Safety training

Safety training was according to different German regulations (I) General lab safety, (II) Special regulation concerning hazardous substances, on (III) Special regulations concerning biological substances, and (IV) Regulations concerning genetic engineering.
The requirements include an initial on site training that has to be confirmed by a personal signature. The training has to be refreshed annually. All regulations are accessible in the intranet.

Local Rules and Regulations

Our team supervisor is also responsible for all issues related to Biological safety in the labs that we use. Therefore he is initimately involved in the biosafety considerations of our project. The iGEM student project was generally discussed with the Officer for Biological safety (Risk Group I) of the Department of Biology, Dr. Annabel Hoepfner.

Instruction manual GenTSV (S1) 
Instruction manual GefStoffV  
Legal regulations
We have listed all used organisms in the strains&constructs section. Additional information about some bacteria are provided in the organisms section. More informaion about our constructed parts can be found on the datapage. Our official spread sheet was submitted before the first of September. Additional information are Lab and Safety form.
Risks of Our Project

We are mainly working with safety strains of E.coli (K-12 derivatives) which are only toxic if they are injected into the blood stream. It would also be problematic if these E. coli strains make contact with the eyes. Oral exposition could change the bacterial population in the gut by delivering new DNA features. Lab safety training included safe handling regulations, mandatory lab coats and eye protection equipment during the work with bacteria.
The definition of biosafety level 1 says that there is no risk according to the current scientific knowledge if everything is done properly. The usage of safe E. coli strains should prevent any risks for the general public. DNA molecules from our strains could be transferred into other bacteria if genetically modified organisms escape the lab. The biggest problems are the antibiotic resistances, because they could be transferred to human pathogenic species. The impact of this problem is reduced by the fact that all resistance genes are already out there. Our lab safety trainings also included instructions on waste disposal requirements for normal and hazardous lab material as well as biologicals or lab materials contaminated by biologicals. All genetically engineered strains and material contaminated with such organisms require sterilization by autoclaving. Afterwards the sterilized material is subjected to garbage incineration. Special decontamination rules regulate hazardous chemicals and materials contaminated with such. The proper disposal of these is handled by the Department of Chemistry at our university. It would be possible to combine all our antibiotic resistances in one pathogenic organism to use it for bioterrorism purposes. We think, that the specific parts and constructs of our project and all possible combinations of these do not have an increased potential for malicious miss-use.
There are several levels of security measures. First of all, there is a personalized electronic access system for all labs, allowing a fine-grained restriction of access and a tracking of all access activities by the authorities of Bielefeld University.
In addition, the mandatory lab safety trainings and the continuous surveillance of measures provides the second level of safety regulation. Next, there is the need for a detailed documentation of all experimental work, including all levels of accidents. Last but not least, an atmosphere of responsible planning and conduct is pursued by all scientists, including the instructors and supervisors of the iGEM projects.

Risks of Our Project in the Future

The single parts of our project are in our opinion almost free of risks. This is implied by their biosafety level classification. We do not expect them to interact in a way which could increase these risks or provide unforseeable ones. As stated above, we are planning to develop inbuilt safety systems, instantly killing the strain upon release from its containment. In addition, the last years iGEM team had started to develop an antibiotics-free selection system and we worked on the improvement of this biosafety system.
Furthermore we are participating in SYNENERGENE. One important task during our participation is the development of possible scenarios for the future of synthetic biology and the development of application senarios. By the way we contacted many experts and talked about possible biosafety issues assocated with our project and future applications.

A proposal of the German iGEM Teams concerning Intellectual Property

During the meetup of the German iGEM teams from 23rd to 25th May also workshops took place in which amongst others we discussed the topic of bioethics. Moral questions were addressed, regarding the value of life and human influence on it, as well as questions dealing with the possible socioeconomic effects of synthetic biology.

Especially the topic of an open source vs. patent controlled field accounted for a large part of the discussion. During the discussion one student brought up the point that the legal status of parts in registry remains unclear and that there are parts (e.g. BBa_K180009) where only upon a closer look it becomes clear that the rights are company–owned. The issue that the legal status of parts in the registry remains uncertain is also mentioned in a recent article published by Nature (Bryn Nelson ‘Synthetic Biology: Cultural Divide ’, Nature 509, 152–154, 08 May 2014) :

"[N]o one can say with any certainty how many of these parts are themselves entirely free of patent claims."

We, the German iGEM teams, therefore like to suggest the addition of a new feature to the parts registry:

A dedicated data field of license information for each BioBrick part.

For the implementation, we propose to introduce two new fields to BioBrick part entries in the registry:

  1. A string property "LicenseInfo"
  2. A traffic light property (grey, green, yellow, red) to indicate the level of legal protection (unknown, BPA-like, free for research purposes, heavily protected)
This image shows a how the proposed field LicenceInfo could look like in the registry.

Implementing this feature would in our opinion further clarify and extend the parts info, provide a machine-readable format and thus improve future entries. With the emerging Entrepreneurship track and applications getting closer to industrial realization, the legal status becomes more and more important. Also it would raise awareness to the topic of the legal status of parts, leading to a debate which could further promote the idea of open source. At the same time we hope that examination of most parts will show that they are indeed free of restrictive legal protections.

The German iGEM Teams,