Safety Science 40 (2002) 359382 www.elsevier.

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Microbiological Risk Assessment of foods in international trade

M. van Schothorst*
Wageningen University, The Netherlands, Nestle, Avenue Nestle 55, 1800 Vevey, Switzerland

Abstract The international workshop on Promotion of Technical Harmonisation on Risk-Based Decision Making reviewed the use of risk-based decision making across a range of industry sectors and countries. This paper presents the contribution to the workshop covering microbiological risk assessment of foods in international trade. The format is a response to a set of questions prepared by the organisers of the workshop covering the use and performance of risk assessment, evaluation of the acceptability of the risk and the use of risk assessment in the decision-making process (see Preface of this special issue). Risk Assessment of foods has been developed for chemical hazards rather than for microbiological ones. Acceptable or tolerable levels of food additives and contaminants have been included in many food standards worldwide. As part of the FAO/WHO Food Standards programme, the Codex Alimentarius Commission has issued many such standards, based on recommendations from two FAO/WHO expert bodies, the Joint FAO/WHO Expert Committee on Food Additives and Contaminants (JECFA) and the Joint FAO/WHO Meeting on Pesticide Residues (JMPR). This need to establish Food Standards on Risk Assessment procedures was reinforced by the signing of the Uruguay Round of Multilateral Trade Negotiations, presently known as WTO Agreements. The agreement on Sanitary and Phytosanitary (SPS) measures put particular emphasis on the establishment of acceptable or tolerable levels for microorganisms important. The SPS text specied that science and risk assessment should be the basis for the determination of the safety of food. Food safety standards issued by Codex Alimentarius were mentioned as the reference, and Codex was also the preferred international body to develop methods for their establishment. # 2001 Elsevier Science Ltd. All rights reserved.
Keywords: Microbiological Risk Assessment; Food products; Codex Alimentarius; Food safety; Hazard Analysis Critical Control Point (HACCP) system

* Tel.: +41-21-924-4241; fax: +41-21-924-4598. E-mail address: michiel.van-schothorst@nestle.com (M. van Schothorst). 0925-7535/01/$ - see front matter # 2001 Elsevier Science Ltd. All rights reserved. PII: S0925-7535(01)00055-8

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1. Development, purpose and general principles of risk assessment use 1.1. Present the historical development and status of the use of risk assessment techniques in your specic technical area, with special emphasis on standardisation eorts Risk Assessment is one of three dierent aspects of Risk Analysis (Fig. 1). Risk Assessment is the scientic aspect, Risk Management the managerial one and Risk Communication assures the interaction between risk assessors, managers and other interested parties (consumer organisations, industries, etc.). A series of reports describe the various aspects (FAO/WHO, 1995, 1997,1998, 1999). Codex took, quite logically, the existing procedures for risk assessment as used by JECFA and JMPR as the recommended method for Microbiological Risk Assessment (MRA). The procedures have been slightly adapted and the Principles and guidelines for the conduct of Microbiological Risk Assessment have been standardised. The document was published by Codex in 1999 (Appendix; CAC, 1999). This document will be used as the basis for this paper. 1.2. For which purposes are you performing risk assessment? In principle, the methodology described in the Codex document is meant to be used by governments or by expert bodies in the context of Codex Alimentarius. Food industries have little experience with this methodology for estimating microbiological risks and are not particularly in favour of using it. The food industry is

Fig. 1. Structure of Risk Analysis adapted from FAO/WHO report (1997).

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interested in producing safe food and assures safety by applying Good Hygienic Practices and the Hazard Analysis and Critical Control Point (HACCP) system as prescribed by Codex (CAC, 1997). It means that potential hazards in raw materials, in processing lines and line-environment are identied and analysed. Signicant ones are identied and measures to prevent product contamination, to ensure elimination or reduction to acceptable (tolerable) levels are taken. The food producer may want to estimate the level of the hazard (safety) achieved by determining the eects of the measures taken to control the identied hazards, but he will normally not have the necessary data to perform a risk assessment according to the Codex protocol (Reij and Van Schothorst, 2000). In most foods processed for safety the level of the residual hazard is too low to measure, and moreover, dose-response relationships for microbes are at the moment either not existent or have too a high level of uncertainty to be of practical value. In short, Microbiological Risk Assessment models are currently under development for governmental use; food industries concentrate more on models for food safety assessment (i.e. determination of levels of hazards rather than the likelihood of their eects). Risk Assessment by governments deals with estimating the impact of hazards in foods on human health. In industry, the scientic analysis that is often erroneously referred to as Risk Assessment consists of studying the impact of control options on hazards in foods. It should be noted that there is a great similarity between Risk Assessment as performed in other industries and HACCP as carried out in the food industry. The HACCP system analyses potential hazards and describes methods of control. MRA provides risk estimates, but decisions concerning control measures are made by the Risk Management. 1.3. Are there any specic requirements related to availability of supporting documents for your risk assessment studies? MRA should be transparent. With the exception of proprietary materials, all documents and data use in the models have to be recorded and available to risk managers and other interested parties. 1.4. What is the nature and quality of risk assessment documentation? Do you follow any established standards/guidelines? Currently, MRA is still in the early stages of development and no specic guidelines except those given in the Codex document are available. However, data and documentation must meet general scientic standards. A guideline on Hazard Characterisation is currently being developed. 1.5. Is the risk assessment maintained as a living entity? If so, how often is it updated? The Codex document contains a section on reassessment. It species that when new data become available, a MRA may need to be revised.

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1.6. How do you ensure the competence of your risk analysts? FAO and WHO have very strict internal requirements for selecting risk assessors to participate in their expert bodies. There must be no conict of interest and participants must be scientic experts in their eld. The Codex document on MRA requires the functional separation of risk assessors and risk managers. 1.7. How do you ensure consistency with state-of-the-art? MRAs conducted by countries to assure that certain products meet the importing countrys requirements may be questioned for their validity. International disputes should be resolved through mechanisms set by the WTO.

2. Terminology 2.1. Could you use for your specic risk assessment purposes the denition of hazard in Table 1? If not, what is the denition you are currently using? This denition of hazard could be accepted for standardisation purposes. However, the following Codex denition is preferred: a biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health eect (Table 2). 2.2. Could you use for your specic risk assessment purposes the denition of risk in Table 1? If not, what is the denition you are currently using? Use of the denition in Table 1 would cause problems. Risk in the Codex denition covers not only the likelihood of an adverse eect, but also its severity. For MRA this is very important because of the range of the severity of possible consequences (the eects of consuming microbes in foods range from diarrhoea to death). The Codex denition of risk is: a function of the probability of an adverse health eect and the severity of that eect, consequential to a hazard(s) in food. 2.3. Could you use for your specic risk assessment purposes the structuring of the risk assessment process given in Table 1? If not, what is the structure you are currently using? The structure for MRA used by Codex is given in the Appendix. The structure as presented in Table 1 could be used, but in the Codex system the step V, i.e. decision making, would be a Risk Management activity. Currently, no comparisons are made, although techniques that would allow this are being developed, for example the DALY concept (Murray and Lopez, 1996). Step II is similar to Exposure Assessment the Codex guidelines. Step III in Table 1 is similar to Hazard Characterisation and Step IV is similar to Risk Characterisation according to Codex.

M. van Schothorst / Safety Science 40 (2002) 359382 Table 1 Basic assumptions on terminology Term Hazard Risk Risk Assessment Denition

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Shall mean the property of a substance or physical situation with a potential for creating damage to human health or the environment Shall mean the likelihood of a specic eect originating from a certain hazard occurring within a specied period or inspecied circumstances Consists of the following four steps Step IHazard Identication Identication of sources with the potential to cause undesired outcomes to subjects of concern that is the focus of the estimation of likelihood Step IIEvent Scenario Assessment Identication of the initiators and sequences of events that can lead to the realisation of the hazard Step IIIConsequence Assessment Identication and assessment of the consequences of the realised hazard Step IVRisk Evaluation Consists of two parts Step IV-ARisk Assessment Assessing and expressing the likelihood of the consequences and describing the quality of such estimates Step IV-BRisk Comparison Comparing derived risk estimates to specied guidelines/criteria/goals and describing the dependence of these estimates on explicitly specied assumptions Step VDecision Making Deciding on actions based on risk evaluation

2.4. Are you following any particular risk standards and/or other guidelines? If yes, what is the origin of this standard, and what are your views on its adequacy and applicability to your situation? In international trade the Codex Principles and Guidelines for the Conduct of Microbiological Risk Assessment has to be followed. This document has been elaborated by member countries of Codex, but most have very little experience with it; thus, it is too soon to evaluate it. 2.5. Can you identify dierences in the terminologies in your applications versus those listed in Table 1? Please elaborate The dierences in terminology are obvious when the Codex denitions are compared with those in Table 1. Dierences in terminology are in itself not important as long as what they intend to describe is the same. This is not entirely the case here. Some comments have been made in Section 2.3 already. The most obvious dierence is that Step V does not exist in the Codex procedure. Decision-making concerning actions to be taken is a Risk Management activity.

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Table 2 Denitions of important terms (according to Codex Alimentarius)a 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 eect Hazard Characterisation The qualitative and/or quantitative evaluation of the nature of the adverse health eects associated with the hazard. For the purpose of Microbiological Risk Assessment the concerns relate to microorganisms and their toxins Hazard Identication The identication of biological, chemical, and physical agents capable of causing adverse health eects and which may be present in a particular food or group of foods Risk A function of the probability of an adverse health eect and the severity of that eect, 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 scientically based process consisting of the following steps: (1) hazard identication, (2) hazard characterisation, (3) exposure assessment, and (4) risk characterisation Risk Characterisation The process of determining the qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health eects in a given population based on hazard identication, hazard characterisation and exposure assessment Risk Communication 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 ndings and the basis of risk management decisions Risk Management 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 for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options
a

Codex Alimentarius Procedural Manual, 11th edition, pp. 4849. 2000, FAO, Rome.

3. Performance of risk assessmentstep I: Hazard Identication 3.1. Please describe briey the overall approach used in this step for your applications Hazard Identication starts when a microorganism in a food is identied as a concern because it has caused a case or an outbreak of a foodborne disease. This is

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in contrast to a chemical RA, which often starts with the selection of a chemical for which a no-eect level has to be established. MRA often starts with the outcome of epidemiological studies. People get ill from a certain food and a laboratory isolates a specic microorganism, which is considered to be the causative agent. The same pathogen in a similar or dierent food may not cause illness. Risk Managers want to know more about this and whether actions have to be taken to protect the consumer. However, priorities have to be set. It is the task of the Risk Managers to decide which microorganisms and foods are of highest concern and which should be the subject of a Risk Assessment. Economic, social and cultural deliberations often play a role in this priority setting. In international trade of food, the Codex Alimentarius Committee on Food Hygiene is the body involved in Hazard Identication. 3.2. Which sources with the potential to cause undesired outcomes are you considering? 3.3. How do you dene potential in the present context? 3.4. Which undesired outcomes are you considering? 3.5. What are the issues of concern? 3.6. In which way do you include likelihood consideration in identifying potentially relevant hazards? 3.7. How do you assure completeness of your results in this step of risk assessment? 3.8. How, if at all, are regulatory authorities involved in this step of risk assessment? 3.9. Which underlying standards/guidelines are you using in this step of risk assessment? 3.10. How much standardisation is currently available for this step of risk assessment? 3.11. Do you have specic Quality Assurance (QA) procedures that you follow? If yes, what recommendations can you make in regards to QA requirements and standardisation?

3.12. How do you address and/or quantify the impact of uncertainties in this step? 3.13. Is the overall approach to this step qualitative or quantitative? How do you relate this to actuarial data, including generic and process/system specic aspects?

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3.14. How do you utilise and view subjective expert judgement? How crucial is the use of expert judgement in this step of the analysis? Questions 3.23.14 do not apply to MRA for foods in international trade. Some of these could be answered in the context of how Hazard Analysis is performed as part of HACCP.

4. Performance of risk assessmentStep II Event Scenario Assessment 4.1. Please describe briey the overall approach used in this step for your applications This step is similar to the Product/Pathogen/Pathway (PPP) analysis as part of the second step in MRA, i.e. Exposure Assessment. It results in an estimate of the frequency and number of the chosen microorganism that will be ingested by a person, a part of a population (some people are more susceptible to certain pathogens than others) or the whole population (ILSI, 1993). This can be done by analysing foods on the market, in homes, institutions, restaurants, etc., it can also be modelled by mimicking the food chain from farm to fork (PPP analysis). The models describe prevalence, dissemination, growth and inactivation of the pathogen at the various stages of the food chain (ICMSF, 1998). Normally, an MRA is carried out for a food product that originates from many production sites. Consequently, prevalence of pathogens and levels may vary. Also the conditions during warehousing, transport, distribution, preparation and use may dier. This is particularly true for foods in international trade. To deal with these widely varying gures, Monte Carlo simulations are used in the calculations (Lammerding, 1997). 4.2. How do you identify the sequences of events (scenarios) that describe or predict the course of events that may lead to an undesired outcome or subsequent eect? First, the normal way that foods are produced, processed, stored, transported, retailed, prepared and used is described. The conditions for contamination, growth, inactivation, elimination and survival for each step in the food chain and eating habits are described and their eects modelled. This leads to the estimation of normal exposure. Then dierences in conditions are introduced, reecting dierent intervention possibilities or worst-case scenarios, that could reduce or increase the exposure. 4.3. By which criteria do you dene the domain and its boundaries into which the undesired outcomes enter? This question does not pertain to MRA.

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4.4. How do you assure completeness of your results in this step of risk assessment? By soliciting as much input as possible from implicated sectors. Currently, many data gaps exists; consequently, many assumptions have to be made, which add to the uncertainty of the nal risk estimate.

4.5. How, if at all, are regulatory authorities involved in this step of risk assessment? MRA is currently mainly a governmental activity. 4.6. Which underlying standards/guidelines are you using in this step of risk assessment? The Codex document. 4.7. How much standardisation is currently available for this step of risk assessment? Very little, the Codex document is not very descriptive in this respect.

4.8. Do you have specic Quality Assurance (QA) procedures that you follow? If yes, what recommendations can you make in regards to QA requirements and standardisation? The Codex has issued a document: Recommended International Code of Practice, General Principles of Food Hygiene (ICMSF, 1998). This document comes close to a description of QA procedures. Annexed to this document is the one on HACCP, which deals particularly with food safety hazards (CAC, 1997).

4.9. How do you address and/or quantify the impact of uncertainties in this step? As much as possible, uncertainties are identied and dierent scenarios can be used to obtain some quantication. Sensitivity analysis can be helpful when models have been used to describe the step in the food chain (Zwietering and van Gerwen, 2000).

4.10. Is the overall approach to this step qualitative or quantitative? How do you relate this to actual data/experience, including generic and process/system specic aspects? Not many MRAs have been performed, they vary greatly in their level of detail. No answer can be given, except that Exposure Assessment by nature is quantitative.

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4.11. How do you utilise and view subjective expert judgement? How crucial is the use of expert judgement in this step of the analysis? Often risk assessors have to rely on the judgement of others as far as the reliability of the data is concerned. Many data may be available in the industry, but industries are currently hesitant to reveal these, because they may lead to law enforcement actions. Very little data are available concerning the situation in developing countries. Relying on expert judgement is often the only practical way to proceed. 4.12. How do you consider the human factor aspects in event / scenario modelling? Assessing consumer behaviour and consumption practices is the most dicult aspect of MRA. Most microbiological foodborne diseases can be prevented by hygienic handling in the kitchen and correct product use. Normal food handling practices should be captured by the HACCP system.

5. Performance of risk assessmentStep III: Consequence Assessment 5.1. How do you perform the consequence assessment? Please describe briey the overall approach used in this step for your applications This step is similar to the third step in MRA called Hazard Characterisation, which could better be called Eect Characterisation. This step deals with the eect of the pathogen on the various categories of consumers. It describes the symptoms, severity and duration of the potential illnesses. An important aspect is the dose-response relationship between pathogen and host. This relationship depends on many factors such as the food in which the pathogen is present, the physiological status and virulence of the pathogen and the susceptibility of the host (ILSI Europe, 1993). In chemical Risk Assessment, animal studies are used to determine the eect of various doses of a substance. Animal studies have very little value in determining dose-response relationships for pathogens and the various categories of consumers. Certain groups are particularly vulnerable, such as the very young, the very old, diseased persons, individuals under certain drug treatments and pregnant women (or their foetus). Moreover, many microbes with the same name behave dierently. For instance, E. coli is a normal inhabitant of the human intestinal tract, but some E. coli such as strains of E. coli O157, H7 are very dangerous, particularly for young children. Often, such dierences cannot be determined by animal experiments. The best information on the eects of microorganisms on the human host is derived from the investigation of cases or outbreaks of foodborne diseases (Buchanan et al., 1997). Attempts are made to model dose-response relationships, but most of the time they cover only the response in healthy human beings, because the data were established by human volunteer studies. Moreover, some foodborne illnesses have long-term secondary eects such as reactive arthritis, which do not appear in animal experiments.

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5.2. By which criteria do you dene the intensity, time and mode of contact? Crucial to MRA is the moment of consumption and the amount of the food consumed. What happens after ingestion depends on many factors. Identication and quantication of these factors is the essence of Hazard Characterisation. This question is not applicable to MRA. 5.3. How do you assure completeness of your results in this step of risk assessment? Appropriateness of the data collection is of greatest importance. Completeness will most probably be an unrealistic goal. Human responses in the global village will vary considerably according to age, health, previous exposure, nutritional status, etc. 5.4. How, if at all, are regulatory authorities involved in this step of risk assessment? See 4.5. 5.5. Which underlying standards/guidelines are you using in this step of risk assessment? The Codex document. 5.6. How much standardisation is currently available for this step of risk assessment? The Codex document gives little guidance, for this reason another document is currently being elaborated by FAO/WHO experts. 5.7. How do you address and/or quantify the impact of uncertainties in this step? Hardly any reliable Dose-Response data are currently available for most food/ pathogen/host combinations. A high level of uncertainty is unavoidable at the moment. 5.8. Is the overall approach to this step qualitative or quantitative? How do you relate this to actual data/experience, including generic aspects? The nature of this step makes it quantitative or semi-quantitative. This step should answer the question: how many people may get ill when they are exposed to this pathogen, with this frequency or number, in this food?. 5.9. How do you utilise and view subjective expert judgement? How crucial is the use of expert judgement in this step of the analysis? Expert judgement is often the only means to interpret information. Experts need to make many assumptions, because scientic data are lacking.

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5.10. Do you include any consequence mitigation measures? If yes, what is the basis for this and do you follow established requirements or otherwise? If vaccination or other preventive measures would be available, the eect could be modelled.

6. Perfomance of Risk AssessmentSTEP IV-A: Risk Estimation 6.1. How do you express the likelihood of eects (qualitative/quantitative, etc.)? The last step of the MRA is Risk Characterisation, which is a summary of the three foregoing elements and a calculation of the risk estimate. The risk estimate is taken by the risk managers to decide upon actions to be taken, if any. The Risk Estimate should be expressed as the likelihood that a certain pathogen in a certain food provokes a certain type of illness in a certain category of a population. This estimate should be accompanied by an estimate of the uncertainty. All the assumptions that were made have to be clearly expressed in order to make the estimate, and the procedure followed for arriving at the estimate, as transparent as possible (Buchanan et al., 2000). This may help the risk managers in their decision making. Sometimes, the risk assessors are asked to elaborate various scenarios. The worst case scenario was already mentioned, but risk managers may also anticipate certain control options and they may want to have a Risk Estimate attached to a scenario in which a certain control option is included. To give an example, a risk assessment of Salmonella enteritidis in eggs carried out in the USA showed that a 12% reduction in illness could be obtained if eggs were cooled down to 7  C directly after laying, and maintained at that temperature until the preparation stage (no attendant uncertainties were given) (Baker et al., 1998). Comparisons with other risks are often not made because the consumer has a very particular perception of Food Safety, for instance compared to road safety. Since MRA is still under development, not many publications exist at this moment that deal with risk estimations. 6.2. What criteria do you use to describe the quality of estimated risk measures? There is not much experience in this area. Expert judgement and common sense, and particularly epidemiological data are used.

6.3. How do you assure the overall completeness of the estimated risk measures? Completeness is at the moment an unattainable goal. Obtained risk estimates depend on the accuracy of the data and of the underlying assumptions.

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6.4. How, if at all, are regulatory authorities involved in this step of risk assessment? As mentioned before, MRA is mainly a government activity. 6.5. How do you display the estimated risk measures? Do you also show the impact of various uncertainties? Please elaborate Risk estimates are expressed, for example, as the number of illnesses per 100,000 of a population, or the chance of getting ill by eating a certain food. Uncertainties should be mentioned, but not much experience is available on how best to do this. 6.6. Do you identify various risk-outliers or vulnerabilities? How do you dene risk-outliers or vulnerabilities? Dierent risk estimates may be obtained for various sub-populations such as the very young, the very old, the diseased and people who, for various reasons, are particularly vulnerable. 6.7. Do you show the sensitivity of the estimated risk measures to the various model assumptions? If yes, how do you address and justify the sensitive and uncertain contributors in the context of overall risk assessment process? When various scenarios are modelled, and the models allow this, then a sensitivity analysis can be carried out (Zwietering and van Gerwen, 2000). Not much experience with these techniques exists at the moment.

7. Performance of Risk AssessmentStep IV-a: Risk Comparison Risk comparison is not carried out in MRA.

8. Decision making Decision making is, according to the Codex procedure, not a risk assessment task but a risk management task. 8.1. How are the results used for industry-internal purposes? As explained above, MRAs are currently not performed in the food industry. In product development, dierent scenarios may be used to determine the potential level of a hazard resulting from the application of various technologies, but they are not precise risk estimates. Scenario analyses are part of the HACCP system.

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8.2. How are the results used for regulatory purposes? Risk Estimates are used by Governmental Authorities to decide whether or not control measures have to be taken. In principle, control measures can be applied to anything inuencing pathogen survival growth from farm to fork. The basis of the HACCP system is that unacceptable contamination, multiplication, dissemination and survival have to be prevented. In international trade, Foods Standards are often used. According to the WTO/ SPS Agreement, such standards should be based on Risk Assessment. The Codex Committee on Food Hygiene has still to elaborate a procedure for translating a Risk Estimate into a microbiological criterion. The existing document on Principles for the Establishment and Application of Microbiological Criteria for Foods (CAC, 1997c) does not deal with this subject. The International Commission on Microbiological Specications for Foods (ICMSF) has proposed to use Risk Assessments for the establishment of Food Safety Objectives (Van Schothorst, 1998). Such a FSO is the maximum level of a hazard in a food considered to be acceptable for consumer protection. This concept has to be worked out in more detail by Codex.

9. Legal/policy issues 9.1. Are there any specic legal/regulatory requirements for performance of risk assessments? If so, are these requirements prescriptive or non-prescriptive? Please comment on the merits and detriments of the existing approach/requirements In principle, food safety standards in international trade should be based on science and Risk Assessment when they are used to reject imported foods at a port of entry. The conict concerning hormones in meat between the USA and the EU illustrates this point. For microorganisms in foods, no standards exist at this moment. Currently, the WHO and FAO are conducting MRAs for a few pathogens and a few selected foods; how this will inuence international trade in the future is not yet clear. 9.2. Are risk goals and/or risk criteria used? If so, are they qualitative or quantitative and are there any compliance requirements? Please elaborate The concept of Microbiological Food Safety Objectives (Van Schothorst, 1998) is currently being elaborated. No experience at the international level is available. 9.3. Is cost/benet analysis required? If so, what are the legal and policy implications? No cost/benet analysis is currently required for MRAs under elaboration at the international level.

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10. Impact of the generic standard 10.1. What would be the merits of a generic standard for risk-based decision making for your specic technical area? A generic standard might facilitate comparisons of microbiological risks with other risks. Moreover, some techniques,that have proven to be valuable in other areas may also be useful in MRA. 10.2. Which implications of its use do you expect (legal obligations, status, liability, compulsory nature, scientic relevance)? No implications for the moment, because the Codex document will remain the Guideline for MRA for food in international trade.

10.3. How would you dene its required scope? The scope of a generic standard would be a document that would allow comparison of risk estimates for various human health risks.

10.4. Who would be its potential users? Potential users would again be government authorities. I believe that food industries would be reluctant to express the safety of their products in terms of their likelihood of causing illness.

11. Risk perception 11.1. In your view, how is the risk specic for your technical area perceived and assessed by the public? Please use the risk perception criteria in Table 3 and mark them as appropriate. There is readily available information and this could not be obtained without a survey of public opinion. The views below are therefore a personal opinion on the perception of risk Many studies have indicated that the public perception of the risks of eating is very dierent from its perception of the risks of smoking, drinking, driving cars, mountaineering, etc. Moreover, public perceptions of risks may dier widely from country to country or culture to culture or even between social classes. In the Western world the consumers opinion is usually expressed as: Food should be safe, eating should be risk-free! Risk Communication is an important aspect of the Risk Analysis framework as depicted in Fig. 1.

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Table 3 Criteria for perceiving the risksa Risk Perceptio criteria Probability of occurrence Extent of potential damage Incertitude of risk estimate Ubiquity of potential damage Persistency of potential damage Reversibility of post-damage Delay between initial event and impact Potential of mobilisation
a

Low

Medium X

High X X X

Not sure

X X X X

These criteria are to be understood, as follows: Incertitude (related to statistical uncertainty, fuzzy uncertainty, and ignorance); Ubiquity denes the geographic dispersion of potential damages (intragenerational justice); Persistency denes the temporal extension of potential damages (intergenerational justice); Reversibility describes the possibility to restore the situation to the state before the damage occurred (possible restoration are e.g. reforestation and cleaning of water); Delay eect characterises a long time of latency between the initial event and the actual impact of damage. The time of latency could be of physical, chemical or biological nature; and Potential of mobilization is understood as violation of individual, social or cultural interests and values generating social conicts and psychological reactions by individuals or groups who feel inicted by the risk consequences.

Acknowledgements The author would like to thank Dr. Susan Jongeneel for her help in the preparation of this manuscript.

Appendix. Principles and guidelines for the conduct of Microbiological Risk Assessment CAC/GL 301999. FAO, Rome (reproduced with kind permission of FAO) Table of contents Introduction 1. Scope 2. Denitions 3. General principles of microbiological risk assessment 4. Guidelines for application 4.1 General considerations 4.2 Statement of purpose of risk assessment 4.3 Hazard identication 4.4 Exposure assessment 4.5 Hazard Characterization

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4.6 Risk Characterization 4.7 Documentation 4.8 Reassessment 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 of ensuring public health protection. This document deals with Risk Assessment which is a key element in ensuring that sound science is used to establish standards, guidelines and other recommendations for food safety to enhance customer 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 nd it valuable. Since Microbiological Risk Assessment is a developing science, implementation of these guidelines may require a period of time and may also require specialised 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.

Scope The scope of this document applies to Risk Assessment of microbiological hazards in food.

Denitions The denitions cited here are to facilitate the understanding of certain words or phrases used in this document. Dose-Response Assessmentthe 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 eects (response). Exposure Assessmentthe 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. Hazarda biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health eect.

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Hazard Characterizationthe qualitative and/or quantitative evaluation of the nature of the adverse health eects associated with the hazard. For the purpose of Microbiological Risk Assessment the concerns relate to microorganisms and/or their toxins. Hazard Identicationthe identication of biological, chemical, and physical agents capable of causing adverse health eects and which may be present in a particular food or group of foods. Quantitative Risk Assessmenta Risk Assessment that provides numerical expressions of risk and indication of the attendant uncertainties. Qualitative Risk Assessmenta Risk Assessment based on data which, while forming an inadequate basis for numerical risk estimations, nonetheless, when conditioned by prior expert knowledge and identication of attendant uncertainties permits risk ranking or separation into descriptive categories of risk. Riska function of the probability of an adverse health eect and the severity of that eect, consequential to a hazard(s) in food. Risk Analysisa process consisting of three components: Risk Assessment, Risk Management and Risk Communication. Risk Assessmenta scientically based process consisting of the following steps: (1) Hazard Identication, (2) Hazard Characterization, (3) Exposure Assessment, and (4) Risk Characterization. Risk Characterizationthe process of determining the qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health eects in a given population based on Hazard Identication, Hazard Characterization and exposure assessment. Risk CommunicationThe 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 ndings and the basis of risk management decisions. Risk Estimateoutput of Risk Characterization. Risk Managementthe 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 for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options. Sensitivity analysisa method used to examine the behaviour of a model by measuring the variation in its outputs resulting from changes to its inputs. Transparentcharacteristics of a process where the rationale, the logic of development, assumptions, value judgements, decisions, limitations and uncertainties of the expressed determination are fully and systematically stated, documented, and accessible for review. Uncertainty analysisa method used to estimate the uncertainty associated with model inputs, assumptions and structure/form.

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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 Identication, 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 identied 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 sucient 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.

Guidelines for application These Guidelines provide an outline of the elements of a Microbiological Risk Assessment indicating the types of decisions that need to be considered at each step. 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 ensure 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, eorts should be made to provide a Risk Assessment process that allows contributions by interested parties. Contributions by interested parties in

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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. Scientic evidence may be limited, incomplete or conicting. 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 recognised that sucient resources will not always be available and constraints are likely to be imposed on the Risk Assessment that will inuence 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.

Statement of purpose of Risk Assessment At the beginning of the work the specic 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 dened. 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 modelling of risk might be structured or mapped into the framework of risk assessment.

Hazard Identication For microbial agents, the purpose of Hazard Identication is to identify the microorganisms or the microbial toxins of concern with food. Hazard Identication will predominately be a qualitative process. Hazards can be identied from relevant data sources. Information on hazards can be obtained from scientic 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 production up to and including consumption, and studies on analogous microorganisms and situations.

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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 inuenced by the characteristics of the pathogenic agent, the microbiological ecology of the food, the initial contamination of the raw material including considerations of regional dierences 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 dierences (population demographics), regional dierences, 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 reect eects of processes, 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 categorised according to the likelihood that the foodstu will or will not be contaminated at its source; whether or not the food can support the growth of the pathogen of concern; whether there is substantial potential for abusive handling of the food; or whether the food will be subjected to a heat process. The presence, growth, survival or death of microorganisms, including pathogens in foods, are inuenced by processing and packaging, the storage environment, including the temperature of storage, the relative humidity of the environment, and the gaseous composition of the atmosphere. Other relevant factors include pH, moisture content or water activity (Aw), nutrient content, the presence of antimicrobial substances, and competing microora. Predictive microbiology can be a useful tool in an Exposure Assessment.

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Hazard Characterization This step provides a qualitative or quantitative description of the severity and duration of adverse eects 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 may change depending on their interaction with the host and the environment; genetic material can be transferred between microorganisms leading to the transfer of characteristics such as antibiotic resistance and virulence factors; 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 eect; 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 doseresponse relationship. When establishing a dose-response relationship, the dierent 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 characterise severity and/or duration of disease.

Risk Characterization Risk Characterization represents the integration of the Hazard Identication, Hazard Characterization, and Exposure Assessment determinations to obtain a Risk Estimate; providing a qualitative or quantitative estimate of the likelihood and severity of adverse eects which could occur in a given population, including a description of the uncertainties associated with these estimates. The estimates can be assessed by comparison with independent epidemiological data that relate hazards to disease prevalence.

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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 condence in the nal estimation of risk will depend on the variability, uncertainty, and assumptions identied in all previous steps. Dierentiation 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 arrive 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 dierence in virulence that exist in microbiological populations and variability in susceptibility within the human population and particular subpopulations. It is important to demonstrate the inuence of the estimates and assumptions used in Risk Assessment; for quantitative Risk Assessment this can be done using sensitivity and uncertainty analyses. Documentation The Risk Assessment should be fully and systematically documented and communicated to the risk manager. Understanding any limitations that inuenced a Risk Assessment is essential for transparency of the process that is important in decision making. For example, expert judgements should be identied and their rationale explained. To ensure a transparent Risk Assessment a 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.

Reassessment Surveillance programmes can provide an ongoing opportunity to reassess the public health risk 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 emphasises the iterative nature of modelling. When new data become available, a Microbiological Risk Assessment may need to be revisited.

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