APPENDIX 5 HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEM

HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEM

by Dr Nagah M. Hafiz

1. Introduction to the Hazard Analysis and Critical Control Point (HACCP) System.
1.1 v v v v v What is HACCP ? HACCP is an abbreviation for Hazard Analysis and Critical Control Point. HACCP system, which is science based and systematic, identifies specific hazards and measures for their control to ensure food safety. The Hazard Analysis and Critical Control Point (HACCP) System is a management tool for food safety assurance focus on prevention rather than relying mainly on end product testing. It can be applied at any stage in food chain, from the point where food is produced to the point of consumption. HACCP is derived from Failure Mode and Effect Analysis FMEA which looks at what could potentially go wrong at each stage in an operation and along with possible causes and the likely effect, before deploying effective control mechanisms.

HACCP steps 1.2 Look at your process / product from start to finish; Identify potential hazards and decide where they could occur; Put in controls and monitor them; Write them all down and keep records ; Ensure that it continues to work effectively. History of HACCP During the airspace program in the 1960's, NASA was looking for a way to guarantee that the food for astronauts on space flights should totally safe. The task was producing Zero Defect Food . The Pillsbury Corporation developed the HACCP system and presented it in 1971 at the first American National Conference for Food Protection. Then the concept has been evolving in the food industry.

Why use HACCP v v Management of product safety Top priority should be given to food safety. HACCP is a system of food control based on prevention. In identifying where the hazards are likely to occur in the process, we have the opportunity to put in place the measures needed to prevent occurrence of those hazards. This will facilitate the move to preventive approach within the food business, reducing the traditional reliance on end product inspection and testing. Limitation of inspection and testing

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v External pressures: Governments / Health Regulation / International standardization (GATT) / Customers / Media.

1.3

Benefits of HACCP

HACCP System 1.3.1 is the most effective method of maximizing product safety. 1.3.2 is a cost-effective control which target resources to critical areas of processing, so reduces risk of manufacturing and selling unsafe products. 1.3.3 facilitates international trade. 1.3.4 can be easily integrated into quality management systems , e.g. ISO 9000 series. 1.3.5 complies with legal requirements . 1.3.6 helps to demonstrate effective food safety management through documented evidence which can be used in the event of litigation.

1.4

Scope HACCP is an applicable powerful system and can be used for both simple and complex operations, new or existing products. It may also be used to ensure the effectiveness of production supporting operations e.g. cleaning system. As HACCP is a universal system, it can be passed to the suppliers to ensure raw material safety.

1.5

HACCP and Quality HACCP system was developed initially for food safety but during recent years, there has been increasing interest in the application of the HACCP technique to product quality. There is a significant body of opinion that believes that HACCP should be restricted to product safety issues. On the other hand, some believes that the flexibility of the HACCP techniques makes it applicable to other areas such as product quality. It is recommended that HACCP is targeted at product safety issues, but where quality issues are included a clear distinction between safety and quality must be shown. Principles of HACCP

1.6

HACCP is a system which identifies specific hazard(s) (i.e. any biological, chemical or physical property that cause an adverse health effect) and specifies measures for their control. This system consists of seven principles (Codex Alimentarius Commission, Alinorm M 97/13 A) : PRINCIPLE 1 Conduct a hazard analysis. Prepare a flow diagram of the steps in the process. Identify and list the hazards and specify the control measures. Determine the critical control point. Establish critical limit(s) which must be met to ensure that each CCP is under control.

PRINCIPLE 2 PRINCIPLE 3

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PRINCIPLE 4 PRINCIPLE 5 PRINCIPLE 6 PRINCIPLE 7

Establish a system to monitor control of the CCP by scheduled testing or observations. Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control. Establish procedures for verification to confirm that HACCP is working effectively. Establish documentation concerning all procedures and records appropriate to these principles and their application.

2. How to set up and conduct a HACCP Study

2.1 2.2 Prerequisite Programmes The production of safe food products requires that the HACCP system be built upon a solid foundation of prerequisite Programmes. Prerequisite programmes provide the basic environmental and operating conditions that are necessary for the production of safe and wholesome food. Many conditions and practices are specified in federal, state and local regulations (e.g., GMPs and food code). In addition, industry often adopts policies and procedures that are specific to their operation. The Codex Alimentarius General Principles of food Hygiene describe the basic conditions and practices expected for foods intended for international trade. The existence and effictiveness of prerequisite programmes should be assessed during the design and implemention of each HACCP plan. All prerequisite programmes should be documented and regularly audited. Prerequisite programmes are established and managed separately from the HACCP plan. Certain aspects, however, of a prerequisite program may be incorporated into a HACCP plan. Education and Training is the most important element in setting up the HACCP system. Provides the technical skills required in implementing HACCP. Helps in changing attitudes of people.

There are a number of key attributes and skills which are required to the HACCP team 1HACCP team training

Team needs to be provided with technical expertise (hazard,risk assessment, drawing process flow diagrams and collating data onto control charts, etc.) beside their knoweledge and additional support skills e.g. GMPs, auditing, problem solving techniques.

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2-

CCP monitor training

The training will be in two ways Awareness of what HACCP is , why it is being used and how crucial their role as monitors of CCP. Specific training in Job requirements. 3Company awareness training

2.3 Developing a HACCP plan What is the HACCP Plan? HACCP Plan is a formal document which pulls together the key information from the HACCP study and holds details of all that are critical to food safety management. The HACCP Plan is drawn up by the HACCP Team and consists of two essential components the Process Flow Diagram and the HACCP Control Chart along with any other necessary support documentation. a). b). The Process Flow Diagram: The Process Flow Diagram is a stepwise sequence of events through the whole process, giving a clear and simple description of the end product is made. It is an essential part of the HACCP Plan which enables the HACCP Team to understand the production process, and is the basis for the hazard analysis. It includes details of all ingredients, handling procedures and follows the process through to the consumer. Consumer action may also be included. At the end of the HACCP study all CCPs identified are highlighted on the Process Flow Diagram. The HACCP Control Chart: The HACCP control chart contains details of all steps or stages in the process where there are CCPs. It is normally documented as a matrix or table of control parameters, and contains details of the hazard and preventive measures associated with each CCP, along with the control criteria and responsibilities. In order to put together a HACCP plan we use the HACCP principles and follow a number of steps.

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The HACCP Control Chart --------------------------------------------------------------------------------------------------------EXAMPLE OF A HACCP WORKSHEET Describe Product Process Flow Diagram

Step

Hazard(s)

Control Measure(s)

CCPs

List Critical Limits

Monitoring Procedures

Corrective Actions

Records

Verification

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2.4 Conducting the HACCP study When conducting a HACCP study, the seven principles may be applied as twelve stages as follows: The HACCP Plan Stage 1 Stage 2 Stage 3 Stage 4 Stage 5 Stage 6 Stage 7 Stage 8 Stage 9 Stage 10 Stage 11 Stage 12 Define terms of reference Select the HACCP team Describe the product and its intended use Construct a flow diagram On-site confirmation of flow diagram List all potential hazards associated with each process step, conduct a hazard analysis and consider any measures to control identified hazards Determine CCPs Establish critical limits for each CCP Establish a monitoring system for each CCP Establish a corrective action plan Establish Verification Procedures. Establish documentation and record keeping

Preliminary steps An introduction to the preliminary steps The development of a HACCP plan is a logical step by step process. Each step builds on the information gathered from the previous step. The process works better if some preliminary steps are taken first. They are five steps as follows:

Stage 1 : Define terms of reference The HACCP study should be carried out on a specific product/ process line or a specific range of activities. For the initial study, the product safety should given the priority and the terms of reference should be simple. Case study : Raw Ground Meat Product (Beef Burger) Terms of reference: This HACCP study considers biological, chemical and physical hazard through out the whole process. For this example, the HACCP plan covers one product, but additional products, undergoing similar processes may be added to the plan at later stage if the company expands its product range. As this product is to be sold as frozen raw in retail or wholesale, the holding and preparation instructions should be on the packaging material.

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Stage 2 : Select the HACCP team Selection of the people with correct skills is essential for success of the HACCP study and it is best carried out by a multi - disciplinary team from 4-6 persons according to the size of the company. Core of HACCP team consists of experts from the following: q A quality assurance / quality control specialist q A production specialist q An engineer q Others e.g. pakaging and distribution experts q In addition, a technical secretary. * The HACCP team needs to be aware of the following:
q q q q

The product / process Food safety hazards of concern The seven principles of HACCP How to apprach the analysis logically.

* The HACCP team isnt limited to the internal resources. If needed, outside expertise may be asked. It is important to list all team member and state clearly what their role is.

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HACCP Team Form

Team Members
---------------------------------------------------------------------------------------

Role
General Manager Quality control Production supervisor Packing supervisor Local microbiologist

Approved by: .

Date: .

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Stage 3 : Describe the product and its intended use: or means complete description of the ingredients , the processing method and distribution of the product. general overview of the product/ process ( big picture). How/ by whom it will be used. General description of the product includes: composition, structure, processing, packaging, storage and distribution, shelf life and instructions for use. The intended use of the product by the consumer and the consumer target group should be defined. Product / process category

Product Description Working with the Product/Process Description Form Describe your product as completely as you can by answering the questions on the form. Add any other important information. The Example Plant kept their descriptions brief, but specific. Common name?(A common name for the product) For example, a cooked sausage could be called franks, hot dogs or wieners. How will this product be used? (How is the product prepared and eaten?) Categories include: Ready-to-eat, heated prior to consumption, or sent out for further processing. The type of package?(What is it mode of, what is special about it?) Categories might include: bulk packaged (e.g. plastic bag, vacuum packaged), layer or stack packed, or patty packed. Length of shelf life? At what temperature?(What is the sell by date? Does temperature affect shelf life?) Does it need to be refrigerated? Where will it be sold? (Who is the intended consumer?) Will it be sold wholesale or retail? If your product is purchased for use in hospitals, schools or institutions, you may need stricter distribution controls. Labeling instructions?(What does the consumer need to know about the product?) Instructions can include; keep refrigerated or keep frozen and cook thoroughly. Is special distribution control needed?(Does the product need specific care?) Will the product become unsafe if not taken care of properly in transit? Raw product being shipped to the grocer needs to be kept refrigerated or frozen. Sign and date the form.

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Raw Ground Meat Product Description Common name Beef Burger

Preparation instructions Cook and consume

Type of package Burger layer stacked and wrapped with poly-lined paper.

Shelf life and storage temperature 3-6 Months at -18o C or below.

Sales location Retail or wholesale.

Labeling instructions Keep frozen.

Special distribution control Keep frozen; Lot code based on production date.

Approved by ..

Date: ..

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Stage 4: Construct a flow diagram The purpose of a flow diagram is to provide a clear, simple outline of the steps involved in the process. Looking at your plants floor plan can help you visualize the process from receiving to shipping. To construct the flow diagram, the HACCP team needs sufficient technical data about all ingredients, raw materials, packaging, process activities, temperature and time profile, equipment and lay out, product reworking, floor plan, storage condition and distribution / customer issues (if included in terms of reference) Working with the Flow Diagram.

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Flow Diagram Development &Verification Form .. Product Process Name: Flow Diagram: Beef Burger

Meat

Other Ingredients

Packaging

Receiving
Refrigerated Storage Assemble/ Preweigh Grinding Mix/ Regrind Forming Packaging/ Labeling Freezing Storage Sales/Shipping

Receiving
Storage

Receiving
Dry Storage

Assemble/ Preweigh

Developed by.

Approved by ..

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Stage 5 : On Site confirmation of flow diagram After the HACCP team has completed the flow diagram, it needs to be checked for accuracy. To do this, walk-through the plant to make sure that the steps listed on the diagram realistically describe what occurs during the production process. If possible, have someone who didnt make the flow The example plant has successfully completed the fact-finding part of the HACCP development process. Your work through the preliminary steps should have produced two tangible pieces of information. 1. 2. A comprehensive list of ingredients and raw materials. and A step-by-step production process breakdown, laid out simply in a flow diagram

With these information you are now ready to proceed to the next stage: Utilizing the 7 Principles of HACCP. HACCP is a series of steps that help us maintain safe food. The steps include : Hazard Analysis deciding what can cause unsafe food Critical Control Points identifying steps that you must control Critical Limits setting measurements for each critical control point Monitoring watching critical points daily Taking Corrective Action making immediate corrections if needed Verification making sure what is being done is correct and still working Record keeping recording what you do in monitoring and corrective action Stage 6: List all potential hazards associated with each process step, conduct hazard analysis and consider any measures to control identified hazards (principle 1) Before starting with the first principle, we need to quickly review two important things: Food safety hazards and control measures. There are three types of hazards: biological, chemical and physical. The most common food safety hazards are biological. More than 95 percent of all human food borne illnesses from meat or poultry are caused by bacteria.

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Table 1: Characteristics of Growth for Nine Pathogens Associated with Meat and Poultry Products Pathogens Bacillus cereus Campylobacter jejuni Clostridium botulinum (Types A,B,E) Clostridium perfringens Escherichia coli O157 :H7 Listeria monocytogenes Salmonella spp. Staphylococcus aureus Yersinia enterocolitica Temperature for Growth 5 48o C 30 47o C 3.3 46o C 15 50o C 10 44.5o C 1.0 - 45o C 5 - 46o C 6.5 - 46o C 0 - 45o C pH 4.9 9.3 4.9 7.5 >4.6 5.0-8.3 4.5 9.0 4.4 9.6 4 -9 4.5 9.3 4.2 9.6 Minimum AW 0.912 ---0.94 0.95 ----0.90 0.94 0.83 0.94

Table 2: Types of Chemical Hazards Location Raw Materials Hazard Pesticides, antibiotics, hormones, toxins, fertilizers, fungicides, heavy metal, PCBs. .. Color additives, inks, indirect additives, packaging materials Direct food additives preservatives (high levels of nitrites),flavor enhancers, color additives. .. Indirect food additives boiler water additives, peeling aids, defoaming agents. Lubricants, paints, coatings Pesticides, cleaners, sanitizers All types of chemicals

Processing

Building and Equipment Maintenance Sanitation Storage and shipping

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Table 3: Examples of Physical Hazards Cause Glass Metal Stones Plastics Bone Bullet/BB Shot/Needles Jewelry Source Bottles, jars, light fixtures, utensils, gauge covers, thermometers Nuts, bolts, screws, steel wool, wire, meat hooks Raw materials Packaging materials, raw materials Raw materials, improper plant processing Animals shot in field, hypodermic needles used for injections Pens/pencils, buttons

Table 4: Examples of Preventive Measures for Chemical Hazards Hazard Naturally Occurring Substances Added Hazardous Chemicals Preventive Measure Supplier warranty or guarantee; verification programme to test each suppliers compliance with the warranty or guarantee. Detailed specifications for each raw material and ingredient; warranty or letter of guarantee from the supplier; vesiting suppliers; requirement that supplier operates with a HACCP plan; testing programme to verify that carcasses do not have residues. Identify and list all direct and indirect food additives and color additives; check that each chemical is approved; check that each chemical is properly used; record the use of any restricted ingredients.

In Process Chemicals

Table 5: Examples of Preventive Measures for Physical Hazards Hazard Preventive Measure

Foreign objects in raw Suppliers HACCP plan; use of specifications, letters of guarantee; vendor inspections and certification; in-line materials magnets; screens, traps, and filters; in-house inspections of raw materials. Foreign objects in Suppliers HACCP plan; use of specifications, letters of packaging materials, guarantee; vendor inspections and certification; in-house cleaning compounds, inspections of materials. etc. Foreign objects In-line metal detectors; visual product examinations; proper introduced by maintenance of equipment; frequent equipment inspections. processing operations or employee practices

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Table 6: Examples of Control Measures for Biological Hazards Pathogen Bacillus cereus Campylobacter jejuni Control measures Proper holding and cooling temperatures of foods; thermal processing of shelf-stable canned food. Proper pasteurization or cooking; avoiding crosscontamination of utensils, equipment; freezing; atmospheric packaging. Thermal processing of shelf-stable canned food; addition of nitrate and salt to cured processed meats; refrigeration of perishable vacuum packaged meats; acidification below pH 4.6; reduction of moisture below water activity of 0.93. Proper holding and cooling temperatures of foods; proper cooking times and temperatures; adequate cooking and avoidance of cross-contamination by unsanitary equipment. Proper heat treatments; rigid environmental sanitation programme; separation of raw and ready to- eat production areas and product. Proper heat treatments; separation of raw and cooked product; proper employee hygiene; fermentation controls; decreased water activity; withdrawing feed from animals before slaughter; avoiding exterior of hide from contacting carcass during skinning; antimicrobial rinses; scalding procedures; disinfecting knives. Employee hygiene; proper fermentation and pH control; proper heat treatment and post-process product handling practices; reduced water activity. Proper refrigeration; heat treatments; control of salt and acidity; prevention of cross-contamination.

Clostridium botulinum

Clostridium perfringens

Listeria monocytogenes

Salmonella spp.

Staphylococcus aureus

Yersinia enterocolitica

Hazard identification The HACCP team should list all potential hazards as defined in the scope of the study that may be expected to occur at each step from primary production until the point of consumption. The consideration should include: 1)- hazards which may be present in the raw materials, 2)- hazards that may be introduced during the process (e.g. contamination from the equipment, environment or personnel) and

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3)- hazards that survive the process step. The team should also consider the way in which the process is managed and what could realistically occur that may not be covered by the flow diagram (e.g. process delays, temporary storage). 4)- The condition of the food (i.e. intrinsic factors including pH, aw , temperature) must also be considered because it might have an effect on the ability of biological, chemical and or physical agents to cause an adverse effect on health. Hazard identification can be regarded as a brain storming session.

Hazard Analysis To determine which hazards are of such a nature that their elimination or reduction to acceptable levels is essential to the production of a safe food. The significance of any hazard to final food safety will need to be assessed, particularly when deciding on the control measures to be implemented. This process is known as risk assessment. Risk : The likelihood the hazard will happen.

Control measures The HACCP team must then consider what control measures. Control measures are those factors or activities which required to eliminate or reduce the occurrence of hazard, to an acceptable level. It is necessary to consider what control measures you have in place and what new measures may need to be put in place. Working with the Hazard Analysis Form: The form is structured so that the three food safety hazard categories (biological, physical and chemical) are addressed in each of the three questions. The top of the form should be filled out with appropriate information. Sign and date the form.

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The first production step to look at is receiving meat. Hazard Analysis Form .

Product/Process Name : Beef Burger Process step from Flow Diagram : Receiving Meat Food Safety Hazard Analysis:

B: Biological List the hazards:

P: Physical

C:Chemical

Pathogens

Plastic Bone Fragments

Pesticides Hormones Antibiotics

Is the hazard reasonably likely to occur? Yes/No Yes No What is the basis for your decision? Loss of control in No historically temperature may lead occurrence at to bacterial growth this plant

No

plants justification is these sources are within defined Limits

What control measures can be applied at this step to prevent, eliminate, or reduce the hazard to an acceptable level?

Temperature control of the truck and meat.

Approved by ..

Date: ..

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The fourth production step to look at is Grinding. Hazard Analysis Form ..

Product/Process Name : Beef Burger Process step from Flow Diagram : Grinding Food Safety Hazard Analysis: B: Biological List the Hazards: Presence or introduction Residues of of foreign materials sanitizer/or Cleaners P: Physical C:Chemical

Introduction of Pathogens

Is the hazard reasonably likely to occur? Yes/No Yes No What is the basis for your decision? Loss of temp.control Visual inspection Unclean processing in place Environment/incorrect cleaning of equipment/ unhygienic practices

No

Correct clean up and sanitizing

What control measures can be applied at this step to prevent, eliminate, or reduce the hazard to an acceptable level?

Temperature control/Maintain a Clean processing enviroment Proper cleaning equipment/utensils Correct employee hygiene ..

Approved by ..

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Stage 7: Determine CCPs (principle2) A critical control point is a point, step or procedure at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level. One strategy to facilitate the identification of each CCP is the use of decision tree. Decision tree is a logical series of questions which are asked for each identified hazard at each process step. Examples of CCPs may include: thermal processing, chilling, testing ingredients for chemical residues, product formulation control, and testing product for metal contaminants.

Application of a decision tree should be flexible and requires common sense.

Training in the application of a decision tree is recommended .

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HACCP Plan: Beef Burger Hazard Analysis and Critical Control Point

Process Step

Potential Hazard

Control measures Proper temperature of meat & truck Visual inspection of container Product inspection

Receiving Meat B Growth of Pathogens P Presence of Foreign Material C Presence of Chemical Contamination Refrigerated storage B Growth of Pathogen P None C None

Is the potential CCP hazard reasonably likely to occur? Yes CCP-1 (B) No

No

Temperature control

Yes No No

CCP-2 (B)

Assemble/preweigh

B Introduction of Pathogens

Temperature controlMaintain clean environment proper cleaning of equipment correct employee hygiene. Visual inspection

Yes

CCP-3 (B)

P Introduction of Foreign Material C None

Yes No

CCP4 -(P)

Approved by: ..

Date : .

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HACCP Plan: Beef Burger Hazard Analysis and Critical Control Point

Process Step Grinding

Potential Hazard B Introduction of Pathogens

Control measures Temperature control Maintain clean processing environment proper cleaning of equipment correct employee hygiene. Visual inspection

Is the potential hazard reasonably likely to occur? Yes

CCP CCP5(B)

P Introduction of Foreign Material C Residues of Sanitizers and/or Cleaners Mix/ Regrind B Introduction of Pathogen P Introduction of Foreign Material C Residues of Sanitizers and/ or Cleaners Forming B Introduction and Growth of Pathogens P None

No

Correct clean up and sanitizing

No

As previous Visual inspection Correct clean up and sanitizing As previous

No Yes No

CCP6(P)

No

None C None None

Approved by: -------------

Date:--------------------------

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Stage 8: Establish critical limits for each CCP (principle 3) Critical limit is the criterion which separates acceptable from unacceptable product (i.e. the division between safe and unsafe). The HACCP team must have detailed knowledge of the potential hazards, along with a full understanding of the factors which are involved in their control. For many practical purposes a target level may be specified as an additional measure to indicate drift in the process, so the process can be adjusted to maintain control before the CCP actually deviates from its critical limits. The specific target level and critical limits set for each CCP/control measure must represent some measurable parameter related to the CCP

Types of Critical limit Each critical limit will be related to the type of hazard that the CCP is designed to control.
q

Chemical limits

Examples: maximum acceptable levels of mycotoxins, pH, salt, aw or the presence or absence of allergens.
q

Physical limits

Examples: absence of metal, intact sieve and temperature and time.

q

Microbiological limits

Should be avoided as a part of the HACCP system, this is because time consuming. Microbiological factors are best for verification. Stage 9: Establish a monitoring system for each CCP (principle 4) Monitoring is one of the most important aspects of any HACCP system and it is a planned sequence of observations or measurements of CCP control measures. The monitoring system describes methods by which, it is able to confirm that all CCPs are operating within specifications and it produces a record of performance for verification Monitoring procedures must be able to detect loss of control at the CCP. Ideally monitoring should provide this information in time for corrective action to be taken to regain control of the process before there is a need to segregate or reject product.

There are two basic types of monitoring procedures: 1On Line systems , where the critical factors are measured during the process. These may be continuous systems where critical data are continuously recorded. 2Off line systems

where samples are taken for measurement of the critical factors else where e.g. salt concentration, pH, aw, total solids.

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In an ideal situation, a monitoring system should be chosen that gives an on-line continuous monitor of performance and responds dynamically to correct changes exceeding the specified tolerance. Five main types of monitoring are employed: Visual observation. Sensory evaluation. Physical. Chemical. Microbiological testing. Microbiological monitoring systems is of limited value for monitoring CCPs. The person who will carry out the monitoring must have the knowledge and authority to take corrective action if the critical limit is not achieved. All records and documents associated with monitoring CCPs should be signed by the person involved in monitoring procedures. The frequency of monitoring will depend on the nature of CCP and the type of monitoring procedures. The designated operators must be trained to understand their monitoring functions and how to carry them out correctly.

Stage 10: Establish a corrective action plan (principle 5) * HACCP Principle 5 requires that corrective action be taken when the monitoring results show a deviation from the critical limit(s) at a CCP. * Or preferably, what action should be taken when monitoring results indicate a trend towards loss of control. There are two main types of corrective action: 1 2Actions which adjust the process to maintain control and prevent a deviation at the CCP This first type of corrective action normally involves the use of target levels within the critical limits. When the process drifts towards or exceeds the target levels, it is adjusted, bringing it back within the normal operating bands. This is typified by on line continuous monitoring systems which automatically adjust the process, e.g. automatic diversion valves in pasteurization process of milk. The factors which are often adjusted to maintain control include temperature and / or time, pH/acidity, ingredient concentrations, flow rates and sanitizer concentrations. Actions to be taken following a deviation at a CCP

Following a deviation, there are two types of action

q q

The process must be adjusted to bring it back under control. Disposition action need to be taken with the food that has been produced during the time period that the CCP was out of control.

Both corrective action and deposition action should be documented.

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HACCP Plan: Beef Burger Critical Limit,Monitoring & Corrective Action Process Step Critical Limit CCP Receiving Meat Temperature< 45 o F CCP-1(B) Monitoring Procedures What will be measured? Temperature and appearance Corrective Action How will the process be corrected ? Identify and control affected product Product disposition Reject chill. If the product is over 45o F move to blast cooler Who is responsible for implementing the CA designee Measures to prevent recurrence Notify supplier

Were will the CL be measured? In receiving area How will the CL be measured? Thermometer Who will monitor the CL? Receiving personnel Frequency? Each shipment Refrigerated storage CCP2(B) Temperature 45 o F What will be measured? Temperature Were will the CL be measured? In storage refrigerator How will the CL be measured? Refrigerator thermometer Who will monitor the CL? Person in charge Frequency? Towice daily

How will the process be corrected ? Identify and correct affected product Product disposition Reject chill. Who is responsible for implementing the CA person in charge Measures to prevent recurrence Adjust refrigerator

Approved by: ..

Date :

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HACCP Plan: Beef Burger Critical Limit,Monitoring & Corrective Action Process Step CCP Assemble/Preweigh CCP4-P Critical Limit No Visible foreign material Monitoring Procedures What will be measured? foreign material Were will the CL be measured? Designed area How will the CL be measured? Visual inspection Who will monitor the CL? Person in charge Frequency? Each batch Grinding CCP- Temperature after 5(B) course grind for fresh product <40 o F What will be measured? Temperature Were will the CL be measured? At the grinder How will the CL be measured? Thermometer or thermal probe Who will monitor the CL? Grinding personnel Frequency? Each Batch How will the process be corrected ? Immediately chill product Product disposition Product will be chilled. Until temperature is below 40o F Who is responsible for implementing the CA grinder personnel Measures to prevent recurrence Adjust process Corrective Action How will the process be corrected ? Eliminate foreign material Product disposition Reject or remove foreign material Who is responsible for implementing the CA? designee Measures to prevent recurrence Adjust process

Approved by: ..

Date : ..

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Stage 11.Establish Verification Procedures The study team should put into place procedures that can be used to demonstrate compliance with the HACCP plan. Verification should examine the entire HACCP system and its records. The study team should specify the methods and frequency of verification procedures.

Verification activities may include: internal/ external auditing systems. microbiological examination of intermediate and final product samples, more searching/vigorous tests at selected CCPs. surveys of the market place for unexpected health/spoilage problems associated with the product. updated data on consumer use of the product. The findings of customer visits and analysis of customer complaints can also form part of verification procedures.

HACCP Plan: Beef Burger Record Keeping and Verification Procedures

Process Step Records CCP Receiving Meat HACCP Receiving CCP-1 (B) log

Responsibility Receiving personnel Monitoring

CCP-Verification Daily check of receiving log-receiving personnel retrained Accuracy of the thermometer will be checked each day recalibrated or replaced as necessary .. Daily check of grinding log Production personnel retrained

Grinding CCP5(B)

Grinding log

.. Production personnel Monitoring

Approved by: ..

Date :

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Stage 12: Establish documentation and record keeping (principle 7) Record Keeping q HACCP principle 7 requires that effective record keeping procedures are established to document HACCP system. q Records need to be kept of all areas which are critical to product safety, as written evidence that the HACCP plan is in compliance i.e verification that the system has been working correctly. Records q Will support a defense under litigation proceedings. q Will be useful in providing a basis for analysis of trends (towards improvements in the system). As well as for internal investigation of any food safety incident. q The records do not all have to be in typed format e.g. Hazard analysis charts and CCP monitoring log sheets. The type of HACCP records which might be retained HACCP plan, History of amendments to the HACCP plan, Critical Control point (CCP) monitoring records, Hold/Trace/Recall record, Training records, Audit records, Meeting records, Calibration records, The HACCP system procedures, It may consist of a HACCP manual which contains firstly companys policy on food safety management.

Review the HACCP plan * A periodic review should be carried out, the frequency of which should be established based on the risk of the product and its intended use. In addition, it is necessary to have a system in place that will automatically trigger a review of a HACCP plan prior to any changes which affect overall product safety. Data arising from HACCP reviews must be documented and form a part of the HACCP record keeping system. Any changes arising from a HACCP review must be fully incorporated into the HACCP plan.

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HACCP Form No : Use for CCP-1(B)

Receiving Log

CCP-1(B) Date Inspected Company by Meat temp. (o F) Corrective action Verification Date Verif. by Preshipment review Date Time Review Signature

Critical limit : CCP1-B temp. < 45oF Verification to be done each shipment corrective action must ensure: 1)- The cause of the deviation is identified and eliminated 2)- The CCP is under control after the corrective action is taken 3)- Measures to prevent recurrence are established 4)- No product that is injurious to health or otherwise adultered as a result of the deviation enters commerce

Approved by :

Date:.

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HACCP Form No : Use for CCP-4(B)

Grinding Log

CCP-4(B) Date Inspected Company by Meat temp. (o F) Corrective action Verification Date Verified by Preshipment review Date Time Review Signature.

Critical limit : CCP4-B temp. < 40oF Verification to be done each time the process takes place Pre shipment review to be done daily And for all CCPs before product can be shipped corrective action must ensure: 1)- The cause of the deviation is identified and eliminated 2)- The CCP is under control after the corrective action is taken 3)- Measures to prevent recurrence are established 4)- No product that is injurious to health or otherwise adultered as a result of the deviation enters commerce

Approved by :

Date:.

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Product / Process Description Form

Common name

How will this product be used?

The type of package

Length of shelf life Where will it be sold?

Labeling instructions

Is special distribution control needed?

Approved by:--------------------

Date: -----------------

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Ingredients & Raw Materials Form Product / Process Category : Product Name :

Meat/Poultry and By-products

Nonmeat Food Ingredients

Binders/Extenders

Spices/Flavorings

Restricted Ingredients

Preservatives Acidifiers

Liquid

Packaging Materials

Others

Approved by: -----------------

Date: ------------------------

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Flow Diagram Development & Verification Form ----------------------------------------------------------------------------------------Product Process Name:

Flow Diagram:

Developed by: --------------------Approved by: ---------------------

Date: ----------------------Date: ------------------------

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Hazard Analysis and Critical Control Point: Is the potential hazard reasonably likely to occur?

Process Step

Potential Hazard

Control Measures

CCP

Approved by: ---------------------

Date: ------------------------

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Critical Limit, Monitoring & Corrective Action

Process Step CCP

Critical limit

Monitoring Procedures What will be measured? Where will the CL be measured? How will the CL be measured? Who will monitor the CL? Frequency? What will be measured? Where will the CL be measured? How will the CL be measured? Who will monitor the CL? Frequency?

Corrective action How will the process corrected? Product disposition Who is responsible for implementing the CA? Measures to prevent recurrence

How will the process corrected? Product disposition Who is responsible for implementing the CA? Measures to prevent recurrence Adjust refrigerator

Approved by: ---------------------

Date: ------------------------

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Record Keeping and Verification Procedures

Process Step CCP

Records

Responsibility

CCP-Verification

Approved by: ---------------------

Date: ------------------------

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References Bryan, F.L. (1992): Hazard Analysis Critical Point Evaluation. A guide to identifying hazards and assessing risks associated with food preparation and storage WHO, Geneva. Codex Alimentarius commission (1997): Hazard Analysis and Critical Control Point (HACCP) System and guidelines for is Application. Codex Alimentarius commission Alinorm M97/13A. Pearson, A.M. and Dutson, T.R. (1995): HACCP in meat, poultry and fish processing. Blackie Academic & professional, Chapman & Hall, Wester Cleddens Road, Bishopbriggs, Glasgow G 64 2 N Z. Sara Mortimore and Carol Wallace (1994): HACCP: A practical Approach Chapman and Hall, London. USDA-FSIS, National Advisory Committee on Microbiology Criteria for foods(1990) HACCP Principles for food production. USDA FSIS Information Office, Washington, D.C. World Health Organization (1995): Hazard Analysis Critical Control Point System. Concept and Application, Report of a WHO Consultation With the participation of FAO 29 31 May 1995. WHO/FUN/FOS, 95.7.

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Case Studies

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Product Description: Poultry Slaughter Common name: Ready to cook whole chicken

How will this product be used? Cooked by consumers

The type of package Foam trays wrapped with poly film.

Length of shelf life? Fresh 5 days at <5o C Frozen 12 months at -18o C Where will it be sold Retail or wholesale

Labeling instructions Keep refrigerated Keep frozen

Is special distribution control needed? No

Approved by ..

Date: ..

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Product Process Name: Flow Diagram:

Chicken receiving

Poultry Slaughter Ready to cook whole chicken

Evisceration

Holding

Trim/Final wash

Shackling

Final inspection

Chilling Slaughtering

Package

Scalding
Freeze or refrigerate

Plucking Washing

Distribution

Head/feet removal

Venting/ opening

Developed by. Date: ..

Approved by ..

Date:

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Case Study Pasteurized Milk ----------------------------------------------------------------------------------------------------

Product description Common name : Preparation instructions: Type of package: Shelf life and storage temp. Sales location: Labeling instructions: Pasteurized milk. Direct consume. Glass or plastic bottles or bags 2 - 3 days Retail. Keep cool, lot code based on production date 6C

Approved by: ---------------

Date: -------------------------

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Process Flow Diagram ----------------------------------------------------------------------------------------------

Product name :

Pasteurized milk

Raw Milk Receiving Refrigerated storage Clarification Standardization Homogenization Heating Cooling Intermediate storage Filling / packing / labeling Storage & distribution

Packaging Materials Receiving Dry storage

Developed by ------------------Approved by --------------------

Date: -------------------Date: --------------------

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APPENDIX 6 MICROBIOLOGICAL RISK ASSESSMENT

MICROBIOLOGICAL RISK ASSESSMENT

by Dr Juliane Brunig, BgVV

Statutes of the Codex Alimentarius Commision FAO/WHO publications regarding Risk Analysis Principle and guidelines for the conduct of microbiological risk assessment Microbiological risk assessment in foods Microbiological risk assessment in foods taking Listeria monocytogenes as an example Recommendations for the detection and evaluation of Listeria monocytogenes foods Quantitative microbiological risk assessment regarding Listeria monocytogenes A German example Listeria monocytogenes - criteria for foods WHO expert consultation on hazard identification and hazard characterization of non typhoid and non paratyphoid Salmonella in broilers and eggs

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STATUS OF THE CODEX ALIMENTARIUS COMMISSION

by Dr Juliane Brunig, BgVV

Slide 1

Codex - Statutes of the Codex Alimentarius Commission An introduction in the Codex Alimentarius Procedure

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Slide 2

Codex
- Statutes of the Codex Alimentarius Commission Rules of Procedure Elaboration Procedures for Codex Standards General Principles and Acceptance of Codex Standards
The Statutes and Rules of Procedure of the Codex Alimentarius Commission were first established by FAO Conference and the World Health Assembly in 1961/1962 when the Commission itself was established. The Statutes were revised in 1966. The Rules of Procedure form the legal basis of the Commissions work and provide its mandate of terms of reference. The Rules of Procedure describe the formal working procedures appropriate to an intergovermental body.

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Slide 3

Codex
- Statutes of the Codex Alimentarius Commission Article 1: The Codex Alimentarius Commission shall be responsible for making proposals to, and shall be consulted by, the Directors General of the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) on all matters pertaining to the implementation of the Joint FAO/WHO Food Standards Programme, the purpose of which is: (a) protecting the health of the consumers and ensuring fair practices in the food trade; (b) promoting co-ordination of all food standards work undertaken by international governmental and non governmental organizations; (c) determining priorities and initiating and guiding the preparation of appropriate organizations;

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Slide 4

Codex
- Statutes of the Codex Alimentarius Commission (2) -

(d) finalizing standards elaborated under (c) above and, after acceptance by governments, publishing them in a Codex Alimentarius either as regional or world wide standards, together with international standards already finalized by other bodies under (b) above, wherever this is practicable; (e) amending published standards, after appropriate survey in the light of development.

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Slide 5

Codex
- Statutes of the Codex Alimentarius Commission Article 2: Membership of the Commission is open to all Member Nations and Associate Members of FAO and WHO which are interested in international food standards. Membership shall comprise such of these nations as have notified the Director General of FAO or of WHO of their desire to be considered as Members.

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Slide 6

Codex- Confirmation of Chairmanship of Codex Committees (1)

Committee Codex Committee on General Principles Codex Committee on Food Additives and Contaminants Codex Committee on Food Hygiene Codex Committee on Food Labelling Codex Committee on Methods of Analysis and Sampling Codex Committee on Pesticides Residues Codex Committee on Residues of Veterinary Drugs in Food Codex Committee on Food Import and Export Inspection and Certification Systems Codex Committee on Nutrition and Food for Special Dietary Uses Codex Committee on Cocoa Products and Chocolate Chairmanship France The Netherlands USA Canada Hungary The Netherlands USA Australia Germany Switzerland
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FAO/WHO PUBLICATIONS REGARDING RISK ANALYSIS

by Dr Juliane Brunig, BgVV

Report of the Joint FAO/WHO Consultation on Application of Risk Analysis to Food Standards Issues, Geneva, March 1995. (WHO/FNU/FOS/95.1) Report of the Joint FAO/WHO Consultation on Risk Management and Food Safety, Rome, January 1997. (FAO Food and Nutrition Paper No. 65) Report of the Joint FAO/WHO Consultation on the Application of Risk Communication to Food Standards and Safety Matters, Rome, 1998. (FAO Food and Nutrition Paper No. 70) Report of a First Joint FAO/WHO Consultation on Microbiological Risk Assessment, Geneva, March 1999. (WHO/SDE/PHE/FOS/99.5) The interaction between Assessors and Managers of Microbiological Hazards in Food. Report of a WHO Expert Consultation, Kiel, Germany, 21-23 March 2000. (WHO/SDE/PHE/FOS/007) Report of the Joint FAO/WHO Consultation on Risk Assessment of Microbiological Hazards in Food. Hazard characterization and exposure assessment of Salmonella spp. in broilers and eggs and Listeria monocytogenes in ready-to-eat foods, Rome 17-21 July 2000. (FAO Food and Nutrition paper No. 71) Report of the Joint FAO/WHO Consultation on Risk Assessment of Microbiological Hazards in Food. Hazard Identification, hazard characterization and exposure assessment of Campylobacter spp. in broiler chickens and Vibrio spp. in seafood, Geneva, 23-27 July 2001. Report of the Joint FAO/WHO Consultation on Risk Assessment of Microbiological Hazards in Food. Risk characterization of Salmonella in eggs and broiler chickens and Listeria monocytogenes in ready-to-eat foods, Rome 30 April-4 May 2001. (FAO Food and Nutrition paper No. 72)

Technical documents also available in the internet: http:/www.fao.org/WAICENT/FAOINFO/ECONOMIC/ESN/pagerisk/riskpage.htm http://www.fao.org/es/ESN/pagerisk/riskpage.htm http://www.who.int/fsf/mbriskassess/index.htm

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PRINCIPLES AND GUIDELINES FOR THE CONDUCT OF MICROBIOLOGICAL RISK ASSESSMENT CAC/GL-30 (1999)
INTRODUCTION Risks from microbiological hazards are of immediate and serious concern to human health. Microbiological Risk Analysis is a process consisting of three components: Risk Assessment, Risk Management, and Risk Communication, which has the overall objective to ensure public health protection. This document deals with Risk Assessment which is a key element in assuring that sound science is used to establish standards, guidelines and other recommendations for food safety to enhance consumer protection and facilitate international trade. The Microbiological Risk Assessment process should include quantitative information to the greatest extent possible in the estimation of risk. A Microbiological Risk Assessment should be conducted using a structured approach such as that described in this document. This document will be of primary interest to governments although other organizations, companies, and other interested parties who need to prepare a Microbiological Risk Assessment will find it valuable. Since Microbiological Risk Assessment is a developing science, implementation of these guidelines may require a period of time and may also require specialized training in the countries that consider it necessary. This may be particularly the case for developing countries. Although Microbiological Risk Assessment is the primary focus of this document, the method can also be applied to certain other classes of biological hazards. 1. SCOPE The scope of this document applies to Risk Assessment of microbiological hazards in food. 2. DEFINITIONS The definitions cited here are to facilitate the understanding of certain words or phrases used in this document. Where available the definitions are those adopted for microbiological, chemical, or physical agents and Risk Management and Risk Communication on an interim basis at the 22nd Session of the Codex Alimentarius Commission. The CAC adopted these definitions on an interim basis because they are subject to modification in the light of developments in the science of risk analysis and as a result of efforts to harmonize similar definitions across various disciplines. Dose-Response Assessment - The determination of the relationship between the magnitude of exposure (dose) to a chemical, biological or physical agent and the severity and/or frequency of associated adverse health effects (response). 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. Hazard - A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect. Hazard Characterization - The qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with the hazard. For the purpose of Microbiological Risk Assessment the concerns relate to microorganisms and/or their toxins. Hazard Identification - The identification of biological, chemical, and physical agents capable of causing adverse health effects and which may be present in a particular food or group of foods. Quantitative Risk Assessment - A Risk Assessment that provides numerical expressions of risk and indication of the attendant uncertainties (stated in the 1995 Expert Consultation definition on Risk Analysis).

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Qualitative Risk Assessment - A Risk Assessment based on data which, while forming an inadequate basis for numerical risk estimations, nonetheless, when conditioned by prior expert knowledge and identification of attendant uncertainties permits risk ranking or separation into descriptive categories of risk. Risk - A function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food. Risk Analysis - A process consisting of three components: risk assessment, risk management and risk communication. Risk Assessment - A scientifically based process consisting of the following steps: (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization. Risk Characterization - The process of determining the qualitative and/or quantitative estimation, includingattendant uncertainties, of the probability of occurrence and severity of known or potential adverse healtheffects in a given population based on hazard identification, hazard characterization and exposureassessment. Risk Communication - The interactive exchange of information and opinions concerning risk and risk management among risk assessors, risk managers, consumers and other interested parties. Risk Estimate - Output of Risk Characterization. Risk Management - The process of weighing policy alternatives in the light of the results of risk assessment and, if required, selecting and implementing appropriate control* (*c ontrol means prevention, elimination, or reduction of hazards and/or minimization of risks.) options, including regulatory measures. Sensitivity analysis - A method used to examine the behavior of a model by measuring the variation in its outputs resulting from changes to its inputs. Transparent - Characteristics of a process where the rationale, the logic of development, constraints, assumptions, value judgements, decisions, limitations and uncertainties of the expressed determination are fully and systematically stated, documented, and accessible for review. Uncertainty analysis - A method used to estimate the uncertainty associated with model inputs, assumptions and structure/form. 3. GENERAL PRINCIPLES OF MICROBIOLOGICAL RISK ASSESSMENT 1. Microbiological Risk Assessment should be soundly based upon science. 2. There should be a functional separation between Risk Assessment and Risk Management. 3. Microbiological Risk Assessment should be conducted according to a structured approach that includes Hazard Identification, Hazard Characterization, Exposure Assessment, and Risk Characterization. 4. A Microbiological Risk Assessment should clearly state the purpose of the exercise, including the form of Risk Estimate that will be the output. 5. The conduct of a Microbiological Risk Assessment should be transparent. 6. Any constraints that impact on the Risk Assessment such as cost, resources or time, should be identified and their possible consequences described. 7. The Risk Estimate should contain a description of uncertainty and where the uncertainty arose during the Risk Assessment process. 8. Data should be such that uncertainty in the Risk Estimate can be determined; data and data collection systems should, as far as possible, be of sufficient quality and precision that uncertainty in the Risk Estimate is minimized. 9. A Microbiological Risk Assessment should explicitly consider the dynamics of microbiological growth, survival, and death in foods and the complexity of the interaction (including sequelae) between human and agent following consumption as well as the potential for further spread. 10. Wherever possible, Risk Estimates should be reassessed over time by comparison with independent human illness data. 11. A Microbiological Risk Assessment may need reevaluation, as new relevant information becomes available.

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4. GUIDELINES FOR APPLICATION These Guidelines provide an outline of the elements of a Microbiological Risk Assessment indicating thetypes of decisions that need to be considered at each step. 4.1 GENERAL CONSIDERATIONS The elements of Risk Analysis are: Risk Assessment, Risk Management, and Risk Communication. The functional separation of Risk Assessment from Risk Management helps assure that the Risk Assessment process is unbiased. However, certain interactions are needed for a comprehensive and systematic Risk Assessment process. These may include ranking of hazards and risk assessment policy decisions. Where Risk Management issues are taken into account in Risk Assessment, the decision-making process should be transparent. It is the transparent unbiased nature of the process that is important, not who is the assessor or who is the manager. Whenever practical, efforts should be made to provide a Risk Assessment process that allows contributions by interested parties. Contributions by interested parties in the Risk Assessment process can improve the transparency of the Risk Assessment, increase the quality of Risk Assessments through additional expertise and information, and facilitate risk communication by increasing the credibility and acceptance of the results of the Risk Assessment. Scientific evidence may be limited, incomplete or conflicting. In such cases, transparent informed decisions will have to be made on how to complete the Risk Assessment process. The importance of using high quality information when conducting a Risk Assessment is to reduce uncertainty and to increase the reliability of the Risk Estimate. The use of quantitative information is encouraged to the extent possible, but the value and utility of qualitative information should not be discounted. It should be recognized that sufficient resources will not always be available and constraints are likely to be imposed on the Risk Assessment that will influence the quality of the Risk Estimate. Where such resource constraints apply, it is important for transparency purposes that these constraints be described in the formal record. Where appropriate, the record should include an evaluation of the impact of the resource constraints on the Risk Assessment. 4.2 STATEMENT OF PURPOSE OF RISK ASSESSMENT At the beginning of the work the specific purpose of the particular Risk Assessment being carried out should be clearly stated. The output form and possible output alternatives of the Risk Assessment should be defined. Output might, for example, take the form of an estimate of the prevalence of illness, or an estimate of annual rate (incidence of human illness per 100,000) or an estimate of the rate of human illness and severity per eating occurrence. The microbiological risk assessment may require a preliminary investigation phase. In this phase, evidence to support farm-to-table modeling of risk might be structured or mapped into the framework of risk assessment. 4.3 HAZARD IDENTIFICATION For microbial agents, the purpose of hazard identification is to identify the microorganisms or the microbial toxins of concern with food. Hazard identification will predominately be a qualitative process. Hazards can be identified from relevant data sources. Information on hazards can be obtained from scientific literature, from databases such as those in the food industry, government agencies, and relevant international organizations and through solicitation of opinions of experts. Relevant information includes data in areas such as: clinical studies, epidemiological studies and surveillance, laboratory animal studies, investigations of the characteristics of microorganisms, the interaction between microorganisms and their environment through the food chain from primary

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production up to and including consumption, and studies on analogous microorganisms and situations. 4.4 EXPOSURE ASSESSMENT Exposure Assessment includes an assessment of the extent of actual or anticipated human exposure. For microbiological agents, Exposure Assessments might be based on the potential extent of food contamination by a particular agent or its toxins, and on dietary information. Exposure assessment should specify the unit of food that is of interest, i.e., the portion size in most/all cases of acute illness. Factors that must be considered for Exposure Assessment include the frequency of contamination of foods by the pathogenic agent and its level in those foods over time. For example, these factors are influenced by the characteristics of the pathogenic agent, the microbiological ecology of the food, the initial contamination of the raw material including considerations of regional differences and seasonality of production, the level of sanitation and process controls, the methods of processing, packaging, distribution and storage of the foods, as well as any preparation steps such as cooking and holding. Another factor that must be considered in the assessment is patterns of consumption. This relates to socio-economic and cultural backgrounds, ethnicity, seasonality, age differences (population demographics), regional differences, and consumer preferences and behavior. Other factors to be considered include: the role of the food handler as a source of contamination, the amount of hand contact with the product, and the potential impact of abusive environmental time/temperature relationships. Microbial pathogen levels can be dynamic and while they may be kept low, for example, by proper time/temperature controls during food processing, they can substantially increase with abuse conditions (for example, improper food storage temperatures or cross contamination from other foods). Therefore, the Exposure Assessment should describe the pathway from production to consumption. Scenarios can be constructed to predict the range of possible exposures. The scenarios might reflect effects of processing, such as hygienic design, cleaning and disinfection, as well as the time/temperature and other conditions of the food history, food handling and consumption patterns, regulatory controls, and surveillance systems. Exposure Assessment estimates the level, within various levels of uncertainty, of microbiological pathogens or microbiological toxins, and the likelihood of their occurrence in foods at the time of consumption. qualitatively foods can be categorized according to the likelihood that the foodstuff will or will not be contaminated at its source; whether or not the food can support the growth of the pathogen of concern; heather there is substantial potential for abusive handling of the food; or whether the food will be subjected o a heat process. The presence, growth, survival, or death of microorganisms, including pathogens in foods, re influenced by processing and packaging, the storage environment, including the temperature of storage, he relative humidity of the environment, and the gaseous composition of the atmosphere. Other relevant actors include pH, moisture content or water activity (aw), nutrient content, the presence of antimicrobial `substances, and competing microflora. Predictive microbiology can be a useful tool in an Exposure Asessment. 4.5 HAZARD CHARACTERIZATION This step provides a qualitative or quantitative description of the severity and duration of adverse effects that may result from the ingestion of a microorganism or its toxin in food. A dose-response assessment should be performed if the data are obtainable. There are several important factors that need to be considered in Hazard Characterization. These are related to both the microorganism, and the human host. In relation to the microorganism the following are important: microorganisms are capable of replicating; the virulence and infectivity of microorganisms can change depending on their interaction with the host and the environment; genetic material can be transferred between microorganisms leading to the transfer of

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characteristics such as antibiotic resistance and virulencefactors; microorganisms can be spread through secondary and tertiary transmission; the onset of clinical symptoms can be substantially delayed following exposure; microorganisms can persist in certain individuals leading to continued excretion of the microorganism and continued risk of spread of infection; low doses of some microorganisms can in some cases cause a severe effect; and the attributes of a food that may alter the microbial pathogenicity, e.g., high fat content of a food vehicle. In relation to the host the following may be important: genetic factors such as Human Leucocyte Antigen (HLA) type; increased susceptibility due to breakdowns of physiological barriers; individual host susceptibility characteristics such as age, pregnancy, nutrition, health and medication status, concurrent infections, immune status and previous exposure history; population characteristics such as population immunity, access to and use of medical care, and persistence of the organism in the population. A desirable feature of Hazard Characterization is ideally establishing a dose-response relationship. When establishing a dose-response relationship, the different end points, such as infection or illness, should be taken into consideration. In the absence of a known dose-response relationship, risk assessment tools such as expert elicitations could be used to consider various factors, such as infectivity, necessary to describe Hazard Characterizations. Additionally, experts may be able to devise ranking systems so that they can be used to characterize severity and/or duration of disease. 4.6 RISK CHARACTERIZATION Risk Characterization represents the integration of the Hazard Identification, Hazard Characterization, and Exposure Assessment determinations to obtain a Risk Estimate; providing a qualitative or quantitative estimate of the likelihood and severity of the adverse effects which could occur in a given population, including a description of the uncertainties associated with these estimates. These estimates can be assessed by comparison with independent epidemiological data that relate hazards to disease prevalence. Risk Characterization brings together all of the qualitative or quantitative information of the previous steps to provide a soundly based estimate of risk for a given population. Risk Characterization depends on available data and expert judgements. The weight of evidence integrating quantitative and qualitative data may permit only a qualitative estimate of risk. The degree of confidence in the final estimation of risk will depend on the variability, uncertainty, and assumptions identified in all previous steps. Differentiation of uncertainty and variability is important in subsequent selections of risk management options. Uncertainty is associated with the data themselves, and with the choice of model. Data uncertainties include those that might arise in the evaluation and extrapolation of information obtained from epidemiological, microbiological, and laboratory animal studies. Uncertainties arise whenever attempts are made to use data concerning the occurrence of certain phenomena obtained under one set of conditions to make estimations or predictions about phenomena likely to occur under other sets of conditions for which data are not available. Biological variation includes the differences in virulence that exist in microbiological populations and variability in susceptibility within the human population and particular subpopulations. It is important to demonstrate the influence of the estimates and assumptions used in Risk Assessment; for quantitative Risk Assessment this can be done using sensitivity and uncertainty analyses. 4.7 DOCUMENTATION The Risk Assessment should be fully and systematically documented and communicated to the risk manager. Understanding any limitations that influenced a Risk Assessment is essential for transparency of the process that is important in decision making. For example, expert judgements should be identified and their rationale explained. To ensure a transparent Risk Assessment a

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formal record, including a summary, should be prepared and made available to interested independent parties so that other risk assessors can repeat and critique the work. The formal record and summary should indicate any constraints, uncertainties, and assumptions and their impact on the Risk Assessment. 4.8 REASSESSMENT Surveillance programmes can provide an ongoing opportunity to reassess the public health risks associated with pathogens in foods as new relevant information and data become available. Microbiological Risk Assessors may have the opportunity to compare the predicted Risk Estimate from Microbiological Risk Assessment models with reported human illness data for the purpose of gauging the reliability of the predicted estimate. This comparison emphasizes the iterative nature of modeling. When new data become available, a Microbiological Risk Assessment may need to be revisited

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