Hazard analysis critical control point approach to food

safety: past, present, and future.

The Past
Certain technical information and thought processes existed before
the hazard analysis critical control point (HACCP) concept evolved.
These came from the fields of food technology, quality control,
microbial ecology, epidemiology, military science, and space
exploration.

In the field of food technology and quality control, certain

processing and quality control developments were being used, including
the Pareto principle, process technology, microbial preservation and
control measures, and statistical-control charting. The Pareto principle
states that for any situation, certain problems (hazards and risks in
the HACCP concept) occur more frequently than others. These are known as
the vital few, and the others are known as the trivial many. Prevention
and control activities should be focused on the vital few - critical
control points (CCPs) in the HACCP concept. Milk technology and
associated testing and control measures were already well established.
They included criteria for pasteurization with monitoring of each
production lot or batch by time and temperature devices; rapid
corrective actions (such as that provided by a flow-diversion valve);
and verification by periodic visits, equipment testing by official
agency personnel, and laboratory testing. Although these criteria were
not HACCP systems per se, they included many of the elements basic to

the HACCP approach.

In epidemiology, surveillance activities had to develop to an

extent when it was realized that there were multiple foodborne diseases
and that the incidence of some of these was high enough to warrant more
effective preventive activities. The databases provided information
about factors that contributed to foodborne outbreaks, which in turn
identified CCPs. Additionally, information about the ecology of the
significant etiologic agents had to be discovered so that their sources
and modes of transmission, survival in foods and the environment,
destruction, and propagation were known.

ln the area of military science, a "fail-safe" concept

emerged to prevent nuclear holocaust. (The HACCP concepts of monitoring
and preventive corrective actions are related.)
The Soviets put a satellite, known as "Sputnik," into
space. The Americans, in competition during the cold war, decided to
initiate a space program to beat the Soviets to the moon. An all-out
program to this end was initiated. Particular efforts were made in all
phases of this program to minimize the chances of failure. This included
food for the astronauts. As a result, a high priority was placed on
conducting hazard analyses of ingredients and processes. Critical
operations were identified and monitored. Whenever control criteria were
not met, prompt correction or product segregation and rejection
occurred. These activities were verified to ensure that control was
effective. This was the start of the HACCP approach to food safety.

Also, at this time, there was dissatisfaction with the status quo of food
sanitation/hygiene/protection/safety programs. The first
National Conference on Food Protection (CFP) was created to evaluate
ongoing food protection activities, to brainstorm, and to make
recommendations for new and, it was hoped, more effective approaches.
The HACCP concept was introduced to the public health community and much
of the food industry by the Food Processing Task Force at that
conference in Denver in 1971. Rather general definitions and elements of
the approach were given in the proceedings (1). This conference was in
part sponsored by federal food-regulating agencies, and these agencies
reviewed the recommendations to determine whether they could implement
them. Following some outbreaks of botulism in commercially canned foods,
modification of processes in that industry, and isolation of Clostridium
botulinum from mushrooms, the U.S. Food and Drug Administration (FDA)
initiated a mandatory HACCP program for low-acid canned foods. The HACCP
concept, some applications, and background information were presented in
a symposium on the subject at the meeting of the Institute of Food
Technologists in New Orleans a few years later. The papers associated
with that proceeding further defined and illustrated the concept (2-5).

ln concert with and in addition to what was discussed at the CFP,

there was growing frustration about traditional approaches (which
focused on inspections and end-product testing) to food safety, and
there was no indication of any decline in the incidence of foodborne
diseases. With the inspection approach, hazards are only identified when
inspections are made, which may be hours, days, or months after the

initial occurrence of the hazards. Interpretations of code requirements

and compliance often differ by inspector and jurisdiction, as may the
operations or facilities selected to receive attention. Hence, some or
perhaps many hazardous situations may be missed. The greatest limitation
of the inspection approach, however, is that the hazards, or even the
operations at which the hazards are likely to occur (and which can be
considered CCPs) may not occur at the time of the inspection; or the
foods of concern may not be processed or prepared at that time and thus
may not be evaluated. Yet an item that has not been checked off as
deficient on an inspection form implies satisfactory compliance in that
area. Corrective actions await identification of hazards during
inspections and willingness of operators to make recommended changes or
to otherwise correct the condition.

End-product testing has several limitations. One of the greatest is

that the number of samples collected may not be sufficient to provide a
high confidence that the product under investigation is not
contaminated. For example, three samples with negative results give 95
percent confidence that the lot or batch is 75 percent or less
contaminated. Even 60 samples with negative results still only give 95
percent confidence that the lot or batch is five percent or less
contaminated. It would take 300 negative samples to provide this level
of confidence that the lot or batch is one percent or less contaminated.
If defective samples are found, it is not known which phase of the
process or preparation was at fault, and hazard analyses have to be
conducted to determine the likely source and mode of contamination or

the process failure that resulted in survival or proliferation of the

contaminant. Of further concern is that tests are not available or are
not routinely conducted for all possible contaminants. Often,
end-product testing uses indirect tests that look for indicator
organisms rather than for pathogens; often these tests have no bearing
on the presence of certain pathogens. Furthermore, the sample collected
may not contain the pathogen even if the product is contaminated; or too
small a quantity of sample may be taken to recover the pathogen. If the
sample is improperly handled, the pathogen may decline, die off, or be
outgrown by other micro-organisms. The media, incubation temperature and
time, confirmatory tests, or other laboratory actions may be
inappropriate for detection of the pathogen under consideration. Hence,
negative results may give a false sense of security. Additionally,
corrective actions cannot begin until the results of the tests are
received - often a few days, a week, or even longer after the samples
were collected. By contrast, CCP monitoring associated with the HACCP
concept allows for immediate action.

Basic principles of the HACCP concept were

defined in a document
prepared for the World Health Organization
(WHO) by the International
Commission on Microbiological Specifications
for Foods (ICMSF) (6). At
that time, the HACCP system had three
components: hazard analysis,
determination of CCPs, and monitoring. A
book by ICMSF further clarified

the concept and gave examples for commodities commonly in international

trade (7).

The National Research Council (NRC) initiated a study on

microbiological criteria for foods in the early 1980s (8). The report
pointed out some limitations of sampling and testing foods, but the most
significant aspect of this report was that it embraced the HACCP
approach. This study was sponsored by FDA, the Food Safety and
Inspection Service of the U.S. Department of Agriculture (USDA), and the
Marine Fisheries of the Department of Interior. No doubt the study
stimulated thinking by federal food-regulatory administrators about the
value of the HACCP approach to food safety. Another recommendation of
the report was to create a National Advisory Committee on
Microbiological Criteria for Foods, which was implemented. Following
this study, NRC also issued reports on the scientific basis of meat and
poultry inspection and seafoods (9, 10). The reports also endorsed the
use of the HACCP concept for these commodities.

The International Association of Milk, Food and Environmental

Sanitarians Committee on Communicable Diseases Affecting Man prepared a
"how-to-do-it" manual, "Procedures to Implement the
Hazard Analysis Critical Control Point (HACCP) System" (11). A year
later, WHO published a manual titled "Hazard Analysis Critical
Control Point Evaluations," geared toward guiding hazard analyses
in homes and at small food shops and street vending operations in
developing countries (12). The manual was based on the experience of

doing hazard analyses of food preparation and storage activities in

homes in which infants had diarrhea and at street vending operations,
and it provided guidance for subsequent activities in these sorts of
activities (13, 14). Additionally, WHO held several expert
consultations/workshops relating to the HACCP concept and HACCP training
approaches (15, 16).

Over time, hazard analyses made during outbreak investigations

generate data on factors that contribute to outbreaks, and the data
indicate likely CCPs (2, 17-24). Guidelines in the form of decision
trees and tables have been developed to aid in selection of CCPs
(25-28). CCPs are usually operations that have contributed to the origin
and spread of contaminants, the survival of pathogens or toxins, and
propagation - and for which effective control actions can be taken.

Seven principles of the HACCP concept were specified by the

National Advisory Committee on Microbiological Criteria for Foods (29).
These are

1. Conduct a hazard analysis.

2. Identify the CCPs in the process.

3. Establish critical limits for preventive measures associated

with each identified CCP.

4. Establish CCP monitoring requirements.

5. Establish corrective actions to be taken when monitoring

indicates that there is a deviation from an established critical limit.

6. Establish effective record-keeping procedures that document the

HACCP system.

7. Establish procedures for verification that the HACCP system is

working correctly.

In the following years, there was an explosion of articles,

seminars, videos, training courses, guidelines, manuals, software, and
other information on the HACCP approach. For example, the HACCP concept
has been endorsed and/or promoted by organizations such as Alberta Food
and Rural Development; the American Meat Institute Foundation; the
Campden Food and Drink Research Association; the Codex Alimentarius Commission; the European
Economic Communities; FDA; the Food Marketing
Institute: the International Association of Milk, Food and Environmental
Sanitarians; the International Life Science Institute-Europe; the
International Meat and Poultry HACCP Alliance; the National Advisory
Committee on Microbiological Criteria for Foods; the National Food
Processors Association; the National Marine Fisheries Service; NRC; the
National Restaurant Association; the National Sanitation Foundation
(NSF); the New York State Department of Health; USDA; WHO; and several
state, provincial, and local health departments in the United States and

Canada (8, 9, 14-16, 24, 29-55). This list is incomplete, but it

illustrates the variety of agencies and associations that have published
documents on the topic. As the HACCP concept evolved, it became very
well defined. Although certain groups have reworked a few of the
definitions (sometimes to the detriment of the concept), the HACCP
method is probably the most clearly defined and focused of all food
safety approaches.

Hazard modeling programs (e.g., for microbial hazards) have been

developed by a few groups (56-58). These will be an aid in hazard
analysis. Computer software for this purpose is available from USDA and
the Institute of Food Research (United Kingdom).

The Present

The HACCP concept evolved to compensate for the shortcomings of

traditional approaches to food protection. Some people who have been
schooled in and are experienced with the traditional approaches act as
if the HACCP approach is threatening; they resist it and the change
necessary to its implementation. Yet they use other state-of-the-art
devices, such as computers, software systems, and the internet. Despite
barriers, acceptance of the HACCP concept is evolving because of its
unique attributes.

The HACCP approach is continuing to gain recognition and acceptance

by the food industry and food-regulatory agencies. Many of the present

activities involving the HACCP approach relate to implementation of

HACCP systems, verification, and validation. For example, USDA has
mandated that HACCP systems be employed in all meat and poultry
processing plants (51, 52). FDA has mandated HACCP systems for seafood
and fresh fruits and vegetables, as well as for low-acid canned foods
(59, 60). Additionally, FDA has endorsed the HACCP systems for food
service establishments, and guidelines have been annexed to the Food
Code (35). Many other nations have similar activities. As a consequence
of these actions, trade associations and professional associations are
sponsoring HACCP-oriented training courses and publishing guidelines.
NSF is integrating ISO-9000 principles with HACCP and initiating a food
safety (HACCP-9000) third-party auditor and registration program (47).
Some HACCP applications are attempting to come in line with the HACCP
guidelines that are annexed to the Codex general principles of food
hygiene (61, 62).

The Codex and some other groups and agencies have advocated
so-called prerequisites for HACCP systems (42, 63). These are
essentially good manufacturing or preparation practices or good
sanitation and hygiene practices or facilities. HACCP systems, however,
should be targeted to safety and should exclude quality control
processes to maintain focus on control measures that are truly critical
to food safety. It would be better to describe the so-called
prerequisites as adjuncts to the HACCP system; most of them are basic to
good production, manufacturing, and preparation practices. Major reasons
for the emergence of the HACCP concept were that emphasis on sanitary

inspections and final product testing was ineffective in reducing the

incidence of foodborne disease and that these traditional activities had
a high cost-to-benefit ratio. If there are any prerequisites to HACCP
systems, they should be (a) management understanding of and commitment
to the HACCP systems and (b) training and discipline of workers who are
responsible for operations and monitoring at CCPs. Assuming that all
hazards are recognized and that appropriate CCPs are identified,
monitoring and prompt corrective actions at CCPs enable the HACCP system
to give high assurance of food safety. This is so regardless of whether
all sanitary and aesthetic measures are in place. (This does not mean,
however, that there are any particular objections to the guidelines in
the codex general principles document.)

Presently, there are software programs, as well as manuals, that

can be used to assist in the development of HACCP systems. Whatever is
used to aid in the development of generic HACCP systems, the systems
must be tailored to meet the unique aspects of the production,
processing, and preparation operations; the equipment being employed;
the foods being processed or prepared; and the personnel.

The Future

The HACCP concept has come out of its lag phase and is in a phase
of rapid deployment. The future probably will record that this concept
replaced traditional approaches such as inspections, health
examinations, and end-product testing. To predict the future, however,

is speculative. Many seemingly unrelated and sometimes unpredictable

events influence outcomes, particularly of actions taken by persons or
companies. Furthermore, it will take time for some of the following
predictions to become reality.

The number of HACCP principles will increase from seven to 10 or

more. This will be done to further clarify this dynamic approach to food
safety. Three principles that will emerge or are now being incorporated
into existing principles or other related guidelines are

1. summary and interpretation of each HACCP system,

2. training, and

3. validation.

The eighth HACCP principle will be summary and interpretation of

HACCP systems. This principle, unfortunately, has not been stressed in
previous literature on the subject, but it is crucial to understanding
the effectiveness of the system and its limitations. Such a review,
which ordinarily fits on a single page, briefly summarizes the system,
points out any remaining hazards, and assesses the risks of occurrence.
Implemented HACCP systems, such as those for raw meat and poultry
processes, may only minimize or, at best, reduce contamination and
prevent bacterial multiplication. Remaining hazards and the risks of
occurrence need to be stressed in the summary, so that those responsible

for food processing or preparation fully understand the limitations, if

any, of their operations. With this information, the processor or
caterer can decide whether to (a) take the risk of starting or
continuing the processing, (b) modify the process to make it safer, or
(c) advise customers of appropriate actions to take to decrease any
remaining hazards. Also, with this information, the purchaser can be
aware of (a) subsequent preparation steps that must be taken to render
the product safe and (b) precautions to take to avoid spreading the
contaminants. Food regulatory officials can become aware of where to
focus their verification activities and inspections and what needs to be
stressed in training and health education.

The ninth HACCP principle will be education and training.

Successful implementation of a HACCP system requires that several groups
of persons be trained and/or educated. These include

* persons who conduct and design HACCP systems;

* persons responsible for operations that are designated as CCPs;

* persons who monitor CCPs;

* persons who verify or validate HACCP systems;

* executive staff of processing and food service establishments,

companies and chains;

* administrators of public health and food regulatory agencies; and

* legislators and policy makers who promulgate laws or formulate

regulations related to food safety and special-interest lobbyists who
influence the passage of the laws or regulations.

Suggestions for approaches for these groups are given by Bryan, Moy
et al., and Mayes (39, 53, 64). Without an understanding of hazards
associated with food safety, food production, food processing and
preparation, rational approaches for prevention and control will not be
realized. Hence, HACCP-focused training of those involved in food
safety, production, processing, and preparation is essential and must be
considered an integral part of the HACCP concept. Presently, training
for food handlers and managers is being conducted to various degrees on
general principles of food hygiene and safety. What is needed for HACCP
systems, however, is training related directly to formulation and
process hazards, CCPs and their monitoring, rapid corrective actions,
and other aspects of the HACCP system.

Validation will be the 10th HACCP principle. It consists of an

initial review of the HACCP system to determine

1. whether it has considered all actual and likely hazards,

2. that it includes all applicable CCPs,

3. that it requires monitoring to be done precisely with calibrated instruments that can evaluate the
process effectively, and

4. that it requires health risks to be reduced to acceptable

levels.

Further validation includes a check that the HACCP system has,

indeed, been implemented. Periodic audits are necessary to evaluate

1. whether the HACCP system is maintained,

2. whether monitoring is being done effectively, and

3. whether additional hazards have been introduced as a result of

modification of formulations or processes.

If such modifications have been made, the system should be

evaluated to determine the need

1. to select additional CCPs,

2. to modify critical limits and corrective actions, and

3. to revise monitoring and verification procedures.

Validation includes

1. reviewing specified hazards and CCPs;

2. reviewing process flow diagrams that indicated hazards and CCPs;

3. reviewing the detailed HACCP system and plan; and

4. observing on-site operations, measuring time-temperature

exposures and characteristics of foods, and testing foods.

Presently, validation is incorporated into the verification

principle, but the uniqueness of each activity is muddied and will need
to be clarified by separation. Validation ought to be conducted by
official agency personnel or third-party teams, not by establishment or
corporate personnel - except to review and test their HACCP systems and
plans.

Monitoring will become more technically sophisticated, even at the

retail level. For temperature monitoring, for example, thermocouple
probes will be inserted into foods, and information such as doneness or
lack of compliance with the critical limit will be signaled and/or
recorded. In some cases, the measurements will be recorded, saved, and
printed out on request at the site or at corporate headquarters. The
data will become part of CCP records available for verification. The
technology is available and will become cheaper as demand for it
increases. Each establishment or chain will have verification forms for
use at various work stations by managers and quality control staff. As

time goes by these forms will become automated and will be saved on
computer disks for verification purposes.

HACCP systems will be verified and validated either by official

agencies or by third-party auditors. This will provide confidence or
certification that those producing, processing, or preparing food have
designed and implemented the HACCP system to ensure that the risk of
food-associated hazards is low Such approval will become an element of
purchase specifications. HACCP systems that are validated by official
agencies with professionally competent and HACCP-trained staff or
certified as valid by accredited third parties should be granted
universal acceptance until proven not to be adequate.

Surveillance of foodborne disease will intensify, and, upon

detection of outbreaks at an implicated establishment, HACCP systems
will be established or modified. Other entities processing or preparing
the same foods or having similar operations will be alerted, and actions
will be taken to ensure implementation or readjustment of HACCP systems.
Summary data will include incidence of foodborne disease cases and
outbreaks, prevalence of vehicles, and relative risks posed by factors
that contributed to the outbreaks. These data can be used to indicate
emerging hazards and CCPs. Regulatory, training, and education
activities will focus on epidemiological data and be revised according
to identification of contributory factors during outbreak
investigations.

Conclusions

The HACCP concept is rational because it is based on historical

data about causes of illness. It focuses attention on critical
operations where control is essential. It is comprehensive because it
relates to ingredients, processes, and subsequent use of products. It is
continuous because problems are detected when they occur and corrective
action is taken at that time. lt is systematic because it covers
step-by-step operations. These attributes give a high degree of
assurance that products processed and prepared under a properly designed
and maintained HACCP system pose a low risk of foodborne illness.

HACCP is the art and science of food safety and is the leading
activity for the future of this endeavor. The sooner food-regulatory
officials and all involved with food production, processing,
distribution, storage, marketing, and preparation learn this, the sooner
foodborne diseases will disappear - and become an interesting note in
history books or a reminder that a HACCP system was improperly designed,
implemented, or maintained.

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Corresponding Author: Frank L. Bryan, Ph.D., M.P.H., Food Safety

Consultation and Training, 8233 Pleasant Hill Rd., Lithonia, GA 30058.

(Adapted with permission from Proceedings of the First NSF

International Conference on Food Safety, Albuquerque, New Mexico,
November 16-18, 1998.)