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Procedures and Terms relating to Microbial Risk Assessments

Summary and conclusions

Quantitative microbial risk assessments is a valuable tool allowing decision- making on a sound scientific basis. One of the obstacles associated with the use of risk assessments is the problem of defining the proper action-oriented terms involved in the process. The problems has been recognised at both national and international level, and therefore WHO has initiated a series of initiatives aiming at standardising both procedures and terms relating to the assessment of risk of human exposure to microbial risks.

One of the problems encountered is the fact that some of the terms vary between different publications endorsed by the WHO organisation. Specifically, the publications Fewtrell and Bartram (2001) and Codex Alimentarius Commission (1999) use different terminology. The objective of the present work is to identify proper procedures and suggest a Danish terminology that fulfils the requirements of the proper procedures and expected results of the international harmonisation projects. A major reference with respect to this work is the joint IPCS/OECD harmonisation project on chemical risk assessment terminology (IPCD and OECD, 2004).

The proposed terminology in Danish and English is summarized in the following table:

Risikoanalyse

  • Risikovurdering
    • Fareidentifikation
    • Dosis-respons analyse
    • Vurdering af eksponering
    • Risikokarakterisering
  • Risikohåndtering
  • Risikokommunikation

Risk analysis

  • Risk assessment
    • Hazard identification
    • Dose-response assessment
    • Exposure assessment
    • Risk characterization
  • Risk management
  • Risk communication

The process of executing a risk assessment has been adopted from IPCD and OECD (2004):" Risk Assessment: A process intended to calculate or estimate the risk to a given target system following exposure to a particular substance, taking into account the inherent characteristics of a substance of concern as well as the characteristics of the specific target system. The process includes four steps: hazard identification, dose-response assessment, exposure assessment, and risk characterization. It is also the first step in risk analysis. Hazard identification: the first stage in risk assessment consisting of the determination of particular hazards a given target system may be exposed to, including attendant toxicity data. Dose-response assessment: The second of four steps in risk assessment consisting in the analysis of the relationship between the total amount of an agent administered, taken or absorbed by a group of organisms and the changes developed in it in reaction to the agent, and inferences derived from such an analysis with respect to the entire population. Exposure assessment: Step in the process of risk assessment consisting of a quantitative and qualitative analysis of the presence of an agent (including its derivatives) which may be present in a given environment and the inference of the possible consequences it may have for a given population of particular concern. Risk characterization (1): Integration of evidence, reasoning and conclusions collected in hazard identification, dose-response assessment and exposure assessment and the estimation of the probability, including attendant uncertainties, of occurrence of an adverse effect if an agent is administered, taken or absorbed by a particular organism or population. It is the last step of risk assessment. Risk characterization (2): the qualitative and/or quantitative estimation, including attendant uncertainties, of the severity and probability of occurrence of known and potential adverse effects of a substance in a given population."

 

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Version 1.0 September2004, © Miljøstyrelsen.