Biosafety

Question 1

Would any of your project ideas raise safety issues in terms of:

• researcher safety,
• public safety, or
• environmental safety?==

Statement: All material used for our genetic engineering work and the material that is generated from our genetic engineering work is treated in agreement with the Federal Genetic Engineering Act (Gentechnikgesetz - GenTG) and the Genetic Engineering Safety Regulations (Gentechnik-Sicherheitsverordnung - GenTSV). In particular the adeno-associated virus strain used by us is categorized at German biosafety level one and the corresponding WHO risk group one and as to these safety laws and guide lines, respectively, considered as non-hazardous and non-infectious for the individual and the community. As to the German laws (GenTG, GenTSV), in vitro work with shRNA in adeno-associated virus is conducted at German biosafety level two and is further acknowledged and permitted according to the Genetic Engineering Documentation Regulations (Gentechnik-Aufzeichnungsverordnung - GenTAufzV). Our work and the products of our work can therefore be considered as safe for the individual researcher, the public, and the environment.

iGEM Question 2. Do any of the new BioBrick parts (or devices) that you made this year raise any safety issues? If yes,

• did you document these issues in the Registry?
• how did you manage to handle the safety issue?
• How could other teams learn from your experience?

Statement: All of our parts submitted to the Registry correspond to German safety level one or the WHO risk group one and are therefore non-hazardous and non-infectious to individuals working with these parts and the community in general. Since we do not submit adeno-associated virus, we do - according to GenTG, GenTSV, and corresponding international acts and regulations - not necessarily need to provide this notification. However, we mention here that parts encoding for shRNA in combination with adeno-associated virus are in vitro (but not in vivo) categorized at German biosafety level two and the corresponding WHO risk group two and therefore raise in this form a small or low (German "gering") risk of infection for the researcher working with this virus.

iGEM Question 3. Is there a local biosafety group, committee, or review board at your institution?

• If yes, what does your local biosafety group think about your project?
• If no, which specific biosafety rules or guidelines do you have to consider in your country?

Dr. Michaela Reichenzeller (deputed to Dr. Angret Joester for iGEM 2010) is our internal iGEM project leader for safety issues. The safety for work connected to iGEM and done in Dr. Dirk Grimm's laboratory is in the responsibility of Dr. Dirk Grimm. The safety leadership at University of Heidelberg is in the responsibility of Dr. Willi Siller. The regulatory authority (Regierungspräsidium Tübingen) controlling the implementation of the Genetic Engineering Act (GenTG) conducted an inspection on October 25, 2010 at Bioquant including the course lab of the iGEM team. The final report is yet pending, however the random site visit was passed well.

iGEM Question 4. Do you have any other ideas how to deal with safety issues that could be useful for future iGEM competitions? How could parts, devices and systems be made even safer through biosafety engineering?

Statement: No, but we are prepared to also encounter this aspect in the future.