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The final result of a comprehensive microbiological risk assessment should be the estimation of a probability and severity of adverse health effects that could occur in the population. Risk assessment requires the use of high quality data so that the assessment results could enable risk managers to take appropriate action at the appropriate moment. In the previous publication the first two stages of microbiological risk assessment were shown, i.e. hazard identification and hazard characterization. The purpose of this publication is to present the other two steps of risk assessment, i.e. exposure assessment and risk characterization. Exposure assessment describes the likelihood of exposure to biological, chemical and physical hazards with the potential to cause adverse health effects in humans and animals. In the case of microbiological risk assessment, exposure assessment should establish the concentration of a pathogenic agent in food for specific groups of consumers, as well as all possible pathways of exposure. On the other hand, risk characterization should establish qualitatively and/or quantitatively, with associated uncertainties, the likelihood and severity of known or potential adverse effects in a given population. Risk characterization is based on the integration of data collected during the previous stages of risk assessment in order to provide a comprehensive risk estimate.
The article describes the major findings concerning the occurrence of previously unrecognized infection with a virus provisionally named “Schmallenberg virus” (SBV) in Germany, the Netherlands, Belgium and Great Britain. The virus belongs to the family Bunyaviridae, genus Orthobunyavirus, serogroup Simbu. Full-length genome sequencing has shown its highest genetic similarity to Shamonda and Akabane viruses. The viruses of this group are transmitted mainly by mosquitoes (Culicidae) and midges (Culicoides) with very limited direct transmission from animal to animal (mostly transplacental transmission from a dam to the foetus during pregnancy). The clinical manifestation of the Schmallenberg virus infection has been associated with non-specific clinical signs in adult cattle (fever, reduced milk yield, diarrhoea), whereas congenital malformations (hydrocephalus with brain hypoplasia, arthrogryposis) have been observed in newborn lambs. For diagnostic purposes, RT-PCR, virus neutralisation and indirect immuno-fluorescence tests have been developed. The latter two assays cannot be applied for large-scale testing, but an assay for serological screening is currently unavailable. The major conclusion of the preliminary risk assessment performed by the European Centre for Disease Prevention and Control (ECDC) is that the threat to human health is very unlikely but cannot be excluded at this stage. None of the infections caused by the viruses of the Simbu serogroup are included in the list of diseases subjected to international notification, but affected countries have notified OIE of the occurrence of SBV infections according to regulations applicable to new and emerging diseases.
Risk assessment is a complex process that requires adequate knowledge of various fields. It consists of four steps: hazard identification, hazard characterization, exposure assessment and risk characterization. It can be conducted in a qualitative, semi-quantitative or a quantitative manner, and its selection depends on the quantity and quality of collected data. The aim of the paper has been to introduce to the historical background, terminology and the first two steps of risk assessment in improving animal health and food safety: hazard identification and hazard characterization. Hazard identification is usually defined as “the identification of biological, chemical, and physical agents capable of causing adverse health effects and which may be present in a particular food or group of foods.” The data concerning a particular hazard can be derived from scientific literature, databases, governmental agencies, international organizations, expert opinions, clinical tests, animal experiments, epidemiological observations, examinations of properties and interactions between microorganisms. Hazard characterization is the qualitative and/or quantitative assessment of the nature of the adverse health effects associated with the hazard. There are several factors considered in hazard characterization, related to both the microorganism and the human host. The most desirable part of this process is establishing a dose-response relationship, describing the relationship between the amount or level of exposure to a substance and the occurrence and intensity of an adverse effect.
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