Biosecurity Law of the People's Republic of China
According to the introduction of the "Note on the Draft Biosecurity Law of the People's Republic of China," biosecurity legislation is essential for safeguarding national security, establishing a comprehensive national biosafety system, enhancing national biosecurity capabilities, addressing public concerns and opinions, and fulfilling international obligations. Biosecurity is intricately linked to social stability, public health, economic development, and national defense construction. The challenges posed by biological factors have always been a significant global concern. In order to effectively address biosecurity threats and ensure the healthy and orderly advancement of biotechnology, it is imperative to establish relevant laws and regulations to govern related behaviors.
The Biosecurity Law of the People's Republic of China was adopted during the 22nd session of the Standing Committee of the 13th National People's Congress on October 17th, 2020, and will come into force on April 15, 2021. This law comprises ten chapters that encompass provisions concerning "the prevention and control system for biosafety risks," "measures for preventing and controlling major emerging infectious diseases as well as animal and plant epidemics," "safety in research, development, and application of biotechnology," "biosafety in laboratories handling pathogenic microorganisms," "safeguarding human genetic resources and biological resources," "prevention against bioterrorism threats" as well as "bioweapons threats", "capacity building for biosafety,"and finally addressing legal responsibilities."
The Regulations on the Safety Management of Genetic Engineering, a significant legislation promulgated by China's National Science and Technology Commission on December 24, 1993, aims to foster biotechnology research and development while enhancing the safety management of genetic engineering endeavors. It ensures public health and safeguards genetic engineering personnel, prevents environmental contamination, and upholds ecological equilibrium. These regulations are applicable to all genetic engineering activities conducted within China's borders, encompassing experimental research, pilot tests, industrial production as well as the release and utilization of genetically engineered organisms and products. They also extend to work carried out in China involving imported genetically engineered organisms. Violators of these regulations will face legal consequences including warnings, work suspension or funding withdrawal, confiscation of illicit gains among other penalties. Severe violations may constitute criminal offenses that will be prosecuted in accordance with the law. The formulation and implementation of these regulations exemplify China's responsible stance in the field of biotechnology aimed at ensuring the safety and sustainability of scientific research activities while promoting sound development in biotechnology.
The Tianjin Biosecurity Guidelines for Codes of Conduct for Scientists
The Tianjin Biosecurity Guidelines for Codes of Conduct for Scientists aim to prevent abuse in the field of bioscience by establishing explicit ethical standards, legal norms, research responsibilities, respect for research subjects, effective management of research processes, comprehensive education and training programs, wide dissemination of research results, active public participation in science and technology endeavors, clear definition of institutional roles and responsibilities, as well as fostering international cooperation. Specifically, they seek to effectively deter the development and proliferation of biological weapons. Additionally, these guidelines emphasize the paramount importance of promoting the peaceful and responsible use of biosciences for the benefit of humanity while ensuring their sustainable development. By adopting and implementing these guidelines rigorously across scientists' community,research institutions,and governments can significantly enhance biosecurity measures,reducing risks associated with potential abuse or harm,and aligning with boththe Biological Weapons Conventionandthe United Nations Sustainable Development Goals.
The Regulations on the Safety Management of Biotechnology Research and Development in China are a crucial legislative measure enacted by China to regulate and promote the safe, orderly, and healthy development of biotechnology research and development activities, as well as to effectively safeguard national biosecurity. These regulations aim to standardize biotechnology research and development activities, enhance safety awareness among relevant individuals, legal entities, and organizations, mitigate biosecurity risks, foster the sound and systematic growth of biotechnology research and development endeavors while ensuring effective biosecurity protection. They apply to all individuals and organizations engaged in such activities within China's jurisdictional boundaries. The regulations emphasize the implementation of hierarchical management for safety control over biotechnology research and development activities based on different risk levels: high-risk level, relatively high-risk level, and general risk level. The competent science department under the State Council is responsible for providing national guidance on biotechnology research safety while collaborating with relevant departments under the State Council in carrying out related security management tasks. Furthermore, these regulations establish a National Expert Committee on Biosecurity Management for Biotechnological Research that conducts strategic security studies along with offering recommendations for risk level categorization lists.
According to this, our group should strictly adhere to these principles in all aspects of our project, including conception, experiment design, conduct, human practice, and other areas. Based on the project introduction, our team will focus on globally distributed diseases such as diabetes and hypertension that significantly impact human life quality and health. Considering the existence of widely developed and applied drugs and treatments for these diseases in clinical diagnosis and treatment, it is crucial to address current issues such as slow diagnosis and significant drug side effects. This project utilizes the engineering design concept of synthetic biology to carry out targeted design, transformation, testing, and application of biosafe synbiotics - Zymomonas mobilis. Its objective is to create a synbioitic therapy integrating three modules: health prevention, diagnostic reporting, and responsive treatment with the ultimate goal of achieving disease treatment while promoting a healthy life free from illnesses. In terms of design concept，the team's project focuses on disease prevention and treatment with scientific research value while minimizing ethical controversies. In terms of specific implementation practices for completing this project process，team members must fully comply with relevant laws, regulations in the field of biology, and medicine. Secondly, the members of the experimental group should adhere to laboratory safety standards and promptly address any non-compliant situations or report them to the teacher and college authorities. Furthermore, during the experiment, it is essential for the members of the experimental group to strictly follow regulations. In terms of human practice, team members should engage in thorough discussions, investigations, and consultations with experts regarding ethical and safety aspects related to the subject matter. They should also provide feedback on practice results in order to enhance and refine the experiment. When conducting human practice activities, team members must consider doctors' professional scope as well as patients' conditions and emotions. It is crucial for them to extensively gather information, collect data accurately by consulting multiple experts whenever possible, ensuring professionalism and relevance of authoritative information in surveys. Additionally, values such as green environmental protection and resource conservation should be taken into consideration during relevant team activities. If there are subsequent stages involving life science research or medical research with human subjects or utilizing human biological samples and information data), strict adherence to aforementioned legislation is necessary in order to prevent ethical issues according to law while promoting a healthy project development.