4Hazard A biological, chemical or physical agent in, or condition of, foodwith the potentialto cause an adverse health effectCodex Alimentarius, 1997The word "hazard" has a particular meaning in the HACCP concept. It refers to something which is unacceptable because it may cause harm to the consumer. This “something” can be a biological, chemical or physical agent in a food. It can also be a feature or condition of a food. For instance, if a food permits the growth of a infectious agent (a “pathogen”), and if the food is not refrigerated properly, such a condition is a hazard.
5Risk A function of the probability of an adverse health effect and the severity of that effectconsequential to a hazard in food
6Risk Analysis A regulatory tool to maintain or enhance the supply of safe food,both locally produced and imported,in a certain countryIt is not only an analysis, it includes also risk management
7of information and opinions Risk AnalysisPolicy basedScience basedMRAMRMMicrobiologicalRisk AssessmentMicrobiologicalRisk ManagementRisk CommunicationInteractive exchangeof information and opinionsconcerning risks andcontrol measures
8Risk Analysis and HACCP GovernmentidentificationIndustryAssessmentFactoryHACCPMarketRISKquantificationdecisionManagementcontrolreview
9An operational system to select and implement HACCPAn operational system to select and implementeffective control measuresto ensure the safety of a food productMicrobiological Risk Assessment ( MRA )A procedure to provide datathat are used in the selection ofappropriate risk reduction measures
11Codex HACCP Guidelines 1. Assemble HACCP team2. Describe product3. Identify intended use4. Construct flow diagram5. Confirm on-site flow diagram6. List all potential hazards, conduct a hazard analysis and consider control measureApply principlesThe Codex guidelines describe how a HACCP study should be performed. These guidelines give a certain universal structure to a study, which will make it more likely to be accepted by other parties (food inspectors and trade partners). The 7 principles may be applied taking specific conditions into account, and not following the guidelines exactly.
12HACCP Principles 1. Conduct a hazard analysis 2. Determine the CCPs 3. Establish critical limit(s)4. Establish a monitoring system5. Establish corrective actions6. Establish verification procedures7. Establish documentationHACCP system consists of 7 principles. These principles form the minimum requirements in the mandatory application of HACCP system. They are simple, provided that we understand the meanings of the terms. Therefore, we will now review the meanings of the essential terms used in these principles
13(1) Assemble HACCP team Obtain top management commitment Appoint a leader and a secretaryAssure participation of experts in QA, microbiology, chemistry, food technologyAssure co-operation of other expertsDefine scope of the studySet prioritiesTo perform a HACCP study, a HACCP team has to be assembled. A leader knowledgeable in HACCP should be appointed as well as a secretary. Documenting the HACCP study is a very important aspect of the exercise. Experts in quality assurance, microbiology, chemistry, food technology etc. will be needed in complicated food production or preparation lines. Often, other experts, e.g. on logistics, agricultural practices etc., may be needed to complete the study. To keep the study manageable, it is important to define its scope and set priorities.
14Assemble Risk Assessment team Same general principles apply,but Risk managers are mainly governmentalregulators and scientists, while a HACCPteam consists mainly of production people.The pathogen and food of concernis often already decided uponby the Risk ManagersMRA
15(2) Describe product Formulation and composition Raw materials & ingredientsParameters influencing safetyProcessingPackagingDistributionOne of the first activities of the study team is to describe the product. Which raw materials and ingredients are used, and who are the suppliers. Which parameters influence safety (pH, Aw, modified atmosphere packaging, storage temperature and time etc.)? What are the processing conditions, temperature treatments etc.? How is the packaging performed, and what are the characteristics of the packaging material? What are the real conditions during distribution, warehousing and sales?
16Products to analysed Same general principles apply, but the product is a commodity,not a specific one.It is a product produced in different mannersby different manufacturers,including manufacturers in other countriesMRA
17(3) Identify intended use Food service establishmentsCaterersHospitalsGeneral populationSpecific groups of the populationPreparation practicesExportationNext, the intended use of the product has to be defined, because this may influence the level of safety to be assured, or the risks which can be taken. If the product is to be sold to hospitals or groups of the population with high susceptibility to certain microbes, more safety has to be built in and critical limits need to be more strict.The use and preparation practices may also influence the safety of a product. HACCP is successful only if applied from farm to fork. For certain products such as hamburgers, the preparation practices determine the final safety for the consumer. For certain bacteria, such as Salmonella, contamination of the raw material (i.e. meat) at the agricultural level can not be prevented. Thus, if the processing does not include any killing step, the only CCP which can render the product safe is the adequate heat treatment during preparation.
18Use of Products Same categories may apply, however, products for exportmay need to be treated separatelybecause of the differencesin use and usersMRA
19(4) Construct flow diagram Cover all steps which might have an influence on the safety of the productInclude important data such as time & temperatureIndicate hygiene level of areas and barriersIndicate personnel movements etc.Raw materialsMixingHeatingTo understand how a product is manufactured, and to have a disciplined approach in the study, it is important to construct a flow diagram covering all steps where product safety could be affected. Temperatures in heat treatments should be mentioned as well as time, time and temperature should also be mentioned for holding the product in buffer tanks, holding vats etc. In many food production and preparation establishments, different areas or rooms have different hygiene levels, and barriers, such as walls or air curtains separate them. For instance, most Good Manufacturing Practices require a clear separation between raw materials and prepared foods. For the same reason, it is important to indicate on the diagram the personnel movements.Filling
20Perform a Product / Pathogen / Pathway ( PPP ) analysis The fate of the pathogen of concernfrom “farm to fork”will be described in detail,data concerning conditions at the various stepsneed to be collected and treated,growth, survival etc. will be “modelled”MRA
21(5) On - Site confirmation of flow diagram Check correctness of informationCheck whether important information was not overlookedCheck during all periods of operation and cleaning, but also during idle hoursDiscuss practices with operatorsUp to this point, the study is a paper exercise. Clearly, what has been put on paper should be confirmed by an on-site inspection. This should check the correctness of the information and ensure that nothing crucial was overlooked. It is important to inspect the site and the practices applied during all hours (night shifts, weekends etc.) of operation, as well as the idle hours. Inspection of the cleaning procedures and validation of their efficacy is very important. Operators often are better informed than Chief Engineers or Production Managers about practices and the problems encountered during the operation, and may have information about problems that were not considered in the study.
22PPP confirmation The pathway and its conditions need to be checked, models need to be validatedand the outcomes verified as far as possible.Uncertainties need to be identified.the PPP in risk analysis is less specificas the one used in HACCPMRA
23Determine which potential hazards (6) List all hazards associated with each step, conduct a Hazard Analysis, consider any measures to control identified hazardsDetermine which potential hazardsare significant and should be controledThis activity will be described in detail during the next lecture.
24Hazard identification The hazard of concern is identified by MRM.Important aspects of the ecology andbehaviour of the pathogen are collected.This is particularly difficult when the riskof a “new” pathogen is assessedin HACCP hazard identification meansdetermination which hazards are significantMRA
25Perform a Hazard Analysis Collect and interpret information on hazardsand conditions leading to their presenceat unacceptable levelsand decide which need to be controlled"the analysis of hazardsmust be quantitativeif it is to be meaningful"ICMSF 1988HA is not RAThis overhead gives the Codex definition of Hazard Analysis.
26Hazard DeterminationQuestions to be answered for each potential hazard for each stepPresence of agentin raw material probable ?Presence of agent in lineor environment probable ?NONONo hazard*YESYESUnaccept. survival,persistence or increaseat this step probable ?Unaccept. contaminationat this step probable ?YESNONONo hazard*YESYES**Reduction, if any, at afurther step adequate ?NOHAZARD* Not a hazard to be controlled at this step** Reduction step becomes thus a CCP
27Acceptable levels ( 1 ) Not all levels (or sizes) of all agents are harmful to all individuals underall conditionsAgents (contaminants) are acceptableas long as their levels remainbelow a certain maximum
28Acceptable levels ( 2 ) Products with a good record of safety are used as a “benchmark”New products, or changed productsshould be as safe as the “benchmark”Performance Objectives are “benchmarks”set by authorities
29Hazard Analysis of aflatoxin in milk Maximum Level accepted 15 μg / kgPossible Probable Likely NoQ1: Presence of hazard atunacceptable levels inraw materialQ2: Persistent during processingQ3: RecontaminationQ4: Increase during shelf-lifeQ5: Reduction during preparationCCP
30HA of Listeria in hotdogs Maximum Level accepted <100 / g ?Possible Probable Likely NoQ1: Presence of hazard atunacceptable levels inraw meatQ2: Survival during processingQ3: RecontaminationQ4: Increase during shelf-lifeQ5: Reduction during preparation or CCP
31Assessment of probability PossibleProbableLikelyReasonably expected to occurThese are semi - quantitative expressions of probability ,based on analytical data or expert knowledge
32Probabilities Risk assessors use “models” to calculate probabilities ofsurvival, persistence, growth etc.Models for recontaminationare being developedthe same models can be and are used in HACCPMRA
33MRA components Hazard identification which pathogen will be assessed Hazard characterizationwhat are the effects and what influences the effectsExposure assessmenthow often and how many will be ingestedRisk characterizationwhat is the chance that the effects will happenMRA
34Hazard characterization curve of Listeria monocytogenes MRAHazard characterization curve of Listeria monocytogenesLog Noof casesper100,000worst - casescenarioBuchanan e.a.1997Log No of ingested L.m., all servings contaminated
35Probabilistic calculation of exposure MRAProbabilistic calculation of exposure
36MRAOutcomes of MRAsthe chance for a person of falling ill by consuming a foodthe estimated number of illnesses (e.g. per year in a country) due to consumption of a specific food/pathogen combinationrisk estimates for different processing, distribution and consumer use conditions and risk reduction scenariosUp to now, not too many countries and organisations have conducted full MRA studies. Little experience has thus been gained yet on articulating risk estimates and interpreting them in risk management decision-making.For most of the MRA studies undertaken, the outcome aimed for was an “absolute” measure of risk, a numerical estimate in it’s own right about the chance of falling ill upon consumption or the number of people falling ill per year in a country.MRAs aiming at “relative” risk estimates, expressing the risk level posed by a particular hazard between products or compared to other products, are few at present but may become frequent [since it may proof to be much more feasible to conduct the in practice as there is less of a need to articulate a explicit risk level].The risk managers will evaluate the outcome of the MRA, with attendant uncertainties, the intervention options possibly included, the expected impact or effect and recommendations or conclusionsRisk managers are ultimately responsible for selecting and implementing appropriate options for control or management of the risk. This may well necessitate careful consideration and weighing of policy alternatives.They often have to weigh different types of risk (biological, chemical, physical) and have to balance that against costs and benefits of interventions.Part of the equation can also be a number of other values and considerations among the various stakeholders that are more societal and less science-based.HACCP in product development uses also different scenarios,but the outcome is a level of safety, not a level of risk
377) Determine Control Measures Determine where measures must be taken (CCPs)Determine how and to which extent they are to be controlled at these CCPsEstablish the critical limitsand monitoring proceduresUp to this point, the study is a paper exercise. Clearly, what has been put on paper should be confirmed by an on-site inspection. This should check the correctness of the information and ensure that nothing crucial was overlooked. It is important to inspect the site and the practices applied during all hours (night shifts, weekends etc.) of operation, as well as the idle hours. Inspection of the cleaning procedures and validation of their efficacy is very important. Operators often are better informed than Chief Engineers or Production Managers about practices and the problems encountered during the operation, and may have information about problems that were not considered in the study.
38MRM components Preliminary MRM activities which pathogen / food will be assessed and whyEvaluation of MRM optionsselection of control measuresImplementation of MRM decisionscommunicate with stakeholders and follow-upMonitoring and Reviewcollect epidemiological and other data, revise decisions if appropriateMRM
39Control measures Risk managers are responsible for the evaluation and selection ofcontrol measures.Food business operators are responsible fortheir executionin HACCP both activities are in the same handsMRM
40Establish Critical Limits They must assure that the required level of safety is obtainedThis level can be the “benchmark”or the “Performance Objective (PO)”The PO may be the outcome of MRM evaluation
41Performance Objective ( PO ) MRMPerformance Objective ( PO )The maximum frequency and / or concentrationof a microbial hazard in a foodat a specified step in the food chainbefore time of consumptionthat still provides or contributes tothe achievement of an Food Safety Objectiveor Appropriate Level Of Protection, as applicable.A PO is an acceptable level of a hazardin HACCP terminology
42Monitoring and Review in MRM 9) Monitoring in HACCPThe act of conducting a planned sequence of observations or measurement of control parameters to assess whether a CCP is under controlMonitoring and Review in MRMAssessment of effectiveness of measures takenReview risk management and / or assessmentas necessary (new option, new information)
43An example of differences and similarities Product Pathogen Pathway ofListeria monocytogenesin a specific paté producedaccording to GHP and HACCPand a “generic” paté, as usedin Microbiological Risk Assessment
44PPP of L. monocytogenes (paté 1) HACCPPPP of L. monocytogenes (paté 1)GHP and HACCP assure safety of specific productsafe levelLog.Lm./gRecontaminationGrowth
45PPP of L. monocytogenes (paté 2) MRAPPP of L. monocytogenes (paté 2)A “generic product” under general conditions in a countryLog.Lm./gInputforMRAChangeconditions ?RecontaminationGrowth
46Risk estimates of listeriosis per 100 Mioinhabitantsof the USAwhich levelacceptable ?level ofL. monocytogenes
47Risk Acceptability concept SeverityIntolerableregionAs low asreasonablyachievableALARAregionAcceptableregionAt which levelsare these lines set ?