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OCR for page 308
10
Expansion of the
HACCP System in Food
Protection Programs
This subcommittee embraces the Hazard Analyses Critical Control Point
(HACCP) concept as an effective and rational approach to the assurance
of safety and to the prevention or delay of spoilage in foods (see Chapter
1 and Appendix G). In the application of HACCP the use of microbio-
logical criteria is at times the most effective means of monitoring critical
control points. In other instances, monitoring of critical control points can
best be accomplished through the use of physical and chemical tests, visual
observations, and sensory evaluations. Thus, microbiological criteria may
play an important role or no role at all depending upon the nature of the
food or the process. The applicability of microbiological criteria to the
monitoring of critical control points in the production of various food
commodities is discussed in detail in Chapter 9.
FACTORS TO BE CONSIDERED
FOR IMPLEMENTATION OF HACCP
Initially, HACCP was established by the FDA as an approach to the
control of microbiological hazards in the mushroom-canning industry.
After considerable refinement, the FDA applied HACCP to all low-acid
canned foods; this approach to the control of microbiological hazards in
low-acid canned foods was then mandated by federal regulations (FDA,
1973a,b).
The application of HACCP as a means of controlling microbiological
hazards in low-acid canned foods has been successful for a number of
reasons:
308
OCR for page 309
EXPANSION OF THE HACCP SYSTEM
309
1. Industry and government, working cooperatively, identified and de-
veloped monitoring procedures for critical control points in the
production of this class of foods. The procedures included details
with respect to the frequency with which the tests should be per-
formed, the keeping of records, and the actions to be taken when
monitoring results indicated lack of compliance, i.e., failure at a
critical control point.
2. The FDA required that operators of retorts, aseptic processing pack-
aging systems, product formulating systems, and container closure
inspectors be under the supervision of a person who had satisfac-
torily completed the prescribed course approved by the FDA Com
· ~
missioner.
3. FDA inspectors were trained in the elements of the HACCP system.
As a result, FDA inspectors became knowledgeable of the critical
control points in the production of these products. At the time of
plant inspections, major emphasis was placed upon review of mon-
itoring results.
4. The use Of the HACCP .;v.stem was mandated by federal regulation.
The four points below are of considerable importance if the HACCP
system is to be more broadly applied in the food industry:
1. The hazard analysis of a food process requires technical sophisti-
cation as does the identification of critical control points and the
establishment of effective monitoring programs. Assistance from
experts from disciplines other than microbiology may be required.
The large, technically sophisticated processor may have personnel
capable of accomplishing these tasks, whereas smaller operators are
less likely to have them. The HACCP system as it has been applied
to low-acid canned foods evolved as a result of joint industry/gov-
ernment cooperation. For it to be applied effectively in other areas,
similar cooperative efforts will be required. This need not necessarily
require industry/government collaboration, but the appropriate tech-
nical manpower can be mobilized within segments of the industry.
This could be done through various industry trade associations. For
example, the American Meat Institute (AMI, 1982) published guide-
lines for the production of dry and semidry sausages. Technical
expertise for the establishment of these guidelines came from within
the industry, and there seems little doubt that they will be acceptable
to the USDA, the organization responsible for regulating these prod-
ucts.
If only the technically sophisticated companies within a given
segment of the food industry apply the HACCP system, then the
OCR for page 310
310 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA
value of an industry-wide application to the production of a given
product or products will be lost. For this reason organized technical
input by industry is essential.
From the pooling of industry and government manpower, specific
codes of Good Manufacturing Practices should evolve. These are
needed since, as indicated in Chapter 1, "umbrella" codes are non-
specific and vague to the degree that the courts have held that they
do not have the force of law (U.S. v. An Article of Food, 19721.
If technical manpower is not utilized to establish HACCP systems
within various segments of the food industry, then the weak links
within a given segment will be the technically unsophisticated com-
panies. The argument many be made that use of the HACCP system
would place such companies at a competitive disadvantage. On the
other hand, their failure; to utilize HACCP would tend to result in
greater exposure of their products to microbiological hazards. The
greatest cost/benefit advantage would accrue if all producers within
a given industry were applying HACCP principles in the control of
their products and if regulators were judging manufacturing practices
according to the HACCP principles, i.e., review of the results of
monitoring critical control points.
2. Those responsible for regulation must be trained in the concepts of
the HACCP system. FDA inspectors were so trained in the HACCP
approach as applied to low-acid canned foods. Furthermore, they
received training in application of the HACCP approach to the reg-
ulation of other types of foods. However, HACCP inspections with
respect to other foods were optional. In fact, there have been no
formal personnel training sessions by FDA since 1975. As a result
of the optional status of HACCP inspections and the failure to train
personnel, the HACCP approach to regulatory control has fallen into
disuse in the United States (except for its application to low-acid
canned foods, where it is mandated by law).
3. The successful use of the HACCP approach to the control of low-
acid canned foods was due in part to the mandatory training of
various categories of food processing technicians. Courses at se-
lected universities were established by the FDA for this purpose. If
HACCP is expanded, it will necessitate similar training of individ-
uals in other segments of the industry. This training could be un-
dertaken by industry, perhaps through trade associations or other
appropriate organizations within various segments of the industry.
Again, technical input could come from the technically sophisticated
segments within a given industry.
OCR for page 311
EXPANSION OF THE HACCP SYSTEM
311
4. An important factor contributing to the successful application of
HACCP in the low-acid canned food industry was mandatory use
of this system. For HACCP use to be broadly realized, it is likely
that the utilization of this system will have to be required by reg-
ulation. It would thus be mandated that food processors establish
monitoring programs relating to critical control points affecting the
microbiological safety or quality of their products, such points hav-
ing been established by hazard analysis. Quality attributes other than
those relating to microbiological hazards would not be subject to
such regulation. The regulation would require only a statement to
identify the basic elements of the HACCP system including a pro-
vision requiring that the appropriate records be readily available to
representatives of regulatory agencies. Details of the mechanism of
applying the HACCP system should be the prerogative of the food
establishment.
PROBLEMS ASSOCIATED WITH IMPLEMENTATION OF THE
HACCP APPROACH
It was thought that the HACCP concept, so successfully applied to low-
acid canned foods, would find its place in other segments of the industry,
and that companies producing a given product or group of similar products
would apply the system and identify critical control points and appropriate
monitoring procedures. The regulatory inspectors would initially review
the plant control protocols and satisfy themselves that the critical control
points in a given program had been properly identified and that appropriate
monitoring systems had been established. Regulatory emphasis would next
be focused on a review of monitoring results that, if satisfactory, would
correctly lead the inspector to conclude that the foods of concern were
being produced under adequate microbiological control. This then would
prevent the inspector from duplicating control efforts and would permit
him to proceed elsewhere to make evaluations, thus providing more ef-
ficient use of inspectional personnel. Herein resides the cost/benefit value
of the HACCP approach in regulatory control.
From a regulatory standpoint, a complete familiarity with and under-
standing of processes and product flows would greatly aid agency as-
sessment of the effectiveness of a food firm's programs designed to assure
product safety and quality. However, it is nearly impossible for any one
regulatory inspector to have an intimate knowledge of every type of food-
processing system. Utilization of HACCP as an integral part of the reg-
ulatory process would do much to obviate need for an investigator to know
OCR for page 312
312 EVALUATION OF THE ROLE OF MlCROBlOLOGlCAL CRlTERlA
everything about the intricacies of a firm's processing systems. The net
result would be cost-effective and less time-consuming and more mean-
ingful to the regulatory evaluation of a firm's ability to assure safe and
wholesome products.
In the past, adversary attitudes and lack
of cooperation between regu-
latory agencies and the food industry have presented a serious hindrance
to achievement of common goals of food quality and safety assurance.
Regulatory agencies and the food industry have failed to recognize their
responsibilities in areas of mutual concern and failed to capitalize on the
special abilities and expertise which each can provide. They have failed
to work in concert in an atmosphere of mutual respect, understanding,
and trust to achieve these common objectives.
A particularly sensitive issue in this regard relates to access to industry
records. Industry 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
purpose is an issue of major disagreement between regulatory agencies
and the food industry. Much of the information in question may relate to
manufacturing practices that may be proprietary in nature. The regulator
should have access to monitoring results on critical control points and the
action taken when limits are exceeded.
The issue of access to records should be reviewed and resolved so that
the food industry's apprehensions are allayed and regulatory agencies have
the necessary assistance for effective execution of their responsibilities.
The adversary atmosphere that has historically existed is counterproductive
to both the processor and the regulator and is the most serious impediment
to the expansion of the HACCP concept. There should be no need for
regulatory access to proprietary information having no relevance to food
safety or quality. There is no fundamental reason why the broad application
of HACCP throughout the food industry should not occur. The costlbenefit
ratio is highly advantageous.
The technical expertise necessary to establish HACCP systems in var-
ious phases of the food industry must come from various experts within
the involved industries. Considerations by these experts would result in
identification of appropriate critical control points, monitoring systems,
and acceptable (and relevant) recordkeeping systems that should be ac-
cessible to regulatory authorities. Regulatory officials should have the
option to assess the appropriateness of the selected critical control points,
the adequacy of the monitoring system, and the actions taken when limits
are exceeded. Essential to the implementation of the HACCP system is
the adequate training of inspectors.
OCR for page 313
EXPANSION OF TlIE HACCP SYSTEM
THE NEED FOR APPLICATION OF HACCP
AT ALL POINTS IN THE FOOD CHAIN
313
The foregoing discussion has focused upon the application of HACCP
in food-processing facilities; however, the concept is applicable at all
points in the food chain. A few examples follow.
1. Diseased meat animals constitute a health hazard. The critical control
point identified by the USDA is at the processing plant prior to
slaughter, and it is monitored by ante mortem inspection by veter
inary authorities.
2. Antibiotic residues in milk constitute a health hazard to sensitized
individuals in the human population. Furthermore, such residues
may prevent desired acid production in milk used to manufacture
cheese. This may lead to spoilage or to health hazards such as the
formation of Staphylococcus enterotoxin. These hazards may be
monitored by analysis of milk samples at the farm level or in the
processing plant.
3. Hazardous pesticide residues in fruits and vegetables can be moni-
tored at appropriate points by chemical tests.
4. Storage of improperly dried grain at the farm or elevator level may
cause spoilage and/or the hazard of mycotoxin formation. Critical
control points can be monitored by appropriate tests to assure proper
moisture control.
5. Microbiological hazards can arise during shipment of both perishable
and shelf-stable foods from the processing plant to storage ware-
houses (see Chapter 91. For example, critical control points in the
shipment of carcass meat include the internal temperature of the
carcasses at the time of loading, the temperature of the air circulating
in the transportation vehicle, the spacing of the carcasses, the air
movement within the transportation vehicle, and the temperature of
that air throughout the shipment. These critical control points can
be monitored by physical tests, e.g., recording thermometers and
visual observations.
In the shipment of shelf-stable products, the cleanliness of vehicles
may affect the safety and quality of goods being shipped and thus
is a critical control point. This should be monitored before loading
by visual inspection. Such inspection should include determination
of general cleanliness, the absence of insect and rodent problems,
and the soundness of the transportation vehicle.
6. Improper warehousing frequently leads to product recalls due to
storage of foods under insanitary conditions. These problems can
OCR for page 314
314 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA
be circumvented by appropriate monitoring of identified critical con-
trol points in the storage facility, for example, the monitoring of
insect and rodent control programs.
7. At the retail level abuse of perishable foods, such as meats, poultry,
and fish may lead to health and spoilage hazards. Storage temperature
is a critical control point, as is the method of loading retail cases,
for these may greatly influence temperature distribution. Hazards
are created by cross-contamination. Cleanliness of equipment is a
critical control point.
At no point in the food chain is there greater need for control over
microbiological hazards than in food service establishments and in homes.
Even if all those responsible for food production, from the farmer to the
retailer, are successful in the control of microbiological hazards, the up
timate user of food products is generally responsible for foodborne diseases
as a result of improper handling and storage practices. Table 10-1 dra-
matically illustrates this point. It will be noted that approximately 97%
of foodborne disease outbreaks reported to the Centers for Disease Control
over a 5-year period were traced to mishandling in food service estab-
lishments and in homes. The relationships shown in Table 10-1 are un-
doubtedly skewed. Foodborne disease outbreaks are poorly reported. Isolated
incidents occurring in homes are far less likely to be noted than are large
outbreaks traced to food service establishments. Furthermore, the figure
for the proportion of outbreaks traced to food-processing plants is un-
doubtedly in error "on the high side," since such outbreaks are more
likely to come to the attention of regulatory authorities. The conclusion
is clear: most foodborne illness is caused by those who prepare foods in
homes and food service establishments. If foods are not properly handled
at these two points, foodborne illness is inevitable; thus, this nullifies to
a large extent preventive measures that may have been applied earlier in
TABLE 10-! Foodborne Disease Outbreaks Classified
by Place of Mishandling Foods, United States, 1974 to
1978
Number ofPercent of
PlaceOutbreaksKnown Places
Food service establishment1,28577
Homes32720
Food processing plants523
Other/unknown/unspecified6 15
TOTAL2,279100
SOURCE: Bryan, 1982, p. 67.
OCR for page 315
EXPANSION OF THE HACCP SYSTEM
315
the food chain, e.g., at processing plants and in distribution channels. No
dramatic decrease in the incidence of foodborne disease can be expected
until those who prepare and handle foods in homes and food service
establishments become knowledgeable in the principles of proper food
handling and apply these principles.
Factors contributing to foodborne disease outbreaks are summarized in
Table 10-2. The ultimate consumer of food must, in most cases, "further
process" the products of the food industry, such processing being done
in a kitchen of a home or a food service establishment. The factors listed
in Table 10-2 include processing errors most frequently made at these
points.
The HACCP approach is applicable to the control of microbiological
hazards in food service establishments jut as it is at previous links in the
food chain. The use of the HACCP system in food service establishments
has been studied extensively by Bryan (1982) (Table 10-31. The hazards,
critical control points, and monitoring procedures applicable to food ser-
vice establishments have been set forth in considerable detail. An extensive
bibliography relating to the use of HACCP in controlling microbiological
hazards in a number of specific foods prepared in food service establish-
ments is also given. No attempt will be made to summarize these studies.
TABLE 10-2 Factors Contributing to Outbreaks of
Foodborne Disease, United States, 1961 to 1976
Factors
Percentagesa
Improper cooling
Lapse of a day or more between preparing and serving
Colonized persons touching cooked foods
Inadequate thermal processing, canning, or cooking
Improper hot storage
Inadequate reheating
Contaminated raw food
Cross-contamination
Improper cleaning of equipment
Obtaining foods from unsafe sources
Use of leftovers
46
21
20
16
16
12
7
4
NOTE: Other factors were faulty fermentations, toxic species of plants
or mushrooms mistaken for edible varieties, poor dry storage practices,
storing high-acid foods in toxic containers, incidental additives, and in-
tentional additives (for example, MSG).
aPercentages exceed 100 because foodborne diseases have multiple caus-
ation: foods must become contaminated, contaminants may survive pro-
cesses, and frequently bacterial pathogens multiply to reach large numbers
or to produce toxins.
SOURCE: Bryan, 1978.
OCR for page 316
316
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326 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA
The salient conclusion is that the HACCP system can be used in the
facilities from which most reported outbreaks of foodborne disease arise.
The situation in the food service industry is analogous to that existing
in the food-processing segment. Various codes of practice exist, but these
contain vague terms subject to interpretation by inspectors and food service
managers. As with processing codes little distinction is made between the
important and unimportant, this leading to emphasis on practices of little
significance and underemphasis on those with direct bearing on foodborne
illnesses. A case in point is the USDHEW Food Service Sanitation Manual
(FDA, 1976), which contains a model food service sanitation ordinance
that has been adopted by many states and municipalities by reference.
Unfortunately, those responsible for making inspections at the state and
local levels often are ill-prepared to uniformly interpret the ordinance in
terms of separation of the essential from the extraneous.
As with food-processing operations, the application of the HACCP
concept in food service operations would identify the critical control points
for appropriate monitoring and thereby place emphasis on factors most
responsible for foodborne illness. The application of HACCP to food
service operations would necessitate input from technical personnel within
the industry as well as public health authorities. It would also require
training of inspectors to this new approach. At the present time one of
the greatest deficiencies in food service sanitation is the lack of adequate
regulatory control. At the point from which most foodborne illness prob-
lems emanate there is the least degree of regulation. The use of the HACCP
system would not obviate this problem, but it would greatly increase the
efficiency and effectiveness of existing manpower for inspection.
The elements of HACCP that are applicable to food service establish-
ments also apply to food handling in the home. As laws and regulations
cannot be applied to practices within the home, the alternative is education
in proper food-handling practices. Unfortunately, sporadic attempts to
accomplish this have not been met with much success. For example, in
April 1973 the Gallup Organization reported that, among women, 74%
did not know what Salmonella is; 66% did not know how to minimize its
spread; and 39% thought that raw meat and poultry are inspected for the
presence of Salmonella by federal and state employees (GAO, 19741.
Clearly, educational efforts have not been successful in reducing the in-
cidence of foodborne illness, including salmonellosis, for its incidence
has remained unchanged or perhaps increased somewhat (Silliker, 1980~.
One reason for lack of success of educational programs directed at adults
may be the sporadic nature of educational efforts. Education and training
for prevention of foodborne illness must be continuing processes. New
personnel continuously enter the food-processing and food service indus
EXPANSION OF THE HACCP SYSTEM
327
tries and new homemakers continuously undertake food preparation in the
home. These facts necessitate constant repetition of good food-handling
educational programs. Perhaps positive effects, though long range, could
be expected from educational programs directed toward tomorrow's home-
makers, schoolchildren. Over a period of time they could become knowl-
edgeable and perhaps even influence their elders in proper food-handling
practices. Such programs are virtually nonexistent in the United States.
In Denmark no formal education is directed toward the consumer, but
there is an intensive program providing students in the seventh, eighth,
ninth, and tenth grades with a course consisting of two hours per week
covering food handling, food preparation, and cooking (Health/Agricul-
ture/Industry Committee on Salmonella, 1979~. Such an approach is wor-
thy of consideration in the United States. Adequate teacher training is
essential for its success.
COST/BENEFIT ASPECTS OF REGULATORY CONTROL
THROUGH HACCP INSPECTIONS
The proper implementation of HACCP by the food industry would lead
to more cost-effective and efficient regulatory control. At the present time
the size of the food industry is so great as to make it physically impossible
for the FDA and other regulatory agencies to inspect establishments under
their control with sufficient frequency. With respect to FDA, HACCP
systems would involve, primarily, review of monitoring results. If these
appeared satisfactory, the inspectors would be free to place emphasis on
other facilities. On-the-line inspections by USDA resident inspectors in
the meat and poultry industry is labor-intensive and expensive. The Booze-
Allen report on the USDA Meat and Poultry Inspection Program (Anon-
ymous, 1977) recommended less on-the-line inspection. Application of
the HACCP concept to meat and poultry inspection (see Chapter 9) would
no doubt greatly increase the efficiency and effectiveness of this regulatory
activity without compromising consumer safety.
Finally, emphasis on the principles of the HACCP system for application
in food service establishments and in the home should measurably improve
food sanitation practices at these two points in the food chain.
REFERENCES
AMI (American Meat Institute)
1982 Good Manufacturing Practices I: Voluntary Guidelines for the Production of Dry
Fermented Sausage. II: Voluntary Guidelines for the Production of Semi-dry Fer-
mented Sausage. Washington, D.C.: American Meat Institute.
328 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA
Anonymous
1977 Study of the federal meat and poultry inspection system. Vols. 1, 2, 3. Submitted to
USDA by Booze, Allen and Hamilton, June 13, 1977. Washington, D.C.
Bryan, F. L.
1978
1982
Factors that contribute to outbreaks of foodborne disease. J. Food Prot. 41:816-827.
Microbiological hazards of feeding systems. Pp. 64-80 in Microbiological Safety of
Foods in Feeding Systems. Committee on Microbiology of Food, Advisory Board on
Military Personnel Supplies, Commission on Engineering and Technical Systems,
National Research Council. Washington, D.C.: National Academy Press.
FDA (Food and Drug Administration)
1973a Thermally processed low-acid foods packaged in hermetically sealed containers. Part
128B (recodified as Part 113), Federal Register 38(16) 2398-2410. Jan. 24.
1973b Emergency permit control. Part 90 (recodified as Part 109), Federal Register 38(92):
12716-12721. May 14.
1976 Food Service Sanitation Manual. Model food service sanitation ordinance. Washing
ton, D.C.: USDHEW/PHS/FDA.
GAO (U.S. General Accounting Office)
1974 Salmonella in raw meat and poultry: An assessment of the problem. Report to Congress
(B- 164031 (2)), July 22. Washington, D. C.
Health/Agriculture/Industry Committee on Salmonella
1979 Report on the Scandinavian Salmonella control program in poultry with added ob-
servations from Finland, Germany and Switzerland. Ottawa, Canada.
Silliker, J. H.
1980 Status of Salmonella 10 years later. J. Food Prot. 43:307-313.
U.S. v. An Article of Food
1972 Pasteurized whole eggs, 339 F. Supp. 131 (N.D. Gal, 1972).
