Biological Safety

At the DKFZ laboratories, our scientists work with a wide variety of organisms, including genetically modified organisms, bacteria, viruses, and medical specimens. The task of Biological Safety is to assess the risks posed by these biological agents and to develop measures to protect researchers, employees, the public, and the environment from potential hazards of research.

The Biological Safety Unit serves as the central point of contact for all questions and matters related to biosafety and research security. Biosafety encompasses measures to prevent accidental exposure of humans and the environment to infectious or toxic biological agents. Biosecurity, on the other hand, aims to prevent deliberate risks such as theft or misuse of biological materials. Research security focuses on protecting scientific results from misuse, especially in connection with publications or exchanges with third parties. Additionally, the unit supports scientists in complying with the Nagoya Protocol, which ensures fair access to genetic resources from their countries of origin and promotes equitable benefit-sharing.

Scope of Biosafety

• Implementation of regulations under the Genetic Engineering Act (GenTG), Infection Protection Act (IfSG), Epizootic Pathogen Ordinance (TierSeuchErV), and Biological Substances Ordinance (BioStoffV)
• Advisory, supervisory, and administrative functions for the safe handling of natural biological agents and genetically modified organisms
• Risk assessments and classifications for e.g. genetic engineering works
• Management of DKFZ’s centralized BSL2/BSL3 laboratories, as well as supervision, control, and monitoring of compliance with statutory obligations, regulatory requirements, and provisions in DKFZ's decentralized genetic engineering facilities
• Consultation on structural changes, new construction projects, and safety-relevant equipment.
• Acting as the operator representative in dealings with authorities
• Support for the Biological Safety Committee
• Development and enforcement of biosecurity measures to prevent the loss, theft, or misuse of highly infectious or highly toxic biological agents and materials
• Implementation of the Nagoya Protocol

Scope of Research Security

• Implementation of export control regulations, particularly the Foreign Trade Act (AWG), the Foreign Trade Ordinance (AWV), and the EU Dual-Use Regulation
• Conducting, overseeing, and supporting checks of goods lists, sanction lists, embargoes, and end-use verification
• Assisting scientists in reflecting on the security implications of their research, particularly regarding misuse potential in their research field ("Know your research") and in collaborations with third parties ("Know your partner")
• Organization and execution of risk analyses
• Support for the Commission for Ethics in Security-Relevant Research (KEF)