Biological Risk Assessment Sheets :
List of practical examples (PDF files)
Risk assessment is a methodology used to organize and analyze scientific information in order to estimate the probability and severity of an adverse effect. The adoption of this methodology, as outlined and illustrated hereunder (figure 1), leads to the implementation of an appropriate set of measures in order to provide maximal protection of human health and environment. For the risk assessment of ‘contained use’ activities, four subsequent steps are distinguished:
Figure 1 : Biological risk assessment and risk management
1. and 2. Identification of biological hazards and determination of the class of risk of the genetically modified or pathogen organism
Classification lists of pathogenic microorganisms have been established and are a useful tool for performing a risk assessment. The Belgian Regional decrees classify human and animal pathogens into three classes of risk and plant pathogens into two classes of risk.
However, some pathogens and most genetically modified organisms are not classified into risk groups. In this case, the most critical properties inherent to the biological material that should be considered for a risk assessment and assignment to a risk group include:
The classification of the biological risk for the plant includes three additional criteria:
In case of genetically modified (micro-) organisms, each element that has been used towards the achievement of the genetic modification should be evaluated as well:
see also Annex III of Directive 98/81/EC, which describes in general terms the elements to be considered for performing a risk assessment of genetically modified micro-organisms. Guidance notes have been published in Commission Decision 2000/608/EC of 27 September 2000.
Not only should risk factors inherent to the biological material be considered, factors associated with the type of operations/manipulations should be examined as well. This include:
The properties inherent to the biological agent and the characteristics of the activity are considered together in a final risk assessment, leading to the assignment of a class of risk of the contained use activity. The class of risk of the activity may be equivalent to the class of risk of the micro-organisms or it may be higher or lower.
The class of risk of the activity defines the level of the recommended containment level. Each level of containment implies the set up of technical requirements, specific equipment, work practices and other protective measures (link in het Nederlands/ lien en français).
Several guidelines and biosafety manuals are available in order to help the user to conduct a comprehensive and thorough risk assessment. For some international references see Guidelines for risk assessment, Biosafety Manuals.
However, it is important to be aware that a risk assessment should always be carried out on a case-by-case basis as all 'contained use' activities deal with unique features.
Following examples (see Table of examples) have been draw up to illustrate the methodology that has been used to conduct the risk assessment. Though each example deals with very different types of biological material and types of manipulation, risk assessment remains based on a common approach.
Table: Practical examples of Risk Assessment and Biosafety recommendations