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Process Control for Biological Hazards

Hazard Analysis and Critical Control Point (HACCP) system consists of two (2) essential processes – product
design and control, and process design and control. Both design controls are typically defined by research and
development groups. Some educators refer to the ‘three (3) Ks’ as a comprehensive program of biological
hazard control in food production, those being – kill them, keep them from growing, and keep them out.
Described more scientifically, these three (3) procedures are (Wallace, 2011):
1. Destruction of microorganisms (kill them). Many well-established and novel procedures are available to
kill microorganisms. These include thermal processes such as cooking, pasteurization, and sterilization,
and non-thermal processes such as irradiation, high hydrostatic pressure, and pulsed electric fields.
2. Prevention of microbial growth (keep them from growing). The primary extrinsic factors used to control
microbial growth are refrigeration, freezing, and drying. The intrinsic factors used to control microbial
growth are salting, dying, acidification, and fermentation.
3. Prevention of contamination (keep them out). Many potential biological hazards can be avoided by
preventing cross-contamination from raw materials and the processing environment to processed foods.
Cleaning and sanitation procedures and personnel practices used in food production facilities are most
important in this regard.
Destruction of Microorganisms
Microorganisms in food materials can be killed by thermal and/or non-thermal processes. Because the
reduction of microbial populations occurs logarithmically (during log phase), several terms have come into
common usage to easily compare the toxic effects of various treatments (Wallace, 2011).
I. Thermal Processes
• Pasteurization. This refers to the destruction of vegetative microbial cells and viruses in food products.
It is also defined as: any process, treatment, or a combination thereof that is applied to food to reduce
the most resistant microorganism of public health significance to a level that is not likely to present a
risk under normal conditions of distribution and storage. It also involves a cooking or heating procedure
conducted at atmospheric pressure. Pasteurization is used to protect public health by killing
microorganisms and to extend product shelf life by killing spoilage microorganisms. Pasteurized
products are not sterile. They must be refrigerated during further distribution unless they are otherwise
preserved.
• Sterilization. This practical procedure for food involves high-temperature thermal processes. Many
food items to be sterilized are packaged into metal, glass, or plastic retail containers, sealed, and
processed under pressure with steam at 121°C or higher. Such process is designed to kill bacterial
spores that could otherwise cause product spoilage or foodborne illness upon consumption of the food.
• Canning processes. Low-acid canned food items require a minimum process to ensure the absence of
spores of Clostridium botulinum.
• Ultra-high Temperature (UHT) processes. Food items may be sterilized at ultra-high temperature for a
very short time (e.g. 140-150°C for several seconds). In a process, the UHT-treated food items are
aseptically packed into packages that have been separately sterilized by chemical sterilants.
• Dry heat processes. Dry hot air can be used instead of steam to sterilize materials. However, very long
times are required. While seldom used directly for food sterilization, dry heat is commonly used for
sterilization of laboratory glassware and sampling devices.
II. Non-Thermal Processes

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• Filtration. It can be used to remove microbes, particles, and some chemicals from clear liquids and
gases. Many organic compounds can be removed from liquids and gases by filtration through activated
carbon.
• Chemical disinfectants. It can be used to reduce microbial loads in liquid or dry food materials. Chlorine
compounds and ozone are often used to sanitize water that may be used in dipping of fruits and
vegetables, as ingredient water, and in the cleaning of food processing equipment.
• Ultraviolet (UV) light. UV light has several food safety and public health applications. Major uses of UV
light for disinfection involve arrays of high-intensity UV bulbs over which liquids flow. Large arrays are
used to disinfect municipal water supplies; smaller arrays are used in food processing plants to
disinfect recycled flowing water. UV rays can also be used in ventilation systems to disinfect air that is
supplied to food production areas.
Prevention of Microbial Growth
The principal process controls to prevent the growth of microorganisms in food include refrigeration, freezing,
hot-holding, and packaging (Wallace, 2011).
• Refrigeration. The widespread availability of mechanical refrigeration for the distribution and storage of
food items in commerce and homes enables consumers to have a wide variety of food available
throughout the year. The shelf life of many refrigerated food items ranges from several weeks to months.
Eventually, almost every food will be spoiled by microorganisms if the storage temperature is too high,
the storage time too long, or if the food has a higher than the normal initial load of spoilage
microorganisms.
• Freezing. The shelf life of refrigerated perishable food items can often be extended by frozen storage.
Commercially produced frozen food items are usually stored at -18°C, a temperature that prevents the
growth of all foodborne microorganisms.
• Hot-holding. Cold is generally defined as 4°C or cooler and hot as 60°C or higher. Food items held at
temperatures between these limits should not be held for more than six (6) hours without prompt
refrigeration or heating. The hot-holding temperature provides a margin of safety; none of the foodborne
pathogens are capable of growth above 50°C.
• Packaging. Some perishable food products are packaged in containers with a headspace of air under
atmospheric pressure. Aerobic microorganisms can grow freely in such products. Their growth can be
inhibited or prevented by the removal of headspace oxygen (vacuum packaging) or the addition of
inhibitory gases (modified atmospheric packaging). The most practical benefit of the two (2) methods
mentioned is the inhibition or prevention of mold growth.
Prevention of Contamination
The third type of process control to enhance the protection of food products against microbial defects is the
prevention of contamination by relevant spoilage and pathogenic microorganisms.
• High-risk Ingredient Control. High-risk ingredients are those that have been historically associated with
particular biological or chemical hazards. The mode of ingredient control has shifted from quarantine and
testing to validation and verification of supplier capabilities.
• Allergenic Ingredient Control. The major allergens are peanuts, tree nuts, crustaceans, fish, eggs, milk, soy,
and wheat. Minor or regional allergens include celery, legumes, mollusks, and seeds of sesame, sunflower,
and poppy. A key control measure to protect allergen-sensitive consumers is adequate product labeling.
A non-allergenic ingredient can be substituted for an allergen when feasible.

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• Sanitary design and procedures. Food safety and quality failures are often associated with a lack of
adequate cleaning and sanitation procedures. In turn, the inadequacy of such procedures is sometimes
associated with the improper sanitary design of food processing equipment and facilities.
• Moisture control. The unsuspected presence of moisture can contribute to food safety and spoilage
incidents. Strict attention to sanitary design and adequate cleaning and sanitation procedures can prevent
many potential microbiological safety and quality problems.
Process Control for Chemical Hazards
Chemical and physical hazards are generally controlled by prerequisite programs and by the use of detection
devices. Programs must be in place to avoid contamination of processed food with chemical hazards such as
undeclared allergens and physical hazards such as insects, metals, wood, and glass fragments.
Food manufacturing facilities should maintain a chemical control plan to prevent contamination of its products
with allergens, mislabeled or adulterated ingredients, and cleaning and maintenance chemicals. As with all
food safety and quality practices, employee training and awareness is an essential factor in minimizing the risk
of chemical hazards in food (Mortarjemi, 2014).
Allergen Control
• Food processors must enact effective control measures to prevent the occurrence of this regulatory and
potential public health hazard. These include verifying the accuracy of the ingredient declarations on
product labels, and the implementation of suitable prerequisite controls for the receipt, storage, and use
of high-risk ingredients.
• Allergen-containing ingredients need to be clearly labeled and stored separately from non-allergen-
containing ingredients.
• Large companies can dedicate a production line or even an entire production facility solely to the
production of a specific allergen-containing or allergen-free food. Production sequencing and scheduling
can be a useful separation technique when multiple food items are produced on a single production line.
• Adequate cleaning and sanitation procedures are essential to prevent the contamination of non-allergen-
containing food with residual allergens from food items produced on the same equipment. Complete wet-
cleaning and sanitation is the best way to remove residual allergens.
White Powder Control
• Hundreds of food ingredients such as salts, leavening agents, preservatives, acidulants, sugars, flours,
starches, and some proteins are in white powder forms, which are similar to cleaning agents and other
non-food chemicals.
• Upon receipt at the facility, a sample of the white powder should be tested by visual or chemical means
to verify its identity. The accuracy of the ingredient labels should be confirmed when placed into storage.
Cleaning, Sanitation, and Maintenance Chemicals
• Food processing facilities should establish a chemical control plan to organize control and monitoring
procedures to prevent food product contamination with chemicals.
• Cleaning and sanitation chemicals and pesticides are needed to be stored in a confined, locked area and
not to be used during periods of food production.
• Ingredient or product containers must never be used to store or handle non-food chemicals such as
cleaning agents, lubricants, and pesticides that are used in the food production facility.
Process Control for Physical Hazards

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Many types of foreign materials may contaminate food products during processing and packaging. The primary
causes of contamination were attributed to the following (Mortarjemi, 2014):
× Inadequate maintenance of processing × Lack of HACCP program
equipment and facilities × Flawed hazard analysis
× Lack of supplier management systems
Exclusion Techniques
• Control of glass and brittle plastic contamination. Maintain a strict prohibition on the use of glass or brittle
plastic instruments, utensils, or food storage and handling vessels to avoid the possible entry of glass
fragments into the food product.
• Control of wood contamination. The contamination of food with wood splinters has largely been
eliminated by the exclusion of wooden pallets and wooden handles on tools and maintenance equipment
used in all production areas.
• Personnel practices. Implementation and training in personnel practices are essential to eliminate the
hazard of items falling into the product stream. Employees should not wear items of jewelry. Employee
uniforms and hair/beard covers are usually required. The uniforms should have no pockets so that items
such as pens and pencils cannot be carried in the pockets and fall into the product. Tools must also be
clean and used with care.
Removal Techniques
• Control of metal contamination. Routine equipment maintenance and inspection are essential to prevent
contamination with ‘tramp metal’ or ‘swarf’ that would break off or be ground off into the food product
flow. Many types of in-line magnets are used by food processors on incoming ingredients, processing
equipment, and packaging operations, both to protect the equipment from damage by tramp metal and
to avoid product contamination.
• Control of foreign material in product streams. In addition to magnets and metal detectors, a wide variety
of filters, screens or sifters can be used to detect or remove physical contaminants in ingredient and
product streams.
Risk Analysis
Decisions on measures required to manage risks are taken in the context of the risk analysis process. There
are different types of models for describing the risk analysis process. This process includes the following three
(3) components according to the Codex Alimentarius Commission (CAC) (Jackson & Jansen, 2009).
 Risk Assessment. It identifies the product of the likelihood of the occurrence and the magnitude of the
consequences of exposure to a hazard on human health. It is a scientifically based process consisting of
the following steps or elements:
I. Hazard Identification – the identification of biological, chemical, and physical agents capable of
causing adverse health effects and which may be present in food.
II. Hazard characterization – the qualitative and/or quantitative evaluation of the nature of the
adverse health effects associated with biological, chemical, and physical agents, which may be
present in food.
III. Exposure assessment – the qualitative and/or quantitative evaluation of the likely intake of
biological, chemical, and physical agents via food as well as exposures from other sources if
relevant. This provides information on the potential damage it may cause in specific populations.

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IV. Risk characterization – the qualitative and/or quantitative estimation, including attendant
uncertainties, of the probability of occurrence and severity of known or potential adverse health
effects in a given population based on hazard identification, hazard characterization, and exposure
assessment.
 Risk Management. This is the process, distinct from risk assessment, of weighing policy alternatives, in
consultation with all interested parties, considering risk assessment and other factors relevant for the
health protection of consumers and the promotion of fair trade practices, and if needed, selecting
appropriate prevention and control options.
 Risk Communication. This is the interactive exchange of information and opinions throughout the risk
analysis process concerning risk, risk-related factors and risk perceptions, among risk assessors, risk
managers, consumers, industry, the academic community and other interested parties, including the
explanation of risk assessment findings and the basis of risk management decisions.

References:
Jackson, L. A., & Jansen, M. (2009). Risk assessment in the international food safety policy arena [Staff Working Paper
ERSD-2009-01]. World Trade Organization Economics Research and Statistics Division.
Mortarjemi, Y. (Ed.), & Lelieveld, H. (Ed.). (2014). Food safety management: A practical guide for the food industry.
Elsevier, Inc.
Wallace, C. S. (2011). Food safety for the 21st century: Managing HACCP and food safety throughout the global supply
chain. John Wiley & Sons, Inc.

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