4. SUMMARY OF GENERAL DISCUSSION

4.1. DEVELOPMENT OF GUIDELINES^[6]

The consultation agreed that the elaboration of guidelines for systematically incorporating MRA in the development of food safety standards was an important goal for FAO, WHO, the Codex Alimentarius Commission (CAC), and national governments. These guidelines should jointly reflect current constraints and future expectations in respect of MRA. It was also agreed that because of the limited experience with MRA to date, development of principles would not be attempted at this stage.

While developing guidelines that primarily focused on the availability of a MRA, the consultation fully recognized that flexibility in risk management responses is essential. In cases of urgency, unpredictability and "emerging" hazards, risk managers may have to implement food controls on the basis of very limited scientific information. In other cases, competent authorities may give advice to interested parties before there is a proven link between an "emerging" hazard and the actual risk to human health.

The consultation recognized that effective use of MRA in the development of food safety standards requires a major change in traditional approaches to developing food controls. General aspects of risk analysis as developed by previous FAO/WHO Expert Consultations^[7] and the CAC^[8] need to be translated into guidelines that specifically address issues and questions related to management of microbiological hazards in foods.

The consultation used the four components of a generic framework for managing food-borne risks as "building blocks" for the development of guidelines:

• Preliminary risk management activities (was Risk evaluation);

• Evaluation of risk management options;

• Implementation;

• Monitoring and review.

The draft guidelines elaborated by the consultation are included in this report as Annex III.

As microbiological food safety issues are brought to the attention of risk managers, the consultation recognized that there needs to be a systematic preliminary risk management process that brings particular issues into focus and guides further action. Risk managers should use the results of the preliminary risk management process to determine if there is a need for an MRA and how it might best contribute to the different types of food safety measures that may be developed. If a MRA is commissioned, the scope of that exercise and the likely contribution to the evaluation of risk management options must be recognized as important risk management responsibilities.

The consultation emphasized that effective communication between all interested parties was arguably the most important single attribute of a generic framework for managing food-borne risks to consumers. Communication is an integral and critical part of the entire risk management process, and essential for engendering trust in risk management decisions. Risk communication needs must be planned as early in the process as possible, and must be continually re-evaluated. Consideration should always be given to providing the right information in a manner appropriate to the situation and intended audience, and to providing opportunities for two-way exchange. It is important to identify which parties need to be involved in communication, and when opportunities for communication will be provided. If a particular group is or may be impacted by the issue or the possible response to the issue, then consideration should be given to communicating with that group.

During their discussions, the consultation noted that MRA was often referred to as being of a "qualitative" or a "quantitative" nature. However, the use of the term "qualitative" in relation to risk assessment is ill-defined. For the purposes of the consultation, the term "microbiological risk assessment" was taken as being inclusive of all approaches used in assessing food-borne risks to consumers, as long as the four steps of MRA (hazard identification, exposure assessment, hazard characterization and risk characterization) were carried out. The consultation also noted that in many cases, effective risk management decisions can still be made when only some of the components of MRA are available, notably exposure assessment.

The consultation recognized that MRA can be used in a number of ways in food control, such as development of standards that contain quantitative elements, guidelines that contain qualitative elements (e.g. codes of practice), and more general texts e.g. general recommendations on design of food safety programmes. Based on experiences to date, the consultation identified and discussed the potential benefits that can flow from the use of MRA in the management of microbiological hazards. These include:

• Objective evaluation of risk management options that are controversial and/or costly;

• Effective development of a range of food safety measures capable of achieving the stated levels of consumer protection;

• Facilitation of the design of "production-to-consumption" food safety programmes by modelling the effectiveness of different food safety measures in reducing risks to consumers e.g. control of Salmonella Enteritidis in shell eggs via feed controls, vaccination of flocks, refrigeration of eggs, consumer education and labelling;

• Development of risk-based performance criteria;

• Creation of modular components, within the risk assessment, that can be adapted by individual countries with different data inputs and different food safety needs;

• Objective demonstration of the equivalence of alternative technologies and food safety measures e.g. a change in post mortem meat inspection procedures;

• Scientific justification of import requirements that are more stringent than benchmark Codex standards;

• Compliance with regulatory policy where a MRA is mandated by law or regulation;

• Identification and focusing of research and data collection needs;

• Communication of the scientific basis of risk management decisions to all interested parties.

The consultation also recognized the importance of MRA for the food industry and noted the main areas in which it can be applied (Annex IV)

4.2. "LESSONS LEARNED" FROM CURRENT MRA ACTIVITIES

A number of countries now have experience with MRA and presented this to the consultation (Annex II). Common experiences and areas where improvement might facilitate the effective use of MRA in risk management decision-making were identified and are summarized here.

Advance planning and appropriate resource allocation is essential if both current and long-term risk management needs are to be met. Sufficient scientific capacity is obviously a key issue, along with provision of adequate resources and time for generation of data. In some cases it may be possible to use an existing MRA "module." This approach can conserve resources and is particularly useful when resources are scarce. Risk managers have a clear responsibility to properly direct the process and ensure effective utilization of outputs. Effective co-ordination among different national competent authorities involved in MRA is also a critical issue.

The need for frequent and adequate communication between risk assessors and risk managers throughout the MRA process was emphasized by all countries with risk assessment experience. The decision to undertake a MRA should be based on sound information from multidisciplinary sources, and incorporation of public health data is an essential element.

A MRA should have a clear purpose and scope. In the elaboration of risk management questions it was recommended that a formal process should be implemented involving both risk assessors and risk managers. Countries also advised that risk managers remain in touch throughout the MRA process so as to avoid any "nasty" surprises at the end. Defining an endpoint is also critical to the utility of a MRA.

In order to address disagreement or misunderstanding between risk assessors and risk managers it was noted that there should be open and objective communication on an on-going basis to resolve any "disputes" between these two groups. While a function of risk managers is to make decisions, it was acknowledged that risk assessors and other scientists had a responsibility to point out the implications of these decisions.

In the MRAs undertaken to date, all countries agreed that communication was a critical issue. When to communicate, with whom, how often, and how and what to communicate are key questions. The importance of communicating the right information in the right format is essential, and the results of MRA need to be communicated in a manner that the recipients of the information will understand. It was clearly recognized that communication will always provide an educational component for all parties involved.

There was universal agreement on the lack of good quality data for undertaking MRA. Data gaps are often difficult to fill, and risk managers should allocate appropriate resources for data generation for future MRA work. Some countries noted the difficulty in gaining access to data which was not in the public domain, and responses to public calls for data tend to be limited and late. It was noted that determining the adequacy of available data was an important consideration before embarking on a risk assessment, and that the food industry was an important source. In some cases, it may be necessary to begin the MRA to identify the most relevant data needs.

It was recognized by all countries that MRA is still an emerging science, and harmonization of approaches would greatly facilitate future understanding and development. Modular approaches, which divide the assessment work into different areas along the food production chain, (e.g., farm, processing, preparation, and consumption modules) are of particular utility in the adaptation of risk assessments to national situations. As yet there is no standardized mechanism for dealing with uncertainty in risk models. Nevertheless, uncertainty should be explicitly acknowledged and expressed in quantitative terms wherever possible.

To achieve transparency and maintain credibility, MRAs should be available in plain language. This should include an interpretation of the mathematical results. It can be useful to move technical details to appendices so that they do not hide the message from the less technical reader.

Risk assessments should be peer reviewed. Such reviews should be multidisciplinary and should be planned when commissioning the MRA. However, resources for peer review are often limited and the results have sometimes been contentious. Different types of peer review have included:

• Advisory or scientific committees;

• External (to the sponsoring institution) scientist(s);

• Internal (to the sponsoring institution) scientist(s); This can be particularly important for sensitive issues prior to wider publication.

• Public review period. It should be noted that public comment requires considerable time and other resources.

Several countries have experienced difficulties in using the outputs of MRA to develop specific food standards. Currently, there are virtually no examples of implementation in these terms. This also highlights the need to reach a common understanding on the goals of the MRA before work commences, and include all interested parties as appropriate during risk management decision-making, e.g. in determining an appropriate level of consumer protection.

4.3. DEVELOPING COUNTRIES

The consultation recognized that many developing countries are in the process of elaborating and strengthening food safety control programmes, but these changes are in an early stage of evolution. National food safety policies may be limited in scope, and food control systems may involve fragmentation and duplication. Therefore, developing countries have difficulties in prioritising and resourcing their work in relation to food safety. Similarly, there are substantial barriers to overcome in order to better understand and utilize MRA in food safety risk management.

Developing countries are often constrained in terms of the technical infrastructure, scientific and financial resources that are necessary to carry out MRA for direct application in their national situation. Risk assessment benefits from multidisciplinary inputs from a range of food safety professionals. Lack of co-operation between the different relevant agencies can result in serious data gaps and the generation of inadequate risk estimates; this is also a problem in developed countries. Adequate data for MRA is necessary not only at the national level, but also at the international level. International MRAs should appropriately reflect the situation in developing countries.

At this stage, many developing countries may not choose to invest in MRA. However, it is essential that developing countries be able to understand, contribute to, and utilize MRAs developed by FAO/WHO and other countries. For this involvement to be effective, developing countries will need to invest more resources in public health surveillance and monitoring of microorganisms in foods, as well as establishing robust links between risk assessors and risk managers at both the national and international level.

The consultation developed the following recommendations related to improving risk management in developing countries.

A. Comprehensive training and training materials for all aspects of MRA and microbiological risk management would be of significant benefit to developing countries. This could be provided by FAO/WHO and/or national governments and could include:

• Development of scientific expertise at the national level;

• Specific guidance on evaluation of risk management options e.g. use of food safety objectives (FSO's)(see Annex III, Section 3.6) and determining appropriate levels of consumer protection;

• Seminars and training modules for medium-level risk managers as appropriate;

• Materials and methods to explain to high-level decision-makers the benefits of applying a generic framework for managing food-borne risks;

• Training that is targeted at the specific needs of a developing country or region;

• Co-operative, "hands-on" training programmes and study visits with experienced countries;

• A commitment from trainees to further train colleagues.

B. Developing countries should establish strategies for appropriate data collection and collation for MRA, especially those data needed for exposure assessment. In the meantime, they could use some of the information available from the FAO/WHO risk assessment activities e.g. the dose-response curves developed could be used, but careful consideration should be given to issues such as the occurrence and size of susceptible subpopulations within the country. Technical resources and funding should be made available for data generation, and technical capabilities of laboratories should be enhanced so as to generate reliable data.

C. Professional networks and collaborative studies should be established between countries and regions that are likely to have similar inputs to MRA e.g. similar food production systems or food-borne disease problems, and consumer consumption patterns.

D. Databases of MRAs that are already available at the international and national level should be made readily accessible via international agencies to developing countries.