论动物转基因科研试验安全监管的法律制度

动物转基因技术种类日益复杂，应用范围不断扩大，但成本和技术要求却不断降低，生物风险和安全威胁越来越大。科研试验阶段是风险防控的关键，因此需要科学而严谨的科研试验法律监管，以预防意外和不正当试验对社会及生态造成不良影响。国内可以指向转基因动物科研试验监管适用的法律规定集中于农业应用领域，不足以形成全面有效的监管。基于动物转基因技术的发展现状和趋势，需要对现有法律法规进行分析，明确科研试验监管的基本原则，以协调监管体系为核心探讨法律完善的关键问题，进而系统性地明确科研试验安全监管法律的进展趋势。

The Legal System in Safety Supervison about Animal Transgenic Scientific Research and Experiment

Animal gene transfer technologies are more and more widely applied with fewer obstacles due to the decrease in cost and technical requirement of transgenic research and the increase in success rate. This situation on the one hand makes it easier for the production of transgenic animals, and on the other hand makes it harder for supervision and management. Since transgenic animal technology has risks in itself and the malicious abuse of it is likely to pose increasing security threats to the human society, safety control of transgenic research at its experimental stage is absolutely necessary. Along with the risks, there are broad application prospects of transgenic animals in areas such as new animal variety breeding, bio-pharmacy, disease research, organ transplantation, environmental protection, landscape ornamental, and gene function research, which mirrors that this technology has great potential values to promote social development. Once the research is to be put into production, the successful regulation of it largely ensures the national economic development and social stability. Therefore, it is important to conduct safety control on transgenic researches at its experimental stage. As required by the public, the supervision and administration should focus on guaranteeing the safety of transgenic animals, and the safety assessment should follow at least three criteria: firstly, the maturity, stability and precision of transgenic techniques; secondly, the characteristics of animal populations, which determine the diversity of security risks; thirdly, the purposes and methods of application, which may give rise to different safety problems. The three criteria suggest that transgenic animal safety is not a problem that can be easily solved by one or two conclusions, but rather a long-lasting issue faced by the society. Again, as risk prevention and control at the experimental stage is the crux of the matter, a well-established system of laws is needed to regulate the supervision and administration of relevant research with both effectiveness and efficiency. However, the current legal system concerning safety control of transgenic animal research seems to be inadequate to fulfill its mission, given some existing problems and developmental problems. To be specific, the laws and regulations are not clear-cut enough; the standards for hierarchical management are not strict enough; safety assessment is not brought into full play; there is a lack of cooperation and coordination between supervision subjects; and there lacks guidelines for supervision and inspection, emergency management, and control measures. To cope with these existing problems, it is necessary to clarify the fundamental principles of safety control, to adjust the scope of objects for regulation, to overall plan and put on record the inspecting and detecting techniques, and to regulate the system of register and trace management. This paper, based on the analysis of the advances and applications of transgenic animal technologies coupled with the tree criteria for transgenic animal safety assessment, summarizes and puts forth some tendencies of the laws and regulations on safety control of transgenic animal research, namely the clarification of supervisory and regulatory principles, the adjustment of supervisory and regulatory scope, the optimization of safety assessment system, the construction of a coordinated supervisory and regulatory system, and the enhancement of legal certainty. The innovation of this paper lies in three aspects: first and foremost, it is a cross-disciplinary (animal science and law science) study of transgenic animal safety related laws based on the development of animal gene transfer technologies; what is more, it provides a comprehensive analysis and a scientific conclusion of the problems and deficiencies of China’s current legal system on transgenic animal research; last but not least, it objectively puts forward a set of “precautionary principle” centered supervisory and regulatory principles, discusses the logical relations among “deeper scientific investigation principle”, “hierarchical and classified supervision principle” and “individual case assessment and regulation principle”, and explicitly denies the applicability of “Substantial Equivalence” in China in view of the international trend, social demand, and safety problems.