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Safety And Security

Here, we delve into the safety considerations of our project, from the laboratory equipment and facilities to the responsible project design and risk assessment.

Overview


While synthetic biology and its applications are nothing short of exciting and promising for a better future, responsibility and safety are key factors to take into account. This was not an exception for us, the team of iGEM Utrecht 2025, as we emphasized the importance of conducting experiments safely throughout the weeks spent in the wet lab.

For a project such as ours, which envisions interactions between the commensal microbiota and engineered microbes, it is crucial to ponder over how experiments can be designed so that the final product is as applicable and safe as possible. This reaches beyond the scope of the wet lab, as the potential societal impact of a novel therapeutic strategy like this one is also an important topic to discuss. Such discussions can elucidate the ways GutFeeling may potentially become a reality and help save the lives of chronic illness patients!

Laboratory Safety


General Remarks

We conducted our wet lab experiments in research laboratories in the Hugo R. Kruytgebouw, Victor J. Koningsbergergebouw and Androclusgebouw buildings, located in the Utrecht University Science Park. There, we only worked in laboratories designated for Biosafety Level 1 (BSL-1/ML-1) work, classified in accordance with the European Union's biosafety directive .

Under the assistance of our supervisors and biosafety officers, we made sure that all our work complied with the Dutch and European biosafety regulations. More specifically, we made sure to adhere to the general biosafety regulations described by the Bureau of Biosecurity (Rijksinstituut voor Volksgezondheid en Milieu) in the Netherlands . This includes both the wet lab work (i.e. plasmid design, bacteria work, zebrafish handling etc.) and the management of the waste resulting from our experiments. Therefore, all team members who did wet lab work received mandatory training on the laboratory safety regulations. This way, we were aware of the responsible lab conduct which calls for adequate clothing and behaviour (i.e. preferably long sleeves, closed-toe shoes, tied up long hair, interdiction of bringing food/drinks, etc.)

Sterile Work

In order to ensure proper sterile handling of the engineered bacteria/zebrafish larvae utilized in our project, we received training on working with GMO and handling potential incidents. This way, we were properly prepared to avoid the possible scenario of GMO leakage into the environment.

On a practical level, we were equipped with lab coats, gloves, sterilized disposables (i.e. flasks, pipette tips, etc.), Bunsen burners and biosafety cabinets. We worked carefully and made sure to disinfect the working surfaces with laboratory grade 70% ethanol. This limited and prevented the occurrence of contaminations, while ensuring that we worked in a clean, safe and controlled environment.

Figure 1: Bacterial handling in the biosafety cabinet

Figure 1: Working in the biosafety cabinet

Figure 2: Sterile handling of bacteria

Figure 2: Sterile handling of bacteria

Specialized Equipment

Throughout our wet lab work, we have utilized an extensive range of specialized lab equipment instruments: biosafety cabinets, HPLC machines and mass spectrometers, to name a few. The team members who worked with these instruments received training from professionals who operate the machines on a regular basis. Moreover, the usage of the HPLC/MS machines was directly supervised by these professionals to ensure a smooth, safe and reliable run of the experiments.

Zebrafish Facility

Zebrafish represented the core model organism in GutFeeling. One of our supervisors, who is highly proficient in working with this organism, demonstrated how to work with zebrafish larvae. This involved breeding the fish, harvesting and bleaching the eggs, and incubating them towards obtaining germ-free zebrafish larvae and subsequently deriving gnotobiotic zebrafish.

Specialized zebrafish work (i.e. breeding the fish) requires documentation and must be conducted by trained experts, according to article 9 of the Dutch Wet op de Dierproeven (Experiments on Animals Act) . Therefore, these specific steps were done by our supervisor in a zebrafish facility which has the corresponding documentation for such experiments.

We conducted the steps following the harvesting of the zebrafish eggs, which do not require official documentation for animal experiments work. This was done under the direct guidance of our supervisor in order to ensure a responsible and safe handling of the zebrafish larvae.

Working with Chemicals

Our work involved the use of multiple chemicals, particularly in the context of producing L-DOPA and running HPLCs for quantification. In our labs, chemicals were properly stored and sorted based on their toxicity. More specifically, hazardous chemicals were stored separately from the non-hazardous ones, in closed containers.

In order to ensure safe handling of these compounds and proper risk mitigation, we made sure to read the safety data sheets (SDS) for every chemical we worked with. These data sheets were readily available online. We worked with only one hazardous (potentially carcinogenic) chemical, catechol (1,2-dihydroxybenzene) – substrate for enzymatic L-DOPA production. After consulting with our supervisors, we made sure to always work with it under a chemical flow cabinet and wear gloves/lab coats in the process. This limited the risks of handling catechol via skin contact and vapour inhalation.

When working with agarose gels to assess our DNA constructs by size, we also made the conscious choice of using the MIDORI Green DNA stain, as an alternative to the traditional ethidium bromide-based nucleic acid stains (mutagenic and carcinogenic). This chemical is much safer and represents a safety measure taken by our team, especially since we ran a large number of gels.

Waste Disposal

Our waste disposal system worked in compliance with the Dutch and European regulations. We collected the BSL-1/ML-1 waste (plastics, glassware and liquid) separately from the uncontaminated waste. The former was labelled properly and autoclaved before its final disposal, to ensure that no GMOs were carried out of the laboratory into the environment. The specialized personnel in our buildings were in charge of these last steps.

The disposal of the leftover zebrafish larvae was done before 5 dpf (the same timeframe as the one used in experiments), as they are still not considered animals at this timepoint, according to European regulations. This was done using a filter, in order to prevent the larvae (either dead or alive) from reaching the sewers/environment.

Chemical waste disposal was also done responsibly, according to the laboratory standards. We separated the compounds based on their pH and (an)organic character, adhering to a readily available guide of our lab.

Figure 3: Waste disposal procedures

Figure 3: Disposal chart for liquids

Figure 4: Autoclave for waste sterilization

Figure 4: Disposal chart for solids

Responsible Project Design


Strains

Bacteria: In our project we relied on two bacterial species as the pillars of our application: Escherichia coli (E. coli) and Pseudomonas alcaligenes (P. alcaligenes).

We chose to first work with E. coli as it is one of the most common model organisms utilized in synthetic biology. The strain we used, DH5-alpha, is not pathogenic to humans and is enhanced for efficient transformations. This made the strain ideal candidates for the initial transformation of our DNA constructs. However, as we were also interested in phenotyping the constructs in the zebrafish model organism, we utilized a self-isolated strain of P. alcaligenes which is commensal to the fish microbiota. Both microbes are classified in risk group 1, as they pose low risk to humans and the environment.

Zebrafish: The model organism in which we tested the constructs was the zebrafish (Danio rerio) larva, out of which we used three strains: wild type AB, casper fli1a:GFP and casper kdrl:mCherry . We worked with larvae younger than 5 days post fertilization, when they are not animals and may be used as embryos and cultured as animal cells, according to the European regulations . Despite this, we treated the larvae very carefully and respected the humane standards of working with animals. The larvae are not harmful to humans or the environment.

Kill Switches

Our project envisions the integration of engineered microbes within the human microbiota. In the scenario of microbial overgrowth, it is not a surprise that our system could potentially pose a threat to the health of the host by unbalancing its commensal microbiota's structure and function. We kept this in mind and introduced a safety regulation mechanism into our bacteria's genetic circuit via kill switches.

We looked into and implemented two types of kill switches, tailored to two distinct scenarios of interest:

  • The arabinose-induced kill switch which can wipe out the entire population of engineered bacteria in the gut by simply administering L-arabinose to the patient. This system is inherently useful to ensure that users of our system would have the autonomy to terminate their treatment whenever they wanted to. This system is logged in the iGEM Registry of Standard Biological Parts (BBa_K3036005) .
  • The LuxR-based density kill switch can be employed to ensure that a stable bacterial population is maintained. The engineered microbes can overexpress the LuxR protein which, under high bacterial populations, leads to induction of cellular death. This system is useful to maintain a relative homeostasis in the gut microbiota, and was previously described by iGEM Squirrel Guangzhou 2024 .

Parts Safety

We attempted to introduce 9 gene constructs and two kill switches into the bacteria. The gene constructs all consist of fluorescent proteins with various tags (FLAG, secretion, cell uptake, etc.), and do not pose any threat to humans or the environment. The kill switches we implemented rely on the usage of endonuclease toxins which are specific to microbes and cannot harm animals.

However, the transformation of the genes of interest was carried out in vectors encoding for antibiotic (kanamycin) resistance cassettes. Moreover, these resistant microbes were fed to the fish larvae. It is well known that bacteria can undergo horizontal gene transfer (HGT), which is a driving factor of the antibiotic resistance problem the medical world is currently facing . In order to not release the engineered organisms into the environment and facilitate the further spread of this issue, we followed the adequate measures to prevent leakage of GMOs (see section above).

Risk Assessment


The risk assessment run by our team managed to highlight a selection of both short and long term risks arising from our project. Fortunately, we could also determine ways to tackle most of our project's underlying perils.

Risks

  • Spread of GMOs into the environment would facilitate HGT of antibiotic resistance cassettes. The engineered microbes could escape their hosts and survive to transfer genetic material to other microorganisms, disturbing ecosystems and spreading antibiotic resistance uncontrollably.
  • The antibiotic resistance of the GMOs could spread to other commensal bacteria or even pathogenic ones, and make future infections more difficult to treat and overall disturb the functional balance of the gut microbiota. Moreover, it would contribute to the antibiotic resistance polemic.
  • P. alcaligenes could potentially outgrow in the gut microbiota, outcompeting the commensal bacteria. This would disrupt its native functionality and cause adverse health effects in the host.
  • There could be insufficient regulation of the L-DOPA production circuits, leading to the overproduction of the drug in vivo. This would likely represent a threat to the host as high concentrations of the product can be highly toxic.

Risk Mitigation

While our project envisions a real-world novel therapeutic strategy, it still represents a proof of concept. For it to be transitioned to an application, very extensive research and testing would definitely have to be conducted first. This applies particularly when it comes to the safety of our system, which would (and should) be a priority for both patients and doctors. Moreover, ethics and policy frameworks would have to be established for safe and responsible implementation of GutFeeling, as you can read on the Human Practices page.

In our project, we are carefully handling GMOs by adhering to the relevant national and European regulations and guidelines. This ensures that the leakage of mutant microbes in the environment is limited and our work is safe. Moreover, we are assessing and phenotyping the GMO-containing zebrafish larvae by tracking their behaviour, viability and other metrics of interest (i.e. heartbeat). By doing this, we can get an understanding of how our system affects the larvae and if, for example, lethal doses of product (L-DOPA) are produced. Lastly, we made sure to emphasize the implementation of kill switches, specifically to target and either control the GMO population or wipe it out completely from the host, ensuring the potential patient's autonomy, safety and control over the treatment.

All in all, GutFeeling brings up a series of potential risks and safety concerns. However, our team considered these factors carefully and developed a responsible research design and plan meant to mitigate most of these risks and ensure a safe and enjoyable experience!

  1. Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work, OJ L 262 17.10.2000, p. 21.
  2. Rijksinstituut voor Volksgezondheid en Milieu. About Biosecurity Office. Accessed October 3rd 2025. https://www.bureaubiosecurity.nl/en/about-biosecurity-office
  3. Rijksdienst voor Ondernemend Nederland (RVO). Rules on animal testing and research. Accessed October 3rd 2025. https://business.gov.nl/regulation/animal-testing/
  4. Pontes, K. C. D. S., Groenewoud, A., Cao, J., Ataide, L. M. S., Snaar-Jagalska, E., & Jager, M. J. (2017). Evaluation of ( fli:GFP ) Casper Zebrafish Embryos as a Model for Human Conjunctival Melanoma. Investigative Opthalmology & Visual Science, 58(14), 6065. https://doi.org/10.1167/iovs.17-22023
  5. Gurung, S., Restrepo, N. K., Chestnut, B., Klimkaite, L., & Sumanas, S. (2022). Single-cell transcriptomic analysis of vascular endothelial cells in zebrafish embryos. Scientific Reports, 12(1), 13065. https://doi.org/10.1038/s41598-022-17127-w
  6. Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes Text with EEA relevance, art 1.3, OJ L 276, 20.10.2010, pp. 33–79
  7. iGEM Registry of Standard Biological Parts. Part:BBa_K3036005. Accessed October 3rd 2025. https://parts.igem.org/Part:BBa_K3036005
  8. iGEM Squirrel Guangzhou Wiki. Parts. Accessed October 3rd 2025. https://2024.igem.wiki/squirrel-guangzhou/
  9. Burmeister, A. R. (2015). Horizontal Gene Transfer. Evolution, Medicine, and Public Health, 2015(1), 193–194. https://doi.org/10.1093/emph/eov018
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