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From 2012.igem.org

Contents 1 Researcher, environmental and public safety 2 Safety and 2012 iGEM team Slovenia project 3 Local and national bio-safety committees and novel potential safety issues associated with Biobricks 4 Synthetic biology and safety

Researcher, environmental and public safety

The iGEM 2012 team Slovenia addressed the issues of safety concerning this year's project at all phases; from the project design, through experimental work as well as further impact of our results on future research activities. Furthermore, the public and the environmental safety were considered. However, our experimental work in the laboratory included only non-infectious host organisms (Biosafety level 1), so no major risks have been identified.

All proposed solutions for medical therapy in our project (production of therapeutic proteins within the organism, use of microencapsulation, control of the release of different therapeutic proteins appropriate for different stages of the therapy switched by the short pulse of the inductor, safety device to eliminate any cells that leak from microcapsules, degradation of microcapsule and induction of apoptosis of therapeutic cells at the end of therapy) were tested in the laboratory using mammalian cells (cell line HEK293, natural killer cells). Our results on mammalian cells showed that all safety mechanisms for inactivation and elimination of the cellular devices at the end of therapy work. We did not perform any experiment with experimental laboratory animals.

Nonetheless, standard precautions and instructions of good laboratory practice have been employed before we began with experimental work. Every student had to pass the mandatory course on Occupational Health and Fire safety that included working with genetically modified organism, handling toxic waste and how to assess and handle accidents in the laboratory. The general precautions like wearing gloves or decontaminating waste material in antibacterial substances, for instance asepsol, staying focused during the experimental work were practiced. In addition, the project team was divided into several sub-groups of students whose work was closely supervised by senior mentors. Such work organization proved to be safer and more efficient.

In regards to public and environmental safety it should be taken into account, that it is illegal to transfer genetically modified organisms (GMOs) into the environment. However, GMOs that we developed in the laboratory have been adapted to prevent their replication, therefore, their survival outside the laboratory.

In conclusion, we believe we took all the necessary precautions to prevent spread of the GMO to the environment and decrease the chance of personal injury.

Safety and 2012 iGEM team Slovenia project

The laboratory in which the experimental work has been performed was approved to work with GMOs of Biosafety level 1 and 2 (Approval documents BSL1 - 35417-6/2010-7 and BSL2 0014/2008). With rapid development of biotechnology, safety must be considered a top priority with new applications. We believe our experimental work did not compromise issues of general safety. All parts that were used in this project have, to our knowledge, do not increase the antibiotic sensitivity of the GMOs used, do not express toxic genes, and in general have little or no potential toxic effect to humans, animals or environment.

However, precautions still need to be taken, since the exact impact of our project on public, environmental and general safety, per se, have not yet be determined. Therapeutic proteins, which we have produced in HEK cells, are all already used as therapeutics in medical practice. Undoubtedly, in the future all aspects of development of microencapsulation of therapeutic cells modified by synthetic biology, new types of universal toggle switches for mammalian cells and new safety mechanisms used for microencapsulated mammalian cells have to be tested intensively and discussed carefully.

Local and national bio-safety committees and novel potential safety issues associated with Biobricks

The project and the self-evaluation of safety risk were reviewed by the Department's biological safety officer. The officer’s task is to asses if the mentors are qualified to supervise the proposed research and whether the laboratories hold the nationally required licenses to host the proposed research. The National Institute of Chemistry holds a license to work with the genetically modified organisms (Approval documents BSL1 - 35417-6/2010-7 and BSL2 0014/2008). The local bio-safety officer also evaluated new risk assessment for all new Biobrick parts and work related with them.

In conclusion, the self-evaluation of risk assessment of the proposed project (including Biobricks) and the local biosafety officer’s review of the proposal did not recognize potential hazards or increased biosafety risk to researchers, public or environment.

Synthetic biology and safety

The field of synthetic biology is defined as »the engineering of biological components and systems that do not exist in nature and are re-engineering of existing biological elements«. The basis of research in synthetic biology is a modification of biological system behavior by mutation of its genetic code. With extremely rapid progress of synthetic biology field many ethical concerns and questions are raised. They must be addressed to scientific as well as lay public.

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