Safety

Introduction

Our team firmly believes that the success of any project must be based on safety. To ensure biosafety, laboratory safety, and environmental safety at every step of the experiment, we adhere strictly to international and national regulations, such as the Biological Safety Law of the People's Republic of China and the Regulations on Laboratory Biosafety Management. Additionally, given the rapid development of gene editing technologies, we place high importance on data privacy and ethical considerations to ensure that the project meets high standards both technically and ethically.

Project Safety

Strain Selection

The strains used in this project include Saccharomyces cerevisiae and Escherichia coli DH5α, both classified as Biosafety Level 1 (BSL-1) microorganisms. According to the *Regulations on Laboratory Biosafety Management of Pathogenic Microorganisms*, BSL-1 microorganisms are not pathogenic to healthy adults. We have thoroughly assessed the biosafety of these strains to ensure their use in the laboratory does not pose a risk to personnel or the environment. It is worth noting that the chassis strain Saccharomyces cerevisiae used in our production is not listed on the iGEM 2024 whitelist. Therefore, we submitted a usage application to the iGEM Committee and received approval on May 22, ensuring the legality and compliance of its use, in accordance with biosafety and ethical requirements.

Work Environment Safety

Our experiments are conducted under sterile conditions, and the laboratory complies with the Regulations on Laboratory Biosafety Management. All operations are performed in biosafety cabinets or sterile workstations. After the experiment, media and materials used are sterilized at high temperatures to ensure environmental safety. Any potential contamination is controlled through regular disinfection and sterilization. Our laboratory safety management strictly follows the requirements of the Biological Safety Law of the People's Republic of China and the Regulations on Laboratory Biosafety Management, and we have developed detailed emergency plans, including protocols for handling biological hazard spills and chemical leaks.

Safety Management During Experiments

Safety Management in Plasmid Construction and Gene Integration

During plasmid construction, we follow standard operating procedures strictly. The Escherichia coli DH5α strain used is well-suited for gene amplification and homologous recombination. According to the Regulations on Laboratory Biosafety Management, we ensure that every step of gene insertion and recombination is conducted under conditions that meet safety standards to prevent gene leakage and potential environmental contamination. In the gene integration process, we use Saccharomyces cerevisiae as the chassis strain and employ competent cell technology to complete gene integration. This method is stable and safe, ensuring no adverse effects on the environment or human health. All operational steps are subject to rigorous risk assessment and adhere to general biosafety standards.

Safety Measures During Fermentation

All operations during fermentation are conducted in a closed system, following the Regulations on Laboratory Biosafety Management to ensure that engineered bacteria do not escape into the external environment. After fermentation, the fermentation broth is sterilized at high temperatures to eliminate any potential residual bacteria.

Waste Management

Waste management is a critical component of laboratory safety. We strictly follow the Regulations on Hazardous Waste Management, categorizing biological and chemical waste for proper disposal. Biological waste is sterilized before being placed in designated waste containers and handled by qualified agencies in accordance with national standards. Waste containers are labeled according to the Regulations on Hazardous Waste Management, and the waste disposal process is closely monitored and inspected to prevent environmental contamination.

Laboratory Safety Operations

Personal Protective Equipment (PPE) According to the Regulations on Laboratory Biosafety Management, all personnel entering the laboratory must wear personal protective equipment, including lab coats, goggles, gloves, and masks. The use of PPE ensures that personnel are protected from potential biological and chemical hazards during operations.

Operational Standards Any non-experimental activities, such as eating and smoking, are strictly prohibited in the laboratory. All experimental operations must follow standard operating procedures, and work surfaces and equipment must be thoroughly cleaned and disinfected after each use to prevent contamination.

Equipment Management Daily management and maintenance of laboratory equipment follow the Laboratory Management Measures, ensuring that equipment is in good working condition. Regular checks and maintenance not only improve efficiency but also prevent potential safety hazards.

Emergency Response To ensure safety within and outside the laboratory, we have established detailed emergency response plans covering biological hazard spills, chemical leaks, and fires. According to the Regulations on Laboratory Safety Emergency Management, all laboratory personnel must undergo safety training before entering the laboratory to effectively handle emergencies.

Biological Hazard Spills In the event of a biological hazard spill, personnel must immediately take isolation measures and use appropriate disinfectants to prevent the spread of biological hazards. All biological hazards are labeled and stored according to the Biological Safety Law.

Chemical Leaks In case of chemical leaks, personnel must wear PPE and follow the laboratory’s spill response procedures. We ensure that all personnel are familiar with the locations of fire extinguishers and first aid kits in the laboratory to respond quickly to chemical accidents.

Fires The laboratory is equipped with emergency evacuation routes, fire extinguishers, and other fire safety equipment. Personnel receive regular fire safety training to ensure they can evacuate quickly and control fires effectively.

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Privacy and Data Protection

All data collection and processing in the project comply with the Cybersecurity Law of the People's Republic of China and the Personal Information Protection Law. Any sensitive information involved in the experiment is encrypted, and data access is restricted to authorized personnel only.

We commit that all personal information will not be used for unauthorized commercial purposes or shared with third parties. After the project concludes, all personal data will be deleted or destroyed within the specified time frame to comply with the Personal Information Protection Law.

Ethics and Gene Editing

Gene editing technology offers vast research opportunities but also raises significant ethical concerns. We have thoroughly considered the ethical implications of gene editing technology and conducted in-depth discussions in accordance with current regulations.

Public Awareness and Transparency

Public awareness is crucial in gene editing research. In line with the Biotechnology Safety Protocol, we ensure that all experimental information is transparent, allowing the public to understand our project’s progress and potential risks. We regularly publish experimental reports and project results to provide accurate information to the public and stakeholders, reducing misunderstandings about gene editing technology.

Environmental Safety and Controllability

The application of gene editing technology may have unpredictable environmental impacts. To ensure environmental safety, we follow strict experimental protocols to prevent engineered bacteria from surviving in the natural environment. This mechanism complies with the Convention on Biological Diversity and related international treaties, minimizing environmental impact.

The long-term impacts of gene editing extend beyond short-term laboratory results and may affect future environments and biodiversity. We conducted thorough risk assessments during the project design phase to ensure traceability and controllability of all gene operations. Through rigorous testing and review, we ensure that strain behavior is predictable, minimizing potential future environmental risks.

Dual Use and Misuse Risks

The dual-use nature of gene editing technology must be addressed. To prevent misuse, we implement anti-misuse measures in experimental design and conduct regular safety assessments to ensure that the technology is not used for unethical purposes.

Researchers’ Responsibilities

As researchers, we are responsible not only for the experimental results but also for ensuring that the experimental process adheres to ethical standards. According to the Code of Ethics for Scientific and Technological Research, our team regularly participates in ethics training to ensure that each member understands and follows ethical norms during the experiment, always prioritizing social responsibility.

The application of gene editing technology in society, especially in agriculture and medicine, has sparked extensive discussion. We conduct social impact assessments to ensure that the project does not negatively affect existing social structures. According to the Guidelines for Ethical Assessment of Scientific and Technological Research, we predict the potential impacts of gene editing technology and engage in dialogue with various societal sectors to ensure that its application meets ethical and legal standards.

Through these enhanced safety and ethical guidelines, we ensure that every member of the laboratory can conduct research in a safe, transparent, and ethical environment. Our goal is not only to advance scientific progress through technology but also to embody social responsibility and environmental protection at every stage.

Additional Information and Relevant Links

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