Qualitative and quantitative risk assessment

Risk assessment and HACCP are related, but fundamentally different processe s. Four major elements of risk assessment are commonly described (hazard id entification; exposure assessment; dose-response assessment or hazard chara cterization; and risk characterization). Some similarities exist between th e inputs for the first elements of risk assessment (hazard identification) and HACCP (hazard analysis). However, HACCP involves the identification of critical control points of a process for the purpose of producing a 'safe' product, and thus is essentially a risk management procedure that does not estimate risk with attendant uncertainty as in the formal structured proced ure described for risk assessment. For quantitative models in microbial ris k assessment, exposure assessment requires data for pathogen occurrence, de nsity or level, and distribution in foods and live animals, parameters for growth and decline, and consumption information. A crucial difference betwe en chemical and microbial risk assessment is that for the latter, exposure models must account for pathogen growth and deactivation, termed predictive microbiology. This field has emphasized prediction of the expected changes in a population of organisms and is extended by an example accounting for the stochastic or random variability of microbial growth in a given circums tance. Dose-response assessment, the third element of risk assessment, is t he crucial link between exposure in food to adverse human health outcomes. Data, from controlled human studies with healthy adult volunteers to descri be dose-response relationships, are limited. Differences between human sub- populations may be inferred from animal studies, based on a common mechanis m, such as the observed pre-disposition of antibiotic-treated animals to su bsequent challenges with enteric pathogens. Professional organizations, suc h as the Society for Risk Analysis, can greatly assist governments, industr y, academia, and stakeholders in scrutinizing the risk analysis processes o f risk assessment, risk management, and risk communication. Published by El sevier Science Ltd.