According to the German and European biosafety legislation biological agents are
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micro-organisms, cell cultures and endoparasites including their genetically modified forms,
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agents associated with transmissible spongiform encephalopathy (TSE), that may constitute a hazard to humans as a result of infections, communicable diseases, toxin formation, sensitization or other effects which are harmful to human health.
The following substances are considered as equivalent to biological agents:
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ectoparasites which may cause autonomous diseases in humans or create sensitising or toxic effects,
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technologically produced biological entities with new properties that may pose a threat to humans in the same way as biological agents.
Micro-organisms are all cellular or non-cellular microscopically or sub-microscopically small biological entities which are capable of replicating or transferring material, in particular bacteria, viruses, protozoa and fungi.
Cell cultures are cells isolated from multicellular organisms and grown in vitro.
Toxins are metabolic products or cell components of biological substances which may have a toxic effect in humans when they are inhaled, ingested or absorbed through the skin, and may therefore result in acute or chronic damage to health or death.
A genetically modified organism (GMO) is any organism whose genetic material has been altered using genetic engineering techniques. Please specifiy Donor organism, genetic sequence, type of modification, use of vector and acceptor organism in detail.
Biological agents are classified into risk groups 1 to 4 according to the infection risk originating from them. The EU's legal classifications (Annex III to Directive 2000/54 EC), as well as additional national classifications, can be found in the technical rules of the biological substance ordinance (TRBA 460–468).
Classification of biological agents into risk groups
Risk group 1
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Biological agents that are unlikely to cause human disease
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Risk group 2
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Biological agents that can cause human disease and might be a hazard to employees; they are unlikely to spread to the community; there is usually effective prophylaxis or treatment available,
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Risk group 3
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Biological agents that can cause severe human disease and present a serious hazard to employees; they may present a risk of spreading to the community, but there is usually effective prophylaxis or treatment available,
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Risk group 4
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Biological agents that cause severe human disease and are a serious hazard to employees; they may present a high risk of spreading to the community; there is usually no effective prophylaxis or treatment available.
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For experiments at the beamlines, only biological samples of risk group 1 can be used.
Biological agents of risk group 2 can only be handled in the support laboratory but not at the experimental stations. GMO samples of risk group 2 will require a notification towards the authorities prior to start of work. Therefore it is important to give as much details about the sample and sample handling in the sample section and in the laboratory support section from the beginning. The work description should include the following:
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a brief summary of your research project that explains the purpose and the aim of the project
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a work description with a flow diagram that explains the working steps ( e.g. production of GMO) including the maximum volume of cell culture used.
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A list of vectors used
In case the proposal has been approved, the biological safety officer (Sandra Plett, sandra.plett@xfel.eu) may need further information on the GMO work that you plan carry out. The complete documentation will be sent to the genetic engineering authority of Schleswig-Holstein accompanied by a letter from the Managing Directors of the European XFEL company for approval.