Safety

Overview

Synthetic biology research holds great potential, but it also requires strict safety management. In the Xylego project, safety is placed at the core of our activities, and we always remain mindful of potential risks that may arise during the course of research. Here, we provide an overview of the policies and systems we have implemented to ensure the safe execution of the project.

Product Safety

Our recombinant E. coli uses xylitol as a nutrient source, which is widely recognized as safe for humans. In addition, we introduced a Kill switch system ensures that once inflammation subsides, the E. coli self-destructs. This prevents unexpected survival within the body from causing intestinal epithelial cancer and prevents spread through environmental survival, thereby enhancing safety. Additionally, the Kill switch system prevents the spread of antibiotic resistance to other bacteria in the environment by having restriction enzymes cut the antibiotic resistance gene along with the genome.

Laboratory Safety

Laboratory Safety Equipment

The experiments conducted in this project are classified under P-1 level, and the laboratory adheres to the following constraints[1]:

  1. The laboratory must be equipped with the necessary structure and facilities required for conducting biological experiments.
  2. When conducting experiments involving genetically modified organisms (GMOs), the following precautions must be observed: (1) Waste containing GMOs (including waste liquids) must be inactivated before disposal. (2) Equipment, machinery, and tools contaminated with GMOs must be decontaminated before disposal or reuse (including prior washing, where applicable). (3) Laboratory benches must be decontaminated after the completion of daily experiments or immediately if contaminated with GMOs. (4) Laboratory doors must remain closed, except when entering or exiting the room. (5) Windows must be kept closed or otherwise secured to prevent insect entry. (6) Aerosol generation must be minimized during all procedures. (7) If GMOs need to be removed from the laboratory or inactivated outside the lab, they must be contained in sealed, leak-proof containers. (8) Personnel handling GMOs must take necessary precautions, such as handwashing, to prevent contamination or infection. (9) Measures must be taken to prevent unauthorized persons from entering the laboratory.

In the laboratories of Professor Nobuhiro Hayashi, Professor Yoshihisa Matsumoto, and Associate Professor Yoichi Tagawa, experiments are conducted under the supervision of graduate students, and access outside of working hours is prohibited.

Waste Management

All waste is sorted into general waste (such as packaging and paper towels not contaminated by chemicals or biological substances) and waste contaminated by biological materials (such as gels and pipette tips). Biohazardous waste is properly sterilized before being collected by a contractor.

Safety Education

At the Institute of Science Tokyo, the “Institute of Science Tokyo Safety Management Regulations for Genetic Modification Experiments” have been established in accordance with the Cartagena Act and the ministerial ordinance concerning containment measures for the use of Type 2 GMOs in research and development[2] The Safety Committee provides guidance, and students involved in experiments are required to attend this training. The content includes:

Participants are issued an experimenter number valid for 3.5 years (for students) as proof of attendance. Before beginning any experiment, participants must input this number in the “Experimenter” section of the experimental plan and pass the university’s review process.

Furthermore, since the 2023 academic year, our university has made courses on bioethics and regulations mandatory for students in the life sciences departments who entered or will enter the university. This ensures that even students not directly involved in experiments receive appropriate ethical education. This initiative was originally introduced at the Tokyo Institute of Technology and has been continued after its integration into the Institute of Science Tokyo.

References

  1. 研究開発等に係る遺伝子組換え生物等の第二種使用等に当たって執るべき拡散防止措置等を定める省令 | e-Gov 法令検索 [Internet]. [cited 2025 Oct 8]. Available from: https://laws.e-gov.go.jp/law/416M60001080001
  2. 国立大学法人東京科学大学遺伝子組換え生物等の実験等安全管理規則 [Internet]. [cited 2025 Oct 8]. Available from: https://www.somuka.titech.ac.jp/reiki_int/reiki_honbun/x385RG00001698.html