談日本基因改造實驗管理規範及其執行現況

日本於2003年通過「規範基因改造生物使用以確保生物多樣性之相關法律」（簡稱卡達赫納法），除將其國內之基因改造科技管理規範提升至法律位階外，並訂有罰則並賦予主管機關發布強制命令或做出緊急處分的權限，以增加其管理規範之強制力。這樣的規範強度增強，亦反映在基因改造實驗的管理規範上。在日本卡達赫納法的規範架構中，基因改造實驗被歸類爲第二種使用樣態，而符合第二種使用樣態而爲GMO使用行爲之使用者，須執行防止擴散措施；在主管機關行政命令（針對研發活動之規定爲研究開發二種省令）有所規定的情況下，使用者須執行該命令所訂之措施，而在主管機關行政命令未有規定之情況下，使用者則須向主管機關申請確認其在使用GMO期間內所執行之防止擴散措施，並須執行經過確認之防止擴散措施。同時，卡達赫納法亦賦予主管機關（研究開發活動的主管機關主要是文部科學省）權限去確保防止擴散措施有適切被執行，並輔以罰則來增加相關規範之強制力，讓主管機關在落實相關法令規範時能更有實效。最後，本文透過三個案例來說明，日本文部科學省如何具體執行以卡達赫納法爲核心的日本基因改造實驗管理規範，並據以點出未來在強化我國基因改造研發活動的管理規範時，可向日本借鏡之處。

關鍵字

日本基因改造實驗管理規範；日本GMO管理規範；卡達赫納法；研究開發二種省令； GMO第二種使用樣態

並列摘要

”The Act on the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms” (Cartagena Law) has been adopted in Japan in 2003, and it makes Japanese GMO regulations lawful and enforceable. In the regulatory framwork established around the Cartagena Law, GMO-related experiments are regarded as ”Type 2 Use”, which means that certain containment measures need to be taken while GMOs are used. When a GMO-related experiment can be categorized in the provisions of ”Containment Measures to Be Taken in Type 2 Use of Living Modified Organisms for Research and Development”, the experiment should be undertaken with implementation of the containment measures mentioned in the provisions. When an experiment can not be categorized, the containment measures which suppose to be implemented during the process of the experiment need to be confirmed by the authority (Ministry of Education, Culture, Sports, Science and Technology) before the experiment is commenced. After the discussion on the details of Japanese regulations on GMO-related experiments, three cases will be described in order to demonstrate how the Japanese Ministry of Education, Culture, Sports, Science and Technology enforces the Cartagena Law and its relevant regulations. And in the end of this article, the suggestions about how to improve the regulations on GMO-related experiments in our country based on the Japanese experiences will be proposed.

並列關鍵字

Japanese regulations on GMO-related experiments ； Japanese GMO regulations ； Type 2 Use ； Cartagena Law

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