Identification, assessment and management of food-related microbiological hazards: historical, fundamental and psycho-social essentials.

Microbiological risk assessment aimed at devising measures of hazard management, should take into account all perceived hazards, including those not empirically identified. It should also recognise that safety cannot be "inspected into" a food. Rather hazard management should be the product of intervention strategies in accordance with the approach made mandatory in the EU Directive 93/43 and the USDA FSIS Pathogen Reduction HACCP system; Final Rule. It is essential too that the inherent variability of the biological attributes affecting food safety is recognised in any risk assessment. The above strategic principles may be conceptualised as a four-step sequence, involving (i) identification and quantification of hazards; (ii) design and codification of longitudinally integrated ("holistic") technological processes and procedures to eliminate, or control growth and metabolism of, pathogenic and toxinogenic organisms; (iii) elaboration of microbiological analytical standard operating procedures, permitting validation of "due diligence" or responsible care, i.e. adherence to adopted intervention strategies. This should be supported by empirically assessed reference ranges, particularly for marker organisms, while the term "zero tolerance" is refined throughout to tolerable safety limit; (iv) when called for, the need to address concerns arising from lay perceptions of risk which may lack scientific foundation. In relation to infectious and toxic hazards in the practical context the following general models for quantitative holistic risk assessment are presented: (i) the first order, basic lethality model; (ii) a second approximation taking into account the amount of food ingested in a given period of time; (iii) a further adjustment accounting for changes in colonization levels during storage and distribution of food commodities and the effects of these on proliferation of pathogens and toxin production by bacteria and moulds. Guidelines are provided to address: (i) unsubstantiated consumer concern over the wholesomeness of foods processed by an innovative procedure; and (ii) reluctance of small food businesses to adopt novel strategies in food safety. Progress here calls for close cooperation with behavioural scientists to ensure that investment in developing measures to contain risk deliver real benefit.