Before an application can be handled the company must assess the risks which the genetically modified microorganisms, animals and plants represent to the sorrounding environment and health.
The purpose with the assessment is to elucidate whether the GMO used in the production represent a risk to the environment and health. The risk assessment must be written and enclosed to the application for production. The form can found below.
Go to Risk Assessment form
Information on the requirements to consider regarding risks to the production can be found in the executive order on approval of production with genetically modified organisms (In Danish) and the executive order on approval of production with genetically modified plants and animals (In Danish). The Working Environment Authority have a guidance on how to make a risk assessment (In Danish) on research, projects and production of GMOs.
It is important to notice that the following description must be considered as a guidance and that it is the information from the Working Environment Authority which are to be followed.
1. Identification of the Risk Factors
The first step is to consider which properties of the recipient organism that could be harmful and, if relevant harmful properties of the host organism as well. In addition, the harmful characteristics related to the vector or the inserted material, including any changes to the recipients existing characteristics must also be considered.
To identify the risks associated to the organisms one could look into the legislation regarding the subject. The EPA recommends looking into the executive order on biological agents and working environment (In Danish). In addition, the EPA recommends looking into the international and national classifications (e.g. WHO and NIH) and adjustments of these in concern of the scientific and technical development.
The classification systems regards native microorganisms abilities to cause diseases in humans, animals or plants, and the seriousness of the disease and to what extent it is contagious. The Working Environment Authority classify microorganisms as biological agents in four risk groups, based on their potential to influence human health, in according to the executive order on biological agents and working environment. In addition, the classification system, which refers to plant- and animal pathogens, must also be considered.
These classification systems indicate a preliminary categorization of the activity into the 4 risk groups, and the appropriate containment strategies.
2. Identification of Hazards
It is recommended that the process of identifying the hazards should be performed from point 2-4. The purpose of identifying the hazards is to get knowledge on the level of risks which are associated to the GMO.
3. Selection of Containment- and other Precaution Measures
The choice of containment- and other precaution measures are made on the basis of the level of risks associated to the GMO. Disposal of waste and discharge of waste water must also be taken into account:
a. The characteristics of the environment (e.g. known biota, which would be negatively affected if exposed to the GMO used in the contained production).
b. Characteristics about the activity (e.g. the volume and species)
c. All non-standardized operations (e.g. inoculation of genetically modifies microorganisms in animals or equipment which cause aerosol formation)
4. Adjustment of Risks
In consideration to the above-mentioned precaution measures (a-c) the level of risk associated to working with the GMO can be elevated, reduced or unchanged.
When the risk analysis is completed, as described above, the activity can be classified into one of the four risk groups. For more information see criteria for classification.