美國生物技術的法律治理研究

Research on the Regulation of Biotechnology in the United States

生物技術的法律治理是世界性難題。在產品主義路徑指引下，美國各聯邦機構 分別根據可適用的聯邦法律，對轉基因生物及產品實施嚴格管理，有效維護了食品安全和環境安全，為美國生物技術產業發展去除了監管障礙。聯邦法院一般尊重聯邦行政機構的專業性權威，通過適用聯邦法律及時解決轉基因糾紛，在維繫產品主義治理路徑方面具有積極的防禦作用。美國國會亦審時度勢，試圖通過立法維繫統一的轉基因食品管理體系。基於科學的基礎和法律的框架，美國的聯邦法律體系可構成治理生物技術的有效機制，其基礎要素包括科學的立法、專業的執法、公平的司法以及對科學問題和法律問題的專業化處置。這些經驗或可有助於中國突破當前的轉基因治理困境和僵局。

Biotechnology is critically important for modern society and its regulation remains a world issue which shall not be ignored. Along the product-based approach, the Food and Drug Administration, the Ministry of Agriculture, and the Environmental Protection Agency, among other federal agencies in the United States of America (US), take their responsibilities respectively in regulation of the genetically modified organisms (GMOs) and their products by applying the relevant federal laws, and in consequence the regulation of GMOs has been able to ensure both food safety and environmental safety, and meanwhile to relieve the regulatory burden for the biotechnology industry in the US. The federal courts in hearing cases involving GMOs generally respect the professional authorities of federal agencies, and help to resolve the disputes by fairly applying the relevant federal laws, and therefore play a positive role of defense in maintaining the product-based approach. The Congress tries as well to unify the federal system for regulation of transgenic food in the US by legislative activities. With scientific basis and the legal framework, the federal legal system constitutes believably an effective mechanism for regulation of biotechnology in the US, which has the following basic elements, among others: a scientific, rational and prospective system of laws, specialized executive agencies, a fair and effective judicial system, and professional disposition of scientific issues and legal issues respectively. These elements can be valuable for China to break the current dilemma and deadlock in regulation of the GMO issues.