raw animal foods and proper
handling of raw and processed animal foods. In view of this need, renewed
efforts to educate all persons that handle raw and processed animal foods
of potential risks and proper food-handling practices are of the highest
priority.
Factors relating to achieving optimum shelf-life of raw meat and poultry
are discussed. These include processing and storage conditions. The ap-
plication of microbiological guidelines to monitor these operations is in-
dicated.
Present inspection practices of food-processing facilities by regulatory
agencies need a more cost-effective approach by application of the HACCP
system. Because the vast majority of foodborne disease is the direct result
of mishandling of foods in food service operations and homes, the extent
of regulatory inspection of food service operations is disproportionate
compared with that of food-processing facilities. Therefore, emphasis of
inspection should be directed more to those areas where mishandling of
animal foods occurs more frequently, namely food service operations.
Fish, Molluscs, and Crustaceans
Measures to promote the safety and shelf-life of fish and shellfish are
treated in this report. Although strict adherence to the recommendations
of the National Shellfish Sanitation Program (NSSP) generally has resulted
in the production of safe shellfish, there is need for more effective measures
for monitoring the safety of these products, particularly with reference to
the presence of viruses that may cause illness in humans.
Intoxication (ciguatera and scombroid and paralytic shellfish poisoning
EPSPl) resulting from consumption of fish and shellfish is a major concern.
The regulatory limits for histamine in tuna and PSP toxin in raw shellfish
are recognized as useful in the control of these foodborne diseases. Relative
to ciguatera there is a need for a simple reliable test to detect toxic fish.
The quality of raw fish can best be assured through application of the
HACCP approach by sensory inspection of raw materials, proper tem-
perature control, sanitation of equipment, and proper handling of product
by employees.
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8 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA
There are conflicting reports about the botulism hazard of raw fish
stored under refrigeration in vacuum packages or in modified atmospheres.
Thus, this packaging-storage method is not recommended for raw fish at
the present time-there is need for research to examine the safety of this
practice.
Except for the NSSP criteria for shellfish, many of the microbiological
criteria for fish and seafoods at the state or local level are not based on
sound data or experience and are impractical from the standpoint of com-
pliance or enforcement. These criteria need to be reexamined relative to
the plans of action proposed in this report. It is recommended that the
recently proposed FDA criteria for frozen crab cakes, frozen fish cakes,
frozen fish sticks, and raw breaded shrimp be reviewed and evaluated
according to the plan proposed in Chapter 11.
Processed Animal Products
Though such products as ground meat, poultry parts, and fish fillets
are classified as processed, the safety and spoilage problems involved are
the same as discussed above relative to raw animal products.
In the present context, processed animal products are foods that are
produced through the application of various physical and/or chemical
treatments to raw animal products. Such treatments as pasteurization,
curing, salting, and acidulation (including fermentation) tend to destroy
or otherwise control the development of the microorganisms that normally
spoil the raw products. Likewise, to a greater or lesser extent, these
treatments destroy or prevent the growth of foodborne disease agents.
These products vary considerably in their stability. Country cured hams
and dry sausages may be stored for long periods at ambient temperatures
without spoilage, whereas luncheon meats, cooked poultry, and smoked
fish are highly perishable. Similarly, some of these products, if contam-
inated and subject to temperature abuse, readily support the growth of
toxigenic organisms. Ham, for example, has historically been the most
important cause of staphylococcal foodborne illness. Others such as dried
meats, poultry, and fish will not support the growth of pathogens but may
create hazards if abused after reconstitution with water.
The application of the HACCP system to the control of the safety and
quality of these products is discussed. In many cases microbiological
criteria play a role and where they apply they have been identified; but
more often, physical and chemical measurements are the most effective
means of monitoring critical control points.
Three products in this category have in recent years caused multiple
outbreaks of foodborne illness, namely smoked fish (botulism), dry sau
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-
EXECUTIVE SUMMARY
sage (staphylococcal intoxication), and cooked roast beef (salmonellosis).
Effective control measures are discussed.
9
Eggs and Egg Products
The regulation of eggs and egg products by the USDA in accordance
with the Egg Products Inspection Act of 1970 is probably largely respon-
sible for the dramatic decrease in egg-associated salmonellosis in recent
years.
Microbiological criteria play no role in the control of shell egg quality.
Defective shell eggs are essentially eliminated from commerce by sorting
and candling.
Microbiological guidelines are useful in the monitoring of critical con-
trol points in the production of egg products, e.g., equipment sanitation
and environmental monitoring. The pasteurizing step is more effectively
monitored by observing time/temperature relationships. A microbiological
standard is applied to finished egg products and is enforced by the USDA.
Deficiencies in the sampling plans embodied in this criterion are discussed
and appropriate changes are recommended.
Fruits and Vegetables
Raw fruits and vegetables as marketed may harbor large populations of
viable microorganisms, but they have not presented a serious public health
problem in the United States and consequently the application of micro-
biological criteria to these foods is not recommended.
In the processing of fruits and vegetables for canning, drying, and
freezing, there are opportunities for microbial buildup on equipment and
growth in the food. Guidelines that limit counts of microorganisms or
utilize microscopic counts for molds are recommended as a means of
monitoring critical control points and promoting good processing condi-
tions.
Fruit Beverages
Because of their high acidity, fruit juice beverages have rarely been
vehicles for foodborne pathogens. Guidelines that limit numbers of viable
organisms or levels of metabolic products can be useful to monitor critical
control points in the processing line. Specifications that restrict spore
counts of heat-resistant molds are recommended as a means to minimize
spoilage outbreaks of pasteurized fruit beverages.
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10 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA
Canned Foods
The production of low-acid, acid, and water activity-controlled canned
foods is regulated by the FDA. Regulations governing this program are
contained in the Code of Federal Regulations. These regulations embody
the HACCP approach to the control of safety and quality. Canned products
were the first foods to which the application of HACCP was mandated
by regulation. The success of this program should serve as a model to
other segments of the food industry.
Though finished-product microbiological criteria play no role in assur-
ing the acceptability of finished products, guidelines are used in monitoring
critical control points including equipment cleaning and sanitizing, mi-
crobial buildup during operations, and the microbiological quality of chill
water. Further, specifications are applied to critical raw materials to assure
that the level of heat-resistant sporeformers does not exceed acceptable
limits.
Cereals and Cereal Products
The usefulness of criteria for grains, pasta products, and pastries was
considered, as were public health problems associated with these foods.
The presence of mycotoxins on grains, contamination of soy and pasta
products with salmonellae, and the growth of Staphylococcus aureus in
certain cream-filled pastries were identified as the major problems. The
use of microbiological criteria in support of HACCP programs is rec-
ommended for these products.
Fats and Oils
Fats and oils in the presence of moisture and other essential nutrients
are subject to degradation by a variety of microorganisms. Such a condition
is provided by several processed foods in which fats and oils are major
ingredients. Mayonnaise, salad dressings, peanut butter, margarine, and
butter are of concern. For each of these products, the application of each
or all of the three types of microbiological criteria is useful and in some
instances essential to safety. For example, with respect to peanut butter
routine testing of raw peanuts for aflatoxin and of the finished product
for Salmonella is essential.
The characteristics of these products that relate to either microbial growth
or inhibition of growth in them are discussed, as are significant sources
of contamination with either spoilage organisms or pathogens. Applica-
tions of microbiological guidelines for monitoring critical control points
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EXECUTIVE SUMMARY
11
of manufacture are described. The need for routine testing of peanut butter
for Salmonella has been emphasized. The subcommittee recommends
amending the standards of identity for mayonnaise and salad dressings to
include a specific requirement for a pH of 4.1 or below in the aqueous
phase of these products.
Sugar, Cocoa, Chocolate, and Confectioneries
The major microbiological concerns for these foods are the presence of
bacterial spores and yeasts in sugar and of salmonellae in cocoa and
chocolate. Specifications that limit thermophilic spores in sugar for can-
ning; yeasts, molds, and mesophilic bacteria in sugar for bottled beverages;
and osmophilic yeasts for confectionery products are appropriate. The
ingredients of confectionery and similar ready-to-eat foods should be free
of enteric pathogens, in particular salmonellae.
Spices
Microbiological concerns are governed by end use. Spices to be used
as table condiments should be free of salmonellae. Spices containing high
numbers of sporeforming bacteria may cause spoilage during the heat
processing of certain luncheon meats; those containing thermophilic spore-
formers may cause spoilage of canned foods. In these instances, spices
as ingredients constitute a critical control point and are generally monitored
via specifications. Ethylene oxide and irradiation treatments are appro-
priate control procedures when necessary.
Yeasts
Salmonellae in yeasts, especially in nutritional yeast that will be eaten
without further heating, are a major concern. HACCP programs in the
yeast industry must include routine testing for this pathogen. Microbio-
logical guidelines are useful in the yeast industry for monitoring good
manufacturing practices. Microbiological testing is also useful for the
detection of contaminants that may cause spoilage of products containing
yeasts, e.g., rope spores.
Formulated Foods
This broad category of products includes commercially prepared ready-
to-cook or ready-to-eat foods containing ingredients from two or more
food commodity categories. Beef and chicken potpies, the various pack
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12 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA
aged meals or "dinners," meat and seafood salads, pizzas, dried infant
formulae, dry soup mixes, and cake mixes are only a few examples of
the host of such products that are available to the public. It has been
emphasized that no useful single microbiological criterion can be devel-
oped. Rather, the potential hazards of each product or group of products
must be identified. Appropriate programs that embody the HACCP system
including microbiological criteria (particularly guidelines as applied at
critical control points in manufacture) must be individually designed if
microbial growth and resulting hazard to health or of spoilage are to be
prevented. Attention has been drawn to regulations of several states that
specify a single criterion for all products within diverse groups such as
salads. The deficiency of such criteria is presented.
Nuts
With the exception of coconut, the water activity of most nuts is suf-
ficiently low to preclude bacterial growth. Because the growth of molds
with the production of mycotoxins is a problem with peanuts and certain
tree nuts, testing for these toxins should be part of a HACCP program.
Nonsterile coconut should be free of salmonellae.
A standard for E. cold on tree nuts has been imposed by the FDA. The
presence of this organism is interpreted as an indication of the presence
of filth. The subcommittee is not aware of epidemiological evidence that
suggests a relationship between the presence of E. cold and enteric path-
ogens in nuts.
Miscellaneous Additives
Gums, enzymes, and food colors are included in this category. There
is little published information on their microbiology. Processors using
these additives should apply various microbiological criteria, depending
on end use, to assure the safety and quality of their products.
Bottled Water, Processing Water, and Ice
Bottled drinking water must be prepared from a safe source and must
be processed, bottled, held, and transported under sanitary conditions.
There is no epidemiological evidence to indicate that bottled drinking
water sold in the United States offers a health hazard to the public. There-
fore, there appears to be no need for additions to or modification of current
standards. A periodic reassessment of practices in this rapidly expanding
industry relative to the microbiological safety of bottled drinking water
should be made.
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EXECUTIVE SUMMARY
13
Water and ice come in contact with or become a part of many foods
during processing and storage and in food preparation. They have the
potential of contributing spoilage bacteria and on occasion pathogens. The
microbiological safety and quality of water and ice that come in contact
with foods must be ensured.
Pet Foods
A major concern is that intermediate moisture and dry pet foods may
harbor viable salmonellae and thus can be a vehicle for infection in the
household of the pet owner. Microbiological control procedures by the
processor should include (1) specifications that limit salmonellae in in-
gredients, e.g., rendered products, and (2) guidelines for monitoring crit-
ical control points in processing and in the plant environment.
EXPANSION OF THE HACCP SYSTEM IN
FOOD PROTECTION PROGRAMS
Despite the successful application of HACCP in the control of the safety
and quality of low-acid canned foods, this approach has not been uni-
versally adopted by either industry or regulatory agencies in the control
of other foods (see Chapter 101.
The successful application of HACCP to low-acid canned foods can be
attributed to several important factors: (1) industry and government, work-
ing cooperatively, identified critical control points and developed appro-
priate monitoring systems; (2) FDA required the training of key people
involved in processing; (3) FDA inspectors were trained in the elements
of HACCP, and plant inspections placed major emphasis upon review of
monitoring results; and (4) the use of HACCP was mandated by federal
regulation.
If the HACCP system is to be more broadly applied in the food industry,
certain requirements must be met, including:
1. Technical expertise must be employed in applying the system to
each food. This involves a careful analysis of hazards, the identification
of critical control points and the establishment of effective monitoring
systems.
2. Those responsible for regulation must be trained in the elements of
HACCP and in this approach to inspectional activity.
3. Those responsible for food processing must be trained in the HACCP
approach, as was done with key personnel in low-acid canned food plants.
4. The use of the HACCP system by all segments of the food industry
relative to microbiological hazards should be mandatory.
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14 EVALUATION OF THE ROLE OF MICROBlOLOGlCAL CRlTERlA
Adversary attitudes and lack of cooperation between regulatory agencies
and the food industry have presented a serious hindrance to the achieve-
ment of common goals of food safety and quality. These problems were
largely overcome with the application of HACCP to low-acid canned
foods. They continue to be a problem in other segments of the food
industry.
A particularly sensitive issue relates to access to industry records. In-
dustry recognizes that records of observations are needed for meaningful
food protection, e.g., monitoring results from critical control points. But
identification of which records are relevant for regulatory purposes is an
issue of major disagreement. Much of the information in question may
relate to manufacturing practices that may be proprietary. The regulator
should have access to monitoring results at critical control points and the
actions taken by the processor when limits are exceeded. The issue of
access of records should be reviewed and resolved, as it is a serious
impediment to expansion of the HACCP concept. Relative to HACCP,
the subcommittee concluded that there should be no need for regulatory
access to proprietary information having no relevance to food quality or
safety.
PLANS OF ACTION
The subcommittee has proposed two plans of action that should be taken
(Chapter 111. The first is a plan of action through which the use of the
HACCP system could be applied universally in food protection programs
of industry. The second is a plan for the implementation of microbiological
criteria.
Representative terms from entire chapter:
critical control