On Biosafety Legislation

With the rapid development of modern biotechnology, biosafety problems become more and more serious. To cope with the challenges through legislation, it is necessary to systemically research on biosafety legislation. The existing relevant research results involve legislation on biotechnology management, environmental impact of biotechnology, economic and the environmental-ethic analysis on biotechnological development. These results, however, can not provide sufficient supports to the biosafety legislation in China, and the biosafety legislation, in turn, fails to provide sufficient supports to resolve the biosafety problems. So this paper systemically studies on the backgrounds, values, targets, systems of the biosafety legislation and China's practices.The development of the modern biotechnology results in several negative influences on agricultural safety, food safety and ecological safety, leading to the emergence of biosafety problems. For the solutions, some argue that the further development of the biotechnology is the effective way out, while others consider the environmental protection is the best choice. China insists in the strategy of sustainable development and the benefits and risks arise from biotechnology should be balanced in polices. The international biosafety laws and the legislations of EU, USA, Japan, Brazil and India provide important references for the further research.While the bio-science in itself is value-free, the modern biotechnology activities have value inclinations, which can be appraised in value. The justice value of biosafety legislation takes form of liberty and equality, with the inclinations of substantial justice and social justice. The order value of biosafety legislation takes form of safety and predictability, with the characteristics of relativity, development and limitation. The efficiency value requires purpose-oriented, condition-focused, balance-implemented and implicit factor-considered, with the characteristics of social interests-relevance and sustainability. In case of conflict, the justice value is the basis for the adjustment of order value within the policy frame, and the efficiency value should come up with the requirement of justice and order.In the purpose system of biosafety legislation,health protection as the dominant requirement of the system is apt to justice value, ecological safety protection as the premise apt to order value, and sustainable development of biotechnology as the basis apt to efficiency value. The common target of the three purposes is to promote the sustainable development of modern biotechnology on the basis of biosafety protection. The basic principles of biosafety law embody the purpose and value of biosafety legislation as the link of them. The principles of risk prevention, cautious development and all-stage management as a whole serve to the target of regulation-development balance.Based on the values, purposes and basic principles of biosafety legislation, together with the provisions of international biosafety laws and biosafety laws of China and other countries, the basic legal systems of biosafety law can be classified as precautional, supportive and remedial systems. The precautional systems include risk resistance system, trade regulation system and the emergency plans in counter-emergency system. The supportive systems include information exchanging system, public participation system and financial supporting system. The remedial systems include emergency measures in counter-emergency system and damage compensating system. These systems are discussed in detail in this paper.The existing biosafety laws in China involve several fields and form a regulation system. In spite of its positive role in China's biosafety management, there are some difficult problems for the regulation system to resolve in several aspects. It needs a comprehensive regulation system to improve biosafety legislation in China. It is emergent at present to enact a comprehensive biosafety law based on the researches on the values, targets and legal systems of biosafety legislation, with consideration on the needs of biosafety management in China, and such important aspects as purposes, principles, regulative scope, management structure, major legal systems, disputes settlement and liability be provided explicitly in the Law.Reviewing current researches on biosafety legislation, the studies on the values and their inclinations are not found yet. The route of studying on the purposes and principles of biosafety law (legislation) based on the values is not adopted in the previous researches, too. And still, the classification to the basic system of biosafety law and the suggestions on China's comprehensive biosafety legislation also contribute further studies on this topic.