要完善转基因生物法律制度，保护人类健康和生态环境，根据我国立法的现状，应从以下两个方面进行完善，以期建立健全的规范体系。
在法律体系构建方面，最优的选择是制定一部专门性、综合性的转基因生物安全法，以解决当前法规效力层次不高、管理混乱的状况。但从现实上讲，制定一部新法的成本巨大，尤其是转基因生物法这种与人类生活密切相关的法律，在制定时必须慎之又慎，耗时长久，而严峻的现况亟需法律的出台。因此我们认为制定专门的转基因生物安全法是最优选择但并非是最合理、最符合现实的选择。我们认为应当借助《
环境保护法》修改的契机，在里面增加有关转基因生物安全的基本原则，并明确转基因生物及产品所涉及各主管部门的职责权限，在此指导下，对现有的法律法规进行清理，使转基因生物法律体系内部协调一致，同时，由全国人大和国务院根据转基因生物所涉及的各过程进行专门立法，确保对转基因生物规制时有法可依。转基因生物管理部门的设置应该顺应法律体系的构建。我们认为可在环保总局下设一个部门专门负责转基因生物安全事务，其职责在于信息收集和协调各部门活动，其它行政主管部门在本部门法律法规指导下各司其职，使转基因生物管理形成一个严密的体系。
在制度完善方面，我国应借鉴外国的经验，并结合我国的现状，建立下列制度： 1，转基因生物监测制度。必须对我国境内所有转基因生物进行监测，以确保生物安全。2，转基因生物许可证制度。许可证制度是环境法中一项重要制度，是指凡是对环境有不良影响的各种规划、开发、建设项目、排污设施或经营活动，其建设者或经营者需事先申请，经主管部门审批，颁发许可证才能从事该项活动，由于转基因生物对人体健康、生态环境具有不确定性，可能造成不良影响，因此转基因生物科研或应用活动都要依法取得许可证。3，转基因专利技术。即赋予转基因专利拥有者在转基因应用领域的高度垄断，享有对转基因的独占权和专有权。其目的在于使研究者收回巨额投资，促进我国转基因生物研究的发展。4，转基因生物标示制度，按国际惯例，基因改造食品、植物的包装上必须有转基因标示，因而应扩大我国标示制度的适用范围，切实保障消费者的知情权。5，转基因生物安全评估制度。转基因生物及其产品必须经过我国相关部门的安全性评估，经我国批准的方能在我国种植和销售。
【作者简介】
张式军，山东大学法学院， 山东济南。
【注释】In this assay, definitions of Genetically modified organisms and Safety of Genetically modified organisms are firstly clarified. The author differentiates the definition of Genetically modified organisms in biological area with the definition in legal area, then he poses that Safety of Genetically modified organisms means “the series of methods used to control the Genetically modified organisms and its related products during the procedure of research, development, production, transportation, sales and consumption, to prevent its endangerment to the environment and to human health, and to remedy harms and damages caused by Genetically modified organisms. Based on these premises, the author analyzes bad effects caused by Genetically modified organisms to the natural biological environment, human health and human social order, etc. The existence of Genetically modified organisms may threaten or even destroy the quality of the environment, the biological system or biological balance. The Abstraction and Accession of gene may add and accumulate the poison elements already existing in foods in addition to the gain of some designed effects. Its existence has also aroused new discrimination between races and genders, as well as the productization of human bodies, offences to human dignities and some other ethical and moral issues. To some serious degree, it can even cause new social ethical and moral risks, economic risks and social turbulence. Genetic arms would bring new army competitions, which would endanger the nation’s safety. The possibility of improving human beings using Genetically modified organisms technology may also cause racial discriminations and racial depopulation.
After discussing all the above, the author demonstrates the necessity to regulate Genetically modified organisms in the aspect of law, and he also discusses the legal basis to legally regulate Genetically modified organisms from the angles of the difference between law and other social regulations, the value of laws and human rights. The inherent defects of moral and religion regulations lead to the unique characteristic of legal regulations, which is based on the enforcement by the nation and also ensures the proper order of the whole transgenesis market. The spread out of Genetically modified organisms, the pollutions of gene food and sharp decrease of biodiversity have all endangered the safety of individuals as well as influenced the whole human society.
To some degree, to legally regulate Genetically modified organisms accords with the legal safety value. The laws currently regulating Genetically modified organisms, however, have just ignored the public’s environmental right to know and to choose. Thus it is badly needed to regulate the Genetically modified organisms。
