ANNEX IV - USE OF ELEMENTS OF (QUANTITATIVE) MICROBIOLOGICAL RISK ASSESSMENT BY INDUSTRY

Industry has the responsibility for producing safe foods. Industrial Food Safety Management includes various general quality assurance systems, particularly HACCP and its prerequisite systems (GMP, GHP), and optimization of hazard control throughout the food supply chain.

At the basis of safe food production practises is the design and manufacture of products with a good safety record. When new products are developed, informed and qualified judgement which considers potential microbiological hazards and the necessary control measures as part of the HACCP concept is used. The hazard analysis part is often referred to as a safety assessment (refers to assessments of product safety by qualified persons on the basis of HACCP and knowledge/experience).

Generally, food industry conducts a safety assessment when designing new products, utilizing new production processes or changing manufacturing specifications. Use is made of scientific knowledge as well as of practical experience, for instance with particular raw material suppliers, the hygienic layout of the premises and the hygienic design of the equipment of the manufacturer. In many cases, safety assessments are supported by collective experience provided by organizations such as trade associations, food research institutes, governmental/regulatory bodies, academia, etc.). Safety assessments may combine qualitative and quantitative elements.

Traditionally the food industry is involved in the exposure assessment phase of risk assessment, and they have been driving developments in that area for many decades. On the other hand, governmental bodies and the academic community have made significant advances in the risk characterization phase. As the food industry is not involved or qualified in all phases of risk assessment, it is not evident that the industry can or should adopt the full risk assessment approach as the method by which the safety of food products is assessed.

Certainly in the manufacturing phase, HACCP is recognized by the food industry as the global standard for safeguarding food safety. Changes in the manufacturing specifications are dealt with through re-evaluation of HACCP plans, following a safety assessment approach. HACCP is very specific for the food product and processing site, an essential feature of its value and success. It should be stressed that hazard analysis is not a qualitative but a quantitative exercise. As expressed by the ICMSF as early as 1988, "the analysis of hazards must be quantitative if it is to be meaningful". This point is raised here because there is a persistent misconception that HACCP is qualitative and that risk assessment is quantitative. Likewise, the concept of an "acceptable level of a hazard" is as fundamental to the HACCP concept as "acceptable level of risk" is to the risk assessment concept. However, with the latter, it should be realized that the two concepts are different and need to be kept as separate systems because they serve different purposes. Through HACCP, industrial safety assessment assures the production of safe food products focussing on a single product and production site. MRA, as described by Codex, takes a broader view and considers safe food production in the larger context encompassing groups of similar food products, multiple producers and/or specific consumer populations.

The differences between a governmental risk assessment and the use of MRA by industry are outlined in Table 1. There are certain elements and aspects of MRA as used by governments that the food industry could benefit from, particularly in the pre-market phase where the safety of the design of a new product and/or manufacturing process needs to be assured. These include the following:

• Adherence to the Codex language and terminology by food manufacturing industries may facilitate discussions in the context of product safety approval (where necessary) or trade issues.

• Once regional/local regulation or other governmental risk management interventions have been established on the risk-reduction based and science-based thinking that underlies risk assessment (i.e. specifying FSOs etc.), the industry can target their food safety management performance accordingly.

• The structured and systematic approach of risk assessment and the custom to make facts and assumptions explicit makes the assessment more transparent and auditable. This runs parallel to the experience of industry with HACCP and it re-enforces elements of HACCP plans. Risk assessment may be of particular value in validating some "artisanal" processes or practices.

• The careful recording of the available knowledge/data and the rationale for use or disregard as practised in risk assessment makes the exercise open and of greater value for future reference, either in re-evaluating an assessment or for knowledge/data retrieval.

• The scientific concepts and tools that have been developed in support of product development such as predictive modelling of microbial behaviour (growth, inactivation, survival), are now included in MRA. The use of similar tools by manufacturers and food control authorities will facilitate dialogue.

• New concepts and tools have been developed in the context of MRA, for example a range of deterministic or probabilistic modelling techniques allow for simple worst-case simulations or for very advanced simulations with factorial influences and sensitivity analysis, for converting expert judgement to mathematical algorithms, etc. These new tools will be helpful in food safety enhancement programmes. They can help to make routine assessments more efficient, better deal with uncertainty and/or biological variability and bridge practical or theoretical knowledge/data gaps. The latter is of specific importance for genuinely novel food products, where the risk assessment tools can help in the effort to establish safe food designs.

• There is an increased sharing of risk assessment tools and data, with governmental bodies and academia building databases and expert systems and making them available in the public domain (mainly internet). To benefit from such data sources and tools, food industry, with the help of supporting organizations, has to adopt to using the appropriate tools.

• The use of MRA tools may help industry to become increasingly more pro-active in product design rather than reactive and to make better use of knowledge/data generated world-wide.

• The practice in risk assessment to develop structured and explicit risk management options is another potential benefit. With the help of risk assessment tools, risk management options can be computed and visualized in new and potentially more helpful ways and this could benefit in particular industries with limited or no in-house expertise on this subject.

The extent to which industry can benefit from elements of MRA will depend on an industry’s or producer’s capabilities and capacities to identify the relevant benefits. Small businesses in many cases will not be able to benefit unless supporting organizations help and facilitate. Many small businesses or even larger companies are only beginning to use tools such as predictive models and thus the use of the new MRA tools will not happen in the immediate future.

Table 1. Differences between governmental (quantitative) Microbiological Risk Assessments and the use of elements of MRA in the food industry.