Storage and access regulations for dual-use organisms

Anyone working in protection level 2 knows that biological agents in risk group 2 must be stored in tightly sealed containers (TRBA 100, paragraph 5.3, sentence 12 / BioStoffV, Annex II). It is important to note that when using dual-use organisms, increased security precautions must be taken to prevent theft of these organisms. If activities are carried out with correspondingly listed organisms, these organisms must be kept under lock and key, even if they are risk group 2 organisms. The same applies to a certain extent for genetically modified organisms whose original organisms fall under this regulation. Furthermore, the general rule is that the number of authorized persons in a protection level 2 area is kept to a minimum, and access is only permitted with the permission of the person responsible. As a more stringent safety measure for work areas involving activities involving dual-use organisms, controlled access (e.g., through electronic access control) is also required for work areas at protection level 2 (TRBA 100, paragraph 5.3, sentence 11 / BioStoffV, Annex II). An overview of the listed organisms and the corresponding genetic modifications considered here can be found in Regulation (EU No. 388/2012) of the European Parliament and of the Council (Community rules for the control of exports, transfer, brokering, and transit of dual-use items, 1C351 Human and animal pathogens and "toxins" and 1C353 Genetic elements and genetically modified organisms). It is therefore necessary in any case to check the biological agents used from risk group 2 and above, as well as the resulting genetically modified organisms, for the aspect of dual use on the basis of the above-mentioned regulation and then, if necessary, to implement the appropriate protective measures with regard to access regulations and storage location.