- 期刊
談美國GMO管理規範之修法趨勢－從「全有全無」到「多階分級」許可管理之制度轉換
Recent GMO Regulation Evolution in the US for Regulating Environmental Release of Genetically Engineered Organisms
摘要
關於基因改造生物(GMO)安全性及其是否會對生態環境或人類動植物造成長期潛在風險之質疑，始終充滿不確定性，而如何規範才足有效控管各種GMO衍生風險，令社會能在適當強度風險管制與引導技術正向發展雙重目的間取得平衡，一直是爲近年各國政府重視科技管理議題。國際間對於GMO之管理，通常係採取規範GMO應於環境釋出前或上市銷售前，進行生物安全評估、通過審查、取得主管機關同意後始得釋出環境之管理模式；其中，主管機關對於GMO上市或釋出申請案件，往往僅能在禁止或是許可此二選項中擇一，而欠缺運用其他中間地帶或過度期間管理措施之彈性。然而，隨著基因改造科技及其應用之多元蓬勃發展，各國目前普遍採用之此種全有全無（即全面禁止或全面許可）管理模式，是否真能符合現今GMO管理需求，似乎已逐漸產生問題。 美國GMO主管機關的農業部(USDA)及環保署(EPA)，近年相繼提出含有分級管理概念之法規檢討與修法草案。在USDA，由於近年產業界逐漸開發出利用基因工程(GE)植物進行生物製藥(Biopharming)或其他工業用途之商業活重，但是這些基因工程植物在申請田間試驗審查及解除管制(deregulation)過程中，常因其含有特殊基因與成分而不容易通過田間試驗，而影響到進行後續種植等商業活動之機會；針對此困境，USDA便提出修法建議，希望能以加強隔離監控之附條件方式，容許這些未能通過解除管制之植物展開商業種植活動，而突破目前全有全無制田間試驗審查規範，而建立較多階、多層次的彈性管理機制，且希望能改以GMO之生物風險程度作爲日後分級管理依據。 我國對於GMO之管理，包括爲生物安全把關之田間試驗管理方面，即係採取禁止或通過二分之管理模式。故，本文希望得透過美國因應新興GMO產品所發展GMO管理法規之新進修法方向之觀察引介，供日後我國檢討或制定GMO相關管理法規時參酌及助益。
並列摘要
Facing the highly controversial biosafety issues about the environment release of Genetically Modified Organisms (GMO), national governments are used to evaluating and reviewing whether a GMO is safe enough to conduct field trials, environmental release and commercial activities by a binary approach or an on-off approach. Under such regulation approach, an applicant must complete and pass the field trial review, and then they can move towards the next stage to apply for a permit of environmental release or commercial activities. And, due to the adoption of on-off approach in field trial review, GMO will not be able to proceed to the next stage to apply for a permit of environment release or commercial activities if it failed to meet all regulatory requirements in its field trial review procedure. In fact, some new use of GMO are largely developed in the recent years. Take Genetically Engineered (GE) plants for example. GE plants are gradually applied not only in the production of biopharmaceuticals as biomass, but also in the production of biofuel and other industrial or environmental products as feedstock. In order to Recall and reflect the actual needs from industry, the United States Department of Agriculture (USDA) indeed has noticed that there are some implicit regulatory issues resulting from the GM plants for biopharming, and has prepared a draft Environmental Impact Assessment (DEIS) for evaluating the environmental consequence of its proposed amendment and revision of biotechnology regulation. In its proposal, the USDA is considering revisions to design a new system of risk-based categories- where GE plants are classified according to risk and familiarity so that oversight and confinement vary by category, and tends to adopt an expanded tiered permitting system based on potential environmental risk and familiarity. Under the so-called multi-tiered or risk-based permitting system, in the special cases of GE plants, the producer can develop and extract pharmaceutical and industrial compounds by subject to certain confinement condition with governmental oversight, rather than grant nonregulated status. The novel concept of establishing an multi-tiered and risk-based permitting system for governing GMO, creates flexibility for GMO authority to implement duly surveillance, and for GMO producer to commence their specific commercial activities. On the one hand, this novel management system can ensure the biosafety of GMO belong to different risk level, and on the other it can also allow industry's positive and necessary use of GMO.