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Question 1

Would any of your project ideas raise safety issues in terms of: researcher safety, public safety, or environmental safety?

If the laboratory safety rules are strictly followed, Dr. Coli is not putting extra safety issues which would affect the researchers health.

Dr. Coli is designed to cure the diseases in the gastrointestinal tract (GIT) of the human body. If no safety regulation will be followed, there exists a risk that Dr. Coli can be transmitted from one person to the other. If Dr. Coli is transmitted with his memory in an ON state to a person who does not have the disease, it will kill himself and will not be harmful. However, in the case that Dr. Coli is transferred with the memory in an OFF state, then it can spread in human beings and might need antibiotic treatment. So, Dr. Coli should not be deliberately introduced to healthy persons.

Medical staff and the patients should pay more attention to the use of Dr.Coli than other conventional drugs, because E. coli has the potential to spread through animals, and water resources and might become a risk for the healthy people.

To reduce the risk of contamination of the healthy population and the environment, a second input mechanism can be incorporated to the E. coli system, which would keep Dr. Coli alive if only both inputs are given.

To minimize the risk of DNA transmission to other species, the bricks can be inserted into the chromosomal DNA instead of using plasmids.

It would be much safer to use Lactobacillus instead of E. coli. Some Lactobacillus are commensals of the GIT, or probiotics, and have the GRAS status (generally regarded as safe).

More detailed explanation on this topic can be found in our ethical analysis.

Question 2 and 3

Is there a local biosafety group, committee, or review board at your institution? What does your local biosafety group think about your project?

There is a (bio)safety group in our university. They take care of all safety issues: not only biosafety, but also fire prevention and more specialized things like radiation safety. Like all the labs at the university, our lab is strictly controlled by the group. The lab is equiped to work with biosafety level II organisms. However, level I is sufficient to construct our Dr. Coli at the moment and appropriate handling directions are followed.

Each team member went also through medical check-up.

In addition, KULeuven Microbiology and Immunology department have an expert at the Belgian Biosafety Advisory Council.

Question 4

Do any of the new BioBrick parts that you made this year raise any safety issues? If yes, did you document these issues in the Registry?

Our BioBricks do not raise extra safety issues than other parts in the Registry.